TY - JOUR
T1 - CarersCanADAPT
T2 - 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
AU - Laidsaar-Powell, Rebekah
AU - Giunta, Sarah
AU - Beatty, Lisa
AU - Butow, Phyllis
AU - Costa, Daniel
AU - Lam, Aaron
AU - Juraskova, Ilona
AU - Cook, Olivia
AU - Crawford-Williams, Fiona
AU - Rankin, Nicole M.
AU - Shaw, Joanne
PY - 2025/1
Y1 - 2025/1
N2 - 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 = 166 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.
AB - 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 = 166 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.
KW - Anxiety
KW - cancer carers
KW - Cognitive behavioural therapy
KW - Depression
KW - Family caregivers
KW - iCBT
KW - Randomised controlled trial
UR - http://www.scopus.com/inward/record.url?scp=85210313134&partnerID=8YFLogxK
U2 - 10.1016/j.cct.2024.107749
DO - 10.1016/j.cct.2024.107749
M3 - Article
C2 - 39561919
AN - SCOPUS:85210313134
SN - 1551-7144
VL - 148
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
M1 - 107749
ER -
