Condition category
Mental and Behavioural Disorders
Date applied
12/11/2012
Date assigned
14/12/2012
Last edited
04/06/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 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

Trial website

http://www.researchintorecovery.com

Contact information

Type

Scientific

Primary contact

Prof Mike Slade

ORCID ID

Contact details

King’s 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 measures

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

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

King’s College London
London
SE5 8AF
United Kingdom

Sponsor information

Organisation

King’s 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

http://www.kcl.ac.uk/

Funders

Funder type

Charity

Funder name

Guy’s & St Thomas' Charity (UK) ref: G101016

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

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24888479

Publication citations

  1. 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.

Additional files

Editorial Notes