Cognitive Behaviour Therapy for Voices and Dissociation

NCT04990414 | Completed Phase 2

• 1 other identifier: x145-119388
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Schizophrenia; Psychological Trauma; Dissociation; Hallucinations

Outcome Measures

Primary Outcomes (2)

• 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

  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

  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 Outcomes (5)

• Change in the Psychotic Symptoms Rating Scale - delusions subscale

  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

  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

  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

  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)

  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

Study Arms (1)

CBT for voices and dissociation

EXPERIMENTAL

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

Other: Cognitive Behavioural Therapy

Interventions

Cognitive Behavioural Therapy OTHER

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.

CBT for voices and dissociation

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Greater Manchester Mental Health NHS Foundation Trust: lead

Related Publications (1)

• 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.

  PMID: 32914542 RESULT

MeSH Terms

Conditions

Schizophrenia; Psychological Trauma; Dissociative Disorders; Hallucinations

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Clinical Lecturer

Model Details: Case series

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: August 4, 2021
• Study Start: November 24, 2013
• Primary Completion: January 29, 2019
• Study Completion: January 29, 2019
• Last Updated: August 4, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share