A Randomised Controlled Trial (RCT) of iCanADAPT, an internet Cognitive Behavioural Therapy (iCBT) program for the treatment of depression and anxiety in early stage cancer patients and cancer survivors.

INTRODUCTION The Clinical Research Unit for Anxiety and Depression (CRUfAD) have developed an online cognitive behavioural therapy (CBT) intervention for anxiety and depression in cancer patients and survivors. It is called iCanADAPT. Aspects of existing online interventions for anxiety and depression were adapted to the cancer context in the development of the iCanADAPT program. iCanADAPT is a 16week self-managed, mixed anxiety and depression program that is tailored to unique aspects of the cancer context, such as fear of cancer recurrence and adapting to illness, side-effects and survivorship. PROPOSAL The proposed study will evaluate the efficacy of the newly developed program as a cancer specific, online intervention for anxiety and depression and will aim to demonstrate that iCBT is an effective program for reducing anxiety and depressive symptoms in cancer patients and survivors. ALLOCATION Participants with elevated anxiety and depression scores and either a current early stage cancer or a prior cancer diagnosis will be recruited. They will complete online screening questionnaires on CRUfAD's clinical trials website (www.virtualclinic.org.au) to assess eligibility to participate, and provide informed consent, before being interviewed over the telephone to assess eligibility for inclusion into the study. If accepted into the study, the participant will be randomly allocated into one of two groups: GROUP 1 receive access to the iCanADAPT program GROUP 2 treatment as usual group (may access care at any point) and after a 16 week period, will then be offered access the iCanADAPT program. OVERVIEW OF PROGRAM The iCanADAPT program consists of eight ‘Modules’ based on cognitive behavioural therapy (CBT). It includes all treatment components typically seen in face-to-face CBT (the first-line treatment for depression and anxiety in early stage cancer patients and survivors). Each of the eight ‘Modules’ can be considered as a discrete package. Each of the ‘Modules’ contains: - A Lesson (consists of a comic based, easy to read story, pertinent to all participants), - An associated Lesson Summary (consists of more dense reading material, likely pertinent to all participants) - Any additional resources for that part (which may not be needed by all participants) - Any additional worksheets for that part (pertinent to all participants) THEMES of THE MODULES The overriding messages in each ‘Module’ i.e. the each ‘Lesson’ and it’s associated ‘Lesson Summary’, and any additional resources is arranged by themes. The main themes are: Module/Lesson 1 Learning about Depression and Anxiety in the cancer context Module /Lesson 2 Identifying and Tackling Thoughts Module/Lesson 3 Tackling Unhelpful Behaviours Module/Lesson 4 Helpful Coping Module/Lesson 5 Adjusting to Change Module/Lesson 6 Tackling Avoidance Module/Lesson 7 Mastering Your Skills Module/Lesson 8 Staying Well in the Long Term and Getting Even Better EXAMPLE of a MODULE Hence, for ‘Module 3’ the theme is “Tackling Unhelpful Behaviours”, hence the Lesson shows the characters addressing their unhelpful behaviours in a comic based, easy to follow story. Further specific, more detailed, writing is contained in the Lesson summary, in this case under the following headings: 1. Tackling Low Activity 2. Before starting activity scheduling and physical activity 3. Daily Activity Scheduling 4. Physical Activity 5. Structured Problem Solving 6. Assertive Communication Skills 7. Your Checklist 8. Summary In this case, the Extra Resources in ‘Module 3’ are: 3.1 - 100 Things To Do (List of Pleasant Activities) 3.2 - Diet 3.3 - Smoking 3.4 - FAQs Module 3 Furthermore, worksheets relevant to the Lesson/ Lesson Summary are provided: 3.W1 - Activity planning and Monitoring worksheet 3.W2 Structured Problem Solving worksheet 3.W3 Pros and Cons Worksheet HOW TO WORK THROUGH THE PROGRAM Participants will asked to complete the Lesson (including the questionnaires beforehand for that lesson). Each lesson will take approximately 45 - 60 minutes to complete. They may go through all slides in a single sitting, or they may take multiple sittings to get to the end. Once they have completed the Lesson, the computer system automatically releases the associated Lesson Summary (i.e. it becomes available for download on completion of the lesson). They participant are asked to practice any associated skills/activities over the course of the following 14 days. Furthermore, upon completion of the Lesson, the extra resources for that part of the course, that ‘Module’, similarly become available. We ask participants to aim for an additional 3 hours per week to read these associated resources and to put into practice the CBT skills. TIMING of EACH MODULE There is a purposeful lock-out time of 5 days between release of the subsequent ‘Module’ i.e. next Lesson & Lesson Summary etc. The 5-day lock-out refers to specific time points for the release of the next lesson and its associated lesson summary. For example, if a participant undertook Lesson 4 in one sitting & hence downloaded the Lesson 4 Summary on 01st of the month, we purposely do not allow them to start ‘Module 5’, i.e. Lesson 5, until at least 5 days later, the 05th of the month. We will recommend instead that they spend up to two weeks (until the 14th of the month) reflecting and working through the prior Module i.e. Lesson 4, Lesson 4 Summary/ recommendations. However, as some patients prefer to progress at a quicker pace we do not necessitate the full 14 day period. Instead a five day minimum is set; to ensure that the patient does not get information overload and to encourage them to reflect and undertake activities for at least a short time period. CONTACT Routine email contact from the clinician (registered clinical psychologist or psychiatry trainee/ medical officer) after completion of the first two lessons will occur. Further email contact will occur then as required. The participant is also able to email or phone the clinician at any point during the trial as required. The participant completes a measure of psychological distress before each lesson and if their scores increase by one or more standard deviations the clinician is automatically alerted and initiates contact with the participant by phone or email. ADHERENCE Strategies used to improved adherence to intervention protocols and procedures for monitoring adherence include: automated email reminders, monitoring the downloading of homework, collection of data on how long participants spent reading lessons and practicing skills.