ClinicalTrials.gg
RecruitingNCT07252206Updated Jul 10, 2026

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

An interventional study of Culturally-adapted cognitive-behavioural therapy in Psychosis and Schizophrenia Spectrum Disorders, sponsored by University of Manchester. Recruiting at 1 site in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-07-10.

Sponsored by University of Manchester · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2026; still recruiting 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
16 Years and older
Sex
All
01

Study 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
02

Conditions studied

  • Psychosis
  • Schizophrenia Spectrum Disorders

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03

In context

Psychotic Disorders

1,587 studies on the registry are indexed under Psychotic Disorders; 281 are open to participants now.

This study's planned enrollment of 6 is below the median of 65 across 1,320 interventional studies indexed under Psychotic Disorders.

Browse Psychotic Disorders studies →

Lead sponsor

University of Manchester is the lead sponsor of 201 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Current, primary diagnosis of substance use disorder
  • Organic aetiology of psychosis
  • Lacking capacity to provide full
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (estimated)

Study arms

  • Experimental
    Therapy

    Behavioral: Culturally-adapted cognitive-behavioural therapy

Interventions

  • BehavioralCulturally-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

06

What researchers measure

Primary outcomes

  1. Semi-structured qualitative interview: Service user acceptability

    Service user satisfaction as assessed by qualitative interview.

    Time frame: End of therapy (16 weeks)

Secondary outcomes

  1. Working Alliance Inventory-Short Form Revised

    Acceptability measured sessionally using the Working Alliance Inventory-Short Form Revised (Hatcher \& Gillaspy, 2006)

    Time frame: End of therapy (16 weeks)

  2. Adverse Events Checklist

    Safety monitored sessionally using an Adverse Events Checklist developed for this study

    Time frame: Each therapy session (16 weeks)

  3. Subjective Experience of Psychosis Scale

    Subjective distress measured by the Subjective Experience of Psychosis Scale (Haddock et al., 2011)

    Time frame: End of therapy (16 weeks)

  4. Questionnaire about the Process of Recovery

    Perceived recovery measured by the Questionnaire about the Process of Recovery (Law et al., 2014)

    Time frame: End of therapy (16 weeks)

  5. Depression, Anxiety and Stress Scales

    Emotional wellbeing measured by the Depression, Anxiety and Stress Scales (Lovibond \& Lovibond, 1995)

    Time frame: End of therapy (16 weeks)

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2026 (actual). Primary completion is estimated for Dec 2026, 10 months after the start.

Of 455 non-industry interventional studies with no phase under Psychotic Disorders, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 52. This study's planned 10 months is below that.

Counting every sponsor, half of 457 studies reached it within 34 months; a quarter within 19 and three quarters within 52.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 30, 2025
First posted
Nov 26, 2025
StartActual
Feb 24, 2026
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2026
Last update
Jul 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07252206
Responsible party
Peter Panayi (Principal Investigator, University of Manchester) — Principal investigator
First posted
Nov 26, 2025
Start date
Feb 24, 2026
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jul 10, 2026

Study contacts

Peter Panayi
Contact
peter.panayi@manchester.ac.uk
+44161 306 6000

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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