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ISRCTN
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ISRCTN06101946
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ClinicalTrials.gov identifier
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Public title
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An evaluation of the Cares of Life Project (CoLP): Fundamentally improving mental health services for Black people in Southwark
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Scientific title
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Acronym
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CoLP (Cares of Life Project)
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Serial number at source
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N0042132131
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Study hypothesis
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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
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Ethics approval
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South London and Maudsley Research Ethics Commitee, approved on 15 November 2002 (ref: 176/02)
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Study design
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A randomised controlled trial.
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Anxiety and /or depression
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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1. Non-English speaking
2. Resident of another borough
3. Did not score positive for symptoms on the WHO checklist for anxiety and depression
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Anticipated start date
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01/06/2002
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Anticipated end date
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31/05/2006
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Status of trial
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Completed
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Patient information material
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Target number of participants
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80
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Interventions
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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.
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Primary outcome measure(s)
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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)
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Secondary outcome measure(s)
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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
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Sources of funding
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Guy's and St Thomas' Charitable Foundation (Grant code GO11019DF) (UK)
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Trial website
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Publications
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Contact name
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Prof
Graham
Thornicroft
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Address
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Health Services and Population Research
Institute of Psychiatry
De Crespigny Park
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City/town
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London
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Zip/Postcode
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SE5 8AF
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Country
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United Kingdom
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Sponsor
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King's College London (UK)
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Address
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Research and Development Office, Room W1.08
Institute of Psychiatry
De Crespigny Park
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City/town
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London
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Zip/Postcode
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SE5 8AF
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Country
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United Kingdom
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Sponsor website:
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http://www.kcl.ac.uk/
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Date applied
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07/06/2007
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Last edited
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14/09/2007
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Date ISRCTN assigned
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14/09/2007
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