Condition category
Mental and Behavioural Disorders
Date applied
28/11/2012
Date assigned
29/11/2012
Last edited
03/08/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Some young people who experience psychological difficulties sometimes find it hard to carry on living the life they want to live; they might have problems going to school or college, finding a job or taking part in social activities. 'Social recovery' is a term used to describe when someone is living the life they want to despite having experienced psychological difficulties. We think that people might make a better social recovery if they work with a therapist using a technique called Social Recovery Cognitive Behavioural Therapy (SRCBT). This research project is being done to see whether working with a therapist in this way can help people to make a better social recovery.

Who can participate?
We are looking to recruit 170 people aged 16 to 25 years who present to youth services in Sussex, East Anglia and Manchester with severe and complex mental health problems and who have associated social disability (defined as 30 hours a week or less spent participating in structured activity). One hundred participants have been recruited to date (July 2015).

What does the study involve?
SRCBT is a relatively new therapy so we don't know whether or not it is helpful yet. To help us find out, we want to compare SRCBT with the care young people currently get. In order to do this, we will allocate people at random into two groups: one group will receive the SRCBT and the other group will not. The programme will last for 9 months with assessments at the beginning of the study, after 9 months, after 15 months and after 24 months. We are also evaluating the programme from the perspective of the participants.

What are the possible benefits and risks of participating?
We hope that the therapy will help those people who are offered it but we can't guarantee this. The information we find out from this research may help us to provide people with better help in the future. All participants will be reimbursed for their time and will also be entered into a prize draw on completion of the study. There are no known risks associated with participating in this study.

Where is the study run from?
Sussex Partnership NHS Foundation Trust, in collaboration with the University of Sussex, the University of East Anglia, The University of Manchester, Norfolk and Suffolk NHS Foundation Trust (NSFT) and Greater Manchester West Mental Health NHS Foundation Trust.

When is the study starting and how long is it expected to run for?
The start date of the study is January 2013. Recruitment of the first 100 participants was achieved by early 2014. Recruitment into the study will re-commence at the beginning of September 2015 with a target of 170 further participations. Recruitment will then continue for 15 months. All participants will be followed up for a period of 24 months. The study is due to end in 2019.

Who is funding the study?
National Institute of Health Research (NIHR) through the Health Technology Assessment (HTA) funding stream.

Who is the main contact?
Clio Berry (Trial Manager)
c.berry@sussex.ac.uk

Trial website

http://www.sussex.ac.uk/spriglab/research/current/prodigy

Contact information

Type

Scientific

Primary contact

Prof David Fowler

ORCID ID

Contact details

School of Psychology
Pevensey 2 5B9
University of Sussex
Falmer
BN1 9QH
United Kingdom
-
d.fowler@sussex.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 10/104/501, 13341

Study information

Scientific title

PRODIGY: Prevention of long-term social disability amongst young people with emerging psychological difficulties - a definitive randomised controlled trial of social recovery cognitive behavioural therapy

Acronym

Study hypothesis

Current hypothesis as of 31/07/2015:
The study is a definitive randomised controlled trial of cognitive behavioural therapy to prevent social disability amongst young people with emerging psychological difficulties.

The primary hypothesis is:
1. In young people who are socially disabled and have severe and complex non-psychotic mental health problems, SRCBT will be superior to ESC in improving social recovery (as measured by hours in constructive activity assessed on the Time Use Survey), over a 15-month follow-up period.

Secondary hypotheses are:
2. SRCBT will be superior to ESC in terms of cost-effectiveness.
3. SRCBT will be superior to ESC in effects on mental health symptoms (attenuated psychotic symptoms and emotional disturbance).

A successful internal pilot has confirmed the inclusion criteria, further informed the power calculation for the overall sample size, confirmed the feasibility of recruitment, clarified data management procedures, and evaluated the intervention from the subjective perspectives of participants.

The study will be a single blind, randomised controlled trial comparing standard care with standard care plus Social Recovery Cognitive Behavioural Therapy. Participants will be stratified by site, age, severity of social disability and symptomatic criteria, and randomised to treatment groups by a remote randomisation service applying a method of concealed allocation. The intervention will last for 9 months with assessments at baseline, 9 months, 15 months and 24 months. Participants will be recruited from early detection and youth services in Sussex, East Anglia and Manchester over a 15-month period.

Previous hypothesis:
The study is a pilot randomised controlled trial of cognitive behavioural therapy to prevent social disability amongst young people with emerging psychological difficulties. The aim of the study is to prepare for a large randomised controlled trial. The objectives are:

1. To provide an empirical basis to clarify inclusion criteria and gain information useful for power calculations in a future study
2. To estimate costs and effects in preparation for a health economic study
3. To assess recruitment rate, quality of data collection and follow up
4. To further clarify data management procedures building on experience in past trials
5. To refine the manual for intervention and undertake a highly detailed analysis of adherence to interventions to further clarify programmes of training, and define the level of experience of therapists required to undertake the intervention

The study will be a single blind, randomised controlled trial comparing standard care with standard care plus Social Recovery Cognitive Behavioural Therapy. Participants will be stratified by age, severity of social disability, and symptomatic criteria and randomised to treatment groups by a remote randomisation service applying a method of concealed allocation. The intervention will last for 9 months with assessments at baseline, 9 months and 15 months. A qualitative substudy will be embedded within the pilot trial to evaluate the intervention from the subjective perspectives of participants themselves. Participants will be recruited from early detection and youth services in East Anglia and Manchester over a 12 month period.

The primary hypothesis is that the intervention (Social Recovery Cognitive Behavioural Therapy) will lead to improvements in social recovery as measured by time spent in structured activity.

The secondary hypotheses are:
1. The intervention will reduce levels of attenuated psychotic symptoms and depression
2. The intervention will prove cost-effective

More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=13341 and http://www.nets.nihr.ac.uk/projects/hta/10104501

On 31/07/2015 the following changes were made to the trial record:
1. The overall trial end date was changed from 01/04/2015 to 01/02/2019.
2. The target number of participants was changed from 100 to 270.

Ethics approval

1. Norfolk Research Ethics Committee, 07/09/2012, ref: 12/EE/0311
2. NRES Committee North West – Preston, 24/07/2015, ref: 15/NW/0590

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 contact c.berry@sussex.ac.uk to request a patient information sheet

Condition

Mental Health / Psychosis

Intervention

1. Social Recovery focused Cognitive Behavioural Therapy
2. Standard care

The intervention is Social Recovery oriented Cognitive Behavioural Therapy (SRCBT) and will be delivered by trained cognitive behavioural therapists and Clinical Psychologists. During the therapy, the therapist works with the client to identify activities the client would like to do. The therapist and the client will then work together to try to understand anything that is making it difficult for the client to do these activities and to overcome these difficulties. The therapy aims to help the client to understand what they are experiencing and feeling, cope with it differently, and feel less worried when they do new things. The therapy sessions will be approximately weekly for up to 9 months.

The previous sponsor for this trial (up to 31/07/2015) was:
Norfolk and Suffolk NHS Foundation Trust
Hellesdon Hospital
Drayton High Road
Norwich
NR6 5BE
United Kingdom

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Current primary outcome measures:
Time Use Survey (hours per week in structured activity) at 15 month follow-up

Previous primary outcome measures:
Time Use Survey (hours per week in structured activity) at baseline, post-intervention and 15 month follow-up

Secondary outcome measures

Current secondary outcome measures:
Secondary outcomes include attenuated psychotic symptoms, anxiety, and depression (also assessed at baseline, 9 months, 15 months, and 24 months), in addition to time use at post-intervention (9 months) and 24 months, and intervention cost-effectiveness at 9 months, 15 months, and 24 months.

Previous secondary outcome measures:
Secondary outcomes include attenuated psychotic symptoms, anxiety, and depression. These are also assessed at baseline, 9 months, and 15 months.

Overall trial start date

01/02/2013

Overall trial end date

01/02/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Young people (male & female) aged 16 to 25 with severe and complex mental health problems showing early signs of persistent social disability
2. Presence of impairment in social and occupational functioning indicated by patterns of structured and constructive economic activity of less than 30 hours per week and a history of social impairment problems lasting for a period of longer than 6 months
3. Presence of severe and complex mental health problems defined operationally as:
3.1. Having attenuated psychotic symptoms which meet criteria for an At Risk Mental State; or
3.2. Having less severe attenuated psychotic symptoms but having severe and complex mental health problems which score at least 50 on the Global Assessment of Function Scale (which indicates the presence of severe symptoms of at least two of depression, anxiety, substance misuse, behavioural or thinking problems or subthreshold psychosis to the degree to impair function).
4. Also having a history of at least moderate symptoms persisting for longer than 6 months

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 270; UK Sample Size: 270; 100 participants have already been recruited

Participant exclusion criteria

1. Age below 16 or above 25
2. Active positive psychotic symptoms or history of first episode psychosis
3. Severe learning disability (those with mild to moderate learning difficulties will not be excluded)
4. Organic neurological disorder
5. Unable to fully understand and answer standardised assessment questions or give informed consent due to insufficient English language proficiency

Recruitment start date

01/02/2013

Recruitment end date

01/01/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Sussex Partnership NHS Foundation Trust
Research & Development Sussex Education Centre Millview Hospital Nevill Avenue
Hove
BN3 7HZ
United Kingdom

Trial participating centre

Norfolk and Suffolk NHS Foundation Trust
Hellesdon Hospital Drayton High Road
Norwich
NR6 5BE
United Kingdom

Trial participating centre

Greater Manchester West Mental Health NHS Foundation Trust
Trust Headquarters Bury New Road Prestwich
Manchester
M25 3BL
United Kingdom

Sponsor information

Organisation

Sussex Partnership NHS Foundation Trust

Sponsor details

Research & Development
Sussex Education Centre
Millview Hospital
Nevill Avenue
Hove
BN3 7HZ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.sussexpartnership.nhs.uk/

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

01/09/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25431429

Publication citations

Additional files

Editorial Notes