Evaluation of a carers' support programme

ISRCTN	ISRCTN78915298
DOI	https://doi.org/10.1186/ISRCTN78915298
Protocol serial number	PSI12-11
Sponsor	Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Funder	NHS Primary and Secondary Care Interface National Research and Development Programme (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	The 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) studied	Schizophrenia and other psychoses
Intervention	1. 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 type	Other
Primary outcome measure(s)	1. 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)
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/09/1999

Participant type(s)	Patient
Age group	Other
Sex	All
Key inclusion criteria	Carers 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 criteria	Does not match inclusion criteria
Date of first enrolment	01/03/1996
Date of final enrolment	01/09/1999

Institute of Psychiatry

London
SE5 8AZ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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