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Kishita, Naoko 
ORCID: https://orcid.org/0000-0001-8453-2714, Gould, Rebecca L., Khondoker, Mizanur ORCID: https://orcid.org/0000-0002-1801-1635, McCracken, Lance M., Riggey, Megan, Trucco, Ana Paula, Howe, David, Couchman, Abbey, Flanagan, Emma, Vishwakarma, Ramesh ORCID: https://orcid.org/0000-0003-2458-2802, Guillard, Cecile, Ashford, Polly-Anna, Turner, David ORCID: https://orcid.org/0000-0002-1689-4147, Losada-Baltar, Andrés, Cabrera-Lafuente, Isabel, Gallego-Alberto, Laura, Richmond, Erica, Czyznikowska, Barbara, Hammond, Matthew, Nautiyal, Aditya and Farquhar, Morag ORCID: https://orcid.org/0000-0001-7991-7679
(2026)
Clinical effectiveness of internet-delivered self-help Aacceptance and Commitment Therapy for family carers of people with dementia (iACT4CARERS): a multicentre, parallel, randomised controlled trial.
The Lancet Regional Health - Europe, 67.
ISSN 2666-7762
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Abstract
Background: As dementia prevalence rises globally, unpaid family carers provide most care and face high mental health risk. Existing psychological interventions offer limited benefit for anxiety in this population. We evaluated the effectiveness of an internet-delivered, self-help Acceptance and Commitment Therapy intervention with minimal non-expert therapist support (iACT4CARERS) to reduce anxiety in dementia family carers. Methods: We conducted a multi-site, single-blind, parallel-group, randomised controlled trial across UK national healthcare services. Eligible participants were family carers of a person with dementia and reported anxiety symptoms (Generalised Anxiety Disorder-7 [GAD-7] score ≥5). Participants were allocated (1:1) to iACT4CARERS plus treatment-as-usual or treatment-as-usual alone, using computer-generated randomisation with minimisation by ethnicity and baseline anxiety. The intervention comprised an eight-session self-help programme guided by non-expert therapists. Outcome assessors and the lead statistician were blinded to allocation. The primary outcome was anxiety symptoms, assessed using the GAD-7 at 12-weeks post-randomisation. Analyses followed the intention-to-treat principle using linear regression models. The trial was pre-registered with ISRCTN (45995725). Findings: Between November 1, 2023, and January 14, 2025, 902 individuals were referred: 567 (63%) were assessed for eligibility and 496 (87%) were randomised (249 to intervention; 247 to control). 397/496 (80%) were female. Primary outcome data were available for 398/496 participants (80%). After adjustment for baseline anxiety, ethnicity, and education, iACT4CARERS plus treatment-as-usual significantly reduced anxiety at 12 weeks compared with treatment-as-usual alone (adjusted mean difference −2.62, 95% CI −3.47 to −1.77; p < 0.0001; d = 0.53), with participants in the intervention group showing clinically meaningful improvement. Three non-intervention-related adverse events were reported; no serious adverse events occurred. Interpretation: iACT4CARERS is an effective intervention for reducing anxiety symptoms and addressing a major unmet mental health need in this population, with strong potential for scalable implementation. Funding: National Institute for Health and Care Research Health Technology Assessment.
| Item Type: | Article |
|---|---|
| Additional Information: | Data sharing statement: De-identified participant data will be made available upon request following publication of the study results. Requests should be directed to the corresponding author and include the specific data fields required and the purpose of the request, ideally accompanied by a detailed protocol or, at minimum, a research plan. The data dictionary can also be provided. The open-access study protocol has been published, and the statistical analysis plan is available on the trial registry website. Requests will be reviewed on a case-by-case basis, and requestors will be required to complete a data-sharing agreement with the study sponsor prior to data transfer. |
| Uncontrolled Keywords: | acceptance and commitment therapy,anxiety,caregivers,dementia,online therapy,self-help,internal medicine,oncology,health policy,public health, environmental and occupational health ,/dk/atira/pure/subjectarea/asjc/2700/2724 |
| 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 Science > Research Groups > Norwich Epidemiology Centre Faculty of Medicine and Health Sciences > Research Groups > Norwich Epidemiology Centre Faculty of Science > Research Groups > Statistics Faculty of Medicine and Health Sciences > Research Groups > Epidemiology and Public Health Faculty of Medicine and Health Sciences > Research Centres > Public Health Faculty of Medicine and Health Sciences > Research Centres > Mental Health and Social Care (fka Lifespan 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 |
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| Depositing User: | LivePure Connector |
| Date Deposited: | 25 Aug 2026 15:16 |
| Last Modified: | 25 Aug 2026 15:16 |
| URI: | https://ueaeprints.uea.ac.uk/id/eprint/104342 |
| DOI: | 10.1016/j.lanepe.2026.101766 |
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