Sustaining Positive Engagement and Recovery (SUPEREDEN) - Improving social recovery in young people with emerging severe social disability

ISRCTN	ISRCTN61621571
DOI	https://doi.org/10.1186/ISRCTN61621571
Secondary identifying numbers	8645

Submission date: 26/06/2012
Registration date: 26/06/2012
Last edited: 15/02/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Psychosis is a mental health problem that causes people to lose contact with reality, and can involve hallucinations or delusions. Social recovery is a return to effective social functioning after treatment (engaging in constructive leisure and social activity and return to education or work). Cognitive behavioural therapy (CBT) is a talking therapy that is most commonly used to treat anxiety and depression, but can be useful for other mental health problems. The aim of this study is to assess whether Social Recovery Orientated Cognitive Behavioural Therapy (SRCBT) increases the time patients spend in structured activity and reduces their levels of depression and hopelessness.

Who can participate?
150 patients with non-affective psychosis (psychosis that is not related to emotions or moods)

What does the study involve?
Participants are randomly allocated to either the control or the experimental group. The experimental group receive regular SRCBT for 9 months. The control group receive treatment as usual. All participants are assessed at the start of the study and after 9 and 15 months.

What are the possible benefits and risks of participating?
We have found from previous studies that most participants welcome participation in research studies, as even contact with the researchers conducting assessments offers support from concerned and trained professionals above that provided in standard care. This is potentially a very important study which could have important implications for clinical practice in mental health services.

Where is the study run from?
The study is sponsored by Birmingham and Solihull Mental Health NHS Foundation trust (BSMHFT) and recruitment will take place in Birmingham, Norfolk and Lancashire Early Intervention Services.

When is the study starting and how long is it expected to run for?
July 2012 to March 2014

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Linda McCarthy
linda.mccarthy@bsmhft.nhs.uk

Contact information

Prof Max Birchwood
Scientific

School of Psychology
Edgbaston
Birmingham
B15 2TT
United Kingdom

Email	m.j.birchwood@warwick.ac.uk

Study information

Study design	Randomised; Interventional; Design type: Process of Care, Treatment
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Sustaining Positive Engagement and Recovery (SUPEREDEN) - the next step after Early Intervention for Psychosis. Study 3: Improving social recovery in young people with emerging severe social disability: A proof of principle randomised controlled trial
Study acronym	SuperEDEN 3
Study objectives	The aim will be to assess the feasibility of Social Recovery orientated Cognitive Behavioural Therapy in a large multicentre trial. Primary hypothesis: The intervention will lead to improvements in the time spent in structured activity. Secondary hypotheses that the intervention will: 1. Reduce levels of depression and hopelessness and 2. Improve negative symptoms A detailed analysis of adherence will help clarify details of training and supervision and assess the ability of staff from different professional backgrounds to apply this intervention across centres.
Ethics approval(s)	NRES Committee West Midlands The Black Country, 10/04/2012, ref: 05/Q0102/44MHRNC
Health condition(s) or problem(s) studied	Topic: Mental Health Research Network; Subtopic: Psychosis; Disease: Psychosis
Intervention	Three UK sites will be taking part: Birmingham, Lancashire and Norwich. Participants will be randomly allocated to two groups: 1. Social Recovery Orientated Cognitive Behavioural Therapy + Treatment As Usual (SRCBT + TAU) 2. TAU only Participants randomly allocated to the SRCBT + TAU group will receive SRCBT over 9 months by a qualified psychologist or an accredited CBT therapist. Sessions will be held either weekly or fortnightly and the therapy will be delivered in 3 stages. Follow Up Length: 15 month(s)
Intervention type	Other
Primary outcome measure	Time Use Survey (Short, 2006) assessed at 9 and 15 months
Secondary outcome measures	The Positive and Negative Syndrome Scale (PANSS)
Overall study start date	01/07/2012
Completion date	31/03/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Planned Sample Size: 150; UK Sample Size: 150
Key inclusion criteria	1. Patients with non-affective psychosis 2. Clients of Norfolk, Birmingham and Lancashire early intervention services 3. Clients who show a low level of structured activity after at least one year of treatment (defined as 30 hours or less per week) 4. Clients who have been with EIS between one and two years 5. Male & Female; Upper Age Limit 35 years ; Lower Age Limit 16 years
Key exclusion criteria	1. Clients who were part of the original National EDEN Cohort 2. Clients who do not speak English 3. Clients who are considered too unwell by their care coordinators will not be approached by the study team
Date of first enrolment	01/07/2012
Date of final enrolment	31/03/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

School of Psychology

Birmingham
B15 2TT
United Kingdom

Sponsor information

Birmingham and Solihull Mental Health NHS Foundation Trust (UK)
Charity

Research & Innovation, Radclyffe House
66-68 Hagley Road
Birmingham
B16 8PF
United Kingdom

"ROR"	https://ror.org/00cjeg736

Funders

Funder type

Government

Programme Grants for Applied Research; Grant Codes: RP-PG-0109-10074
Government organisation / National government

Alternative name(s): NIHR Programme Grants for Applied Research, PGfAR
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2018		Yes	No

Editorial Notes

15/02/2018: Publication reference added.
19/01/2016: Plain English summary added.
03/09/2013: The overall trial end date was changed from 01/09/2013 to 31/03/2014.