Contact information
Type
Scientific
Primary contact
Dr George Szmukler
ORCID ID
Contact details
Institute of Psychiatry
Maudsley Hospital
Denmark Hill
London
SE5 8AZ
United Kingdom
+44 (0)20 7703 6333 ext 2349
g.szmukler@iop.kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PSI12-11
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Other
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
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)
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/03/1996
Overall trial end date
01/09/1999
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/03/1996
Recruitment end date
01/09/1999
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Institute of Psychiatry
London
SE5 8AZ
United Kingdom
Sponsor information
Organisation
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Primary and Secondary Care Interface National Research and Development Programme (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
Basic results (scientific)
Publication list
1. 2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12910336
Publication citations
-
Results
Szmukler G, Kuipers E, Joyce J, Harris T, Leese M, Maphosa W, Staples E, An exploratory randomised controlled trial of a support programme for carers of patients with a psychosis., Soc Psychiatry Psychiatr Epidemiol, 2003, 38, 8, 411-418, doi: 10.1007/s00127-003-0652-1.