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
Protocol serial number	JUMRC6002
Sponsor	Brent Mental Health Service (UK)
Funder	Funded by Brent Mental Health Service and The Brent Relapse Prevention Programme (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	RPGP
Study objectives	Following 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) studied	Schizophrenia
Intervention	Relapse prevention programme as opposed to treatment as usual
Intervention type	Other
Primary outcome measure(s)	1. Increased self-efficacy 2. Greater knowledge in medication, support services and illnesses 3. Improved quality of life 4. Reduced severity of symptomatology
Key secondary outcome measure(s)	1. Decrease in admission rates 2. Decrease in length of stay following admission 3. Increase in the attendance rates of hospital appointments
Completion date	11/05/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	45 Years
Sex	All
Target sample size at registration	96
Key inclusion criteria	1. 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 criteria	1. 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 CPNs 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 enrolment	11/09/2006
Date of final enrolment	11/05/2007

Park Royal Centre for Mental Health

London
NW10 7NS
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	01/09/2008		Yes	No