Relapse Prevention Group Programme for service users with an international statistical classification of diseases and related health problems (ICD10, chapter F20) diagnosis of schizophrenia in a community setting - a randomised controlled trial

ISRCTN ISRCTN11138647
DOI https://doi.org/10.1186/ISRCTN11138647
Secondary identifying numbers JUMRC6002
Submission date
29/06/2006
Registration date
27/07/2006
Last edited
04/02/2010
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

Mr Rami Jumnoodoo
Scientific

Park Royal Centre for Mental Health
Acton Lane
Central Way
London
NW10 7NS
United Kingdom

Phone +44 (0)20 8955 4444
Email rami.jumnoodoo@nhs.net

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymRPGP
Study objectivesFollowing an eight week Relapse Prevention (RP) programme, service users have:
1. Decrease in admission rates
2. Decrease in length of stay following admission
3. Increase in the attendance rates of hospital appointments
4. Increased their self-efficacy
5. Greater knowledge in medication, support services and illnesses
6. Improved quality of life
7. Reduced severity of symptomatology

It is expected that there will be a significant difference in these variables between individuals receiving the RP programme (treatment group) and individuals receiving treatment as usual (comparison group) that this is maintained at three and six months follow-up.
Ethics approval(s)COREC - Brent Medical Ethics Committee
Health condition(s) or problem(s) studiedSchizophrenia
InterventionRelapse prevention programme as opposed to treatment as usual
Intervention typeOther
Primary outcome measure1. Increased self-efficacy
2. Greater knowledge in medication, support services and illnesses
3. Improved quality of life
4. Reduced severity of symptomatology
Secondary outcome measures1. Decrease in admission rates
2. Decrease in length of stay following admission
3. Increase in the attendance rates of hospital appointments
Overall study start date11/09/2006
Completion date11/05/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit45 Years
SexBoth
Target number of participants96
Key inclusion criteria1. Newly diagnosed by a Community Psychiatric Nurse (CPN)
2. Age group 18-45, men and women
3. Have a diagnosis of schizophrenia (ICD 10-F20)
4. Sufficiently stable to take part in the programme
5. Assessment conducted by CPN
6. Living in the community
7. Be able to consent to participate
8. Be on a therapeutic dose of anti-psychotic medication
Key exclusion criteria1. Patients who do not speak English or cannot use an interpreter because this will be another confounder to the study
2. Patients with drug dependency as indicated by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)although alcohol/drug abusers will still be eligible for the study. The DSM- IV criterion for abuse is very restrictive and would capture most alcohol/drug use by mental health service users. The CPN’s will be provided with this to make this assessment
3. Organic brain diseases (e.g. dementia) as assessed by the psychiatrist. The psychiatrist will be asked to assess whether the patient is capable of giving informed consent and understanding what they have been asked to do
4. Patients who have previously been treated with RP
5. Patients who refuse to provide consent
Date of first enrolment11/09/2006
Date of final enrolment11/05/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Park Royal Centre for Mental Health
London
NW10 7NS
United Kingdom

Sponsor information

Brent Mental Health Service (UK)
Hospital/treatment centre

32 London Road
Wembley
Middlesex
HA9 7SS
England
United Kingdom

Funders

Funder type

Hospital/treatment centre

Funded by Brent Mental Health Service and The Brent Relapse Prevention 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 01/09/2008 Yes No