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

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

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

Contemp Clin Trials. 2024 Nov 17:107749. doi: 10.1016/j.cct.2024.107749. Online ahead of print.

Authors

Affiliations

¹ Psycho-Oncology Co-operative Research Group, University of Sydney, Sydney, Australia; School of Psychology, University of Sydney, Sydney, Australia. Electronic address: rebekah.laidsaar-powell@sydney.edu.au.
² Psycho-Oncology Co-operative Research Group, University of Sydney, Sydney, Australia; School of Psychology, University of Sydney, Sydney, Australia.
³ College of Education, Psychology & Social Work, Flinders University, Adelaide, Australia.
⁴ School of Psychology, University of Sydney, Sydney, Australia.
⁵ McGrath Foundation, NSW, Australia; School of Nursing and Midwifery, Monash University, Melbourne, Australia.
⁶ McGrath Foundation, NSW, Australia.
⁷ Evaluation and Implementation Science Unit, Melbourne School of Population and Global Health, Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, Melbourne, Australia.

PMID: 39561919
DOI: 10.1016/j.cct.2024.107749

Abstract

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.

Keywords: Anxiety; Cognitive behavioural therapy; Depression; Family caregivers; Randomised controlled trial; cancer carers; iCBT.