Cognitive Behaviour Therapy for Voices and Dissociation

July 27, 2021 updated by: Filippo Varese, Greater Manchester Mental Health NHS Foundation Trust

Cognitive Behaviour Therapy for Voices and Dissociation: A Case Series

Case series design with participants with psychosis with a history of interpersonal trauma/abuse and current distressing auditory verbal hallucinations and dissociative experience. Participants were offered up to 24 therapy sessions over a 6-month intervention window.

Study Overview

Detailed Description

Objectives: Previous studies have suggested that dissociation might represent an important mechanism in the maintenance of auditory verbal hallucinations (i.e., voices) in people who have a history of traumatic life experiences. This study investigated whether a cognitive behavioural therapy (CBT) intervention for psychosis augmented with techniques specifically targeting dissociative symptoms could improve both dissociation and auditory hallucination severity in a sample of voice hearers with psychosis and a history of interpersonal trauma (e.g., exposure to sexual, physical, and/or emotional abuse).

Design: Case series.

Methods: A total of 19 service users with psychosis were offered up to 24 therapy sessions over a 6-month intervention window. Participants were assessed four times over a 12-month period using measures of dissociation, psychotic symptoms severity, and additional secondary mental-health and recovery measures.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Be in contact with mental health services.
  2. Have an identified care coordinator.
  3. Meet ICD-10 criteria for schizophrenia, schizoaffective disorder or delusional disorder or meet entry criteria for an Early Intervention in Psychosis service in order to allow for diagnostic uncertainty in early phases of psychosis.
  4. History of voice-hearing for a minimum of six months.
  5. Aged 16 and above.
  6. Score ≥ 2 (i.e. "Voices occurring at least once a day") on the frequency item of the PSYRATS.
  7. Score ≥ 3 (i.e. "Voices are very distressing, although subject could feel worse") on the distress intensity rating of the PSYRATS.
  8. Confirmed that they consider AVHs, dissociative experiences, and/or trauma as their main problem or presenting difficulty, and that would like to receive a psychological intervention specifically designed to address these difficulties - this will be assessed using four items integrated in the PSYRATS interview administered as part of the present study, and the self-reported therapy goals generated through the CHOICE short form.
  9. Score ≥ 1 on any of the items of the Bref Betrayal Trauma Survey assessing lifetime exposure to interpersonal trauma (i.e. items 3-11).
  10. scores suggestive of clinical levels of dissociative symptoms, as indicated by a score > 20 on the Dissociative Experiences Scale, time bound
  11. Capacity to provide informed consent.
  12. Judged by their clinician to be clinically stable for the preceding 4 weeks

Exclusion Criteria:

  1. Any person without capacity to provide written informed consent.
  2. If the experience of voices/psychosis is organic in origin (for example, hallucinatory experiences linked to traumatic brain injuries, organic psychoses, or emerging in the context of dementing conditions).
  3. Insufficient command of English to complete the research interviews and measures.
  4. Intellectual disability, or severe cognitive dysfunction that might preclude the individual's ability to provide informed consent, understand the study procedure and/or fully appreciate the potential consequences of their participation.
  5. Primary diagnosis of substance misuse dependency.
  6. Where care coordinators identify reasons for why participation might be potentially detrimental.
  7. Inpatient/acute care needed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CBT for voices and dissociation
24 sessions of Cognitive Behavioural Therapy (CBT) over a 6-month period treatment window.
Sessions 1-4 were focused on engagement, assessment of presenting problems, identification of treatment goals and normalization/ psychoeducation. Sessions 5- 14, focused on techniques to manage dissociative responses and/or increase perceived controllability of dissociation. Although further work on dissociation and/or trauma was encouraged, the targets for intervention in subsequent sessions (15-22) and the strategies selected depended on individual formulation of clients' difficulties and negotiation with the client. This could include re-appraisals on negative beliefs about dissociative experiences, cognitive and/or behavioural change strategies targeting core appraisals of voices leading to related distress, trauma-related techniques (e.g., imagery techniques,), or consolidation of a developmental/longitudinal psychological formulation of the client's difficulties. The final two sessions focused on plans for relapse prevention and maintenance of gains.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Dissociative Experiences Scale - time bound
Time Frame: baseline, at mid-treatment (approximately 3 months after the baseline assessment), at the end of treatment (6 months after baseline), and again at 6 months following the end of treatment
Change in the frequency of dissociative experiences, assessed via a questionnaire measure assessing presence and frequency of dissociative experiences in the previous month
baseline, at mid-treatment (approximately 3 months after the baseline assessment), at the end of treatment (6 months after baseline), and again at 6 months following the end of treatment
Change in the Psychotic Symptoms Rating Scale - auditory hallucinations subscale
Time Frame: baseline, at mid-treatment (approximately 3 months after the baseline assessment), at the end of treatment (6 months after baseline), and again at 6 months following the end of treatment
change in the severity of hallucinatory experiences, assessed via a clinical interview measuring for presence and severity of auditory hallucinations in the previous week
baseline, at mid-treatment (approximately 3 months after the baseline assessment), at the end of treatment (6 months after baseline), and again at 6 months following the end of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Psychotic Symptoms Rating Scale - delusions subscale
Time Frame: baseline, at mid-treatment (approximately 3 months after the baseline assessment), at the end of treatment (6 months after baseline), and again at 6 months following the end of treatment
change in the severity of delusional beliefs, assessed via a clinical interview measuring for presence and severity of delusions in the previous week
baseline, at mid-treatment (approximately 3 months after the baseline assessment), at the end of treatment (6 months after baseline), and again at 6 months following the end of treatment
Change in the Impact of Events Scale Revised
Time Frame: baseline, at mid-treatment (approximately 3 months after the baseline assessment), at the end of treatment (6 months after baseline), and again at 6 months following the end of treatment
change in the severity of post-traumatic symptoms, assessed via a questionnaire measuring arousal, hypervigilance, and intrusions in the previous week
baseline, at mid-treatment (approximately 3 months after the baseline assessment), at the end of treatment (6 months after baseline), and again at 6 months following the end of treatment
Change in the short Depression, Anxiety and Stress Scales
Time Frame: baseline, at mid-treatment (approximately 3 months after the baseline assessment), at the end of treatment (6 months after baseline), and again at 6 months following the end of treatment
change in the severity of emotional distress, assessed via a questionnaire measuring symptoms of anxiety, depression, and stress in the previous week
baseline, at mid-treatment (approximately 3 months after the baseline assessment), at the end of treatment (6 months after baseline), and again at 6 months following the end of treatment
Change in the Questionnaire about the Process of Recovery
Time Frame: baseline, at mid-treatment (approximately 3 months after the baseline assessment), at the end of treatment (6 months after baseline), and again at 6 months following the end of treatment
change in subjective recovery from psychosis, assed via a self-report questionnaire measuring perceived recovery from psychosis-related difficulties
baseline, at mid-treatment (approximately 3 months after the baseline assessment), at the end of treatment (6 months after baseline), and again at 6 months following the end of treatment
Change in the short-form of the CHoice of Outcome In Cbt for psychosEs (CHOICE)
Time Frame: baseline, at mid-treatment (approximately 3 months after the baseline assessment), at the end of treatment (6 months after baseline), and again at 6 months following the end of treatment
change in service user-led outcome measure, assessed using a validated questionnaire developed to evaluate outcomes of cognitive behavioural interventions for psychosis
baseline, at mid-treatment (approximately 3 months after the baseline assessment), at the end of treatment (6 months after baseline), and again at 6 months following the end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 24, 2013

Primary Completion (ACTUAL)

January 29, 2019

Study Completion (ACTUAL)

January 29, 2019

Study Registration Dates

First Submitted

June 24, 2021

First Submitted That Met QC Criteria

July 27, 2021

First Posted (ACTUAL)

August 4, 2021

Study Record Updates

Last Update Posted (ACTUAL)

August 4, 2021

Last Update Submitted That Met QC Criteria

July 27, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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