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| An evaluation of the Cares of Life Project (CoLP): Fundamentally improving mental health services for Black people in Southwark |
| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN06101946 |
| Date ISRCTN assigned | 14/09/2007 |
| Local reference number(s) | N0042132131 |
| Public title | An evaluation of the Cares of Life Project (CoLP): Fundamentally improving mental health services for Black people in Southwark |
| Scientific title | |
| Acronym | CoLP (Cares of Life Project) |
| Disease/condition/study domain | Anxiety and /or depression |
| Study hypothesis | The primary hypothesis for the study was that compared to individuals who were randomised to the 'standard access' control group, individuals randomised to the 'rapid access' intervention group would after a 3-month follow-up period: 1. Show significantly improved levels of psychological well-being Secondary hypotheses were that individuals in the intervention group would: 1. Rate mental health services as being more culturally sensitive 2. Have greater trust in mental health services 3. Be more satisfied with mental health services 4. Have reduced negative beliefs about mental health services |
| Design/methodology | A randomised controlled trial. |
| Research ethics review | South London and Maudsley Research Ethics Commitee, approved on 15 November 2002 (ref: 176/02) |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Individuals who were referred to the service were included in the study if they met all of the following criteria: 1. Resident of the London Borough of Southwark 2. Of Black African origin (Black African individuals born in sub-Saharan Africa or born in the UK with at least one parent of sub-Saharan decent) or Black Caribbean origin (Black patients born in the Caribbean or born in the UK with at least one parent of Caribbean decent). 3. Scored positive for symptoms on the World Health Organisation Mental Health Checklist for Anxiety and Depression indicating a diagnosis of clinical depression (ICD-10 codes F32, F33.0 - F33.2) and/or anxiety (F40, F41.1, F41.2) 4. Consented to being randomised |
| Participants - exclusion criteria | 1. Non-English speaking 2. Resident of another borough 3. Did not score positive for symptoms on the WHO checklist for anxiety and depression |
| Patient information material | |
| Anticipated start date | 01/06/2002 |
| Anticipated end date | 31/05/2006 |
| Status of trial | Completed |
| Target number of participants | 80 |
| Interventions | The experimental group had rapid access to Community Health Workers who delivered a needs-led package of care comprising psychological therapies (cognitive behavioural therapy, Brief Solution Focused Therapy), health education, advocacy, mentoring and some physical health investigations (blood pressure and blood sugar testing). The control group had 'standard access.' Individuals were followed up after 3 months of receiving the intervention. |
| Primary outcome measure(s) | Psychological well-being and general functioning were rated using the following at baseline and 3-month follow-up: 1. General Health Questionnaire (GHQ-28) 2. Short Form 36 (SF-36) 3. Global Assessment of Functioning (GAF) |
| Secondary outcome measure(s) | 1. Perceived access to and cultural sensitivity of mental health services, rated using the Accessibility and Cultural Sensitivity Schedule (ACCeSS), assessed at baseline and 3-month follow-up 2. Satisfaction with mental health services rated using the Treatment Perceptions Questionnaire (TPQ) at 3-month follow-up 3. Trust in mental health services examined using the TRUST semi-structured interview schedule at 3-month follow-up 4. Cost of service use (CSRI) assessed at baseline and 3-month follow-up 5. The social context of mental health rated using the Shortened Life Events and Difficulties Schedule (SLEDS) at baseline and 3-month follow-up |
| Sources of funding | Guy's and St Thomas' Charitable Foundation (Grant code GO11019DF) (UK) |
| Sponsor name | King's College London (UK) |
| Sponsor details | Research and Development Office, Room W1.08 Institute of Psychiatry De Crespigny Park London United Kingdom SE5 8AF |
| Sponsor website | http://www.kcl.ac.uk/ |
| Contact name | Prof Graham Thornicroft |
| Contact details | Health Services and Population Research Institute of Psychiatry De Crespigny Park London United Kingdom SE5 8AF |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN06101946 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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