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
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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.
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 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 measure
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 (if study stopped)
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
Funders
Funder type
Government
Funder name
Programme Grants for Applied Research; Grant Codes: RP-PG-0109-10074
Alternative name(s)
NIHR Programme Grants for Applied Research, PGfAR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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
Basic results (scientific)
Publication list
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29242000