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Cognitive Behaviour Therapy for Voices and Dissociation

Primary Purpose

Schizophrenia, Psychological Trauma, Dissociation

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Cognitive Behavioural Therapy

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

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

Inclusion Criteria:

Be in contact with mental health services.
Have an identified care coordinator.
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.
History of voice-hearing for a minimum of six months.
Aged 16 and above.
Score ≥ 2 (i.e. "Voices occurring at least once a day") on the frequency item of the PSYRATS.
Score ≥ 3 (i.e. "Voices are very distressing, although subject could feel worse") on the distress intensity rating of the PSYRATS.
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.
Score ≥ 1 on any of the items of the Bref Betrayal Trauma Survey assessing lifetime exposure to interpersonal trauma (i.e. items 3-11).
scores suggestive of clinical levels of dissociative symptoms, as indicated by a score > 20 on the Dissociative Experiences Scale, time bound
Capacity to provide informed consent.
Judged by their clinician to be clinically stable for the preceding 4 weeks

Exclusion Criteria:

Any person without capacity to provide written informed consent.
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).
Insufficient command of English to complete the research interviews and measures.
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.
Primary diagnosis of substance misuse dependency.
Where care coordinators identify reasons for why participation might be potentially detrimental.
Inpatient/acute care needed.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CBT for voices and dissociation

Arm Description

24 sessions of Cognitive Behavioural Therapy (CBT) over a 6-month period treatment window.

Outcomes

Primary Outcome Measures

Change in the Dissociative Experiences Scale - time bound

Change in the frequency of dissociative experiences, assessed via a questionnaire measure assessing presence and frequency of dissociative experiences in the previous month

Change in the Psychotic Symptoms Rating Scale - auditory hallucinations subscale

change in the severity of hallucinatory experiences, assessed via a clinical interview measuring for presence and severity of auditory hallucinations in the previous week

Secondary Outcome Measures

Change in the Psychotic Symptoms Rating Scale - delusions subscale

change in the severity of delusional beliefs, assessed via a clinical interview measuring for presence and severity of delusions in the previous week

Change in the Impact of Events Scale Revised

change in the severity of post-traumatic symptoms, assessed via a questionnaire measuring arousal, hypervigilance, and intrusions in the previous week

Change in the short Depression, Anxiety and Stress Scales

change in the severity of emotional distress, assessed via a questionnaire measuring symptoms of anxiety, depression, and stress in the previous week

Change in the Questionnaire about the Process of Recovery

change in subjective recovery from psychosis, assed via a self-report questionnaire measuring perceived recovery from psychosis-related difficulties

Change in the short-form of the CHoice of Outcome In Cbt for psychosEs (CHOICE)

change in service user-led outcome measure, assessed using a validated questionnaire developed to evaluate outcomes of cognitive behavioural interventions for psychosis

Full Information

NCT ID

NCT04990414

First Posted

June 24, 2021

Last Updated

July 27, 2021

Sponsor

Greater Manchester Mental Health NHS Foundation Trust

1. Study Identification

Unique Protocol Identification Number

NCT04990414

Brief Title

Cognitive Behaviour Therapy for Voices and Dissociation

Official Title

Cognitive Behaviour Therapy for Voices and Dissociation: A Case Series

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

November 24, 2013 (Actual)

Primary Completion Date

January 29, 2019 (Actual)

Study Completion Date

January 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Greater Manchester Mental Health NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia, Psychological Trauma, Dissociation, Hallucinations

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Case series

Masking

None (Open Label)

Allocation

N/A

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CBT for voices and dissociation

Arm Type

Experimental

Arm Description

24 sessions of Cognitive Behavioural Therapy (CBT) over a 6-month period treatment window.

Intervention Type

Other

Intervention Name(s)

Cognitive Behavioural Therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in the Dissociative Experiences Scale - time bound

Description

Change in the frequency of dissociative experiences, assessed via a questionnaire measure assessing presence and frequency of dissociative experiences in the previous month

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

Title

Change in the Psychotic Symptoms Rating Scale - auditory hallucinations subscale

Description

change in the severity of hallucinatory experiences, assessed via a clinical interview measuring for presence and severity of auditory hallucinations in the previous week

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

Secondary Outcome Measure Information:

Title

Change in the Psychotic Symptoms Rating Scale - delusions subscale

Description

change in the severity of delusional beliefs, assessed via a clinical interview measuring for presence and severity of delusions in the previous week

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

Title

Change in the Impact of Events Scale Revised

Description

change in the severity of post-traumatic symptoms, assessed via a questionnaire measuring arousal, hypervigilance, and intrusions in the previous week

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

Title

Change in the short Depression, Anxiety and Stress Scales

Description

change in the severity of emotional distress, assessed via a questionnaire measuring symptoms of anxiety, depression, and stress in the previous week

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

Title

Change in the Questionnaire about the Process of Recovery

Description

change in subjective recovery from psychosis, assed via a self-report questionnaire measuring perceived recovery from psychosis-related difficulties

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

Title

Change in the short-form of the CHoice of Outcome In Cbt for psychosEs (CHOICE)

Description

change in service user-led outcome measure, assessed using a validated questionnaire developed to evaluate outcomes of cognitive behavioural interventions for psychosis

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Be in contact with mental health services. Have an identified care coordinator. 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. History of voice-hearing for a minimum of six months. Aged 16 and above. Score ≥ 2 (i.e. "Voices occurring at least once a day") on the frequency item of the PSYRATS. Score ≥ 3 (i.e. "Voices are very distressing, although subject could feel worse") on the distress intensity rating of the PSYRATS. 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. Score ≥ 1 on any of the items of the Bref Betrayal Trauma Survey assessing lifetime exposure to interpersonal trauma (i.e. items 3-11). scores suggestive of clinical levels of dissociative symptoms, as indicated by a score > 20 on the Dissociative Experiences Scale, time bound Capacity to provide informed consent. Judged by their clinician to be clinically stable for the preceding 4 weeks Exclusion Criteria: Any person without capacity to provide written informed consent. 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). Insufficient command of English to complete the research interviews and measures. 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. Primary diagnosis of substance misuse dependency. Where care coordinators identify reasons for why participation might be potentially detrimental. Inpatient/acute care needed.

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32914542

Citation

Varese F, Douglas M, Dudley R, Bowe S, Christodoulides T, Common S, Grace T, Lumley V, McCartney L, Pace S, Reeves T, Morrison AP, Turkington D. Targeting dissociation using cognitive behavioural therapy in voice hearers with psychosis and a history of interpersonal trauma: A case series. Psychol Psychother. 2021 Jun;94(2):247-265. doi: 10.1111/papt.12304. Epub 2020 Sep 10.

Results Reference

result

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Cognitive Behaviour Therapy for Voices and Dissociation

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