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

作者：Naoko Kishita, Rebecca L. Gould, Lance M. McCracken, Mizanur Khondoker, David A. Turner, Polly‐Anna Ashford, Emma Flanagan, Barbara Czyznikowska, Erica Richmond, Megan Riggey, Ana Paula Trucco, Matthew Hammond, Aditya Nautiyal, Morag Farquhar · 发表于：Contemporary Clinical Trials · 年份：2024 · DOI：10.1016/j.cct.2024.107685 · 被引用次数：3 · 研究领域：Dementia and Cognitive Impairment Research、Family Caregiving in Mental Illness、Mental Health and Patient Involvement

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 a...