Emotional DisordersNCT07129941
Unified Protocol Group Treatment in a University Outpatient Clinic
A study testing Unified Protocol in people with Emotional Disorders and Anxiety, run by University of Bergen at 1 site in Norway.
Trial summary
This clinical trial aims to evaluate the effectiveness and underlying processes of change of the Unified Protocol (UP) for treating emotional disorders in a university outpatient clinic. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotional Disorders, Anxiety, Depression - Major Depressive Disorder
- What is being tested?
- Unified Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteNorway
- Study dates
- 8 May 2025to Dec 2034
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-40
- Fulfilling diagnostic criteria for an anxiety disorder and/or unipolar depression (ICD F.3x - 4x)
- Motivated for short-term treatment in group format
Who cannot join
- Suicidality
- Self-harm
- Severe psychiatric disorder (bipolar disorder, psychosis)
- Substance use disorders
- Use of anxiolytic medication (i.e., benzodiazepines)
- Unstable antidepressant medication (i.e., stable dosage <6 months)
- Other ongoing psychological treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Department of Clinical Psychology
Bergen, Vestland, 5009
Jon Vøllestad, Ph.D., 0047 95 21 32 86, jon.vollestad@uib.no
Elisabeth Schanche, Ph.D., 0047 97 77 42 17, elisabeth.schanche@uib.no
About this study
Official title: Transdiagnostic Group Treatment of Emotional Disorders: A Cross-sectional and Naturalistic Study of Outcome, Change Processes, and Clinical Training
This clinical trial aims to evaluate the effectiveness and underlying processes of change of the Unified Protocol (UP) for treating emotional disorders in a university outpatient clinic. The study will involve 140 patients receiving UP treatment in a group format, delivered either by experienced or novice therapists, along with a non-clinical control group of 45 participants. Participants will self-refer on the basis of advertisement about the study through flyers, posters, project website, social media or local news media. Outcomes will be assessed through self-report measures of well-being, symptoms, emotion regulation, and the non-specific factors of treatment credibility and therapeutic alliance. Additionally, psychophysiological measures of heart rate variability and interoception will be used to explore processes influencing treatment response. Qualitative interviews will complement the quantitative data by capturing participants' perspectives on the treatment and experiences of what contributed to change.
Read the detailed description
Background Anxiety and depression are the most common mental disorders, incurring vast personal and societal costs. While effective evidence-based treatments exist, healthcare systems struggle to meet the growing demand for services. A key challenge in delivering care is that most treatments are diagnosis specific. This complicates training and implementation due to clinicians having to learn multiple treatment manuals. In addition, these single-disorder treatments may also often have poor applicability to the complex symptoms and patterns of comorbidity typically seen in real-world clinical settings. As a response to these challenges, several transdiagnostic treatment protocols have been developed to target psychological processes underlying different diagnoses. One such model is the "Unified Protocol for Transdiagnostic Treatment of Emotional Disorders" (UP) developed by David Barlow and colleagues. UP addresses the functional processes that maintain emotional disorders, such as negative reactions to emotions and avoidance behaviors.
The Unified Protocol (UP) has shown non-inferiority to diagnosis-specific CBT and superiority to treatment as usual in both individual and group formats. Meta-analyses confirm its effectiveness for comorbid emotional disorders and suggest potential for cost-effective, scalable implementation.
Knowledge gaps
- Norwegian Setting: Only one small feasibility study of UP has been conducted in Norway. A larger naturalistic trial is needed to assess outcomes (quality of life, functioning, symptoms) and potential negative effects in a public health context.
- Processes of Change: More research is needed to identify active treatment mechanisms (e.g., emotion regulation, mindfulness, cognitive flexibility) and their association with outcomes in group UP. Non-specific factors such as credibility and group alliance also require investigation.
- Psychophysiological Measures: UP's impact on objective emotion regulation markers (e.g., heart rate variability, interoception) is unexplored. Inclusion of such measures can reduce bias and clarify underlying mechanisms.
- Novice Therapists: The ability of graduate psychology students to deliver UP with high fidelity in group format remains unclear and merits further investigation.
Study objectives This study aims to explore outcomes, processes of change, and user experiences of UP group treatment for patients with emotional disorders in a naturalistic clinical sample in a Norwegian setting. Additionally, it will compare the clinical sample to a healthy control group to better understand how transdiagnostic characteristics serve as vulnerability or resilience factors in the development of emotional disorders. Lastly, the study examines whether novice therapists can be trained to deliver the treatment with high levels of fidelity based on ratings of adherence and competence.
Main aims and research questions i. Assessing treatment effectiveness: To determine whether UP group treatment leads to improvements in key clinical outcomes, identify factors that influence these outcomes, and assess any negative treatment effects.
Research questions:
- Does UP group treatment lead to improvements in quality of life, everyday functioning, emotion regulation, and self-reported symptoms?
- To what extent do clinical and demographic factors impact treatment adherence and outcome?
- What type and frequency of negative treatment effects do participants report? ii. Examining processes of change: To investigate the role of emotion regulation, interoception, and UP skill use as predictors and mediators of treatment outcomes, using both self-report and objective measures.
Research questions:
- Specific factors: To what extent do changes in UP-relevant skills and processes (e.g., emotion regulation, acceptance, cognitive flexibility, and interoception) predict or mediate outcomes?
- Non-specific factors: To what extent do treatment expectations and group alliance predict outcomes? iii. Understanding patients' experience of UP: To explore patients' experience of UP treatment through in-depth qualitative interviews.
Research questions:
- How do participants describe their experience of benefits and challenges with the UP program?
- How do participants describe their experience of change during and after the treatment? iv.) Understanding transdiagnostic factors in emotional vulnerability and resilience: To explore whether individuals with emotional disorders differ cross-sectionally from healthy controls.
Research question:
- Do patients with emotional disorders differ significantly from healthy controls on measures of emotion regulation, acceptance, cognitive flexibility, and psychophysiological markers (interoception, heart rate variability)? v.) Examining UP group therapy delivered by novices: To assess whether novice therapists can be trained to deliver UP with high fidelity.
Research question:
- Can novice therapists (i.e., graduate students in clinical psychology under supervision) be trained to high levels of fidelity in delivering the UP group treatment?
- Being tested
- Unified Protocol
- Keywords
- Unified Protocol, Transdiagnostic treatment, Emotional disorders, Anxiety, Depression, Group therapy
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unified ProtocolBehavioural
The Unified Protocol is a transdiagnostic intervention for emotional disorders here delivered in a group format
| Study group | Role | What they receive |
|---|---|---|
| Unified Protocol group treatment | Experimental | The Unified Protocol (UP) is a time-limited modular treatment addressing core emotion regulation difficulties in patients with emotional disorders. There will be 8-10 patients and two or three therapists in the group. Treatment consists of one individual session of diagnostic assessment, and one or two individual preparation sessions (case formulation and goal setting), and 12 weekly 2 ½ hour group treatment sessions. Receives: Behavioral: Unified Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
WHO-5: Wellbeing index
The WHO-5 is a self-report measure of positive mental health. It consists of five items that are rated on a 6-point scale from 'All of the time' to 'At no time'. High scores indicate a more positive rating of wellbeing
Measured: From enrollment to follow-up at 6 months
Secondary outcomes (18)
Work and Social Adjustment Scale
The WSAS is a five-item scale that addresses impairments in work/study, home, social life, private leisure activities, and interpersonal relations. Each item is self-rated on a nine-point Likert scale that ranges from "Not at all" (0) to "Severely impaired" (8).
Measured: From enrollment to follow-up at 6 months
Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a nine-item scale measuring depression severity. Each item is self-rated on a four-point Likert scale that ranges from "Not at all" (0) to "Nearly every day" (3).
Measured: From enrollment to follow-up at 6 months
Generalized Anxiety Disorder Scale (GAD-7)
The GAD-7 is a seven-item scale measuring anxiety severity. Each items is self-rated on a four point Likert scale that ranges from "Not at all" (0) to "Nearly every day" (3).
Measured: From enrollment to follow-up at 6 months
Multidimensional Emotional Disorders Inventory (MEDI)
The MEDI is a 49-item scale measuring nine transdiagnostic factors involved in emotional disorders. Each item is self-rated on a nine point Likert scale that ranges from 0 (Not at all characteristic of me) to 8 (Totally characteristic of me). The dimensions measured are Neurotic temperament, positive temperament, depressive mood, autonomic arousal, somatic anxiety, intrusive thoughts, traumatic re-experiencing and avoidance.
Measured: From enrollment to follow-up at 6 months
Level of Personality Functioning Scale Brief Form (LPFS-BF)
The LPFS-BF is a 12-item scale measuring the level of personality functioning based on the Criterion "A" of the alternative model for personality disorders in the DSM-5; Identity, self-direction, empathy and intimacy. Each item is self-rated on a 4-point Likert scale that ranges from 0 (Little or no impairment) to 3 (Severe impairment).
Measured: From enrollment to follow-up at 6 months
Difficulty in Emotion Regulation Scale (DERS-16)
The DERS is a 16-item scale measuring individuals' typical levels of difficulties in emotion regulation. Each item is self-rated on a 5-point Likert scale that ranges from 1 (Almost never) to 5 (Almost always).
Measured: From enrollment to follow-up at 6 months
Acceptance and Action Questionnaire- version 2 (AAQ-II)
The AAQ-II is a 7-item scale measuring experiential avoidance and psychological inflexibility. Each item is self-rated on a 7-point Likert scale that ranges from 1 (Never right) to 5 (Always right). The total score ranges between 0-49. Higher scores indicate less psychological flexibility and more experiential avoidance.
Measured: From enrollment to follow-up at 6 months
Five Facet Mindfulness Questionnaire (FFMQ)
The FFMQ is a 15-item scale measuring mindfulness with regard to thoughts, experiences, and actions in daily life. Each item is self-rated on a 5-point Likert scale that ranges from 1 (Never or rarely true) to 5 (Very often or always true).
Measured: From enrollment to follow-up at 6 months
Unified Protocol Cognitive Skills Questionnaire (UP-CSQ)
The UP-CSQ is a 7-item scale measuring the cognitive skills taught in the UP. Each item is self-rated on a 5-point Likert scale that ranges from 1 (Never) to 5 (Always or when needed)
Measured: From enrollment to follow-up at 6 months
Multidimensional Assessment of Interoceptive Awareness-2 (MAIA)
The MAIA is a 37-item scale measuring interoceptive awareness. Each item is self-rated on a 6-point Likert scale that ranges from 0 (Never) to 5 (Always).
Measured: From enrollment to follow-up at 6 months
Overall Anxiety Severity and Impairment Scale (OASIS)
The OASIS is a 5-item scale measuring the frequency and severity of anxiety, avoidance, work/school/home interference, and social interference due to anxiety. Each item is self-rated on a 5-point Likert scale that ranges from 0 (None, never) to 4 (Extreme, constant). The OASIS is used as an in-session UP measures to examine processes of change
Measured: At each treatment session through the 12 weeks of treatment
Overall Depression Severity and Impairment Scale (ODSIS)
The ODSIS is a 5-item scale measuring the frequency and severity of depression symptoms, avoidance, work/school/home interference, and social interference due to depression. Each item is self-rated on a 5-point Likert scale that ranges from 0 (None/never) to 4 (Extreme/constant). The ODSIS is used as an in-session UP measures to examine processes of change
Measured: At each treatment session through the 12 weeks of treatment
Unified Protocol Skill Use Scale (UPSUS)
The UPSUS is a 7-item scale measuring the frequency with which individuals use UP-skills in distressing situations. Each item is self-rated on a 6-point Likert scale that ranges from 0 (Not at all) to 5 (Nearly all the time). Each item was written to describe core skills taught in each of the five core UP-modules. The UPSUS is used as an in-session UP measure to examine processes of change
Measured: At each treatment session through the 12 weeks of treatment
Dimension of Skillfulness and Use Scale (DSUS)
The DSUS is a 4-item scale measuring the understanding of UP skills learned in the prior session, frequency of skill use, quality of skill use, and effectiveness and skill use. Each item is self-rated on a 5-point Likert scale that ranges from 0 (Not at all) to 4 (Extremely well/every day). The DSUS is used as an in-session UP measures to examine processes of change
Measured: At each treatment session through the 12 weeks of treatment
Client Satisfaction Questionnaire (CSQ-8)
The CSQ-8 is an 8-item scale measuring clients' satisfaction with treatment. Each item is scored on a 4-point Likert scale that ranges from 0 to 3.
Measured: At final treatment session (week 12)
The Negative Effects Questionnaire (NEQ)
The NEQ is a 32-item scale measuring adverse or unwanted events during treatment. Each item is designed to assess adverse effects related to psychological treatments. Items are scored on a five-point Likert scale (0-4) and differentiates between treatment-related negative effects and those from external factors.
Measured: At final treatment session (week 12)
The Heartbeat Counting Task (HBC)
The HBC task evaluates three dimensions of interoception: 1) Interoceptive accuracy in the form of ratio of detected to actual heartbeats, 2) Interoceptive sensibility in the form of self-reported interoception through interviews and questionnaires, and 3) Interoceptive awareness in the form of metacognitive awareness of accuracy, measured by the correlation between confidence and actual performance using receiver operating characteristics (ROC) curve analysis.
Measured: From enrollment to follow-up at 6 months
Heart Rate Variability (HRV) via a 24-hour ECG Monitoring.
24-hour ECG data will be collected using BioPoint sensors from SiFi Labs, which are wearable, small and designed for continuous monitoring. The sensor is placed below the sternum. The data are not intended for clinical evaluation of heart function but suitable for investigating potential changes in HRV before and after psychotherapy in addition to possible differences in HRV in groups of patients with emotional disorders compared to healthy controls.
Measured: From enrollment to follow-up at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start8 May 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm uncontrolled naturalistic trial. All eligible patients will receive the Unified Protocol (UP) intervention, but will be randomly assigned to receive treatment from either experienced psychologists or psychology students.
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jon Vøllestad, Ph.D., Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129941
- Sponsor's protocol ID
- REK-ID 840156
- Status last verified
- May 2025
- First submitted
- 22 May 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transdiagnostic Group Treatment of Emotional Disorders: A Cross-sectional and Naturalistic Study of Outcome, Change Processes, and Clinical Training
- ClinicalTrials.gov ID
- NCT07129941
- Acronym / sponsor ID
- REK-ID 840156
- Keywords
- Unified Protocol, Transdiagnostic treatment, Emotional disorders, Anxiety, Depression, Group therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Study start
- 8 May 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2034 (estimated)
- First posted
- 19 Aug 2025 (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.
This clinical trial aims to evaluate the effectiveness and underlying processes of change of the Unified Protocol (UP) for treating emotional disorders in a university outpatient clinic. The study will involve 140 patients receiving UP treatment in a group format, delivered either by experienced or novice therapists, along with a non-clinical control group of 45 participants. Participants will self-refer on the basis of advertisement about the study through flyers, posters, project website, social media or local news media. Outcomes will be assessed through self-report measures of well-being, symptoms, emotion regulation, and the non-specific factors of treatment credibility and therapeutic alliance. Additionally, psychophysiological measures of heart rate variability and interoception will be used to explore processes influencing treatment response. Qualitative interviews will complement the quantitative data by capturing participants' perspectives on the treatment and experiences of what contributed to change.
Detailed description
Background Anxiety and depression are the most common mental disorders, incurring vast personal and societal costs. While effective evidence-based treatments exist, healthcare systems struggle to meet the growing demand for services. A key challenge in delivering care is that most treatments are diagnosis specific. This complicates training and implementation due to clinicians having to learn multiple treatment manuals. In addition, these single-disorder treatments may also often have poor applicability to the complex symptoms and patterns of comorbidity typically seen in real-world clinical settings. As a response to these challenges, several transdiagnostic treatment protocols have been developed to target psychological processes underlying different diagnoses. One such model is the "Unified Protocol for Transdiagnostic Treatment of Emotional Disorders" (UP) developed by David Barlow and colleagues. UP addresses the functional processes that maintain emotional disorders, such as negative reactions to emotions and avoidance behaviors.
The Unified Protocol (UP) has shown non-inferiority to diagnosis-specific CBT and superiority to treatment as usual in both individual and group formats. Meta-analyses confirm its effectiveness for comorbid emotional disorders and suggest potential for cost-effective, scalable implementation.
Knowledge gaps
- Norwegian Setting: Only one small feasibility study of UP has been conducted in Norway. A larger naturalistic trial is needed to assess outcomes (quality of life, functioning, symptoms) and potential negative effects in a public health context.
- Processes of Change: More research is needed to identify active treatment mechanisms (e.g., emotion regulation, mindfulness, cognitive flexibility) and their association with outcomes in group UP. Non-specific factors such as credibility and group alliance also require investigation.
- Psychophysiological Measures: UP's impact on objective emotion regulation markers (e.g., heart rate variability, interoception) is unexplored. Inclusion of such measures can reduce bias and clarify underlying mechanisms.
- Novice Therapists: The ability of graduate psychology students to deliver UP with high fidelity in group format remains unclear and merits further investigation.
Study objectives This study aims to explore outcomes, processes of change, and user experiences of UP group treatment for patients with emotional disorders in a naturalistic clinical sample in a Norwegian setting. Additionally, it will compare the clinical sample to a healthy control group to better understand how transdiagnostic characteristics serve as vulnerability or resilience factors in the development of emotional disorders. Lastly, the study examines whether novice therapists can be trained to deliver the treatment with high levels of fidelity based on ratings of adherence and competence.
Main aims and research questions i. Assessing treatment effectiveness: To determine whether UP group treatment leads to improvements in key clinical outcomes, identify factors that influence these outcomes, and assess any negative treatment effects.
Research questions:
- Does UP group treatment lead to improvements in quality of life, everyday functioning, emotion regulation, and self-reported symptoms?
- To what extent do clinical and demographic factors impact treatment adherence and outcome?
- What type and frequency of negative treatment effects do participants report? ii. Examining processes of change: To investigate the role of emotion regulation, interoception, and UP skill use as predictors and mediators of treatment outcomes, using both self-report and objective measures.
Research questions:
- Specific factors: To what extent do changes in UP-relevant skills and processes (e.g., emotion regulation, acceptance, cognitive flexibility, and interoception) predict or mediate outcomes?
- Non-specific factors: To what extent do treatment expectations and group alliance predict outcomes? iii. Understanding patients' experience of UP: To explore patients' experience of UP treatment through in-depth qualitative interviews.
Research questions:
- How do participants describe their experience of benefits and challenges with the UP program?
- How do participants describe their experience of change during and after the treatment? iv.) Understanding transdiagnostic factors in emotional vulnerability and resilience: To explore whether individuals with emotional disorders differ cross-sectionally from healthy controls.
Research question:
- Do patients with emotional disorders differ significantly from healthy controls on measures of emotion regulation, acceptance, cognitive flexibility, and psychophysiological markers (interoception, heart rate variability)? v.) Examining UP group therapy delivered by novices: To assess whether novice therapists can be trained to deliver UP with high fidelity.
Research question:
- Can novice therapists (i.e., graduate students in clinical psychology under supervision) be trained to high levels of fidelity in delivering the UP group treatment?
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm uncontrolled naturalistic trial. All eligible patients will receive the Unified Protocol (UP) intervention, but will be randomly assigned to receive treatment from either experienced psychologists or psychology students.
| Arm | Type | Receives |
|---|---|---|
| Unified Protocol group treatment | Experimental | Behavioral: Unified ProtocolThe Unified Protocol (UP) is a time-limited modular treatment addressing core emotion regulation difficulties in patients with emotional disorders. There will be 8-10 patients and two or three therapists in the group. Treatment consists of one individual session of diagnostic assessment, and one or two individual preparation sessions (case formulation and goal setting), and 12 weekly 2 ½ hour group treatment sessions. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-40
- Fulfilling diagnostic criteria for an anxiety disorder and/or unipolar depression (ICD F.3x - 4x)
- Motivated for short-term treatment in group format
Key exclusion criteria (7 listed)
- Suicidality
- Self-harm
- Severe psychiatric disorder (bipolar disorder, psychosis)
- Substance use disorders
- Use of anxiolytic medication (i.e., benzodiazepines)
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 |
|---|---|---|
| Unified ProtocolThe Unified Protocol is a transdiagnostic intervention for emotional disorders here delivered in a group format | Behavioural | Unified Protocol group treatment |
Primary outcome
WHO-5: Wellbeing index
Time frame: From enrollment to follow-up at 6 months
The WHO-5 is a self-report measure of positive mental health. It consists of five items that are rated on a 6-point scale from 'All of the time' to 'At no time'. High scores indicate a more positive rating of wellbeing
18 secondary outcomes
Work and Social Adjustment Scale
Time frame: From enrollment to follow-up at 6 months
Patient Health Questionnaire (PHQ-9)
Time frame: From enrollment to follow-up at 6 months
Generalized Anxiety Disorder Scale (GAD-7)
Time frame: From enrollment to follow-up at 6 months
Multidimensional Emotional Disorders Inventory (MEDI)
Time frame: From enrollment to follow-up at 6 months
Level of Personality Functioning Scale Brief Form (LPFS-BF)
Time frame: From enrollment to follow-up at 6 months
Difficulty in Emotion Regulation Scale (DERS-16)
Time frame: From enrollment to follow-up at 6 months
Acceptance and Action Questionnaire- version 2 (AAQ-II)
Time frame: From enrollment to follow-up at 6 months
Five Facet Mindfulness Questionnaire (FFMQ)
Time frame: From enrollment to follow-up at 6 months
Unified Protocol Cognitive Skills Questionnaire (UP-CSQ)
Time frame: From enrollment to follow-up at 6 months
Multidimensional Assessment of Interoceptive Awareness-2 (MAIA)
Time frame: From enrollment to follow-up at 6 months
Overall Anxiety Severity and Impairment Scale (OASIS)
Time frame: At each treatment session through the 12 weeks of treatment
Overall Depression Severity and Impairment Scale (ODSIS)
Time frame: At each treatment session through the 12 weeks of treatment
Unified Protocol Skill Use Scale (UPSUS)
Time frame: At each treatment session through the 12 weeks of treatment
Dimension of Skillfulness and Use Scale (DSUS)
Time frame: At each treatment session through the 12 weeks of treatment
Client Satisfaction Questionnaire (CSQ-8)
Time frame: At final treatment session (week 12)
The Negative Effects Questionnaire (NEQ)
Time frame: At final treatment session (week 12)
The Heartbeat Counting Task (HBC)
Time frame: From enrollment to follow-up at 6 months
Heart Rate Variability (HRV) via a 24-hour ECG Monitoring.
Time frame: From enrollment to follow-up at 6 months
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 19 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Jon Vøllestad, Ph.D. principal investigator
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unified Protocol in people with Emotional Disorders and Anxiety, run by University of Bergen at 1 site in Norway.
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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 19 Aug 2025. 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 Norway. 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 Jon Vøllestad, Ph.D. (0047 95 21 32 86, jon.vollestad@uib.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WHO-5: Wellbeing index (time frame: From enrollment to follow-up at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2025.