Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N0042132131
Study information
Scientific title
Acronym
CoLP (Cares of Life Project)
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
Ethics approval(s)
South London and Maudsley Research Ethics Commitee, approved on 15 November 2002 (ref: 176/02)
Study design
A randomised controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Other
Study type
Not Specified
Patient information sheet
Condition
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
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 measures
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
Overall study start date
01/06/2002
Overall study end date
31/05/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Not Specified
Sex
Both
Target number of participants
80
Participant 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
Recruitment start date
01/06/2002
Recruitment end date
31/05/2006
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Health Services and Population Research
London
SE5 8AF
United Kingdom
Sponsor information
Organisation
King's College London (UK)
Sponsor details
Research and Development Office
Room W1.08
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
England
United Kingdom
Sponsor type
University/education
Website
ROR
Funders
Funder type
Charity
Funder name
Guy's and St Thomas' Charitable Foundation (Grant code GO11019DF) (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2010 | Yes | No |