Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

062452

Study information

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

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

Trial setting

Other

Trial 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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/12/2001

Overall trial end date

31/10/2006

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

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

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Psychology
London
SE5 8AF
United Kingdom

Sponsor information

Organisation

King's College London (UK)

Sponsor details

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

Sponsor type

University/education

Website

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

Funders

Funder type

Charity

Funder name

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

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. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16889588
2. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18515890
3. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22499781
4. 2012 subgroup analysis results in http://www.ncbi.nlm.nih.gov/pubmed/21939591
5. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/22499781

Publication citations

  1. Results

    Fialko L, Freeman D, Bebbington PE, Kuipers E, Garety PA, Dunn G, Fowler D, Understanding suicidal ideation in psychosis: findings from the Psychological Prevention of Relapse in Psychosis (PRP) trial., Acta Psychiatr Scand, 2006, 114, 3, 177-186, doi: 10.1111/j.1600-0447.2006.00849.x.

  2. Results

    Garety PA, Fowler DG, Freeman D, Bebbington P, Dunn G, Kuipers E, Cognitive--behavioural therapy and family intervention for relapse prevention and symptom reduction in psychosis: randomised controlled trial., Br J Psychiatry, 2008, 192, 6, 412-423, doi: 10.1192/bjp.bp.107.043570.

  3. Results

    Garety PA, Gittins M, Jolley S, Bebbington P, Dunn G, Kuipers E, Fowler D, Freeman D, Differences in cognitive and emotional processes between persecutory and grandiose delusions., Schizophr Bull, 2013, 39, 3, 629-639, doi: 10.1093/schbul/sbs059.

  4. Subgroup analysis results

    Dunn G, Fowler D, Rollinson R, Freeman D, Kuipers E, Smith B, Steel C, Onwumere J, Jolley S, Garety P, Bebbington P, Effective elements of cognitive behaviour therapy for psychosis: results of a novel type of subgroup analysis based on principal stratification., Psychol Med, 2012, 42, 5, 1057-1068, doi: 10.1017/S0033291711001954.

  5. Results

    Garety PA, Gittins M, Jolley S, Bebbington P, Dunn G, Kuipers E, Fowler D, Freeman D, Differences in cognitive and emotional processes between persecutory and grandiose delusions., Schizophr Bull, 2013, 39, 3, 629-639, doi: 10.1093/schbul/sbs059.

Editorial Notes