Rebekah Laidsaar-Powell, Sarah Giunta, Lisa Beatty, Phyllis Butow, Daniel Costa, Aaron Lam, Ilona Juraskova, Olivia Cook, Fiona Crawford-Williams, Nicole M Rankin, Joanne Shaw
{"title":"CarersCanADAPT：针对患有焦虑症和抑郁症的癌症照护者的在线认知行为疗法 (iCBT) 程序的阶梯式照护路径和混合型 1 类有效性实施试验的研究方案。","authors":"Rebekah Laidsaar-Powell, Sarah Giunta, Lisa Beatty, Phyllis Butow, Daniel Costa, Aaron Lam, Ilona Juraskova, Olivia Cook, Fiona Crawford-Williams, Nicole M Rankin, Joanne Shaw","doi":"10.1016/j.cct.2024.107749","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Family or friend carers of people with cancer report high levels of depression, anxiety, caregiving strain, and unmet needs. Limited strategies for identification and management of distress have been established among cancer carers. This paper describes the protocol of two linked studies: Study 1a, a distress screening and stepped care pathway feasibility study and Study 1b, a hybrid implementation-effectiveness Randomised Controlled Trial (RCT) to assess the benefit of a comprehensive, carer-centred online Cognitive Behavioural Therapy (iCBT) program for carers with anxiety and depression.</p><p><strong>Methods: </strong>For Study 1a, 300 cancer carers will be screened for distress. Carers with low distress will be referred to publicly available carer resources. Carers scoring 4 and higher on the distress thermometer will complete depression and anxiety measures. Carers with high anxiety/depression will be recommended psychological therapy. Carers with mild/moderate anxiety and/or depression will be allocated to the Carers iCBT Program, evaluated via a RCT with waitlist control group (Study 1b). For Study 1b, intervention group carers will receive access to a 6-lesson self-directed online iCBT program. Waitlist-controls will access the intervention at 14 weeks. Intervention and control groups will complete baseline, 6 week, and 14 week self-report measures; controls will complete additional measures at 20 and 28 weeks. A sample size of n = 88 carers in the iCBT RCT is needed.</p><p><strong>Conclusions: </strong>If acceptable, feasible and effective, this pathway and iCBT intervention could offer a sustainable, scalable and low-cost approach to identifying and managing distress in carers, and potentially improving patient and carer outcomes.</p><p><strong>Trial registration: </strong>Australian and New Zealand Clinical Trial Registry number: ACTRN12623001341617p.</p>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":" ","pages":"107749"},"PeriodicalIF":2.0000,"publicationDate":"2024-11-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"CarersCanADAPT: Study protocol of a stepped care pathway and hybrid type 1 effectiveness-implementation trial of an online cognitive behavioural therapy (iCBT) program for cancer carers with anxiety and depression.\",\"authors\":\"Rebekah Laidsaar-Powell, Sarah Giunta, Lisa Beatty, Phyllis Butow, Daniel Costa, Aaron Lam, Ilona Juraskova, Olivia Cook, Fiona Crawford-Williams, Nicole M Rankin, Joanne Shaw\",\"doi\":\"10.1016/j.cct.2024.107749\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Family or friend carers of people with cancer report high levels of depression, anxiety, caregiving strain, and unmet needs. Limited strategies for identification and management of distress have been established among cancer carers. This paper describes the protocol of two linked studies: Study 1a, a distress screening and stepped care pathway feasibility study and Study 1b, a hybrid implementation-effectiveness Randomised Controlled Trial (RCT) to assess the benefit of a comprehensive, carer-centred online Cognitive Behavioural Therapy (iCBT) program for carers with anxiety and depression.</p><p><strong>Methods: </strong>For Study 1a, 300 cancer carers will be screened for distress. Carers with low distress will be referred to publicly available carer resources. Carers scoring 4 and higher on the distress thermometer will complete depression and anxiety measures. Carers with high anxiety/depression will be recommended psychological therapy. Carers with mild/moderate anxiety and/or depression will be allocated to the Carers iCBT Program, evaluated via a RCT with waitlist control group (Study 1b). For Study 1b, intervention group carers will receive access to a 6-lesson self-directed online iCBT program. Waitlist-controls will access the intervention at 14 weeks. Intervention and control groups will complete baseline, 6 week, and 14 week self-report measures; controls will complete additional measures at 20 and 28 weeks. A sample size of n = 88 carers in the iCBT RCT is needed.</p><p><strong>Conclusions: </strong>If acceptable, feasible and effective, this pathway and iCBT intervention could offer a sustainable, scalable and low-cost approach to identifying and managing distress in carers, and potentially improving patient and carer outcomes.</p><p><strong>Trial registration: </strong>Australian and New Zealand Clinical Trial Registry number: ACTRN12623001341617p.</p>\",\"PeriodicalId\":10636,\"journal\":{\"name\":\"Contemporary clinical trials\",\"volume\":\" \",\"pages\":\"107749\"},\"PeriodicalIF\":2.0000,\"publicationDate\":\"2024-11-17\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Contemporary clinical trials\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.cct.2024.107749\",\"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://doi.org/10.1016/j.cct.2024.107749","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
CarersCanADAPT: Study protocol of a stepped care pathway and hybrid type 1 effectiveness-implementation trial of an online cognitive behavioural therapy (iCBT) program for cancer carers with anxiety and depression.
Background: Family or friend carers of people with cancer report high levels of depression, anxiety, caregiving strain, and unmet needs. Limited strategies for identification and management of distress have been established among cancer carers. This paper describes the protocol of two linked studies: Study 1a, a distress screening and stepped care pathway feasibility study and Study 1b, a hybrid implementation-effectiveness Randomised Controlled Trial (RCT) to assess the benefit of a comprehensive, carer-centred online Cognitive Behavioural Therapy (iCBT) program for carers with anxiety and depression.
Methods: For Study 1a, 300 cancer carers will be screened for distress. Carers with low distress will be referred to publicly available carer resources. Carers scoring 4 and higher on the distress thermometer will complete depression and anxiety measures. Carers with high anxiety/depression will be recommended psychological therapy. Carers with mild/moderate anxiety and/or depression will be allocated to the Carers iCBT Program, evaluated via a RCT with waitlist control group (Study 1b). For Study 1b, intervention group carers will receive access to a 6-lesson self-directed online iCBT program. Waitlist-controls will access the intervention at 14 weeks. Intervention and control groups will complete baseline, 6 week, and 14 week self-report measures; controls will complete additional measures at 20 and 28 weeks. A sample size of n = 88 carers in the iCBT RCT is needed.
Conclusions: If acceptable, feasible and effective, this pathway and iCBT intervention could offer a sustainable, scalable and low-cost approach to identifying and managing distress in carers, and potentially improving patient and carer outcomes.
Trial registration: Australian and New Zealand Clinical Trial Registry number: ACTRN12623001341617p.
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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