Plain English Summary
Background and study aims
Well-being is important for everyone, including people with severe mental illness. Well-being can help to improve functioning, resilience, and life satisfaction and may protect against mental illness.
Positive Psychotherapy (PPT) was developed in the field of positive psychology. It aims to increase well-being by building positive emotions, character strengths, and meaning. So far, PPT has been shown to decrease symptoms and increase well-being in people with depression and other common mental disorders. There are no established interventions to increase well-being in people with severe mental illness, but PPT is a promising approach. In a previous project we adapted PPT to be suitable as a group therapy for people with psychosis. We have done so with the input of service users, professional carers, and experts in the field. In this study we will show how the adapted intervention can be best delivered to people with psychosis.
Who can participate?
Adults with an experience of psychosis from a London NHS Trust.
What does the study involve?
Participants will receive the WELLFOCUS programme, in group therapy format in addition to their usual care, or continue to receive their usual care as before. Participants will be assessed with a range of questionnaires before and after the study period and they will be asked to participate in personal interviews and focus groups.
What are the possible benefits and risks of participating?
Participants may experience increased personal well-being and there are no known risks for participants.
Where is the study run from?
Institute of Psychiatry at Kings College London, UK
When is study starting and how long is it expected to run for?
Recruitment will start in early 2013 the study is expected to run until 2015.
Who is funding the study?
Guys & St Thomas Charity, UK
Who is the main contact?
Dr Beate Schrank
beate.schrank@kcl.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Mike Slade
ORCID ID
Contact details
Kings College London
Institute of Psychiatry
Health Service and Population Research Department
Denmark Hill
London
SE5 8AF
United Kingdom
-
mike.slade@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G101016
Study information
Scientific title
Pilot randomised controlled trial of a modified intervention to improve well-being in people with psychosis
Acronym
WELLFOCUS
Study hypothesis
No specific hypothesis is tested as this is a pilot randomised controlled study. This means that it will establish if the intervention works as it is expected to and if it can be delivered as planned in a research setting. The results will help to further adapt the intervention and the research process and help to plan a big study to investigate the intervention.
Ethics approval
Not provided at time of registration
Study design
Pilot randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please contact beate.schrank@kcl.ac.uk to request a patient information sheet
Condition
Psychosis
Intervention
Participants will be randomised into either of the following groups:
1. The WELLFOCUS intervention: adapted PPT for people with psychosis in a group format, once a week over 12 weeks, in addition to treatment as usual.
2. Treatment as usual
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Personal well-being assessed using the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)
Secondary outcome measures
1. Quality of life as assessed by the Manchester Short Assessment of Quality of Life (MANSA)
2. Happiness as assessed by the Short Depression-Happiness Scale (SDHS)
3. Hope as assessed by the Integrative Hope Scale (IHS)
4. Savouring as assessed by the Savouring Beliefs Inventory (SBI)
5. Symptoms and functioning as assessed by Brief Psychiatric Rating Scale (BPRS)
6. The Health of the Nation Outcome Scale (HoNOS)
7. The Global Assessment of Functioning (GAF)
Overall trial start date
01/01/2013
Overall trial end date
01/01/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Adults with a primary diagnosis of psychosis who are not currently receiving in-patient care or are in prison, speak and understand English and are sufficiently well to participate
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80
Participant exclusion criteria
1. Serious cognitive impairment
2. Unable to give informed consent
Recruitment start date
01/01/2013
Recruitment end date
01/01/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Kings College London
London
SE5 8AF
United Kingdom
Sponsor information
Organisation
Kings College London (UK)
Sponsor details
Institute of Psychiatry
Denmark Hill
London
SE5 8AF
United Kingdom
-
jennifer.liebscher@kcl.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Guy's and St Thomas' Charity ref: G101016
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
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
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24888479
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25270758
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/25698298
Publication citations
-
Protocol
Schrank B, Riches S, Coggins T, Rashid T, Tylee A, Slade M, WELLFOCUS PPT - modified positive psychotherapy to improve well-being in psychosis: study protocol for a pilot randomised controlled trial., Trials, 2014, 15, 203, doi: 10.1186/1745-6215-15-203.