The clinical and cost effectiveness of internet-delivered self-help Acceptance and Commitment Therapy for family carers of people with dementia (iACT4CARERS): Study protocol for a randomised controlled trial with ethnically diverse family carers

Kishita, Naoko ORCID: https://orcid.org/0000-0001-8453-2714, Gould, Rebecca L., McCracken, Lance M., Khondoker, Mizanur ORCID: https://orcid.org/0000-0002-1801-1635, Turner, David A. ORCID: https://orcid.org/0000-0002-1689-4147, Ashford, Polly-Anna, Flanagan, Emma, Czyznikowska, Barbara, Richmond, Erica, Riggey, Megan, Trucco, Ana Paula, Hammond, Matthew ORCID: https://orcid.org/0000-0002-0739-3412, Nautiyal, Aditya and Farquhar, Morag ORCID: https://orcid.org/0000-0001-7991-7679 (2024) The clinical and cost effectiveness of internet-delivered self-help Acceptance and Commitment Therapy for family carers of people with dementia (iACT4CARERS): Study protocol for a randomised controlled trial with ethnically diverse family carers. Contemporary Clinical Trials, 146. ISSN 1551-7144

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Abstract

Background: Following the successful completion of feasibility and acceptability studies of internet-delivered self-help Acceptance and Commitment Therapy for family carers of people with dementia (iACT4CARERS), a full-scale randomised controlled trial (RCT) evaluating its clinical and cost effectiveness will be conducted. This paper describes the design and protocol for a multi-site, parallel, single-blind, 2-arm RCT evaluating the clinical and cost effectiveness of iACT4CARERS plus treatment-as-usual (TAU) in comparison to TAU alone for reducing anxiety in family carers of people with dementia. Methods: 496 family carers aged ≥18 years, who are caring for a person with dementia, will be recruited from national healthcare services, general practices and community groups in England. Participants randomised to the intervention arm will receive iACT4CARERS over 12 weeks. Participants will complete outcome measures at baseline (0 weeks) and at 12-weeks and 24-weeks post-randomisation. The primary outcome and timepoint will be anxiety at 12 weeks. Secondary outcomes will include psychological flexibility, depression, and cost-effectiveness (cost per quality adjusted life years). Primary analyses will be by intention-to-treat and data will be analysed using linear mixed models. Fidelity and quality of implementation will be assessed and contextual factors associated with variation in outcomes identified in a process evaluation. Conclusion: If iACT4CARERS is found to be effective and affordable, this self-help intervention, including minimal contact with minimally trained therapists, has the potential to be rolled out widely within healthcare services in the UK, reducing inequality in access to psychological services among this population. Clinical trials registration: ISRCTN registry identifier ISRCTN45995725.

Item Type:	Article
Additional Information:	Data availability statement: No data were used for the research described in the article. Funding information: This study is funded by the NIHR Health Technology Assessment programme (Award ID: NIHR150071). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. The study protocol has undergone full external peer review by the funding body as part of the peer review process.
Faculty \ School:	Faculty of Medicine and Health Sciences > School of Health Sciences Faculty of Medicine and Health Sciences > Norwich Medical School
UEA Research Groups:	Faculty of Medicine and Health Sciences > Research Centres > Lifespan Health Faculty of Medicine and Health Sciences > Research Groups > Dementia & Complexity in Later Life Faculty of Arts and Humanities > Research Groups > Centre for Japanese Studies Faculty of Science > Research Groups > Norwich Epidemiology Centre Faculty of Medicine and Health Sciences > Research Groups > Norwich Epidemiology Centre Faculty of Medicine and Health Sciences > Research Groups > Epidemiology and Public Health Faculty of Medicine and Health Sciences > Research Centres > Population Health Faculty of Medicine and Health Sciences > Research Groups > Norwich Clinical Trials Unit Faculty of Medicine and Health Sciences > Research Groups > Health Services and Primary Care Faculty of Medicine and Health Sciences > Research Groups > Health Economics Faculty of Medicine and Health Sciences > Research Centres > Norwich Institute for Healthy Aging Faculty of Medicine and Health Sciences > Research Groups > Health Promotion
Depositing User:	LivePure Connector
Date Deposited:	10 Sep 2024 14:30
Last Modified:	10 Nov 2024 00:52
URI:	https://ueaeprints.uea.ac.uk/id/eprint/96671
DOI:	10.1016/j.cct.2024.107685

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