Mental DisordersOBSCURANCT07866794
Group Transdiagnostic Cognitive Behavioural Therapy for Intolerance of Uncertainty Versus Applied Relaxation
A study testing Group Transdiagnostic Cognitive Behavioural Therapy for Intolerance of Uncertainty (CBT-IU) and Group Transdiagnostic Applied Relaxation (AR) in people with Mental Disorders and Mood Disorders, run by Medical Research Council Cognition and Brain Sciences Unit at 1 site in United Kingdom.
Trial summary
Many people find uncertainty distressing, but for some, it may become overwhelming and drive persistent anxiety, worry, and avoidance. This tendency is called intolerance of uncertainty (IU), and appears across many mental health conditions, including generalised anxiety, social anxiety, depression, and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mental Disorders, Mood Disorders, Anxiety Disorders
- What is being tested?
- Group Transdiagnostic Cognitive Behavioural Therapy for Intolerance of Uncertainty (CBT-IU) and Group Transdiagnostic Applied Relaxation (AR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Sep 2026to 30 Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Normal or corrected-to-normal vision
- Fluency in English
- Capable of giving informed consent
- Live locally/ within commutable distance to Cambridge
- Intolerance of Uncertainty Scale - Short form (IUS-12) score > 28
- Generalized Anxiety Disorder scale (GAD-7) score >= 8
- Medication-free, or on a stable medication regimen prior to and throughout the study
Who cannot join
- High risk of suicidal intent or self-harm (defined as an affirmative response on item 9 of the PHQ-9 above the clinical threshold, and/or corresponding clinical risk indicators during the SCID-5 interview)
- Engagement with any other psychological treatment within the 3 months prior to the study or during the study period
- Current diagnosis of obsessive-compulsive disorder (OCD)
- Current substance use disorder
- Acute psychosis
- History of traumatic brain injury
Show all 9Show fewer
- Learning disability
- Epilepsy/seizures
- Severe cognitive impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
MRC Cognition and Brain Sciences Unit (MRC-CBU), University of Cambridge
Cambridge, Cambridgeshire, CB2 7EF
Ido Shalev, PhD, 07541030621, is622@cam.ac.uk
Millie Lowther, PhD, 07854235572, el634@cam.ac.uk
About this study
Official title: Outcomes and Behavioural Signatures of Coping With Uncertainty-Related Anxiety (OBSCURA) Trial
Many people find uncertainty distressing, but for some, it may become overwhelming and drive persistent anxiety, worry, and avoidance. This tendency is called intolerance of uncertainty (IU), and appears across many mental health conditions, including generalised anxiety, social anxiety, depression, and obsessive-compulsive disorder, which is why researchers describe it as a transdiagnostic feature.
A type of therapy called Cognitive Behavioural Therapy for Intolerance of Uncertainty (CBT-IU) has been shown to reduce anxiety in previous trials. What remains to be known is how uncertainty changes when targeted directly, and whether the same mechanism applies across diagnoses. IU has mostly been measured using questionnaires, which indicate whether people find uncertainty difficult, but not what is actually happening when they encounter it. Recent research suggests that IU is not a single trait but a set of differences in how people estimate different kinds of uncertainty. Therefore, in addition to standard questionnaires, computer-based tasks will be used to explore an "uncertainty fingerprint" for each participant, capturing different aspects of uncertainty processing in a way that self-report measures cannot.
In this study, the investigators are comparing CBT-IU, adapted to work across disorders, against Applied Relaxation. Applied relaxation is a well-established therapy that teaches people to notice and release physical tension but does not focus on uncertainty. Adults with high IU and anxiety symptoms (regardless of formal diagnosis) will be randomly allocated to one of the two 12-session group therapies. The investigators will measure anxiety and IU using standard questionnaires as the primary outcomes. Additionally, cognitive tasks will be used to measure the uncertainty fingerprint before therapy, immediately after, and three months later. The aim is to test whether reductions in IU are specific to CBT-IU rather than shared with an equally credible therapy that does not target uncertainty. Going beyond self-reports, the trial will then begin to resolve which specific aspects of uncertainty processing change, so that future treatments can be more precisely targeted and better matched to each person.
Read the detailed description
Rationale. Intolerance of uncertainty (IU) is a recognised transdiagnostic risk factor for a broad range of mental health problems, including generalised anxiety, social anxiety, panic, depression, and obsessive-compulsive symptoms. Cognitive Behavioural Therapy for Intolerance of Uncertainty (CBT-IU) has demonstrated efficacy in previous randomised trials. However, it was primarily developed and tested in the context of generalised anxiety disorder and further inquiry into its effectiveness across diagnoses is required. To that end, a treatment that targets a clinical sample characterised by high IU rather than by a specific diagnosis would be more readily deployed than one tied to a single disorder.
A second gap concerns how therapy changes uncertainty processing, and whether such changes drive clinical improvement. Existing interventions and trials rely heavily on self-report scales such as the Intolerance of Uncertainty Scale (IUS), which are informative about dispositional reactivity to uncertainty but are largely agnostic to how individuals represent different forms of uncertainty or why uncertainty is experienced as aversive. Recent work in computational psychiatry reframes IU not as a unitary disposition but as a set of individual differences in how people estimate distinct forms of uncertainty, the probability of outcomes, the volatility of the environment. Recent work also shows that experiences of IU may depend on the contextual factors that govern a situation. This suggests that distinct profiles of uncertainty processing may characterise different presentations of anxiety, and that identifying which of these profiles shift in response to IU-focused intervention is essential for refining both the construct of IU and the treatments that target it.
Accordingly, the trial combines established IU questionnaires with a computational task battery designed to estimate distinct forms of uncertainty across contexts. The primary hypothesis of this study is that both therapies will reduce anxiety, with CBT-IU producing greater reduction in self-reported IU than applied relaxation. Applied Relaxation will serve as an active comparator matched on group format, duration, and therapist contact but which does not directly target uncertainty. To gain additional insights into the mechanisms underlying changes in IU, the computational battery will be used to construct an individualised "uncertainty fingerprint". Due to the novelty of this approach, these analyses will be exploratory, where the investigators will examine whether components of the fingerprint change differentially between arms, and whether such change relates to symptom reduction at 3-month follow-up.
Design. This is a single-blind, parallel-group mechanistic randomised controlled trial conducted at the MRC Cognition and Brain Sciences Unit (MRC-CBU), University of Cambridge, UK. The trial compares two active psychological treatments on anxiety and self-reported IU, with an embedded mechanistic component examining change in uncertainty processing. Adults scoring above threshold for IU and anxiety symptoms will be randomised to one of two 12-session group-based interventions running over 14 weeks: (1) Group Transdiagnostic CBT-IU, drawing on the Dugas and Robichaud model, and Making Friends with Uncertainty by Mofrad and colleagues; or (2) Applied Relaxation. Recruitment is transdiagnostic and no specific diagnostic category is required, consistent with the scope of the treatment manual and with IU being a transdiagnostic construct.
Both interventions comprise ten weekly plus two fortnightly 2-hour sessions, delivered in groups of 6-9 participants and co-facilitated by a clinical psychologist and an assistant.
Sample size was determined via a Bayesian hierarchical mediation simulation fitted with JAGS, using 1,000 replications per candidate design, to reflect the planned analysis and data structure: participants nested within therapy groups of 6-9, with the mediated effect a × b (with the IUS being the mediator) estimated alongside between-group variance under weakly informative priors. Effect size estimations were drawn from the Miller and McGuire (2023) meta-analysis. The trial is powered for a scenario with a = 0.89 (meta-analytic mean for the effect of CBT-IU on intolerance of uncertainty), b = 0.60 (the mediator-outcome path), and a between-group SD of 0.2, deliberately larger than the empirical SDs typically reported in the literature to provide a conservative scenario. Two criteria informed the target: power, defined as the proportion of replications in which the 95% highest-density interval (HDI) for the mediation effect excluded zero, and the width of that HDI as an index of estimation precision. Power exceeds 80% at 14 groups and nears 100% from 16 groups onward; at 16 groups the 95% HDI width is ~0.77 and stabilises thereafter. Sixteen groups would therefore satisfy both criteria, but a target of 18 therapy groups (9 per arm; approximately N = 135 participants) was selected to account for attrition.
Outcomes. The co-primary outcomes are the IUS-12 and the Generalized Anxiety Disorder-7 (GAD-7). Exploratory measures comprise a battery of computational tasks indexing learning and decision-making under uncertainty across cognitive contexts, from which the per-participant uncertainty fingerprint is derived. Secondary outcomes include the Penn State Worry Questionnaire (PSWQ) and the Patient Health Questionnaire (PHQ-9), the Work and Social Adjustment Scale (WSAS), and the Affective Response to Daily Uncertainty Scale (ARDUS), alongside measures of putative maintaining processes including worry behaviours, rumination, emotion regulation difficulties, emotional reactivity, fear of negative evaluation, and beliefs about losing control. Unless otherwise specified, all measures are administered at baseline, post-treatment (week 14), and 3-month follow-up. Treatment credibility and expectancy, working alliance, and group climate are collected as process measures, and the CORE-10 is administered weekly for monitoring. In addition, a lifetime history of potentially traumatic experiences (TEC) will be assessed at baseline as a candidate moderator of treatment response.
Randomisation and blinding. Stratified minimisation based on baseline GAD-7 and IUS-12 severity scores and demographics, executed by the trial statistician who is blind to study objectives. Outcome assessors at baseline, post-treatment, and follow-up are blind to treatment allocation.
- Being tested
- Group Transdiagnostic Cognitive Behavioural Therapy for Intolerance of Uncertainty (CBT-IU), Group Transdiagnostic Applied Relaxation (AR)
- Keywords
- Uncertainty, Cognitive Behavioural Therapy, Relaxation Therapy, Behaviour and Behaviour Mechanisms, Anxiety, Cognitive Science, Clinical Psychology, Group Psychotherapy, Intolerance of Uncertainty
- Medical subject headings
- Mental Disorders, Mood Disorders, Anxiety Disorders, Generalized Anxiety Disorder, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Transdiagnostic Cognitive Behavioural Therapy for Intolerance of Uncertainty (CBT-IU)Behavioural
Also called Transdiagnostic CBT-IU, Group CBT-IU
Manualised group-based transdiagnostic CBT-IU delivered over 12 sessions by a clinical psychologist and a co-facilitator. The modular intervention integrates evidence-based frameworks, including the Dugas and Robichaud CBT-IU model for GAD (Dugas \& Robichaud, 2007) and the Making Friends with Uncertainty (Mofrad et al., 2020). Modules cover: 1. Psychoeducation and awareness of uncertainty responses (Session 1-2); 2. Recognising and monitoring uncertainty (Sessions 3-4); 3. Structured problem-solving skills (Sessions 5-6); 4. Behavioural experiments with individualised uncertainty hierarchies (Session 7-10); and 5. Relapse prevention and maintenance planning (Sessions 11-12).
Between-session home practice is set each week. Treatment fidelity is monitored via a per-session checklist, weekly clinical supervision with the trial lead, and independent rating of random audio-recorded sessions against the manual.
Group Transdiagnostic Applied Relaxation (AR)Behavioural
Also called Applied Relaxation
Manualised group-based transdiagnostic Applied Relaxation delivered over 12 sessions by a clinical psychologist and a co-facilitator, following Öst (1987). Content is organised into five modules: 1. Psychoeducation, self-monitoring and 16-muscle-group Progressive Muscle Relaxation (PMR; Sessions 1-2); 2. Stepwise condensing of PMR (16-muscle → 7-muscle → 4-muscle → release-only → cue-controlled → rapid relaxation); introduction of diaphragmatic breathing; early cue detection. 3. Afterwards, the application phase begins, in which participants use rapid relaxation proactively at the first signs of tension (Sessions 3-7). Safe-place imagery and self-soothing as additional relaxation pathways (Sessions 8-9). 4. Participants consolidate all learned techniques into a personal Applied Relaxation toolkit (Session 10); and 5. Relapse prevention and maintenance planning.
Between-session home practice is set each week. Treatment fidelity is monitored identically to the CBT-IU arm.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioural Therapy for Intolerance of Uncertainty (CBT-IU) | Experimental | Twelve group-based sessions (ten weekly + two fortnightly, ~2 hours each with a 15-minute break, 6-9 participants per group) co-facilitated by a clinical psychologist and an assistant. The manualised intervention draws on established frameworks: the Dugas and Robichaud CBT-IU model for GAD (Dugas \& Robichaud, 2007) and the Making Friends with Uncertainty (Mofrad et al., 2020) programme. Content is organised into five modules covering psychoeducation and awareness of uncertainty responses, recognising uncertainty in daily life, skills acquisition and structured problem-solving, behavioural experiments using individualised uncertainty hierarchies, and relapse prevention. Between-session home practice reinforces learning. Receives: Behavioral: Group Transdiagnostic Cognitive Behavioural Therapy for Intolerance of Uncertainty (CBT-IU) |
| Applied Relaxation (AR) | Active comparator | Twelve group-based sessions (ten weekly + two fortnightly, ~2 hours each with a 15-minute break, 6-9 participants per group) co-facilitated by a clinical psychologist and an assistant. The manualised intervention is based on Öst (1987) and adapted for transdiagnostic group delivery, progressing from foundational Progressive Muscle Relaxation through condensed and release-only variants to cue-controlled and rapid relaxation (~20-30 seconds), combined with diaphragmatic breathing, early cue detection, safe-place imagery, and self-soothing. Then, a formal application-training phase begins, in which participants use rapid relaxation proactively in daily life at the first signs of tension. Between-session home practice reinforces learning. Receives: Behavioral: Group Transdiagnostic Applied Relaxation (AR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intolerance of Uncertainty Scale (IUS-12)
The reduced Intolerance of Uncertainty Scale (IUS-12; Carleton et al., 2007; Freeston et al., 1994) is a 12-item self-report measure of cognitive, emotional, and behavioural reactions to uncertainty. Higher scores indicate greater intolerance of uncertainty.
Measured: Prescreen, Baseline, post-treatment (Week 14), and 3-month follow-up
Generalized Anxiety Disorder-7 (GAD-7)
The GAD-7 (Spitzer et al., 2006) is a 7-item self-report measure of generalised anxiety symptom severity. Scores range from 0 to 21; higher scores indicate greater severity.
Measured: Prescreen, Baseline, post-treatment (Week 14), and 3-month follow-up
Secondary outcomes (26)
Patient Health Questionnaire (PHQ-9)
The PHQ-9 (Kroenke et al., 2001) is a 9-item self-report measure of depressive symptom severity. Scores range from 0 to 27; higher scores indicate greater severity.
Measured: Prescreen, Baseline, post-treatment (Week 14), and 3-month follow-up
Work and Social Adjustment Scale (WSAS)
The WSAS (Mundt et al., 2002) is a 5-item self-report measure of functional impairment attributed to mental health problems across work, home management, social leisure, private leisure, and close relationships. Items are rated from 0 to 8. Higher scores indicate greater impairment.
Measured: Prescreen, Baseline, post-treatment (Week 14), and 3-month follow-up
Penn State Worry Questionnaire (PSWQ)
The PSWQ (Meyer et al., 1990) is a 16-item self-report measure of pathological worry validated in GAD populations. Higher scores indicate more pervasive and uncontrollable worry.
Measured: Baseline, post-treatment (Week 14), and 3-month follow-up
Affective Response to Daily Uncertainty Scale (ARDUS)
The ARDUS (Wang et al., 2026) is a 37-item self-report measure of how often individuals experience negative affect (worry, anxiety, low mood, or concern) when faced with uncertainty across six everyday domains: academic/professional, climate, financial, health, political, and social. Items are rated on a 6-point Likert scale from 0 (Never) to 5 (Always), with an additional option indicating that the type of uncertainty has not been encountered in the past year. Higher scores reflect greater affective reactivity to daily uncertainty.
Measured: Baseline, post-treatment (Week 14), and 3-month follow-up
Instrumental and Pavlovian Transport Volatility Learning Task
The Transport Volatility Learning Task is a probabilistic associative learning task assessing how participants track action-outcome contingencies in environments where outcome probabilities change over time. On each trial, participants encounter one of two cues (train lines) probabilistically associated with a binary outcome (delay vs no delay), with one cue carrying a higher probability of the aversive outcome at any given time. The underlying contingency reverses periodically, and volatility (the rate of contingency change) is manipulated across blocks to dissociate stable from volatile learning environments. Two task variants are administered to distinguish observational from instrumental learning: a prediction-only variant in which the cue is determined by the environment and participants predict the outcome, and a choice variant in which participants actively choose between cues and outcomes follow from their selection.
Measured: Baseline, post-treatment (Week 14), and 3-month follow-up
Social Evaluation Learning Task (SELT)
The SELT is an associative learning task assessing how individuals estimate and update beliefs under social-evaluative uncertainty (adapted from Lau et al., 2024). On each trial, participants are presented with a positive and a negative word and rate, on a continuous slider, the probability that an avatar (the "rater") will select that word to describe the target; they then receive feedback indicating which word the rater chose. The task crosses two referential conditions (self-referential, in which the participant is the target of evaluation, vs other-referential, in which a third character is the target) with rule conditions defining the underlying probability of positive feedback. After each block, participants make a global judgement of the rater's overall evaluative tendency, and at the end of the task participants make forced choices about preferred social partners for themselves and for the other-referential target.
Measured: Baseline, post-treatment (Week 14), and 3-month follow-up
Balloon Analogue Risk Task (BART)
The BART is a decision-making task in which participants accumulate points by inflating a virtual balloon and choose when to stop and bank their earnings (Lejuez et al., 2002). Each pump carries an unobserved probability of the balloon bursting and forfeiting that trial's points. Across blocks, the underlying probability distribution of the explosion point is manipulated to dissociate distinct components of uncertainty, including the mean and variance of the distribution.
Measured: Baseline, post-treatment (Week 14), and 3-month follow-up
Information Sampling Task (IST)
The IST is a task in which participants actively sample binary information to reduce uncertainty before committing to a categorical decision (Hauser et al., 2017). On each trial, participants are presented with a set of 25 hidden samples drawn from an underlying binary distribution and choose, one at a time, how many to reveal before deciding which of two categories the source distribution belongs to. A log of revealed samples remains on screen throughout. Two conditions are administered: a free-sampling condition in which sampling is unconstrained, and a costly-sampling condition in which each sample reveal incurs an explicit monetary cost against a fixed per-trial budget, with correct and incorrect decisions yielding gains and losses scaled to the number of samples taken.
Measured: Baseline, post-treatment (Week 14), and 3-month follow-up
Uncertain Face Selection Task
The Uncertain Face Selection Task is an emotion-categorisation task in which participants view facial expressions varying in perceptual ambiguity, achieved by morphing between happy and angry prototypes. The task comprises two blocks. In a forced-choice baseline block, participants categorise each briefly presented face as happy or angry under speeded response conditions, providing a measure of perceptual sensitivity to the morphed emotion continuum. In a subsequent free-response block, participants are given two additional options on each trial: re-viewing the same face before deciding (a checking response) or skipping the face entirely without categorising it (an avoidance response), with skipping carrying no time benefit so that it cannot be motivated by efficiency.
Measured: Baseline, post-treatment (Week 14), and 3-month follow-up
Ambiguous Cue Task (ACT)
The ACT is a perceptual decision-making paradigm assessing how participants interpret ambiguous cues with uncertain outcomes (adapted from Aylward et al., 2019). On each trial, participants are presented with a visual cue that lands at one of several orientations and must categorise it as belonging to one of two classes (horizontal vs vertical) under time pressure. The two classes are associated with asymmetric reward magnitudes, such that one categorisation yields a higher payoff than the other. Cue orientations span a continuum from clearly belonging to one class through fully ambiguous (intermediate) angles, allowing participants' classification of the ambiguous cues to be modelled as a function of perceptual evidence and prior expectations.
Measured: Baseline, post-treatment (Week 14), and 3-month follow-up
Translational Probabilistic Reward Learning Task (TPRLT)
The TPRLT is a probabilistic reward learning paradigm presented in a rodent-themed visual environment to advance cross-species translation of computational measures. On each trial, participants control an on-screen rat avatar and choose between two spatially-distinct response ports (left vs right). One port is associated with a higher probability of reward (a piece of cheese) at any given time, with the rewarded port determined probabilistically; the more rewarded option changes across the task, requiring participants to track and update reward contingencies through trial-and-error. Feedback (reward delivery vs no reward) is presented on each trial in a designated feedback zone.
Measured: Baseline, post-treatment (Week 14), and 3-month follow-up
Aversive Learning Task
In the Aversive Learning Task participants choose between two visually-distinct options (street images) on each trial. One option carries a higher probability of an aversive event (a pickpocketing incident resulting in a monetary loss), and participants must learn which option is currently safer through trial-and-error feedback. The safer option changes periodically across the task, so participants must continuously update their beliefs. Participants begin with an initial endowment, and accumulated losses are deducted from this balance. Two referential conditions are administered: a self-referential condition in which choices determine the participant's own outcome, and an other-referential condition in which the participant chooses on behalf of another participant whose monetary bonus is determined by the participant's performance, and reciprocally receives choices made on their behalf. This distinguishes between aversive learning for self from aversive learning for other.
Measured: Baseline, post-treatment (Week 14), and 3-month follow-up
Brief Fear of Negative Evaluation (BFNE)
The BFNE (Leary, 1983) is a 12-item self-report measure of apprehension about being evaluated unfavourably by others. Items are rated from 1 (not at all characteristic of me) to 5 (extremely characteristic of me). Higher scores indicate greater fear of negative evaluation.
Measured: Baseline, post-treatment (Week 14), and 3-month follow-up
Traumatic Experiences Checklist (TEC)
The TEC (Nijenhuis et al., 2002) is an inventory of 29 potentially traumatic events across the lifespan, spanning emotional neglect, emotional abuse, physical abuse, sexual harassment, sexual abuse, bodily threat, loss, and war-related experiences. Each event is rated for occurrence, age at occurrence, and subjective impact from 1 to 5, yielding indices of trauma frequency and severity.
Measured: Baseline
Difficulties in Emotion Regulation Scale (DERS)
The DERS (Gratz \& Roemer, 2004) is a 36-item self-report measure of problems in emotion regulation. Items are rated from 1 to 5 across six subscales covering nonacceptance of emotional responses, difficulty engaging in goal-directed behaviour, impulse control difficulties, lack of emotional awareness, limited access to regulation strategies, and lack of emotional clarity. Higher scores indicate greater difficulties.
Measured: Baseline, post-treatment (Week 14), and 3-month follow-up
Emotional Reactivity Scale (ERS)
The ERS (Nock et al., 2008) is a 21-item self-report measure of the sensitivity, intensity, and persistence of emotional responses. Items are rated from 0 to 4. Higher scores indicate greater emotional reactivity.
Measured: Baseline, post-treatment (Week 14), and 3-month follow-up
Ruminative Responses Scale (RRS-10)
The RRS-10 (Treynor et al., 2003) is a 10-item self-report measure of ruminative responses to low mood. Items are rated from 1 to 4 and yield brooding and reflection subscale scores. Higher scores indicate greater rumination.
Measured: Baseline, post-treatment (Week 14), and 3-month follow-up
Beliefs About Losing Control Inventory (BALCI)
The BALCI (Radomsky \& Gagné, 2020) is a 21-item self-report measure of negative beliefs about losing control over one's thoughts, behaviour, emotions, and bodily functions, and about the importance of staying in control. Items are rated from 0 to 4. Higher scores indicate stronger beliefs about losing control.
Measured: Baseline, post-treatment (Week 14), and 3-month follow-up
Worry Behaviours Inventory (WBI)
The WBI (Mahoney et al., 2016) is a self-report measure of behaviours used to prevent, control, or avoid worry, including checking, reassurance seeking, avoidance, and overpreparation. Items are rated from 0 to 4. Higher scores indicate greater use of worry-related behaviours.
Measured: Baseline, post-treatment (Week 14), and 3-month follow-up
Self-Concept Clarity Scale (SCCS)
The SCCS (Campbell et al., 1996) is a 12-item self-report measure of the degree to which self-beliefs are clearly defined, internally consistent, and temporally stable. Items are rated from 1 to 5. Higher scores indicate greater self-concept clarity.
Measured: Baseline, post-treatment (Week 14), and 3-month follow-up
Epistemic Trust, Mistrust and Credulity Questionnaire (ETMCQ)
The ETMCQ (Campbell et al., 2021) is a 15-item self-report measure of an individual's stance towards accepting knowledge communicated by others. Items are rated from 1 to 7 and yield three subscale scores for trust, mistrust, and credulity.
Measured: Baseline, post-treatment (Week 14), and 3-month follow-up
Experiences in Close Relationships-Relationship Structures (ECR-RS)
The ECR-RS (Fraley et al., 2011) is a 9-item self-report measure of adult attachment. Items are rated from 1 to 7 and yield scores on two dimensions, attachment-related avoidance and attachment-related anxiety. Higher scores indicate greater attachment insecurity on each dimension. Here it is administered with reference to close relationships in general.
Measured: Baseline, post-treatment (Week 14), and 3-month follow-up
Brief Core Schema Scales (BCSS)
The BCSS (Fowler et al., 2006) is a 24-item self-report measure of core evaluative beliefs about the self and others. Respondents endorse each belief (no or yes) and, if endorsed, rate conviction from 1 to 4, yielding four subscale scores for negative-self, positive-self, negative-other, and positive-other schemas.
Measured: Baseline, post-treatment (Week 14), and 3-month follow-up
Multidimensional Assessment of Interoceptive Awareness - Version 2 (MAIA-2)
MAIA-2 (Mehling et al., 2018) is a self-report measure of interoceptive body awareness. In the 24-item form used here, items are rated from 0 to 5, spanning facets including noticing, attention regulation, emotional awareness, self-regulation, body listening, and trusting. Higher scores indicate greater interoceptive awareness.
Measured: Baseline, post-treatment (Week 14), and 3-month follow-up
Grief and Response to Altered Core Experience of the Self Questionnaire (GRACES-Q)
The GRACES-Q (Shalev et al., unpublished) is a 25-item self-report measure of reaction and grief-like responses to changes to the self following the onset of a mental health condition. After identifying the earliest condition, its time of onset, and two open-ended reflections on the self before and after onset, respondents rate statements from 0 to 5 across five subscales covering identity discontinuity and self-alienation, longing and grieving the past self, grieving the future self, acceptance and moving forward, and dual-process oscillation.
Measured: Baseline, post-treatment (Week 14), and 3-month follow-up
Premenstrual Symptoms Screening Tool (PSST)
The PSST (Steiner et al., 2003) is a 19-item self-report screening measure of premenstrual symptoms, comprising 14 items covering emotional, behavioural, and physical symptoms and 5 items covering interference with daily functioning. Each item is rated from 1 (not at all) to 4 (severe).
Measured: Baseline, post-treatment (Week 14), and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start21 Sep 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Mental DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel arms receive 12 weekly group-based therapy sessions (10 weekly + 2 fortnightly, 2 hours each, in groups of 6-9): CBT-IU (experimental) or Applied Relaxation (active control condition). Participants are randomised 1:1 using stratified minimisation on baseline GAD-7, PHQ-9, IUS-12 severity, and demographics. Outcome assessments occur at baseline, post-treatment (week 14), and 3-month follow-up.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Research Council Cognition and Brain Sciences Unit
- Sponsor type
- Other government
- Collaborators
- University of Cambridge
- Responsible party
- Principal investigator, Ido Shalev, Medical Research Council Cognition and Brain Sciences Unit
- Investigators
- Rebecca Lawson, PhD, Study chair, Psychology Department, University of CambridgeTim Dalgleish, PhD, Principal investigator, MRC Cognition and Brain Sciences Unit, University of Cambridge; Psychology Department, University of CambridgeAnna Bevan, PhD, Study director, MRC Cognition and Brain Sciences Unit, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07866794
- Sponsor's protocol ID
- PRE.2025.060
- Other IDs
- 226776/Z/22/Z
- Acronym
- OBSCURA
- Status last verified
- Oct 2026
- First submitted
- 26 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised individual-level data from the trial will be made publicly available via an open-access data repository at the conclusion of the study. Shared data will include de-identified participant-level outcome measures, demographic variables, computational task data, and derived "uncertainty fingerprint" parameters consistent with informed consent and institutional data-sharing policies.
Publications
Ægisdóttir S, Gerstein LH. Beliefs About Psychological Services (BAPS): Development and psychometric properties. Couns Psychol Q. 2009;22(2):197-219.
Aylward J, Valton V, Ahn WY, Bond RL, Dayan P, Roiser JP, Robinson OJ. Altered learning under uncertainty in unmedicated mood and anxiety disorders. Nat Hum Behav. 2019 Oct;3(10):1116-1123. doi: 10.1038/s41562-019-0628-0. Epub 2019 Jun 17.
PubMed 31209369Barkham M, Bewick B, Mullin T, Gilbody S, Connell J, Cahill J, Mellor-Clark J, Richards D, Unsworth G, Evans C. The CORE-10: A short measure of psychological distress for routine use in the psychological therapies. Couns Psychother Res. 2013;13(1):3-13.
Campbell C, Tanzer M, Saunders R, Booker T, Allison E, Li E, O'Dowda C, Luyten P, Fonagy P. Development and validation of a self-report measure of epistemic trust. PLoS One. 2021 Apr 16;16(4):e0250264. doi: 10.1371/journal.pone.0250264. eCollection 2021.
PubMed 33861805Campbell JD, Trapnell PD, Heine SJ, Katz IM, Lavallee LF, Lehman DR. Selfconcept clarity: Measurement, personality correlates, and cultural boundaries. J Pers Soc Psychol. 1996;70(1):141-156.
Carleton RN, Norton MA, Asmundson GJ. Fearing the unknown: a short version of the Intolerance of Uncertainty Scale. J Anxiety Disord. 2007;21(1):105-17. doi: 10.1016/j.janxdis.2006.03.014. Epub 2006 May 2.
PubMed 16647833Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.
PubMed 11132119Dugas MJ, Robichaud M. Cognitive-behavioral treatment for generalized anxiety disorder: From science to practice. New York: Routledge; 2007.
Fowler D, Freeman D, Smith B, Kuipers E, Bebbington P, Bashforth H, Coker S, Hodgekins J, Gracie A, Dunn G, Garety P. The Brief Core Schema Scales (BCSS): psychometric properties and associations with paranoia and grandiosity in non-clinical and psychosis samples. Psychol Med. 2006 Jun;36(6):749-59. doi: 10.1017/S0033291706007355. Epub 2006 Mar 27.
PubMed 16563204Fraley RC, Heffernan ME, Vicary AM, Brumbaugh CC. The Experiences in Close Relationships-Relationship Structures questionnaire: a method for assessing attachment orientations across relationships. Psychol Assess. 2011 Sep;23(3):615-25. doi: 10.1037/a0022898.
PubMed 21443364Freeston MH, Rhéaume J, Letarte H, Dugas MJ, Ladouceur R. Why do people worry? Pers Individ Dif. 1994;17(6):791-802.
Gratz KL, Roemer L. Multidimensional assessment of emotion regulation and dysregulation: Development, factor structure, and initial validation of the Difficulties in Emotion Regulation Scale. J Psychopathol Behav Assess. 2004;26(1):41-54.
Hatcher RL, Gillaspy JA. Development and validation of a revised short version of the Working Alliance Inventory. Psychother Res. 2006;16(1):12-25.
Hauser TU, Moutoussis M; NSPN Consortium; Dayan P, Dolan RJ. Increased decision thresholds trigger extended information gathering across the compulsivity spectrum. Transl Psychiatry. 2017 Dec 18;7(12):1296. doi: 10.1038/s41398-017-0040-3.
PubMed 29249811Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes and Behavioural Signatures of Coping With Uncertainty-Related Anxiety (OBSCURA) Trial
- ClinicalTrials.gov ID
- NCT07866794
- Acronym / sponsor ID
- OBSCURA / PRE.2025.060
- Keywords
- Uncertainty, Cognitive Behavioural Therapy, Relaxation Therapy, Behaviour and Behaviour Mechanisms, Anxiety, Cognitive Science, Clinical Psychology, Group Psychotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Medical Research Council Cognition and Brain Sciences UnitOther government
- Collaborators
- University of Cambridge
- Study start
- 21 Sep 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 8 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many people find uncertainty distressing, but for some, it may become overwhelming and drive persistent anxiety, worry, and avoidance. This tendency is called intolerance of uncertainty (IU), and appears across many mental health conditions, including generalised anxiety, social anxiety, depression, and obsessive-compulsive disorder, which is why researchers describe it as a transdiagnostic feature.
A type of therapy called Cognitive Behavioural Therapy for Intolerance of Uncertainty (CBT-IU) has been shown to reduce anxiety in previous trials. What remains to be known is how uncertainty changes when targeted directly, and whether the same mechanism applies across diagnoses. IU has mostly been measured using questionnaires, which indicate whether people find uncertainty difficult, but not what is actually happening when they encounter it. Recent research suggests that IU is not a single trait but a set of differences in how people estimate different kinds of uncertainty. Therefore, in addition to standard questionnaires, computer-based tasks will be used to explore an "uncertainty fingerprint" for each participant, capturing different aspects of uncertainty processing in a way that self-report measures cannot.
In this study, the investigators are comparing CBT-IU, adapted to work across disorders, against Applied Relaxation. Applied relaxation is a well-established therapy that teaches people to notice and release physical tension but does not focus on uncertainty. Adults with high IU and anxiety symptoms (regardless of formal diagnosis) will be randomly allocated to one of the two 12-session group therapies. The investigators will measure anxiety and IU using standard questionnaires as the primary outcomes. Additionally, cognitive tasks will be used to measure the uncertainty fingerprint before therapy, immediately after, and three months later. The aim is to test whether reductions in IU are specific to CBT-IU rather than shared with an equally credible therapy that does not target uncertainty. Going beyond self-reports, the trial will then begin to resolve which specific aspects of uncertainty processing change, so that future treatments can be more precisely targeted and better matched to each person.
Detailed description
Rationale. Intolerance of uncertainty (IU) is a recognised transdiagnostic risk factor for a broad range of mental health problems, including generalised anxiety, social anxiety, panic, depression, and obsessive-compulsive symptoms. Cognitive Behavioural Therapy for Intolerance of Uncertainty (CBT-IU) has demonstrated efficacy in previous randomised trials. However, it was primarily developed and tested in the context of generalised anxiety disorder and further inquiry into its effectiveness across diagnoses is required. To that end, a treatment that targets a clinical sample characterised by high IU rather than by a specific diagnosis would be more readily deployed than one tied to a single disorder.
A second gap concerns how therapy changes uncertainty processing, and whether such changes drive clinical improvement. Existing interventions and trials rely heavily on self-report scales such as the Intolerance of Uncertainty Scale (IUS), which are informative about dispositional reactivity to uncertainty but are largely agnostic to how individuals represent different forms of uncertainty or why uncertainty is experienced as aversive. Recent work in computational psychiatry reframes IU not as a unitary disposition but as a set of individual differences in how people estimate distinct forms of uncertainty, the probability of outcomes, the volatility of the environment. Recent work also shows that experiences of IU may depend on the contextual factors that govern a situation. This suggests that distinct profiles of uncertainty processing may characterise different presentations of anxiety, and that identifying which of these profiles shift in response to IU-focused intervention is essential for refining both the construct of IU and the treatments that target it.
Accordingly, the trial combines established IU questionnaires with a computational task battery designed to estimate distinct forms of uncertainty across contexts. The primary hypothesis of this study is that both therapies will reduce anxiety, with CBT-IU producing greater reduction in self-reported IU than applied relaxation. Applied Relaxation will serve as an active comparator matched on group format, duration, and therapist contact but which does not directly target uncertainty. To gain additional insights into the mechanisms underlying changes in IU, the computational battery will be used to construct an individualised "uncertainty fingerprint". Due to the novelty of this approach, these analyses will be exploratory, where the investigators will examine whether components of the fingerprint change differentially between arms, and whether such change relates to symptom reduction at 3-month follow-up.
Design. This is a single-blind, parallel-group mechanistic randomised controlled trial conducted at the MRC Cognition and Brain Sciences Unit (MRC-CBU), University of Cambridge, UK. The trial compares two active psychological treatments on anxiety and self-reported IU, with an embedded mechanistic component examining change in uncertainty processing. Adults scoring above threshold for IU and anxiety symptoms will be randomised to one of two 12-session group-based interventions running over 14 weeks: (1) Group Transdiagnostic CBT-IU, drawing on the Dugas and Robichaud model, and Making Friends with Uncertainty by Mofrad and colleagues; or (2) Applied Relaxation. Recruitment is transdiagnostic and no specific diagnostic category is required, consistent with the scope of the treatment manual and with IU being a transdiagnostic construct.
Both interventions comprise ten weekly plus two fortnightly 2-hour sessions, delivered in groups of 6-9 participants and co-facilitated by a clinical psychologist and an assistant.
Sample size was determined via a Bayesian hierarchical mediation simulation fitted with JAGS, using 1,000 replications per candidate design, to reflect the planned analysis and data structure: participants nested within therapy groups of 6-9, with the mediated effect a × b (with the IUS being the mediator) estimated alongside between-group variance under weakly informative priors. Effect size estimations were drawn from the Miller and McGuire (2023) meta-analysis. The trial is powered for a scenario with a = 0.89 (meta-analytic mean for the effect of CBT-IU on intolerance of uncertainty), b = 0.60 (the mediator-outcome path), and a between-group SD of 0.2, deliberately larger than the empirical SDs typically reported in the literature to provide a conservative scenario. Two criteria informed the target: power, defined as the proportion of replications in which the 95% highest-density interval (HDI) for the mediation effect excluded zero, and the width of that HDI as an index of estimation precision. Power exceeds 80% at 14 groups and nears 100% from 16 groups onward; at 16 groups the 95% HDI width is ~0.77 and stabilises thereafter. Sixteen groups would therefore satisfy both criteria, but a target of 18 therapy groups (9 per arm; approximately N = 135 participants) was selected to account for attrition.
Outcomes. The co-primary outcomes are the IUS-12 and the Generalized Anxiety Disorder-7 (GAD-7). Exploratory measures comprise a battery of computational tasks indexing learning and decision-making under uncertainty across cognitive contexts, from which the per-participant uncertainty fingerprint is derived. Secondary outcomes include the Penn State Worry Questionnaire (PSWQ) and the Patient Health Questionnaire (PHQ-9), the Work and Social Adjustment Scale (WSAS), and the Affective Response to Daily Uncertainty Scale (ARDUS), alongside measures of putative maintaining processes including worry behaviours, rumination, emotion regulation difficulties, emotional reactivity, fear of negative evaluation, and beliefs about losing control. Unless otherwise specified, all measures are administered at baseline, post-treatment (week 14), and 3-month follow-up. Treatment credibility and expectancy, working alliance, and group climate are collected as process measures, and the CORE-10 is administered weekly for monitoring. In addition, a lifetime history of potentially traumatic experiences (TEC) will be assessed at baseline as a candidate moderator of treatment response.
Randomisation and blinding. Stratified minimisation based on baseline GAD-7 and IUS-12 severity scores and demographics, executed by the trial statistician who is blind to study objectives. Outcome assessors at baseline, post-treatment, and follow-up are blind to treatment allocation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two parallel arms receive 12 weekly group-based therapy sessions (10 weekly + 2 fortnightly, 2 hours each, in groups of 6-9): CBT-IU (experimental) or Applied Relaxation (active control condition). Participants are randomised 1:1 using stratified minimisation on baseline GAD-7, PHQ-9, IUS-12 severity, and demographics. Outcome assessments occur at baseline, post-treatment (week 14), and 3-month follow-up.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioural Therapy for Intolerance of Uncertainty (CBT-IU) | Experimental | Behavioral: Group Transdiagnostic Cognitive Behavioural Therapy for Intolerance of Uncertainty (CBT-IU)Twelve group-based sessions (ten weekly + two fortnightly, ~2 hours each with a 15-minute break, 6-9 participants per group) co-facilitated by a clinical psychologist and an assistant. The manualised intervention draws on established frameworks: the Dugas and Robichaud CBT-IU model for GAD (Dugas \& Robichaud, 2007) and the Making Friends with Uncertainty (Mofrad et al., 2020) programme. Content is organised into five modules covering psychoeducation and awareness of uncertainty responses, recognising uncertainty in daily life, skills acquisition and structured problem-solving, behavioural experiments using individualised uncertainty hierarchies, and relapse prevention. Between-session home practice reinforces learning. |
| Applied Relaxation (AR) | Active comparator | Behavioral: Group Transdiagnostic Applied Relaxation (AR)Twelve group-based sessions (ten weekly + two fortnightly, ~2 hours each with a 15-minute break, 6-9 participants per group) co-facilitated by a clinical psychologist and an assistant. The manualised intervention is based on Öst (1987) and adapted for transdiagnostic group delivery, progressing from foundational Progressive Muscle Relaxation through condensed and release-only variants to cue-controlled and rapid relaxation (~20-30 seconds), combined with diaphragmatic breathing, early cue detection, safe-place imagery, and self-soothing. Then, a formal application-training phase begins, in which participants use rapid relaxation proactively in daily life at the first signs of tension. Between-session home practice reinforces learning. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Normal or corrected-to-normal vision
- Fluency in English
- Capable of giving informed consent
- Live locally/ within commutable distance to Cambridge
- Intolerance of Uncertainty Scale - Short form (IUS-12) score > 28
Key exclusion criteria (9 listed)
- High risk of suicidal intent or self-harm (defined as an affirmative response on item 9 of the PHQ-9 above the clinical threshold, and/or corresponding clinical risk indicators during the SCID-5 interview)
- Engagement with any other psychological treatment within the 3 months prior to the study or during the study period
- Current diagnosis of obsessive-compulsive disorder (OCD)
- Current substance use disorder
- Acute psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Transdiagnostic Cognitive Behavioural Therapy for Intolerance of Uncertainty (CBT-IU)Also: Transdiagnostic CBT-IU, Group CBT-IUManualised group-based transdiagnostic CBT-IU delivered over 12 sessions by a clinical psychologist and a co-facilitator. The modular intervention integrates evidence-based frameworks, including the Dugas and Robichaud CBT-IU model for GAD (Dugas \& Robichaud, 2007) and the Making Friends with Uncertainty (Mofrad et al., 2020). Modules cover: 1. Psychoeducation and awareness of uncertainty responses (Session 1-2); 2. Recognising and monitoring uncertainty (Sessions 3-4); 3. Structured problem-solving skills (Sessions 5-6); 4. Behavioural experiments with individualised uncertainty hierarchies (Session 7-10); and 5. Relapse prevention and maintenance planning (Sessions 11-12). Between-session home practice is set each week. Treatment fidelity is monitored via a per-session checklist, weekly clinical supervision with the trial lead, and independent rating of random audio-recorded sessions against the manual. | Behavioural | Cognitive Behavioural Therapy for Intolerance of Uncertainty (CBT-IU) |
| Group Transdiagnostic Applied Relaxation (AR)Also: Applied RelaxationManualised group-based transdiagnostic Applied Relaxation delivered over 12 sessions by a clinical psychologist and a co-facilitator, following Öst (1987). Content is organised into five modules: 1. Psychoeducation, self-monitoring and 16-muscle-group Progressive Muscle Relaxation (PMR; Sessions 1-2); 2. Stepwise condensing of PMR (16-muscle → 7-muscle → 4-muscle → release-only → cue-controlled → rapid relaxation); introduction of diaphragmatic breathing; early cue detection. 3. Afterwards, the application phase begins, in which participants use rapid relaxation proactively at the first signs of tension (Sessions 3-7). Safe-place imagery and self-soothing as additional relaxation pathways (Sessions 8-9). 4. Participants consolidate all learned techniques into a personal Applied Relaxation toolkit (Session 10); and 5. Relapse prevention and maintenance planning. Between-session home practice is set each week. Treatment fidelity is monitored identically to the CBT-IU arm. | Behavioural | Applied Relaxation (AR) |
Primary outcome
Intolerance of Uncertainty Scale (IUS-12)
Time frame: Prescreen, Baseline, post-treatment (Week 14), and 3-month follow-up
The reduced Intolerance of Uncertainty Scale (IUS-12; Carleton et al., 2007; Freeston et al., 1994) is a 12-item self-report measure of cognitive, emotional, and behavioural reactions to uncertainty. Higher scores indicate greater intolerance of uncertainty.
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Prescreen, Baseline, post-treatment (Week 14), and 3-month follow-up
The GAD-7 (Spitzer et al., 2006) is a 7-item self-report measure of generalised anxiety symptom severity. Scores range from 0 to 21; higher scores indicate greater severity.
26 secondary outcomes
Patient Health Questionnaire (PHQ-9)
Time frame: Prescreen, Baseline, post-treatment (Week 14), and 3-month follow-up
Work and Social Adjustment Scale (WSAS)
Time frame: Prescreen, Baseline, post-treatment (Week 14), and 3-month follow-up
Penn State Worry Questionnaire (PSWQ)
Time frame: Baseline, post-treatment (Week 14), and 3-month follow-up
Affective Response to Daily Uncertainty Scale (ARDUS)
Time frame: Baseline, post-treatment (Week 14), and 3-month follow-up
Instrumental and Pavlovian Transport Volatility Learning Task
Time frame: Baseline, post-treatment (Week 14), and 3-month follow-up
Social Evaluation Learning Task (SELT)
Time frame: Baseline, post-treatment (Week 14), and 3-month follow-up
Balloon Analogue Risk Task (BART)
Time frame: Baseline, post-treatment (Week 14), and 3-month follow-up
Information Sampling Task (IST)
Time frame: Baseline, post-treatment (Week 14), and 3-month follow-up
Uncertain Face Selection Task
Time frame: Baseline, post-treatment (Week 14), and 3-month follow-up
Ambiguous Cue Task (ACT)
Time frame: Baseline, post-treatment (Week 14), and 3-month follow-up
Translational Probabilistic Reward Learning Task (TPRLT)
Time frame: Baseline, post-treatment (Week 14), and 3-month follow-up
Aversive Learning Task
Time frame: Baseline, post-treatment (Week 14), and 3-month follow-up
Brief Fear of Negative Evaluation (BFNE)
Time frame: Baseline, post-treatment (Week 14), and 3-month follow-up
Traumatic Experiences Checklist (TEC)
Time frame: Baseline
Difficulties in Emotion Regulation Scale (DERS)
Time frame: Baseline, post-treatment (Week 14), and 3-month follow-up
Emotional Reactivity Scale (ERS)
Time frame: Baseline, post-treatment (Week 14), and 3-month follow-up
Ruminative Responses Scale (RRS-10)
Time frame: Baseline, post-treatment (Week 14), and 3-month follow-up
Beliefs About Losing Control Inventory (BALCI)
Time frame: Baseline, post-treatment (Week 14), and 3-month follow-up
Worry Behaviours Inventory (WBI)
Time frame: Baseline, post-treatment (Week 14), and 3-month follow-up
Self-Concept Clarity Scale (SCCS)
Time frame: Baseline, post-treatment (Week 14), and 3-month follow-up
Epistemic Trust, Mistrust and Credulity Questionnaire (ETMCQ)
Time frame: Baseline, post-treatment (Week 14), and 3-month follow-up
Experiences in Close Relationships-Relationship Structures (ECR-RS)
Time frame: Baseline, post-treatment (Week 14), and 3-month follow-up
Brief Core Schema Scales (BCSS)
Time frame: Baseline, post-treatment (Week 14), and 3-month follow-up
Multidimensional Assessment of Interoceptive Awareness - Version 2 (MAIA-2)
Time frame: Baseline, post-treatment (Week 14), and 3-month follow-up
Grief and Response to Altered Core Experience of the Self Questionnaire (GRACES-Q)
Time frame: Baseline, post-treatment (Week 14), and 3-month follow-up
Premenstrual Symptoms Screening Tool (PSST)
Time frame: Baseline, post-treatment (Week 14), and 3-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- BackgroundÆgisdóttir S, Gerstein LH. Beliefs About Psychological Services (BAPS): Development and psychometric properties. Couns Psychol Q. 2009;22(2):197-219.
- Background: PubMed 31209369Aylward J, Valton V, Ahn WY, Bond RL, Dayan P, Roiser JP, Robinson OJ. Altered learning under uncertainty in unmedicated mood and anxiety disorders. Nat Hum Behav. 2019 Oct;3(10):1116-1123. doi: 10.1038/s41562-019-0628-0. Epub 2019 Jun 17.
- BackgroundBarkham M, Bewick B, Mullin T, Gilbody S, Connell J, Cahill J, Mellor-Clark J, Richards D, Unsworth G, Evans C. The CORE-10: A short measure of psychological distress for routine use in the psychological therapies. Couns Psychother Res. 2013;13(1):3-13.
- Background: PubMed 33861805Campbell C, Tanzer M, Saunders R, Booker T, Allison E, Li E, O'Dowda C, Luyten P, Fonagy P. Development and validation of a self-report measure of epistemic trust. PLoS One. 2021 Apr 16;16(4):e0250264. doi: 10.1371/journal.pone.0250264. eCollection 2021.
- BackgroundCampbell JD, Trapnell PD, Heine SJ, Katz IM, Lavallee LF, Lehman DR. Selfconcept clarity: Measurement, personality correlates, and cultural boundaries. J Pers Soc Psychol. 1996;70(1):141-156.
- Background: PubMed 16647833Carleton RN, Norton MA, Asmundson GJ. Fearing the unknown: a short version of the Intolerance of Uncertainty Scale. J Anxiety Disord. 2007;21(1):105-17. doi: 10.1016/j.janxdis.2006.03.014. Epub 2006 May 2.
- Background: PubMed 11132119Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.
- BackgroundDugas MJ, Robichaud M. Cognitive-behavioral treatment for generalized anxiety disorder: From science to practice. New York: Routledge; 2007.
- Background: PubMed 16563204Fowler D, Freeman D, Smith B, Kuipers E, Bebbington P, Bashforth H, Coker S, Hodgekins J, Gracie A, Dunn G, Garety P. The Brief Core Schema Scales (BCSS): psychometric properties and associations with paranoia and grandiosity in non-clinical and psychosis samples. Psychol Med. 2006 Jun;36(6):749-59. doi: 10.1017/S0033291706007355. Epub 2006 Mar 27.
- Background: PubMed 21443364Fraley RC, Heffernan ME, Vicary AM, Brumbaugh CC. The Experiences in Close Relationships-Relationship Structures questionnaire: a method for assessing attachment orientations across relationships. Psychol Assess. 2011 Sep;23(3):615-25. doi: 10.1037/a0022898.
- BackgroundFreeston MH, Rhéaume J, Letarte H, Dugas MJ, Ladouceur R. Why do people worry? Pers Individ Dif. 1994;17(6):791-802.
- BackgroundGratz KL, Roemer L. Multidimensional assessment of emotion regulation and dysregulation: Development, factor structure, and initial validation of the Difficulties in Emotion Regulation Scale. J Psychopathol Behav Assess. 2004;26(1):41-54.
- Individual participant dataSharing planned: Yes. Anonymised individual-level data from the trial will be made publicly available via an open-access data repository at the conclusion of the study. Shared data will include de-identified participant-level outcome measures, demographic variables, computational task data, and derived "uncertainty fingerprint" parameters consistent with informed consent and institutional data-sharing policies.
Related trials for Mental Disorders
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rebecca Lawson, PhD study chair
Psychology Department, University of Cambridge
Tim Dalgleish, PhD principal investigator
MRC Cognition and Brain Sciences Unit, University of Cambridge; Psychology Department, University of Cambridge
Anna Bevan, PhD study director
MRC Cognition and Brain Sciences Unit, University of Cambridge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Transdiagnostic Cognitive Behavioural Therapy for Intolerance of Uncertainty (CBT-IU) and Group Transdiagnostic Applied Relaxation (AR) in people with Mental Disorders and Mood Disorders, run by Medical Research Council Cognition and Brain Sciences Unit at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ido Shalev, PhD (07541030621, is622@cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intolerance of Uncertainty Scale (IUS-12) (time frame: Prescreen, Baseline, post-treatment (Week 14), and 3-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07866794, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.