ISRCTN ISRCTN78915298
DOI https://doi.org/10.1186/ISRCTN78915298
Secondary identifying numbers PSI12-11
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
11/09/2012
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

Dr George Szmukler
Scientific

Institute of Psychiatry
Maudsley Hospital
Denmark Hill
London
SE5 8AZ
United Kingdom

Phone +44 (0)20 7703 6333 ext 2349
Email g.szmukler@iop.kcl.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeOther
Scientific title
Study objectivesThe major aim of the study was to evaluate the effectiveness of a carer's support programme of intermediate intensity and duration. A secondary aim was to evaluate the adequacy of a stress-appraisal-coping model of caregiving.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSchizophrenia and other psychoses
Intervention1. Carers' support programme of intermediate intensity and duration, comprising of 6 individual family sessions in the carers' home followed by 12 fortnightly relatives' groups.
2. 'Standard care'.
Intervention typeOther
Primary outcome measure1. General Health Questionnaire (GHQ)
2. Assessment of physical status
3. Experience of Caregiving Inventory (ECI)
4. Involvement Evaluation Questionnaire (IEQ)
5. Brief Psychiatric Rating Scale (BPRS)
6. Health of the Nation Outcome Scales (NoNoS)
7. Camberwell Assessment of Needs (CAN)
8. Life Skills Profile (LSP)
9. Ways of Coping (WOC)
10. The Positive and Negative Affects Scale (PANAS)
11. Provision of Social Relationships (PSR)
12. Family Environment Scale (FES)
Secondary outcome measuresNot provided at time of registration
Overall study start date01/03/1996
Completion date01/09/1999

Eligibility

Participant type(s)Patient
Age groupOther
SexBoth
Target number of participantsNot provided at time of registration
Key inclusion criteriaCarers were relatives of patients suffering from a psychotic illness - schizophrenia, schizoaffective disorder, bipolar affective disorder or psychotic depression - under the care of the mental health services. All eligible carers in a defined catchment area of inner southeast London were identified and offered participation in the project.
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment01/03/1996
Date of final enrolment01/09/1999

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Institute of Psychiatry
London
SE5 8AZ
United Kingdom

Sponsor information

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Primary and Secondary Care Interface National Research and Development Programme (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/08/2003 Yes No