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
{"title":"针对痴呆症患者家庭照护者的互联网自助式 \"接纳与承诺疗法\"（iACT4CARERS）的临床和成本效益：针对不同种族家庭照护者的随机对照试验研究方案","authors":"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","doi":"10.1016/j.cct.2024.107685","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>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.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Conclusion</h3><p>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.</p><p>Clinical trials registration: ISRCTN registry identifier ISRCTN45995725.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"146 ","pages":"Article 107685"},"PeriodicalIF":2.0000,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1551714424002684/pdfft?md5=0a9b753137f736d6325f012e66a2cfb6&pid=1-s2.0-S1551714424002684-main.pdf","citationCount":"0","resultStr":"{\"title\":\"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\",\"authors\":\"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\",\"doi\":\"10.1016/j.cct.2024.107685\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>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.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Conclusion</h3><p>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.</p><p>Clinical trials registration: ISRCTN registry identifier ISRCTN45995725.</p></div>\",\"PeriodicalId\":10636,\"journal\":{\"name\":\"Contemporary clinical trials\",\"volume\":\"146 \",\"pages\":\"Article 107685\"},\"PeriodicalIF\":2.0000,\"publicationDate\":\"2024-09-12\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S1551714424002684/pdfft?md5=0a9b753137f736d6325f012e66a2cfb6&pid=1-s2.0-S1551714424002684-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Contemporary clinical trials\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1551714424002684\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary clinical trials","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1551714424002684","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
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
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.
期刊介绍：
Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.
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