Feasibility study of Culturally adapted Cognitive Behaviour Therapy for psychosis for ethnic minority groups
| ISRCTN | ISRCTN95603741 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95603741 |
| Protocol serial number | 7499 |
| Sponsor | Hampshire Partnership NHS Foundation Trust (UK) |
| Funder | Department of Health (UK) - Delivering Race Equality Programme |
- Submission date
- 21/05/2010
- Registration date
- 21/05/2010
- Last edited
- 12/12/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Peter Phiri
Scientific
Scientific
Royal South Hants Hospital
Research & Development, 1st Floor
University Dept of Psychiatry
Brintons Terrace
Southampton
SO14 0YG
United Kingdom
| peter.phiri@hantspt-sw.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised interventional treatment trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A multicentre randomised interventional treatment trial to develop culturally sensitive Cognitive Behaviour Therapy (CBT) for psychosis for ethnic minority patients |
| Study acronym | CaCBTp |
| Study objectives | This study follows on from a recently conducted qualitative study using semi-structured interviews and focus groups to develop culturally sensitive cognitive behaviour therapy (CBT) for psychosis for ethnic minority patients by exploration and incorporation of service users' and health professionals' views and opinions. The project has been funded by delivering race equality (Department of Health) Clinical trailblazers group. We will now conduct a pilot randomised controlled trial (RCT) with an intervention (CaCBTp) in black and ethnic minority populations. Participants will be randomised to two groups: intervention or treatment as usual. Those in the intervention group will receive 16 sessions of CaCBTp over a 4 month period. |
| Ethics approval(s) | Southampton & South West Hampshire Research Ethics Committee (B) approved on the 28th January 2009 (ref: 09/H0504/4) |
| Health condition(s) or problem(s) studied | Topic: Mental Health Research Network; Subtopic: Schizophrenia, Psychosis; Disease: Schizophrenia, Psychosis |
| Intervention | Control group (TAU): Treatment as usual as provided by mental health services Treatment group (CaCBTp): 16 sessions of CaCBTp with a trained therapist over a four month period Follow up length: 6 months Study entry: single randomisation only |
| Intervention type | Other |
| Primary outcome measure(s) |
Reduction in overall Comprehensive Psychopathological Rating Scale (CPRS) scores post-therapy. Outcome is assessed at baseline, the end of the intervention period (4 months) and the end of the follow up period (6 months). |
| Key secondary outcome measure(s) |
Acceptability of intervention as assessed by satisfaction, number of sessions attended and drop-out rate. Outcome is assessed at the end of the intervention period and the end of the follow up period. |
| Completion date | 31/07/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Key inclusion criteria | 1. Diagnosis of schizophrenia using International Classification of Disease, version 10 (ICD-10) criteria 2. Belong to an ethnic minority community 3. Willingness to participate in the interview and have notes made and/or be tape recorded 4. Have capacity to consent and understand the interview 5. Able to speak English or willing to participate with the assistance of interpreters 5. Male and female, lower age limit of 18 years |
| Key exclusion criteria | 1. Severe illness which may affect capacity or markedly affect their ability to participate in the interviews 2. Lacks capacity or not giving consent 3. Those patients who in the opinion of the key worker would be thought to be distressed by the interview due to low insight |
| Date of first enrolment | 01/04/2009 |
| Date of final enrolment | 31/07/2010 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Royal South Hants Hospital
Southampton
SO14 0YG
United Kingdom
SO14 0YG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2013 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
