Testing the clinical effectiveness of Social Recovery Therapy for people with psychosis and social disability

ISRCTN ISRCTN11089633
DOI https://doi.org/10.1186/ISRCTN11089633
Integrated Research Application System (IRAS) 346911
Central Portfolio Management System (CPMS) 63757
National Institute for Health and Care Research (NIHR) NIHR169529
Sponsor Sussex Partnership NHS Foundation Trust
Funder National Institute for Health and Care Research
Submission date
24/03/2026
Registration date
08/04/2026
Last edited
08/04/2026
Recruitment status
Not yet recruiting
Overall study status
Ongoing
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Schizophrenia spectrum disorders are the mental health problems most frequently associated with poor social outcomes and the personal and economic costs are large, particularly for those from minoritised groups. Existing psychosocial interventions have small and short-term effects on social functioning, with the effects being weakest for people experiencing more severe social disability. We have conducted two early-phase randomised controlled trials of a novel intervention, social recovery therapy (SRT) with promising effects, but a definitive trial is needed to demonstrate effectiveness and confirm wider implementation.
Our primary hypothesis is that in people experiencing persistent social disability in the context of a schizophrenia spectrum diagnosis, social recovery therapy plus treatment as usual (SRT+TAU) will be superior to TAU alone on the primary outcome of time spent in structured activity, measured using the Time Use Survey. Secondary outcomes will include psychotic symptoms, mood, hopefulness, and quality of life. We will also test the hypothesis that SRT will be cost-effective compared to TAU. We will collect data on intervention maintenance effects at 24 months using data from patient records on employment and education, service engagement, and relapse. Alongside the trial we will conduct a mixed-methods process evaluation to understand implementation, causal mechanisms and contextual factors which shape outcomes, with a particular focus on the experiences of underserved groups and any adaptations required to increase cultural sensitivity.

Who can participate?
Working age adults (18 – 65 years old) with non-affective psychosis, presenting with less than 30 hours in structured activity per week.

What does the study involve?
Participants who agree to take part will be asked to complete questionnaires at three timepoints. Participants allocated to the intervention group will receive social recovery therapy in addition to usual care, whilst participants allocated to the control group will receive usual care.

What are the possible benefits and risks of participating?
Participants will get a chance to meet with a researcher to identify meaningful activities for themselves, have regular meetings with a therapist and receive three £20 vouchers.
People may feel pressured into undertaking new activities, which could result in the returning or worsening of certain psychological difficulties.

Where is the study run from?
1. Norfolk and Suffolk NHS Foundation Trust (UK)
2. Cambridgeshire and Peterborough NHS Foundation Trust (UK)
3. Sussex Partnership NHS Foundation Trust (UK)
4. Pennine Care NHS Foundation Trust (UK)
5. Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
July 2026 to December 2029

Who is funding the study?
NIHR Health Technology Assessment (UK)

Who is the main contact?
1. Dr Joanne Hodgekins, j.hodgekins@uea.ac.uk
2. Lauren Ooi, isrip.study@uea.ac.uk

Contact information

Lauren Ooi
Public

Norwich Clinical Trials Unit
Norwich Medical School
University of East Anglia
Norwich
NR4 7TJ
United Kingdom

ORCiD logoORCID ID 0000-0002-8312-8207
Email isrip.study@uea.ac.uk
Dr Joanne Hodgekins
Scientific, Principal investigator

Department of Clinical Psychology and Psychological Therapies (CPPT)
Norwich Medical School
University of East Anglia
Norwich
NR4 7TJ
United Kingdom

ORCiD logoORCID ID 0000-0003-4124-854X
Email j.hodgekins@uea.ac.uk

Study information

Primary study designInterventional
Study designRandomized controlled trial
Secondary study designRandomised controlled trial
Scientific titleImproving Social Recovery in Psychosis (ISRIP): a definitive randomised controlled trial and process evaluation of Social Recovery Therapy compared to treatment as usual for people with psychosis and severe social disability
Study acronymISRIP
Study objectives Primary Objective:
1. Determining whether Social Recovery Therapy plus Treatment as Usual (intervention) will be superior to Treatment as Usual alone (control) in improving social recovery at 15 months post-randomisation.

Study Objectives:
1. Assessing whether Social Recovery Therapy plus Treatment as Usual (intervention) will be superior to Treatment as Usual alone (control) in improving social recovery at 9 months post-randomisation.
2. Evaluating mental health symptoms at 9 and 15 months post-randomisation.
3. Assessing service user-defined recovery at 9 and 15 months post-randomisation.
4. Evaluating quality of life and hope at 9 and 15 months post-randomisation.
5. Evaluating the cost-effectiveness of the intervention compared to the control at 9 and 15 months post-randomisation.
6. Explore the maintenance of intervention effects at 24 months post-randomisation.

An embedded mixed-methods process evaluation will address the following aims:   
1. Assess the extent to which SRT was implemented as intended, by measuring treatment fidelity, dose and reach 
2. Explore patterns of uptake and adherence to SRT, with particular focus on underserved groups  
3. Test hypothesised mechanisms of change of SRT  
4. Explore participant, family and therapist experiences of SRT, with a particular focus on the experiences of underserved groups and any adaptations made to increase cultural sensitivity 
5. Identify contextual factors that maximise intervention delivery and interact with effectiveness, to inform implementation
Ethics approval(s)

Submitted 11/02/2026, London - Bloomsbury Research Ethics Committee (Health Research Authority, 2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; -; bloomsbury.rec@hra.nhs.uk), ref: 26/LO/0203

Health condition(s) or problem(s) studiedPsychosis
InterventionThis study will use an assessor-blind randomised controlled trial design to compare Social Recovery Therapy plus treatment as usual (SRT + TAU) to TAU alone, with a 9-month intervention period and a 24-month follow-up period. An embedded process evaluation will inform interpretation of outcomes and provide understanding of how SRT might be applied in routine practice, with a particular focus on delivery to under-served groups.

We will recruit working-age adults who have non-affective psychosis (schizophrenia spectrum diagnosis) and social disability (defined as activity levels lower than 30 hours per week) from community-based mental health services across five UK sites. Participants will be approached about the study by their clinical teams and asked if they would be interested in taking part. Following verbal consent to contact, participants will be provided with a Participant Information Sheet (PIS) by a member of the research team and asked to provide informed consent for their participation. Following a screening and baseline assessment, participants will be randomised to receive either SRT + TAU or TAU alone. SRT will be delivered by NHS-employed non-expert psychological practitioners, trained and supervised by SRT experts. The intervention period will last for 9 months, with approximately weekly to fortnightly sessions.

Research assessments will be conducted by trained research assistants (RAs) at baseline, 9 months (end of treatment), and 15 months (primary follow-up). Assessment procedures have been designed to be flexible and are based on assertive outreach principles, which involves the delivery of assessments wherever most suitable for the participant. Assessments are likely to take up to 2 hours but can be split over several assessment visits. Participants will be supported by study RAs to complete outcome measures, either face-to-face or online where requested by the participant. All RAs will receive training and supervision in engaging individuals with psychosis, as well as training in completing the outcome measures. We will also provide cultural competency training to all research staff.

At 24 months, data linkage with the NHS England Mental Health Services Dataset (MHSDS) will be used to collect routine data on service use and education/employment status. Participants will also be contacted by an automated text message to ask about their education and employment since the last follow-up visit. This method of data collection has been chosen to reduce attrition from in-person research visits and loss to follow-up. Information about data linkage is included in the PIS.

Following the end of the intervention period, participants will be invited to take part in a qualitative interview, lasting approximately 1 hour, about their experiences of the study and the intervention. We will also invite family members to share their experiences in a separate interview and will seek specific informed consent from family members to participate in this.

In addition, we will seek consent from SRT therapists to complete feedback questionnaires before and after they receive SRT training and the extent to which they expect the intervention will cause a positive change in social recovery for people with psychosis. At the end of the intervention period, SRT therapists will be invited to participate in a qualitative interview, lasting approximately 1 hour, about their experiences of delivering the intervention, with a specific focus on understanding any adaptations made for under-served groups. A separate PIS and consent form has been developed for trial therapists.

Wider stakeholders from NHS mental health services (e.g., team leads, service managers) will be invited to participate in focus groups to explore their views on SRT and the potential ‘fit’ of the approach within standard care for people with psychosis. We will explore suggestions for improvements and wider perspectives on the team and service context. This will include potential barriers and facilitators of SRT implementation, including uptake, engagement, delivery feasibility and acceptability, as well as the service resource and training needs required.
Intervention typeBehavioural
Primary outcome measure(s)

Hours per week in structured activity, assessed through the Time Use Survey at 15 months post-randomisation

Key secondary outcome measure(s)

1. Hours per week in structured activity assessed using the Time Use Survey at 9 months
2. Functioning assessed using Recovering Quality of Life (ReQoL), Goal-Based Outcomes, and the WHO Disability Assessment Schedule (WHO-DAS) at baseline, 9 and 15 months post-randomisation
3. Quality of life assessed using EQ-5D-5L at baseline, 9 and 15 months post-randomisation
4. Psychotic symptoms assessed using Clinical Global Impression-Schizophrenia (CGI-SCH) and Scale for the Assessment of Negative Symptoms (SANS) at baseline, 9 and 15 months post-randomisation
5. Mood assessed using Patient Health Questionnaire-9 (PHQ-9) and Generalised Anxiety Disorder-7 (GAD-7) at baseline, 9 and 15 months post-randomisation
6. Hopelessness and suicidal ideation assessed using the Beck Hopelessness Scale (BHS) at baseline, 9 and 15 months post-randomisation
7. Service engagement (contact with mental health teams) and relapse rate (number of hospitalisations) recorded at 24 months
8. Education and employment status recorded at 24 months

Completion date31/12/2029

Eligibility

Participant type(s)
Age groupMixed
Lower age limit18 Years
Upper age limit65 Years
SexAll
Target sample size at registration410
Key inclusion criteria1. Diagnosis of non-affective psychosis
2. Working-age adult (18-65 years)
3. Social disability indicated by structured activity of <30 hours per week on the Time Use Survey
4. History of social impairment indicated by a score of <60 on the Global Assessment of Functioning for >6 months
5. Under the care of secondary mental health services
6. Capacity and ability to provide informed consent
Key exclusion criteria1. Organic aetiology indicated for psychosis (e.g., brain injury)
2. Severe learning disability that would prevent engagement with intervention or assessments
3. Current involvement in any other interventional research study
4. Immediate serious risk to self or other
Date of first enrolment01/07/2026
Date of final enrolment01/01/2028

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centres

Sussex Partnership NHS Foundation Trust
Trust Hq
Swandean
Arundel Road
Worthing
BN13 3EP
England
Norfolk and Suffolk NHS Foundation Trust
County Hall
Martineau Lane
Norwich
NR1 2DH
England
Cambridgeshire and Peterborough NHS Foundation Trust
Elizabeth House
Fulbourn Hospital
Fulbourn
Cambridge
CB21 5EF
England
Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
St Nicholas Hospital
Jubilee Road
Gosforth
Newcastle upon Tyne
NE3 3XT
England
Pennine Care NHS Foundation Trust
225 Old Street
Ashton-under-lyne
OL6 7SR
England

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
IPD sharing plan

Editorial Notes

24/03/2026: Study's existence confirmed by the NIHR.