DissociationDisCSNCT06054009
Dissociation CBT Studies
A study testing Brief CBT in people with Dissociation and Depersonalization, run by University of Birmingham at 1 site in United Kingdom.
Trial summary
Dissociation involves distressing feelings of unreality and disconnection. Evidence suggests it is particularly common amongst people with existing mental health difficulties, where it has been linked with greater clinical severity, poorer treatment response, and increased self-harm and suicidality. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Dissociation, Depersonalization, Dissociative Disorder
- What is being tested?
- Brief CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Sep 2023to 12 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aged between 16 years to 80 years;
- Outpatient of UK mental health services (at the time of referral to the study);
- Experiencing significant levels of 'felt sense of anomaly'-type dissociation (defined as a score within the 'moderately severe' or 'severe' range on the ČEFSA-14 (i.e., 39 or above); Černis et al., in prep.);
- Want help to improve their dissociative experiences;
- Willing and able to give consent for participation in the study;
- Available to undertake the baseline assessment in the indicated week;
- Available to undertake the therapy sessions within the indicated therapy 'window'.
Who cannot join
- The participant may not enter the study if ANY of the following apply:
- Diagnosis of an Axis II ("personality") disorder;
- Primary diagnosis of alcohol/substance dependency, organic syndrome, or learning disability;
- Presence of risk issues that would be a clinical priority above managing dissociative symptoms (e.g., moderate to severe self-harm; active suicidal behaviour; etc.);
- Current engagement in any other individual psychological therapy (or psychological therapy due to begin within the participation window for this study).
- A participant may also not enter the study if there is another factor (i.e., with higher clinical priority), which, in the judgement of the investigator, would preclude the participant from providing informed consent or from safely engaging with the study procedures.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Birmingham Womens and Childrens NHS Foundation Trust
Birmingham
About this study
Official title: Treating 'Felt Sense of Anomaly'-Type Dissociative Experiences by Targeting Hypothesised Psychological Maintenance Mechanisms: A Single Case Experimental Design Series
Dissociation involves distressing feelings of unreality and disconnection. Evidence suggests it is particularly common amongst people with existing mental health difficulties, where it has been linked with greater clinical severity, poorer treatment response, and increased self-harm and suicidality. However, there are currently no psychological treatments for dissociation that have been developed from a scientific understanding of its underpinning psychological factors.
In this project, three studies, each with four participants, will test a different psychological factor. Participants will be: adults (16+ years); on a waiting list for NHS psychological therapy; high scorers on a dissociation questionnaire. Participants will complete assessments before and after treatment, and at a one-month follow-up. The studies follow a 'multiple baseline design', meaning that all four participants for that study will complete their baseline assessment in the same week, and then be randomly allocated to wait either one, two, three, or four weeks before starting the intervention. The intervention will consist of four therapy sessions taking place within a five-week 'window'. Taking part in the research is voluntary. Before deciding whether to participate, we will explain the study and answer any questions.
Read more
Daily, participants will record a score for their dissociation and the psychological factor being targeted. At baseline, post-therapy, and follow-up, the researchers will also measure their levels of other factors related to dissociation (i.e. those not targeted by the therapy). Additionally, feedback will be requested from participants about the therapy at the end of their involvement, in order to improve it in future.
Ultimately, if successful, these interventions could form a pilot therapy for further testing and development. This could mean fewer people struggle with the challenges of dissociation.
Read the detailed description
- What is dissociation? "I was in a totally different world; it was going on all around me. I thought that I might have died and was in hell, and I was thinking maybe that's what it was." -- "Maria" Dissociation involves confusing and upsetting feelings of unreality, unfamiliarity, or disconnection in relation to your mind, body, or surroundings. For example, some people describe being detached from their own emotions, including affection for loved ones, or feeling profoundly 'strange', as though they are living life from behind a thick pane of glass. These experiences can cause significant distress, and have been linked with risk of self-harm or suicide, and with increased severity and incomplete treatment-response of comorbid mental health diagnoses. Many dissociative experiences considered transdiagnostic. For example, dissociation is present at a very high rate in psychotic disorders (potentially up to 50%). Crucially, in this context, it may even be instrumental in the development and maintenance of key psychotic symptoms, such as paranoid delusions and auditory hallucinations. However, dissociation has traditionally been considered within the context of post-traumatic responses. As a result, a fuller understanding of dissociation as an independent construct - rather than simply as another post-traumatic symptom - has yet to be achieved. This 'neglect', and extensive debate within the field, has also resulted in a lack of clarity about the precise accepted definition of 'dissociation' as a construct. Therefore, in previous work, our research group delineated a subgroup of common dissociative experiences unified by a core phenomenological experience of a 'felt sense of anomaly' (FSA). Thus, the term 'dissociation' is operationalised within this project by focusing on this specific type of dissociative experiences (FSA-dissociation), since this has been demonstrated to be common and transdiagnostic.
- What are the psychological maintenance mechanisms of dissociation? Understanding the psychological mechanisms of a pathological presentation is vital to developing an effective intervention for it. Seminal work developing (now gold standard) cognitive behavioural therapy (CBT) interventions for anxiety disorders and PTSD have demonstrated the clinical efficacy of identifying, verifying, and then precisely targeting the underlying causal mechanisms of the problem to be treated. However, much remains unknown about the psychological mechanisms underpinning dissociation. To date, only two experimental studies inferring causality in dissociation have been carried out: one of which was by our group. In our recent work, we began the process of identifying plausible mechanisms of FSA-dissociation, resulting in a provisional cognitive model of the problem. This model suggests that dissociative experiences are maintained by a two feedback loops. The first is caused by catastrophic appraisals (negative interpretations or beliefs about the dissociative experience), which lead to rumination and counterproductive 'safety behaviours' (actions intended to mitigate potential harm), both of which serve to keep attention focused on the dissociation and reinforce interpretations of this experience as threatening. This first loop therefore proposes three possible maintenance mechanisms: catastrophic appraisals of dissociation, perseverative thinking (rumination), and counterproductive safety behaviours. The second hypothesised feedback loop explains why the appraisals of dissociation are catastrophic in nature - as opposed to benign or benevolent. Across two large studies of online survey and NHS patient (psychosis) respondents, previous data has indicated relationships between dissociation and both high affect intolerance and low self-efficacy. In essence, people who feared shifts or peaks in their mood, and simultaneously felt powerless to manage or cope with challenges, were more likely to have FSA-dissociative experiences - as was indicated by previous qualitative evidence. This second feedback loop therefore suggests two further plausible mechanisms of dissociation: affect intolerance and self-efficacy. In this project, the researchers have chosen to focus on the three mechanisms with the largest effect sizes from this research: negative cognitive appraisals of the dissociative experience (causal effect 0.73 in a non-clinical group; 0.72 in a psychosis group), perseverative thinking (rumination) (0.31; 0.52), and affect intolerance (0.26; 0.41).
- The current study
The aim of this project is therefore to test the three largest psychological contributors to FSA-dissociation as identified in this previous research: cognitive appraisals, rumination, and affect intolerance. Whilst there is evidence that these are all associated with dissociative experiences in the context of psychosis, to date there has been no experimental manipulation of these factors to demonstrate their role in maintaining dissociative difficulties. Evidence of their causal effect on dissociation is required before a translational psychological intervention can be developed.
Using an interventionist-causal approach (experimentally manipulating the factor of interest via attempting to ameliorate it with therapeutic techniques) allows researchers to combine an experimental test of causal relationships with the first stages of treatment development. This project constitutes an intermediate stage along the trajectory of treatment development, in that the primary aim of these three studies will be to demonstrate proof-of-concept for the interventions, in order that a larger study with adequate statistical power to test for causal relationships and treatment efficacy may be carried out.
- Conditions
- Dissociation, Depersonalization, Dissociative Disorder
- Being tested
- Brief CBT
- Keywords
- 'felt sense of anomaly'
- Medical subject headings
- Dissociative Disorders, Depersonalization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief CBTBehavioural
Also called CBT
In Study 1: x4 CBT sessions addressing cognitive appraisals of dissociation. In Study 2: x4 CBT sessions addressing rumination/worry. In Study 3: x4 CBT sessions addressing affect intolerance.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | In Study 1: x4 CBT sessions addressing cognitive appraisals of dissociation. In Study 2: x4 CBT sessions addressing rumination/worry. In Study 3: x4 CBT sessions addressing affect intolerance. Receives: Behavioral: Brief CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study 1: Cognitive Appraisals of Dissociation
Visual Analogue Scale (0-100 rating) for cognitive appraisals of dissociation (higher scores = worse outcome)
Measured: Through study completion, average of 3 months
Study 2: Perseverative Thinking
Visual Analogue Scale (0-100 rating) for cognitive appraisals of perseverative thinking (higher scores = worse outcome)
Measured: Through study completion, average of 3 months
Study 3: Affect intolerance
Visual Analogue Scale (0-100 rating) for affect intolerance (higher scores = worse outcome)
Measured: Through study completion, average of 3 months
Secondary outcomes (1)
Levels of dissociative experience (felt sense of anomaly subtype dissociation)
Visual Analogue Scale (0-100 rating) for FSA-dissociation (higher scores = worse outcome)
Measured: Through study completion, average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start20 Sep 2023
- Primary completion12 Mar 2025
- Study completion12 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DissociationStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Three N=4 randomised multiple baseline design (MBD) single case experimental design studies, with A1B1A2 structure.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emma Cernis, DPhil, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054009
- Sponsor's protocol ID
- RG_23-015
- Other IDs
- 325448, 23/NW/0163
- Acronym
- DisCS
- Status last verified
- Nov 2024
- First submitted
- 5 Sep 2023
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the small sample sizes of each of the three studies, individual data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating 'Felt Sense of Anomaly'-Type Dissociative Experiences by Targeting Hypothesised Psychological Maintenance Mechanisms: A Single Case Experimental Design Series
- ClinicalTrials.gov ID
- NCT06054009
- Acronym / sponsor ID
- DisCS / RG_23-015
- Conditions
- Dissociation, Depersonalization, Dissociative Disorder
- Keywords
- 'felt sense of anomaly'
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 12 Mar 2025 (actual)
- Study completion
- 12 Mar 2025 (actual)
- First posted
- 26 Sep 2023 (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.
Dissociation involves distressing feelings of unreality and disconnection. Evidence suggests it is particularly common amongst people with existing mental health difficulties, where it has been linked with greater clinical severity, poorer treatment response, and increased self-harm and suicidality. However, there are currently no psychological treatments for dissociation that have been developed from a scientific understanding of its underpinning psychological factors.
In this project, three studies, each with four participants, will test a different psychological factor. Participants will be: adults (16+ years); on a waiting list for NHS psychological therapy; high scorers on a dissociation questionnaire. Participants will complete assessments before and after treatment, and at a one-month follow-up. The studies follow a 'multiple baseline design', meaning that all four participants for that study will complete their baseline assessment in the same week, and then be randomly allocated to wait either one, two, three, or four weeks before starting the intervention. The intervention will consist of four therapy sessions taking place within a five-week 'window'. Taking part in the research is voluntary. Before deciding whether to participate, we will explain the study and answer any questions.
Daily, participants will record a score for their dissociation and the psychological factor being targeted. At baseline, post-therapy, and follow-up, the researchers will also measure their levels of other factors related to dissociation (i.e. those not targeted by the therapy). Additionally, feedback will be requested from participants about the therapy at the end of their involvement, in order to improve it in future.
Ultimately, if successful, these interventions could form a pilot therapy for further testing and development. This could mean fewer people struggle with the challenges of dissociation.
Detailed description
- What is dissociation? "I was in a totally different world; it was going on all around me. I thought that I might have died and was in hell, and I was thinking maybe that's what it was." -- "Maria" Dissociation involves confusing and upsetting feelings of unreality, unfamiliarity, or disconnection in relation to your mind, body, or surroundings. For example, some people describe being detached from their own emotions, including affection for loved ones, or feeling profoundly 'strange', as though they are living life from behind a thick pane of glass. These experiences can cause significant distress, and have been linked with risk of self-harm or suicide, and with increased severity and incomplete treatment-response of comorbid mental health diagnoses. Many dissociative experiences considered transdiagnostic. For example, dissociation is present at a very high rate in psychotic disorders (potentially up to 50%). Crucially, in this context, it may even be instrumental in the development and maintenance of key psychotic symptoms, such as paranoid delusions and auditory hallucinations. However, dissociation has traditionally been considered within the context of post-traumatic responses. As a result, a fuller understanding of dissociation as an independent construct - rather than simply as another post-traumatic symptom - has yet to be achieved. This 'neglect', and extensive debate within the field, has also resulted in a lack of clarity about the precise accepted definition of 'dissociation' as a construct. Therefore, in previous work, our research group delineated a subgroup of common dissociative experiences unified by a core phenomenological experience of a 'felt sense of anomaly' (FSA). Thus, the term 'dissociation' is operationalised within this project by focusing on this specific type of dissociative experiences (FSA-dissociation), since this has been demonstrated to be common and transdiagnostic.
- What are the psychological maintenance mechanisms of dissociation? Understanding the psychological mechanisms of a pathological presentation is vital to developing an effective intervention for it. Seminal work developing (now gold standard) cognitive behavioural therapy (CBT) interventions for anxiety disorders and PTSD have demonstrated the clinical efficacy of identifying, verifying, and then precisely targeting the underlying causal mechanisms of the problem to be treated. However, much remains unknown about the psychological mechanisms underpinning dissociation. To date, only two experimental studies inferring causality in dissociation have been carried out: one of which was by our group. In our recent work, we began the process of identifying plausible mechanisms of FSA-dissociation, resulting in a provisional cognitive model of the problem. This model suggests that dissociative experiences are maintained by a two feedback loops. The first is caused by catastrophic appraisals (negative interpretations or beliefs about the dissociative experience), which lead to rumination and counterproductive 'safety behaviours' (actions intended to mitigate potential harm), both of which serve to keep attention focused on the dissociation and reinforce interpretations of this experience as threatening. This first loop therefore proposes three possible maintenance mechanisms: catastrophic appraisals of dissociation, perseverative thinking (rumination), and counterproductive safety behaviours. The second hypothesised feedback loop explains why the appraisals of dissociation are catastrophic in nature - as opposed to benign or benevolent. Across two large studies of online survey and NHS patient (psychosis) respondents, previous data has indicated relationships between dissociation and both high affect intolerance and low self-efficacy. In essence, people who feared shifts or peaks in their mood, and simultaneously felt powerless to manage or cope with challenges, were more likely to have FSA-dissociative experiences - as was indicated by previous qualitative evidence. This second feedback loop therefore suggests two further plausible mechanisms of dissociation: affect intolerance and self-efficacy. In this project, the researchers have chosen to focus on the three mechanisms with the largest effect sizes from this research: negative cognitive appraisals of the dissociative experience (causal effect 0.73 in a non-clinical group; 0.72 in a psychosis group), perseverative thinking (rumination) (0.31; 0.52), and affect intolerance (0.26; 0.41).
- The current study
The aim of this project is therefore to test the three largest psychological contributors to FSA-dissociation as identified in this previous research: cognitive appraisals, rumination, and affect intolerance. Whilst there is evidence that these are all associated with dissociative experiences in the context of psychosis, to date there has been no experimental manipulation of these factors to demonstrate their role in maintaining dissociative difficulties. Evidence of their causal effect on dissociation is required before a translational psychological intervention can be developed.
Using an interventionist-causal approach (experimentally manipulating the factor of interest via attempting to ameliorate it with therapeutic techniques) allows researchers to combine an experimental test of causal relationships with the first stages of treatment development. This project constitutes an intermediate stage along the trajectory of treatment development, in that the primary aim of these three studies will be to demonstrate proof-of-concept for the interventions, in order that a larger study with adequate statistical power to test for causal relationships and treatment efficacy may be carried out.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Three N=4 randomised multiple baseline design (MBD) single case experimental design studies, with A1B1A2 structure.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Brief CBTIn Study 1: x4 CBT sessions addressing cognitive appraisals of dissociation. In Study 2: x4 CBT sessions addressing rumination/worry. In Study 3: x4 CBT sessions addressing affect intolerance. |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Aged between 16 years to 80 years;
- Outpatient of UK mental health services (at the time of referral to the study);
- Experiencing significant levels of 'felt sense of anomaly'-type dissociation (defined as a score within the 'moderately severe' or 'severe' range on the ČEFSA-14 (i.e., 39 or above); Černis et al., in prep.);
- Want help to improve their dissociative experiences;
- Willing and able to give consent for participation in the study;
Key exclusion criteria (6 listed)
- Diagnosis of an Axis II ("personality") disorder;
- Primary diagnosis of alcohol/substance dependency, organic syndrome, or learning disability;
- Presence of risk issues that would be a clinical priority above managing dissociative symptoms (e.g., moderate to severe self-harm; active suicidal behaviour; etc.);
- Current engagement in any other individual psychological therapy (or psychological therapy due to begin within the participation window for this study).
- A participant may also not enter the study if there is another factor (i.e., with higher clinical priority), which, in the judgement of the investigator, would preclude the participant from providing informed consent or from safely engaging with the study procedures.
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 |
|---|---|---|
| Brief CBTAlso: CBTIn Study 1: x4 CBT sessions addressing cognitive appraisals of dissociation. In Study 2: x4 CBT sessions addressing rumination/worry. In Study 3: x4 CBT sessions addressing affect intolerance. | Behavioural | Treatment |
Primary outcome
Study 1: Cognitive Appraisals of Dissociation
Time frame: Through study completion, average of 3 months
Visual Analogue Scale (0-100 rating) for cognitive appraisals of dissociation (higher scores = worse outcome)
Study 2: Perseverative Thinking
Time frame: Through study completion, average of 3 months
Visual Analogue Scale (0-100 rating) for cognitive appraisals of perseverative thinking (higher scores = worse outcome)
Study 3: Affect intolerance
Time frame: Through study completion, average of 3 months
Visual Analogue Scale (0-100 rating) for affect intolerance (higher scores = worse outcome)
1 secondary outcome
Levels of dissociative experience (felt sense of anomaly subtype dissociation)
Time frame: Through study completion, average of 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Open Science Framework project page, including pre-registered protocolLink provided by the sponsor.
- Individual participant dataSharing planned: No. Due to the small sample sizes of each of the three studies, individual data will not be shared.
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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. This study is not recruiting at the moment.
Emma Cernis, DPhil principal investigator
University of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief CBT in people with Dissociation and Depersonalization, run by University of Birmingham 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 6 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: finished, as of the sponsor's last update on 3 Jul 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study 1: Cognitive Appraisals of Dissociation (time frame: Through study completion, average of 3 months). The study lists 3 primary outcomes in all. 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 3 Jul 2025.