None listed
Conditions
Brief summary
The primary aim of this study is to test the effectiveness of an online Cognitive Behavioural Therapy (iCBT) intervention (called CarersCanADAPT) for carers of people with cancer in reducing symptoms of anxiety and depression compared to carers in the wait list control condition. Who is it for? You may be eligible for this study if you are an adult who is a primary carer for an adult diagnosed with cancer. Study details Participants will be asked to complete the CarersCanADAPT 6 week online cognitive behavioural therapy program. You will be randomly allocated to join either the immediate access group or the waitlist group. Either way you will receive access to the CarersCanADAPT program, however those people in the waitlist group will get access to the program in 14 weeks’ time. You will also be asked to complete an online initial (baseline) questionnaire, and 2 more questionnaires at 6 and 14 weeks after beginning the trial. If you are allocated to the waitlist group, you will also be asked to complete an additional 2 questionnaires at 20 and 28 weeks after beginning the trial. This research offers an opportunity to test the effectiveness and implementation of an evidence-based online support module for carers, which if found to be effective can be broadly disseminated and potentially implemented into routine care.
Interventions
Materials: Online therapeutic iCBT intervention (CarersCanADAPT) will be delivered via a secure web based program to study participants over a 6 week period. Each section will take 1-2 hours to complete. The lesson topics are:
Lesson 1: Learning about depression and anxiety
Lesson 2: Identifying and tackling thoughts
Lesson 3: Tackling unhelpful behaviours
Lesson 4: Helpful coping
Lesson 5: Adjusting to change, communication, and support
Lesson 6: Staying well in the long term and getting eve
Materials: Online therapeutic iCBT intervention (CarersCanADAPT) will be delivered via a secure web based program to study participants over a 6 week period. Each section will take 1-2 hours to complete. The lesson topics are: Lesson 1: Learning about depression and anxiety Lesson 2: Identifying and tackling thoughts Lesson 3: Tackling unhelpful behaviours Lesson 4: Helpful coping Lesson 5: Adjusting to change, communication, and support Lesson 6: Staying well in the long term and getting even better Website back-end analytics will be used to monitor adherence to the intervention - data will be captured on number of log-ins, date of log-ins, time spent on each section, and interaction with activities, e.g. downloading worksheets and summaries. Procedures: Participants in the RCT will be randomly assigned to the intervention or wait list control condition, 1:1 allocation ratio. The randomisation will be electronically generated using an access database. Participants in the intervention (iCBT) condition will receive immediate access to CarersCanADAPT iCBT via the secure CarersCanADAPT Portal and will complete 1 lesson per week over 6 weeks, and then complete follow-up measures immediately post intervention and 8 weeks later (i.e. 14 weeks). Participants in the wait list control condition will not be provided with the CarersCanADAPT iCBT and will complete measures only. After the wait list control group has completed 14 weeks on the wait list, they will receive access to the CarersCanDAPT iCBT and will continue to complete measures for the duration of the intervention and follow-up period. Additionally, Participants will complete the PHQ-9 and GAD-7 as part of the pre-lesson screening/monitoring measure every 2 weeks during the intervention phase Delivery: The intervention will be delivered by the research team, who will send participants a link to access the web-platform which contains structured lessons and activities, supported by multimedia storylines. The intervention will be delivered online. Participants may complete the intervention anywhere they chose where they have access to a device which connects to the internet. There will be six lessons for individuals to work through at their own pace. One lesson will be made available weekly to participants, who will be sent an email reminder when a new lesson becomes available. Participants who have not completed the training will be sent up to 3 reminder emails from the research team to encourage completion.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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. o NB: 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
Outcome results
None listed