COPe-support-a multi-component digital intervention for family carers for people affected by psychosis: study protocol for a randomized controlled trial

Autor: Dominique Spence-Polin, Jacqueline Sin, Steve Gillard, Aurora Sesé Hernández, Jack Elkes, Luke Woodham, Tao Chen, Claire Henderson, Victoria Cornelius, Rachel Batchelor
Přispěvatelé: National Institute for Health Research
Jazyk: angličtina
Rok vydání: 2020
Předmět:
wm_100
020205 medical informatics
Carers
medicine.medical_treatment
Digital interventions
02 engineering and technology
HN
law.invention
Study Protocol
0302 clinical medicine
Randomized controlled trial
law
lcsh:Psychiatry
Adaptation
Psychological
MENTAL-HEALTH KNOWLEDGE
SCHIZOPHRENIA
0202 electrical engineering
electronic engineering
information engineering
Single-Blind Method
PSYCHOEDUCATIONAL INTERVENTIONS
030212 general & internal medicine
Psychiatry
Wellbeing
wa_305
SIBLINGS
Psychiatry and Mental health
Distress
England
CAREGIVERS
Psychology
BURDEN
Life Sciences & Biomedicine
RCT
lcsh:RC435-571
BF
ILLNESS
Peer Group
1117 Public Health and Health Services
03 medical and health sciences
Nursing
Patient Education as Topic
Intervention (counseling)
eMentalHealth
Psychoeducation
medicine
eHealth
Expressed emotion
Humans
Internet
Data collection
Science & Technology
Social Support
1103 Clinical Sciences
wy_20_5
Psychosis
Mental health
wm_20
Psychotic Disorders
1701 Psychology
RC0321
EXPRESSED EMOTION
EXPERIENCE
Zdroj: BMC Psychiatry
BMC Psychiatry, Vol 20, Iss 1, Pp 1-14 (2020)
ISSN: 1471-244X
Popis: Background Psychosis often causes significant distress and impacts not only in the individuals, but also those close to them. Many relatives and friends (‘carers’) provide long-term support and need resources to assist them. We have co-produced a digital mental health intervention called COPe-support (Carers fOr People with Psychosis e-support) to provide carers with flexible access to high quality psychoeducation and interactive support from experts and peers. This study evaluates the effectiveness of COPe-support to promote mental wellbeing and caregiving experiences in carers. Methods This study is a single-blind, parallel arm, individually randomized controlled trial (RCT) comparing COPe-support, with attention control. Both groups continue to receive usual care. COPe-support provides interactive web-based psychoeducation on psychosis-related issues, wellbeing-promotion and network support through forums. The attention-control is a non-interactive online information resource pack. Carers living in England are eligible if they provide at least weekly support to a family member or close friend affected by psychosis, and use internet communication (including emails) daily. All trial procedures are run online, including collection of outcome measurements which participants will directly input into our secure platform. Following baseline assessment, a web-based randomization system will be used to allocate 360 carers to either arm. Participants have unlimited access to the allocated condition for 40 weeks. Data collection is at three time points (10, 20, and 40 weeks after randomization). Analyses will be conducted by trial statisticians blinded to allocation. The primary outcome is mental wellbeing measured by Warwick Edinburgh Mental Wellbeing Scale (WEMWBS), at 20 weeks. As well as an intention-to-treat analysis, a complier average causal effect (CACE) analysis will be conducted to estimate the intervention effect in participants who have accessed COPe-support content twice or more. The secondary objectives and analysis will examine other health and caregiving-related outcomes and explore mechanisms. In a process evaluation, we will interview 20% of the intervention arm participants regarding the acceptability of COPe-support. We will explore in detail participants’ usage patterns. Discussion The results of this trial will provide valuable information about the effectiveness of COPe-support in promoting wellbeing and caregiving experiences in carers. Trial registration The RCT is registered with the Current Controlled Trials registration (ISRCTN 89563420, registration date: 02/03/2018).
Databáze: OpenAIRE
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