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

ISRCTN	ISRCTN04199273
DOI	https://doi.org/10.1186/ISRCTN04199273
Protocol serial number	G101016
Sponsor	Kings College London (UK)
Funder	Guy's and St Thomas' Charity ref: 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 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

Contact information

Prof Mike Slade
Scientific

Kings 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

Primary study design	Interventional
Study design	Pilot randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Pilot randomised controlled trial of a modified intervention to improve well-being in people with psychosis
Study acronym	WELLFOCUS
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Personal well-being assessed using the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)
Key secondary outcome measure(s)	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)
Completion date	01/01/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	80
Key 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
Key exclusion criteria	1. Serious cognitive impairment 2. Unable to give informed consent
Date of first enrolment	01/01/2013
Date of final enrolment	01/01/2015

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Kings College London

London
SE5 8AF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	01/01/2015		Yes	No
Results article	results	01/06/2016		Yes	No
Protocol article	protocol	03/06/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

04/10/2018: Publication references added.