CarersCanADAPT: Evaluation of an online cognitive behavioural therapy (iCBT) program for cancer carers

Not Applicable

• Conditions: Cancer carers; Anxiety; Depression; Carer burden; Cancer - Any cancer; Mental Health - Anxiety; Mental Health - Depression

• Registration Number: ACTRN12623001341617
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-12-19
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Australian carers of people with cancer with elevated levels of distress will be included in the main trial.
Carers inclusion:
•Elevated levels of distress will be operationalised as a score of 4 or more on the distress thermometer, followed by a score of 5 or more on the PHQ-9 and a score of 5 or more on GAD-7
•Are a person biologically, legally, or emotionally related to an adult person who has ever received a diagnosis of primary cancer or cancer recurrence.
oNB: we have not imposed time limits for when a loved one received a cancer diagnosis (so long as they were 18 years or older at time of diagnosis) as carers may experience depression, anxiety and/or caregiving related stress at any point from diagnosis to many years into survivorship.
•Identifies as a primary carer, providing unpaid support to the cancer patient
•Aged over 18 years
•The person they care for was diagnosed with cancer as an adult (aged >18 years old at time of diagnosis)
•Has sufficient English language skills to complete the intervention and/or questionnaires
•Willing to participate in the study

Exclusion Criteria

•Insufficient cognitive capacity or English language skills to provide informed consent and complete the intervention and/or questionnaires
•The person with cancer they care for has a life expectancy of less than 12 months
•Actively receiving psychological therapy for carer related distress

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Depression (measured using PHQ-9) [ Difference in carer depression (PHQ-9 scores) of intervention group at 6 and 14 weeks’ post baseline time point compared to depression measures of waitlist control group at 6 and 14 weeks.];Carer Anxiety ( measured using GAD-7)[ Difference in carer anxiety (GAD-7 scores) of intervention group at 6 and 14 weeks’ post baseline time point compared to anxiety measures of waitlist control group at 6 and 14 weeks.]

Secondary Outcome Measures

Name	Time	Method
Carer burden: measured using the 22-item Carer Burden Scale[ Difference in carer burden (measured using the Carer Burden Scale) of intervention group at 6 and 14 weeks’ post baseline time point compared to carer burden measures of waitlist control group at 6 and 14 weeks.];Acceptability of iCBT module assessed with optional post-intervention qualitative interview. Interviews are expected to last approximately 30 minutes and will be conducted one-on-one over the phone, zoom or in person. Interviews will be guided by an interview schedule of open-ended questions about participant's experiences using the module and their feedback on the module content. All interviews will be audio recorded and transcribed verbatim. [ 6 weeks post-intervention (optional qualitative interview)]