Testing an Online Intervention for Inflammatory Bowel Disease (IBD) Patients

This study will be a parallel two-arm randomised controlled trial (RCT) with a 1:1 allocation ratio comparing an intervention group to a waitlist control group—designed following the CONSORT guidelines. The proposed study will examine the effects of a seven-day online Acceptance and Commitment Therapy (ACT) intervention (iACT4IBD) on depression, stress, and anxiety levels in adult IBD patients residing in Aotearoa New Zealand. After the intervention, up to 15 participants from the intervention group will be invited to attend focus groups or interviews to explore their views of the ACT intervention and explore gaps in current psychosocial support services for patients with IBD. Potential participants will be directed from the study website to REDCap (a secure web application for managing online surveys and databases) to review the Participant Information Sheet (which will be available for download), read and complete an online screening questionnaire for eligibility. If eligible for the study, participants will complete an online consent form and then fill out baseline questionnaires on REDCap. The consent form and questionnaires will link to the intervention website via a URL for participants to access. The ACT modules will be secured with password protection on the iACT4IBD website. Upon completion of the consent form and baseline questionnaires on REDCap, participants will be randomised into either the intervention group or waitlist control group by a researcher outside the study team using an online random number generator. Participants in the intervention group will receive an email with a link to the intervention website and the password to access the ACT modules. Intervention group participants will be instructed to log onto the iACT4IBD website daily for one week at a location of their choice. They will spend approximately 20 minutes daily on an ACT module for seven consecutive days. Throughout the intervention, participants will receive emails to remind them to complete a module each day. Four weeks after completing the baseline questionnaires, intervention group participants will receive an email with a link to complete follow-up questionnaires on REDCap. The intervention is a brief online therapeutic intervention based on the core processes of ACT and designed to be completed in seven days. Daily modules guide participants through the six core processes within the ACT model to increase psychological flexibility: (1) awareness of the present moment, (2) cognitive defusion, (3) self as context, (4) acceptance of unpleasant experiences, (5) recognition of personal values, and (6) committed action to living meaningfully according to one’s values. Each daily module is self-directed and will take approximately 20 minutes to complete. The content of the modules are as follows: introduction to the intervention; being mindful and aware of the present moment; cognitive defusion; self as context; acceptance of unpleasant experiences or thoughts; recognition of personal values; and taking value-driven committed action. Exercises within the modules include relaxation techniques, mindfulness exercises, goal setting, self-compassion exercises, and gratitude. Content will be delivered within the modules through written information, audio recordings, short videos, and basic graphics/iconography and animations. At the end of the intervention, participants will be asked to select a statement that represents the extent that they adhered to the intervention. For example, “I completed all modules”, “I completed one module”, “I completed two modules” or “I completed no modules”. An acceptable adherence rate requires the completion of five out of seven modules (Hayes et al., 1980). Participants will also rate the extent to which they found each module helpful upon module completion by answering the question “how helpful did you find this module?”. Participants will indicate that the module was either very helpful, somewhat helpful, only a little helpful, or not helpful. This question will be asked at the end of each module and represent another indicator of adherence to the intervention and provide feedback on the most helpful/unhelpful modules.