Feasibility study of Culturally adapted Cognitive Behaviour Therapy for psychosis for ethnic minority groups
| ISRCTN | ISRCTN95603741 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95603741 |
| Secondary identifying numbers | 7499 |
- 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
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
| Study design | Multicentre randomised interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 hypothesis | 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) |
| Condition | 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 | 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). |
| Secondary outcome measures | 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. |
| Overall study start date | 01/04/2009 |
| Overall study end date | 31/07/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned sample size: 40; UK sample size: 40 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/04/2009 |
| Recruitment end date | 31/07/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal South Hants Hospital
Southampton
SO14 0YG
United Kingdom
SO14 0YG
United Kingdom
Sponsor information
Hampshire Partnership NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Tatchbury Mount
Calmore
Southampton
SO40 2RZ
England
United Kingdom
| Website | http://www.hampshirepartnership.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/03qesm017 |
Funders
Funder type
Government
Department of Health (UK) - Delivering Race Equality Programme
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
