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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
What is being tested?
Brief CBT
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

Other trials in United Kingdom

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
  1. 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.
  2. 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).
  3. 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.

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 groups in NCT06054009
Study groupRoleWhat they receive
TreatmentExperimentalIn 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.

  1. 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

  2. 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

  3. 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)
  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.

  1. First posted26 Sep 2023
  2. Study start20 Sep 2023
  3. Primary completion12 Mar 2025
  4. Study completion12 Mar 2025

Resources

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)
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.

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.

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