Evidence map›Paper›PMID 35379593›Full record

Trial reportThe Lancet. Digital health2022

Effect of digital psychoeducation and peer support on the mental health of family carers supporting individuals with psychosis in England (COPe-support): a randomised clinical trial.

Jacqueline Sin, Claire Henderson, Jack Elkes, Victoria Cornelius, Luke A Woodham, Rachel Batchelor, Tao Chen, Ana Maria Corredor, David Coughlan, Ranjita Dhital and 10 more

Open access · goldAbstract readRandomized Controlled TrialEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Lancet. Digital health, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 3 pooled it
5.0field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 3 syntheses or guidelines pooled it, 26 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors at 12 institutions in 1 country.

Jacqueline SinSchool of Health Sciences, City, University of London, London, UK. Electronic address: jacqueline.sin@city.ac.uk.
Claire HendersonHealth Service & Population Research Department, King's College London, Institute of Psychiatry, Psychology & Neuroscience, London, UK; South London and Maudsley NHS Foundation Trust, Maudsley Hospital, London, UK.
Jack ElkesImperial Clinical Trials Unit, School of Public Health, Imperial College London, London, UK.
Victoria CorneliusImperial Clinical Trials Unit, School of Public Health, Imperial College London, London, UK.
Luke A WoodhamSt George's, University of London, Centre for Technology in Education, London, UK.
Rachel BatchelorSchool of Health Sciences, City, University of London, London, UK.
Tao ChenDepartment of Public Health, Policy & Systems, Institute of Population Health, The University of Liverpool, Liverpool, UK.
Ana Maria CorredorSouth West London and St George's Mental Health NHS Trust, Springfield University Hospital, London, UK.
David CoughlanSouth West London and St George's Mental Health NHS Trust, Springfield University Hospital, London, UK.
Ranjita DhitalArts and Sciences Department, University College London, London, UK.
Sian EvansSouth London and Maudsley NHS Foundation Trust, Maudsley Hospital, London, UK.
Ban HaiderSt George's, University of London, Centre for Technology in Education, London, UK.
Julia HeathcoteSouth West London and St George's Mental Health NHS Trust, Springfield University Hospital, London, UK.
Sarah MansfieldSussex Partnership NHS Foundation Trust and Oxford Cognitive Therapy Centre, Newhaven, UK.
Aileen O'BrienSt George's, University of London, Centre for Technology in Education, London, UK.
Mona QassimBerkshire Healthcare NHS Foundation Trust, Bracknell, UK.
Juliet SserunkumaSpecialist Services, Improving Access to Psychological Therapies, East London NHS Foundation Trust, London, UK.
Clive H TravisParanoidschizophrenia.co.uk, Bedford, UK.
Elen WilliamsLocum GP, London, UK.
Steve GillardSchool of Health Sciences, City, University of London, London, UK.
City, University of London · GBSt George's, University of London · GBImperial College London · GBSpringfield University Hospital · GBBerkshire Healthcare NHS Foundation Trust · GBEast London NHS Foundation Trust · GBMaudsley Hospital · GBSouth London and Maudsley NHS Foundation Trust · GBSouth West London and St George's Mental Health NHS Trust · GBSussex Partnership NHS Foundation Trust · GBUniversity College London · GBUniversity of Liverpool · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPsychoeducation delivered face-to-face is effective in alleviating mental health morbidities in family carers of individuals with psychosis. However, research in such interventions delivered online is scarce. We evaluated the effectiveness of a digital multicomponent intervention-COPe-support-in improving carers' mental wellbeing and caregiving-related outcomes.

methodsIn this two-arm, individually randomised, superiority trial, people aged 18 years or older who provided at least weekly support in any format for a relative or close friend affected by psychosis across England were randomly assigned (1:1) to either COPe-support or a passive online information resource using an independent online system. Participants were recruited through 30 mental health UK National Health Service trusts. The study team were masked to allocation and assessment of outcomes as all data collection took place online. Participants had access to either condition for 40 weeks and were advised to spend at least half an hour per week over the initial 20 weeks to go through materials at their own pace and to allow time to integrate knowledge and skills learned into practice. It was not feasible to mask participants or the online facilitator to intervention allocation. COPe-support provided psychoeducation on psychosis-related caregiving strategies and forums with professionals and other carers, and the control intervention comprised a passive online information resource. The primary outcome at 20 weeks was mental wellbeing measured by the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS; minimally clinically important difference [MCID] 3). This trial is registered with ISRCTN, 89563420.

findingsBetween March 1, 2018, and Feb 14, 2020, 407 participants were randomly assigned, with 204 allocated to COPe-support and 203 allocated to control. The participants (mean age 53·1 years, SD 13·2) were mostly female (330 [81%] of 407 participants) and White (359 [88%] of 407 participants). 346 (85%) of 407 participants provided primary endpoint data, 174 (85%) of 204 participants in the COPe-support group and 172 (85%) of 203 participants in the control group. The mean WEMWBS score at 20 weeks was 44·5 (SD 8·31) for the COPe-support group and 43·3 (9·19) for the control group. We found no evidence of a difference in wellbeing between the two groups (adjusted mean difference 0·37, 95% CI -1·14 to 1·88; p=0·63). In the COPe-support group, 106 (52%) of 204 participants met the complier definition of a minimum of two logins in separate weeks. The complier average causal effect analysis increased the difference in WEMWBS scores (adjusted difference 0·83, 95% CI -1·45 to 3·11; p=0·47), but this was lower than the MCID. There were no adverse events.

interpretationOur findings did not support the use of COPe-support over a passive online information resource. However, further research to optimise digital interventions adjunctive to face-to-face support for carers remains important.

fundingNational Institute for Health Research.

Indexed as

CaregiversPsychotic DisordersEnglandFemaleHumansMaleMental HealthMiddle AgedState Medicine

Identifiers

PMID35379593
PMCPMC9021027
OpenAlexW4223989549

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.