- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07252206
A Case Series of Culturally-adapted CBTp for Black People in the UK
Culturally-adapted Cognitive-behavioural Therapy for Black Sub-Saharan African and Caribbean People Experiencing Psychosis: A Case Series
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Peter Panayi
- Phone Number: +44161 306 6000
- Email: peter.panayi@manchester.ac.uk
Study Locations
-
-
-
Manchester, United Kingdom
- Recruiting
- Greater Manchester Mental Health NHS Foundation Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
- 16 years or older
- Sufficient understanding of English to complete study measures and engage with CBTp
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Therapy
|
Cognitive-behavioural therapy for psychosis culturally-adapted for Black Sub-Saharan African and Caribbean people using a dedicated, integrated treatment manual
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Semi-structured qualitative interview: Service user acceptability
Time Frame: End of therapy (16 weeks)
|
Service user satisfaction as assessed by qualitative interview.
|
End of therapy (16 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Working Alliance Inventory-Short Form Revised
Time Frame: End of therapy (16 weeks)
|
Acceptability measured sessionally using the Working Alliance Inventory-Short Form Revised (Hatcher & Gillaspy, 2006)
|
End of therapy (16 weeks)
|
|
Adverse Events Checklist
Time Frame: Each therapy session (16 weeks)
|
Safety monitored sessionally using an Adverse Events Checklist developed for this study
|
Each therapy session (16 weeks)
|
|
Subjective Experience of Psychosis Scale
Time Frame: End of therapy (16 weeks)
|
Subjective distress measured by the Subjective Experience of Psychosis Scale (Haddock et al., 2011)
|
End of therapy (16 weeks)
|
|
Questionnaire about the Process of Recovery
Time Frame: End of therapy (16 weeks)
|
Perceived recovery measured by the Questionnaire about the Process of Recovery (Law et al., 2014)
|
End of therapy (16 weeks)
|
|
Depression, Anxiety and Stress Scales
Time Frame: End of therapy (16 weeks)
|
Emotional wellbeing measured by the Depression, Anxiety and Stress Scales (Lovibond & Lovibond, 1995)
|
End of therapy (16 weeks)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NHS002287
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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