Condition category
Mental and Behavioural Disorders
Date applied
07/06/2007
Date assigned
14/09/2007
Last edited
12/05/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Graham Thornicroft

ORCID ID

Contact details

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

Additional identifiers

EudraCT 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

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

Trial setting

Other

Trial 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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/06/2002

Overall trial end date

31/05/2006

Reason abandoned

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

Patient

Age group

Not Specified

Gender

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

United Kingdom

Trial 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
United Kingdom

Sponsor type

University/education

Website

http://www.kcl.ac.uk/

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20547421

Publication citations

  1. Results

    Afuwape SA, Craig TK, Harris T, Clarke M, Flood A, Olajide D, Cole E, Leese M, McCrone P, Thornicroft G, The Cares of Life Project (CoLP): an exploratory randomised controlled trial of a community-based intervention for black people with common mental disorder., J Affect Disord, 2010, 127, 1-3, 370-374, doi: 10.1016/j.jad.2010.05.017.

Additional files

Editorial Notes