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The EMPOWER blended digital intervention for relapse prevention in schizophrenia : A feasibility cluster randomised controlled trial in Scotland and Australia
Gumley, Andrew I. Bradstreet, Simon Ainsworth, John Allan, Stephanie Álvarez-Jiménez, Mario Aucott, Lorna Birchwood, Maximillian Briggs, Andrew Bucci, Sandra Cotton, Sue M.
Gumley, Andrew I.
Bradstreet, Simon
Ainsworth, John
Allan, Stephanie
Álvarez-Jiménez, Mario
Aucott, Lorna
Birchwood, Maximillian
Briggs, Andrew
Bucci, Sandra
Cotton, Sue M.
Author
Gumley, Andrew I.
Bradstreet, Simon
Ainsworth, John
Allan, Stephanie
Álvarez-Jiménez, Mario
Aucott, Lorna
Birchwood, Maximillian
Briggs, Andrew
Bucci, Sandra
Cotton, Sue M.
Engel, Lidia
French, Paul
Lederman, Reeva
Lewis, Shôn
Machin, Matthew
MacLennan, Graeme
McLeod, Hamish
McMeekin, Nicola
Mihalopoulos, Cathy
Morton, Emma
Norrie, John
Schwannauer, Matthias
Singh, Swaran P.
Sundram, Suresh
Thompson, Andrew
Williams, Chris
Yung, Alison R.
Farhall, John
Gleeson, John
Bradstreet, Simon
Ainsworth, John
Allan, Stephanie
Álvarez-Jiménez, Mario
Aucott, Lorna
Birchwood, Maximillian
Briggs, Andrew
Bucci, Sandra
Cotton, Sue M.
Engel, Lidia
French, Paul
Lederman, Reeva
Lewis, Shôn
Machin, Matthew
MacLennan, Graeme
McLeod, Hamish
McMeekin, Nicola
Mihalopoulos, Cathy
Morton, Emma
Norrie, John
Schwannauer, Matthias
Singh, Swaran P.
Sundram, Suresh
Thompson, Andrew
Williams, Chris
Yung, Alison R.
Farhall, John
Gleeson, John
Abstract
Background
Early warning signs monitoring by service users with schizophrenia has shown promise in preventing relapse but the quality of evidence is low. We aimed to establish the feasibility of undertaking a definitive randomised controlled trial to determine the effectiveness of a blended digital intervention for relapse prevention in schizophrenia.
Methods
This multicentre, feasibility, cluster randomised controlled trial aimed to compare Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) with treatment as usual in community mental health services (CMHS) in Glasgow and Melbourne. CMHS were the unit of randomisation, selected on the basis of those that probably had five or more care coordinators willing to participate. Participants were eligible if they were older than 16 years, had a schizophrenia or related diagnosis confirmed via case records, were able to provide informed consent, had contact with CMHS, and had had a relapse within the previous 2 years. Participants were randomised within stratified clusters to EMPOWER or to continue their usual approach to care. EMPOWER blended a smartphone for active monitoring of early warning signs with peer support to promote self-management and clinical triage to promote access to relapse prevention. Main outcomes were feasibility, acceptability, usability, and safety, which was assessed through face-to-face interviews. App usage was assessed via the smartphone and self-report. Primary end point was 12 months. Participants, research assistants and other team members involved in delivering the intervention were not masked to treatment conditions. Assessment of relapse was done by an independent adjudication panel masked to randomisation group. The study is registered at ISRCTN (99559262).
Findings
We identified and randomised eight CMHS (six in Glasgow and two in Melbourne) comprising 47 care coordinators. We recruited 86 service users between Jan 19 and Aug 8, 2018; 73 were randomised (42 [58%] to EMPOWER and 31 [42%] to treatment as usual). There were 37 (51%) men and 36 (49%) women. At 12 months, main outcomes were collected for 32 (76%) of service users in the EMPOWER group and 30 (97%) of service users in the treatment as usual group. Of those randomised to EMPOWER, 30 (71%) met our a priori criterion of more than 33% adherence to daily monitoring that assumed feasibility. Median time to discontinuation of these participants was 31·5 weeks (SD 14·5). There were 29 adverse events in the EMPOWER group and 25 adverse events in the treatment as usual group. There were 13 app-related adverse events, affecting 11 people, one of which was serious. Fear of relapse was lower in the EMPOWER group than in the treatment as usual group at 12 months (mean difference –7·53 (95% CI –14·45 to 0·60; Cohen's d –0·53).
Interpretation
A trial of digital technology to monitor early warning signs blended with peer support and clinical triage to detect and prevent relapse appears to be feasible, safe, and acceptable. A further main trial is merited.
Funding
UK National Institute for Health Research Health Technology Assessment programme and the Australian National Health and Medical Research Council.
Keywords
Date
2022
Type
Journal article
Journal
The Lancet Psychiatry
Book
Volume
9
Issue
6
Page Range
477-486
Article Number
ACU Department
School of Behavioural and Health Sciences
Faculty of Health Sciences
Faculty of Health Sciences
Relation URI
Source URL
Event URL
Open Access Status
Published as ‘gold’ (paid) open access
License
CC BY-NC-ND 4.0
File Access
Open