PsychosisNCT07252206
A Case Series of Culturally-adapted CBTp for Black People in the UK
A study testing Culturally-adapted cognitive-behavioural therapy in people with Psychosis and Schizophrenia Spectrum Disorders, run by University of Manchester at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Psychosis, Schizophrenia Spectrum Disorders
- What is being tested?
- Culturally-adapted cognitive-behavioural therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Feb 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Greater Manchester Mental Health NHS Foundation Trust
Manchester
About this study
Official title: 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
- Conditions
- Psychosis, Schizophrenia Spectrum Disorders
- Being tested
- Culturally-adapted cognitive-behavioural therapy
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally-adapted cognitive-behavioural therapyBehavioural
Cognitive-behavioural therapy for psychosis culturally-adapted for Black Sub-Saharan African and Caribbean people using a dedicated, integrated treatment manual
| Study group | Role | What they receive |
|---|---|---|
| Therapy | Experimental | Not described Receives: Behavioral: Culturally-adapted cognitive-behavioural therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semi-structured qualitative interview: Service user acceptability
Service user satisfaction as assessed by qualitative interview.
Measured: End of therapy (16 weeks)
Secondary outcomes (5)
Working Alliance Inventory-Short Form Revised
Acceptability measured sessionally using the Working Alliance Inventory-Short Form Revised (Hatcher \& Gillaspy, 2006)
Measured: End of therapy (16 weeks)
Adverse Events Checklist
Safety monitored sessionally using an Adverse Events Checklist developed for this study
Measured: Each therapy session (16 weeks)
Subjective Experience of Psychosis Scale
Subjective distress measured by the Subjective Experience of Psychosis Scale (Haddock et al., 2011)
Measured: End of therapy (16 weeks)
Questionnaire about the Process of Recovery
Perceived recovery measured by the Questionnaire about the Process of Recovery (Law et al., 2014)
Measured: End of therapy (16 weeks)
Depression, Anxiety and Stress Scales
Emotional wellbeing measured by the Depression, Anxiety and Stress Scales (Lovibond \& Lovibond, 1995)
Measured: End of therapy (16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start24 Feb 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Panayi, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252206
- Sponsor's protocol ID
- NHS002287
- Status last verified
- Nov 2025
- First submitted
- 30 Sep 2025
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally-adapted Cognitive-behavioural Therapy for Black Sub-Saharan African and Caribbean People Experiencing Psychosis: A Case Series
- ClinicalTrials.gov ID
- NCT07252206
- Acronym / sponsor ID
- NHS002287
- Conditions
- Psychosis, Schizophrenia Spectrum Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 24 Feb 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Therapy | Experimental | Behavioral: Culturally-adapted cognitive-behavioural therapy |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culturally-adapted cognitive-behavioural therapyCognitive-behavioural therapy for psychosis culturally-adapted for Black Sub-Saharan African and Caribbean people using a dedicated, integrated treatment manual | Behavioural | Therapy |
Primary outcome
Semi-structured qualitative interview: Service user acceptability
Time frame: End of therapy (16 weeks)
Service user satisfaction as assessed by qualitative interview.
5 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally-adapted cognitive-behavioural therapy in people with Psychosis and Schizophrenia Spectrum Disorders, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Panayi (+44161 306 6000, peter.panayi@manchester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Semi-structured qualitative interview: Service user acceptability (time frame: End of therapy (16 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.