An evaluation of the Cares of Life Project (CoLP): Fundamentally improving mental health services for Black people in Southwark

ISRCTN	ISRCTN06101946
DOI	https://doi.org/10.1186/ISRCTN06101946
Protocol serial number	N0042132131
Sponsor	King's College London (UK)
Funder	Guy's and St Thomas' Charitable Foundation (Grant code GO11019DF) (UK)

Submission date: 07/06/2007
Registration date: 14/09/2007
Last edited: 12/05/2011

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

Prof Graham Thornicroft
Scientific

Health Services and Population Research
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom

Study information

Primary study design	Interventional
Study design	A randomised controlled trial.
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	CoLP (Cares of Life Project)
Study objectives	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
Ethics approval(s)	South London and Maudsley Research Ethics Commitee, approved on 15 November 2002 (ref: 176/02)
Health condition(s) or problem(s) studied	Anxiety and /or depression
Intervention	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.
Intervention type	Other
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)
Key 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
Completion date	31/05/2006

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	80
Key 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
Key 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
Date of first enrolment	01/06/2002
Date of final enrolment	31/05/2006

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Health Services and Population Research

London
SE5 8AF
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	01/12/2010		Yes	No