Psychological Prevention of Relapse in Psychosis

Plain English Summary

Not provided at time of registration

Study website

Type

Scientific

Contact name

Prof Philippa Garety

ORCID ID

Contact details

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

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Protocol/serial number

062452

Scientific title

A randomised controlled trial of cognitive behavioural therapy and family intervention for the prevention of relapse and reduction of symptoms in psychosis

Acronym

PRP

Study hypothesis

The trial is designed to answer questions both about outcome and about mechanisms of treatment change of Cognitive Behaviour Therapy (CBT) and Family Intervention (FI) for psychosis. The trial consists of two pathways (for those with carers and those without) incorporating randomisation within each pathway, after stratification by treatment centre and whether the participant is an inpatient at the time of recruitment.

Trial I has two conditions: CBT and Treatment As Usual (TAU).
Trial II has three conditions: CBT, FI and TAU.

Primary Outcome hypotheses:
1. In Trial Pathway I, CBT will reduce rates of relapse and total days in hospital in the two year follow up compared to TAU, and that CBT will be cost neutral.
2. In Trial Pathway II, Both CBT and FI will reduce relapse and days in hospital at two year follow up compared with TAU, and that CBT and FI will be cost neutral.

Secondary outcome hypotheses:
1. CBT and FI will both reduce relapse and psychotic and emotional symptoms at 12 months (end of treatment) compared with TAU. The main change in psychotic symptoms will be in delusions and hallucinations.
2. FI, but not CBT, will increase social functioning compared to TAU at 24 months.
3. CBT, but not FI, will reduce psychotic and emotional symptoms at 24 months compared with TAU.

Ethics approval(s)

Added 03/03/2009: South East Multi-Centre Research Ethics Committee gave approval on the 4th June 2001 (ref: MREC01/1/24). All local research ethics committees also subsequently approved the study.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

Other

Study type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Psychosis

Intervention

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

Intervention type

Other

Primary outcome measure

Relapse and days in hospital over 24 months.

Secondary outcome measures

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

Overall study start date

01/12/2001

Overall study end date

31/10/2006

Reason abandoned (if study stopped)

Participant 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

Participant type(s)

Patient

Age group

Adult

Lower age limit

18 Years

Sex

Both

Target number of participants

301

Participant 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

Recruitment start date

01/12/2001

Recruitment end date

31/10/2006

Countries of recruitment

England, United Kingdom

Study participating centre

Department of Psychology
London
SE5 8AF
United Kingdom

Organisation

King's College London (UK)

Sponsor details

Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
England
United Kingdom
+44 (0)20 7848 0675
g.dale@iop.kcl.ac.uk

Sponsor type

University/education

Website

http://www.iop.kcl.ac.uk

ROR

https://ror.org/0220mzb33

Funder type

Charity

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Individual participant data (IPD) sharing plan

IPD sharing plan summary

Not provided at time of registration

Study outputs