Condition category
Mental and Behavioural Disorders
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
11/09/2012
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

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

1. 2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12910336

Publication citations

  1. 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.

Additional files

Editorial Notes