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Dissociation CBT Studies (DisCS)

Primary Purpose

Dissociation, Depersonalization, Dissociative Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Brief CBT
Sponsored by
University of Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dissociation focused on measuring 'felt sense of anomaly'

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Aged between 16 years to 80 years; Outpatient of UK mental health services (at the time of referral to the study); Have undergone assessment for psychological therapy in the NHS and subsequently have been entered onto a waiting list for said therapy; 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'. Exclusion Criteria: 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Treatment

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Study 1: Cognitive Appraisals of Dissociation
    Visual Analogue Scale (0-100 rating) for cognitive appraisals of dissociation (higher scores = worse outcome)
    Study 2: Perseverative Thinking
    Visual Analogue Scale (0-100 rating) for cognitive appraisals of perseverative thinking (higher scores = worse outcome)
    Study 3: Affect intolerance
    Visual Analogue Scale (0-100 rating) for affect intolerance (higher scores = worse outcome)

    Secondary Outcome Measures

    Levels of dissociative experience (felt sense of anomaly subtype dissociation)
    Visual Analogue Scale (0-100 rating) for FSA-dissociation (higher scores = worse outcome)

    Full Information

    First Posted
    September 5, 2023
    Last Updated
    September 21, 2023
    Sponsor
    University of Birmingham
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06054009
    Brief Title
    Dissociation CBT Studies
    Acronym
    DisCS
    Official Title
    Treating 'Felt Sense of Anomaly'-Type Dissociative Experiences by Targeting Hypothesised Psychological Maintenance Mechanisms: A Single Case Experimental Design Series
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    September 2024 (Anticipated)
    Study Completion Date
    September 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Birmingham

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dissociation, Depersonalization, Dissociative Disorder
    Keywords
    'felt sense of anomaly'

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Three N=4 randomised multiple baseline design (MBD) single case experimental design studies, with A1B1A2 structure.
    Masking
    None (Open Label)
    Masking Description
    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.
    Allocation
    N/A
    Enrollment
    12 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Brief CBT
    Other Intervention Name(s)
    CBT
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Study 1: Cognitive Appraisals of Dissociation
    Description
    Visual Analogue Scale (0-100 rating) for cognitive appraisals of dissociation (higher scores = worse outcome)
    Time Frame
    Through study completion, average of 3 months
    Title
    Study 2: Perseverative Thinking
    Description
    Visual Analogue Scale (0-100 rating) for cognitive appraisals of perseverative thinking (higher scores = worse outcome)
    Time Frame
    Through study completion, average of 3 months
    Title
    Study 3: Affect intolerance
    Description
    Visual Analogue Scale (0-100 rating) for affect intolerance (higher scores = worse outcome)
    Time Frame
    Through study completion, average of 3 months
    Secondary Outcome Measure Information:
    Title
    Levels of dissociative experience (felt sense of anomaly subtype dissociation)
    Description
    Visual Analogue Scale (0-100 rating) for FSA-dissociation (higher scores = worse outcome)
    Time Frame
    Through study completion, average of 3 months
    Other Pre-specified Outcome Measures:
    Title
    Acceptability of therapy and study to participants
    Description
    Qualitative feedback (written or verbal)
    Time Frame
    Through study completion, average of 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Aged between 16 years to 80 years; Outpatient of UK mental health services (at the time of referral to the study); Have undergone assessment for psychological therapy in the NHS and subsequently have been entered onto a waiting list for said therapy; 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'. Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Emma Cernis, DPhil
    Phone
    01214147221
    Email
    e.cernis@bham.ac.uk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Emma Cernis, DPhil
    Organizational Affiliation
    University of Birmingham
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Due to the small sample sizes of each of the three studies, individual data will not be shared.
    Links:
    URL
    https://doi.org/10.17605/OSF.IO/RWC9N
    Description
    Open Science Framework project page, including pre-registered protocol

    Learn more about this trial

    Dissociation CBT Studies

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