Cite as Schrank B, Riches S, Coggins T, Rashid T, Tylee A, Slade M (2014) WELLFOCUS PPT – modified Positive Psychotherapy to improve well-being in psychosis: study protocol for pilot randomised controlled trial, Trials, 15, 203. WELLFOCUS PPT – modified Positive Psychotherapy to improve well- being in psychosis: study protocol for pilot randomised controlled trial Beate Schrank (corresponding author) King’s College London, Institute of Psychiatry Medical University of Vienna, Department of Psychiatry and Psychotherapy Email: [email protected]Simon Riches King’s College London, Institute of Psychiatry Email: [email protected]Tony Coggins South London and Maudsley NHS Foundation Trust, Mental Health Promotion Email: [email protected]1
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Cite as Schrank B, Riches S, Coggins T, Rashid T, Tylee A, Slade M (2014) WELLFOCUS PPT – modified Positive Psychotherapy to improve well-being in psychosis: study protocol for pilot randomised controlled trial, Trials, 15, 203.
WELLFOCUS PPT – modified Positive Psychotherapy to improve well-being in
psychosis: study protocol for pilot randomised controlled trial
Beate Schrank (corresponding author)
King’s College London, Institute of Psychiatry
Medical University of Vienna, Department of Psychiatry and Psychotherapy
of Coherence Scale; SDHS: Short Depression-Happiness Scale; SF-SU:
Sociodemographics Form - Service User; SLaM: South London and Maudsley NHS
Foundation Trust; TAU: treatment as usual, WEMWBS: Warwick-Edinburgh Mental Well-
Being Scale
Competing interests
The authors declare that they have no competing interests.
Authors’ contributions
BS: conception and design, data collection and analysis, manuscript writing and final
approval of the manuscript. SR: data collection, critical revision and final approval of the
manuscript. TC: critical revision and final approval of the manuscript. TR: critical revision and
final approval of the manuscript. AT: conception and design, critical revision and final
approval of the manuscript. MS: conception and design, supervision of data collection and
analysis, supervision of manuscript writing and final approval of the manuscript.
Acknowledgments
The WELLFOCUS study is funded by Guy’s & St Thomas’ Charity (Ref G101016). Mike
Slade receives salary support from the National Institute for Health Research (NIHR)
Biomedical Research Centre for Mental Health at South London and Maudsley NHS
Foundation Trust and [Institute of Psychiatry] King's College London. The views expressed
are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department
of Health.
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We thank the participating trial facilitators (Nicola Gawn, Zara Kanji, Steven Livingstone,
Matthew Richardson, Marieke Wrigley) and Sherry Clarke for their contributions to the
development of WELLFOCUS PPT. Data were also collected by Tamsin Brownell, Agnes
Chevalier, Zivile Jakaite, Charley Larkin and Judy Tchikaya.
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Figure titles and legends
Table 1: outcome measures used in the WELLFOCUS study
Figure 1: The WELLFOCUS Model
Figure 2: Consort flow chart of WELLFOCUS RCT
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Figure 1: The WELLFOCUS Model
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Figure 2: Consort flow chart of WELLFOCUS RCT
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Referral by care co-ordinator or clinician
Baseline assessments
Assessment of eligibility by researcher and consent by participant
Excluded (n= )
Reasons (to assess feasibility of trial procedures)
Excluded
Not meeting inclusion criteria (n= )
Refused to participate (n= )
Other reasons (n=)Randomised (n= )
WELLFOCUS PPT + TAU
Allocated to intervention (n= )
Received allocated intervention (n= )
Did not receive allocated intervention Reasons (n= )
Treatment as usual
Allocated to control (n= )
Analysed (n= )
Excluded from analysisReasons (n= )
Process evaluation interviews and focus groups (n= )
Excluded from process evaluationReasons (n= )
Lost to follow-upReasons (n= )
Discontinued interventionReasons (n= )
Lost to follow-upReasons (n= )
Analysed (n= )
Excluded from analysisReasons (n= )
Table 1: outcome measures used in the WELLFOCUS study
WELLFOCUS Model component
Measure Rater Rationale
Distal outcomePersonal well-being WEMWBS Patient Measures overall well-being, i.e.
enhanced sense of self
Proximal outcomesGood feelings SBI Patient Assesses pleasure in the past present
and future, which is a form of good feeling addressed in the intervention
PPTI positive emotions
Patient Assesses enjoyment and happiness which is a form of good feeling addressed in the intervention
Symptom relief SDHS Patient Measures depression the reduction of which is an intended outcome of PPT
BPRS Researcher Measures general symptom severity including psychosis specific symptoms
CORE10 Patient Measures general symptom severity
Connectedness PPTI relationships Patient Measures the presence of supportive relationships as a form of connectedness addressed in the intervention
Hope IHS Patient Measures hope which is an indicator of well-being
Self-worth R-SES Patient Measures self-worth which is an indicator of well-being
Empowerment RES Patient Measures empowerment which is an indicator of well-being
Meaning SCS Patient Measures meaning which is an indicator of well-being
PPTI meaning Provides a PPT specific measure of meaning
Other outcomes
Quality of Life MANSA Patient Quality of life is a form of well-being measure, allowing triangulation with the WEMWBS
Social disability HoNOS Researcher To give opportunity to compare changes in well-being with social disability
Functioning GAF Researcher To give opportunity to compare changes in well-being with functioning