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Recruiting NCT07252206

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

No phase Interventional Psychosis Schizophrenia Spectrum Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Culturally-adapted cognitive-behavioural therapy.
Who it may be relevant to
Registry conditions: Psychosis, Schizophrenia Spectrum Disorders. Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Culturally-adapted Cognitive-behavioural Therapy for Black Sub-Saharan African and Caribbean People Experiencing Psychosis: A Case Series

Overview

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

Interventions

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

Primary outcome measures

  • Semi-structured qualitative interview: Service user acceptability [Time frame: End of therapy (16 weeks)]
Secondary outcome measures (5)
  • Working Alliance Inventory-Short Form Revised [Time frame: End of therapy (16 weeks)]
  • Adverse Events Checklist [Time frame: Each therapy session (16 weeks)]
  • Subjective Experience of Psychosis Scale [Time frame: End of therapy (16 weeks)]
  • Questionnaire about the Process of Recovery [Time frame: End of therapy (16 weeks)]
  • Depression, Anxiety and Stress Scales [Time frame: End of therapy (16 weeks)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United Kingdom · 1 center
  • Greater Manchester Mental Health NHS Foundation Trust — Manchester

Identifiers

NCT: NCT07252206 · NHS002287

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗