TY - JOUR

T1 - Evaluating the effects of the World Health Organization's online intervention ‘iSupport’ to reduce depression and distress in dementia carers: a multi-centre six-month randomised controlled trial in the UK

AU - Windle, Gill

AU - Flynn, Greg

AU - Hoare, Zoe

AU - Goulden, Nia

AU - Masterson Algar, Patricia

AU - Edwards, Rhiannon Tudor

AU - Anthony, Bethany

AU - Kurana, Suman

AU - Spector, Aimee

AU - Hughes, Gwenllian

AU - Proctor, Danielle

AU - Ismail, Fatene

AU - Jackson, Kiara

AU - Egan, Kieren

AU - Stott, Joshua

PY - 2024/11/20

Y1 - 2024/11/20

N2 - Background Sustaining the capabilities of dementia carers is a global priority. ‘iSupport’ is a self-guided onlineintervention designed by the World Health Organization (WHO) to reduce mental health problems in dementiacarers. iSupport is undergoing global implementation, however there is an absence of effectiveness evidence. Thisstudy tested the effectiveness of iSupport to reduce distress and depression in dementia carers.Methods A pragmatic randomised controlled trial was conducted in three centres. Adult carers (18+) living in thecommunity were recruited in England, Wales and Scotland and randomly assigned (1:1) through a web-basedsystem to iSupport or usual care. Outcome assessors were masked to allocation. The primary outcomesassessed the difference in distress and depression between baseline and six-months. The target sample sizewas 350 to enable 90% power, significance at 2.5% including 25% attrition (262 completers) on eitheroutcome. Analysis followed the intention-to-treat (ITT) principle. The trial was registered with ISRCTNregistry (17420703).Findings Between 12th November 2021 and 31st March 2023,177 carers (50.3%) were randomised to usual care and175 (49.7%) to iSupport. 263 (74.7%) completed the trial. All were included in the ITT analysis. Mean distress scoresat six-months were 20.0 (SD = 8.3) for usual care and 20.6 (SD = 8.6) for iSupport. The mean difference was 0.16 (95%CI −1.17 to 1.49, p = 0.29) after adjusting for covariates. Mean depression scores at six-months were 9.5 (SD = 7.0) forusual care and 9.8 (SD = 6.5) for iSupport. The mean difference at six-months was −0.54 (95% CI = −1.70 to 0.62,p = 0.44). No serious adverse events were linked to the trial.Interpretation To our knowledge this is the largest trial evaluating a self-guided online intervention in UK dementiacarers, and the first to successfully evaluate the effectiveness of iSupport. The null findings are significant given theongoing global implementation of iSupport by the WHO and the adoption of self-guided interventions intomainstream care delivery as part of digital health transformations.Funding NIHR.

AB - Background Sustaining the capabilities of dementia carers is a global priority. ‘iSupport’ is a self-guided onlineintervention designed by the World Health Organization (WHO) to reduce mental health problems in dementiacarers. iSupport is undergoing global implementation, however there is an absence of effectiveness evidence. Thisstudy tested the effectiveness of iSupport to reduce distress and depression in dementia carers.Methods A pragmatic randomised controlled trial was conducted in three centres. Adult carers (18+) living in thecommunity were recruited in England, Wales and Scotland and randomly assigned (1:1) through a web-basedsystem to iSupport or usual care. Outcome assessors were masked to allocation. The primary outcomesassessed the difference in distress and depression between baseline and six-months. The target sample sizewas 350 to enable 90% power, significance at 2.5% including 25% attrition (262 completers) on eitheroutcome. Analysis followed the intention-to-treat (ITT) principle. The trial was registered with ISRCTNregistry (17420703).Findings Between 12th November 2021 and 31st March 2023,177 carers (50.3%) were randomised to usual care and175 (49.7%) to iSupport. 263 (74.7%) completed the trial. All were included in the ITT analysis. Mean distress scoresat six-months were 20.0 (SD = 8.3) for usual care and 20.6 (SD = 8.6) for iSupport. The mean difference was 0.16 (95%CI −1.17 to 1.49, p = 0.29) after adjusting for covariates. Mean depression scores at six-months were 9.5 (SD = 7.0) forusual care and 9.8 (SD = 6.5) for iSupport. The mean difference at six-months was −0.54 (95% CI = −1.70 to 0.62,p = 0.44). No serious adverse events were linked to the trial.Interpretation To our knowledge this is the largest trial evaluating a self-guided online intervention in UK dementiacarers, and the first to successfully evaluate the effectiveness of iSupport. The null findings are significant given theongoing global implementation of iSupport by the WHO and the adoption of self-guided interventions intomainstream care delivery as part of digital health transformations.Funding NIHR.

U2 - 10.1016/j.lanepe.2024.101125

DO - 10.1016/j.lanepe.2024.101125

M3 - Article

VL - 48

JO - Lancet Regional Health - Europe

JF - Lancet Regional Health - Europe

M1 - 101125

ER -