A Case Series of Culturally-adapted CBTp for Black People in the UK

NCT07252206 | Not Yet Recruiting

• 1 other identifier: NHS002287
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this case series study is to learn if culturally-adapted cognitive-behavioural therapy is practical, acceptable and safe among Black Sub-Saharan African and Caribbean people experiencing psychosis. The main question it aims to answer is: Is culturally-adapted CBT for psychosis feasible, acceptable to and safe for Black Sub-Saharan African and Caribbean people experiencing psychosis? Participants will be asked to:

• Answer some questionnaires about how things are at the moment
• Attend up to 16 sessions of therapy
• Answer the same questionnaires to see what has changed, if anything
• Complete a semi-structured interview about their expectations and experience of therapy

Conditions

Schizophrenia Spectrum Disorders; Psychosis

Outcome Measures

Primary Outcomes (1)

• Semi-structured qualitative interview: Service user acceptability

  Service user satisfaction as assessed by qualitative interview.

  End of therapy (16 weeks)

Secondary Outcomes (5)

• Working Alliance Inventory-Short Form Revised

  End of therapy (16 weeks)

• Adverse Events Checklist

  Each therapy session (16 weeks)

• Subjective Experience of Psychosis Scale

  End of therapy (16 weeks)

• Questionnaire about the Process of Recovery

  End of therapy (16 weeks)

• Depression, Anxiety and Stress Scales

  End of therapy (16 weeks)

Study Arms (1)

Therapy

EXPERIMENTAL

Behavioral: Culturally-adapted cognitive-behavioural therapy

Interventions

Culturally-adapted cognitive-behavioural therapy BEHAVIORAL

Cognitive-behavioural therapy for psychosis culturally-adapted for Black Sub-Saharan African and Caribbean people using a dedicated, integrated treatment manual

Therapy

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:

• Service users who identify as Black British, Black Caribbean, Black African, African-Caribbean or Mixed African/Caribbean with at least one parent and/or grandparent born in a Sub-Saharan African or Caribbean country
• People with a current ICD-10 schizophrenia spectrum disorder diagnosis, or who are currently receiving or have received support from an Early Intervention in Psychosis team
• years or older
• Sufficient understanding of English to complete study measures and engage with CBTp

You may not qualify if:

• Current, primary diagnosis of substance use disorder
• Organic aetiology of psychosis
• Lacking capacity to provide full informed consent
• Currently experiencing a mental health crisis (i.e., are open to a home-based treatment team; are currently under Section of the Mental Health Act or have been under Section in the past 3 months) or immediate high risk to self or others (i.e., current suicidal intent or plans; unmanaged and intense non-suicidal self-injury)
• Currently receiving CBTp or received CBTp within the preceding 3 months
• Unwilling to participate in culturally-adapted CBTp

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (1)

Greater Manchester Mental Health NHS Foundation Trust

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Peter Panayi

CONTACT

+44161 306 6000; peter.panayi@manchester.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: November 26, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)