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Register:	ISRCTN
Last refreshed on:	13 January 2015
Main ID:	ISRCTN83557988
Date of registration:	25/06/2003
Prospective Registration:	No
Primary sponsor:	King's College London (UK)
Public title:	Psychological Prevention of Relapse in Psychosis
Scientific title:	A randomised controlled trial of cognitive behavioural therapy and family intervention for the prevention of relapse and reduction of symptoms in psychosis
Date of first enrolment:	01/12/2001
Target sample size:	301
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN83557988
Study type:	Interventional
Study design:	Randomised controlled trial (Treatment)
Phase:

Countries of recruitment
United Kingdom

Contacts

Name:	Philippa Garety
Address:	Department of Psychology PO Box 77 Institute of Psychiatry Denmark Hill SE5 8AF London United Kingdom
Telephone:	+44 (0)20 7848 0197
Email:	P.Garety@iop.kcl.ac.uk
Affiliation:

Name:
Address:
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Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria: Participants are recruited from identified psychiatric teams in four NHS Trusts.

Entry criteria:
1. Current diagnosis of psychosis
2. Non-affective (International Statistical Classification of Diseases and Related Health Problems, Tenth edition [ICD-10], F20)
3. Aged 18 to 65 years, either sex
4. Second or subsequent episode, which started not more than three months before entry
5. Rated at least four (moderate severity) on the Positive and Negative Syndrome Scale (PANSS) on at least one positive psychotic symptom
Exclusion criteria: Added 03/03/2009:
1. Primary diagnosis of alcohol or substance dependency, organic syndrome or learning disability
2. Inadequate command of English to engage in psychological therapy
3. Unstable residential arrangements and so unlikely to be available for therapy and/or assessments over period of trial

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Psychosis
Mental and Behavioural Disorders
Psychosis

Intervention(s)

For participants with carers:
1. Cognitive behavioural therapy (CBT) and treatment as usual (TAU)
2. Family intervention (FI) and TAU
3. TAU only

For participants with no carers:
1. CBT and TAU
2. TAU only

Primary Outcome(s)

Relapse and days in hospital over 24 months.

Secondary Outcome(s)

1. Pattern of symptom change (PANSS total scores and subscale scores, Psychotic SYmptom RATing Scales [PSYRATS], Beck Depression Inventory [BDI], Beck Anxiety Inventory [BAI]) over 12 and 24 months
2. Social functioning (time budget) at 24 months

Secondary ID(s)

062452

Source(s) of Monetary Support

The Wellcome Trust (UK) (grant ref: 062452)

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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