WELLFOCUS study: to investigate an intervention to improve well-being in people with psychosis

ISRCTN ISRCTN04199273
DOI https://doi.org/10.1186/ISRCTN04199273
Secondary identifying numbers G101016
Submission date
12/11/2012
Registration date
14/12/2012
Last edited
04/10/2018
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
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 King’s 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?
Guy’s & St Thomas Charity, UK

Who is the main contact?
Dr Beate Schrank
beate.schrank@kcl.ac.uk

Study website

Contact information

Prof Mike Slade
Scientific

King’s College London
Institute of Psychiatry
Health Service and Population Research Department
Denmark Hill
London
SE5 8AF
United Kingdom

Email mike.slade@kcl.ac.uk

Study information

Study designPilot randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeQuality of life
Participant information sheet Not available in web format, please contact beate.schrank@kcl.ac.uk to request a patient information sheet
Scientific titlePilot randomised controlled trial of a modified intervention to improve well-being in people with psychosis
Study acronymWELLFOCUS
Study objectivesNo 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedPsychosis
InterventionParticipants 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 typeOther
Primary outcome measurePersonal well-being assessed using the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)
Secondary outcome measures1. 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 study start date01/01/2013
Completion date01/01/2015

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants80
Key inclusion criteriaAdults 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
Key exclusion criteria1. Serious cognitive impairment
2. Unable to give informed consent
Date of first enrolment01/01/2013
Date of final enrolment01/01/2015

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

King’s College London
London
SE5 8AF
United Kingdom

Sponsor information

King’s College London (UK)
University/education

Institute of Psychiatry
Denmark Hill
London
SE5 8AF
England
United Kingdom

Email jennifer.liebscher@kcl.ac.uk
Website http://www.kcl.ac.uk/
ROR logo "ROR" https://ror.org/0220mzb33

Funders

Funder type

Charity

Guy's and St Thomas' Charity ref: G101016
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
Guy's and St Thomas' Charity, Guy's and St Thomas' Foundation, GSTTFoundation
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 03/06/2014 Yes No
Results article results 01/01/2015 Yes No
Results article results 01/06/2016 Yes No

Editorial Notes

04/10/2018: Publication references added.