Condition category
Mental and Behavioural Disorders
Date applied
26/06/2012
Date assigned
26/06/2012
Last edited
19/01/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Max Birchwood

ORCID ID

Contact details

School of Psychology
Edgbaston
Birmingham
B15 2TT
United Kingdom
-
m.j.birchwood@warwick.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

8645

Study information

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

Acronym

SuperEDEN 3

Study hypothesis

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.

More details can be found at http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=8645

Ethics approval

NRES Committee West Midlands – The Black Country, 10/04/2012, ref: 05/Q0102/44MHRNC

Study design

Randomised; Interventional; Design type: Process of Care, Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

Time Use Survey (Short, 2006) assessed at 9 and 15 months

Secondary outcome measures

The Positive and Negative Syndrome Scale (PANSS)

Overall trial start date

01/07/2012

Overall trial end date

31/03/2014

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 150; UK Sample Size: 150

Participant 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

Recruitment start date

01/07/2012

Recruitment end date

31/03/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Psychology
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

Birmingham and Solihull Mental Health NHS Foundation Trust (UK)

Sponsor details

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

Sponsor type

Charity

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Programme Grants for Applied Research; Grant Codes: RP-PG-0109-10074

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

Publication citations

Additional files

Editorial Notes

19/01/2016: Plain English summary added. On 03/09/2013, the overall trial end date was changed from 01/09/2013 to 31/03/2014.