Dissociation CBT Studies

NCT06054009 | Completed

• 3 other identifiers: RG_23-01532544823/NW/0163
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dissociation; Depersonalization; Dissociative Disorder

Keywords

'felt sense of anomaly'

Outcome Measures

Primary Outcomes (3)

• Study 1: Cognitive Appraisals of Dissociation

  Visual Analogue Scale (0-100 rating) for cognitive appraisals of dissociation (higher scores = worse outcome)

  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)

  Through study completion, average of 3 months

• Study 3: Affect intolerance

  Visual Analogue Scale (0-100 rating) for affect intolerance (higher scores = worse outcome)

  Through study completion, average of 3 months

Secondary Outcomes (1)

• Levels of dissociative experience (felt sense of anomaly subtype dissociation)

  Through study completion, average of 3 months

Other Outcomes (1)

• Acceptability of therapy and study to participants

  Through study completion, average of 3 months

Study Arms (1)

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.

Behavioral: Brief CBT

Interventions

Brief CBT BEHAVIORAL

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.

Also known as: CBT

Treatment

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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'.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Birmingham: lead

Study Sites (1)

Birmingham Womens and Childrens NHS Foundation Trust

Birmingham, United Kingdom

Location

Related Links

• Open Science Framework project page, including pre-registered protocol

MeSH Terms

Conditions

Dissociative Disorders; Depersonalization

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Emma Cernis, DPhil

  University of Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This study does not involve blinding. However, to incorporate a degree of impartiality, assessments will be carried out by a research assistant, not the therapist.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three N=4 randomised multiple baseline design (MBD) single case experimental design studies, with A1B1A2 structure.

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 26, 2023
• Study Start: September 20, 2023
• Primary Completion: March 12, 2025
• Study Completion: March 12, 2025
• Last Updated: July 3, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)