Trial Details

Not Recruiting
Basic Information
Clinical ID c2256
Identifier ACTRN12622001263785
Trial Title Internet Acceptance and Commitment Therapy For Inflammatory Bowel Disease (iACT4IBD): Testing the effect of an Online Intervention on the Psychological Wellbeing of IBD Patients A Two-armed Randomised Controlled Trial
Trial URL Visit Original Page
Study Information
Study Results

Yes

Conditions depression;stress;anxiety;inflammatory bowel disease;Crohn disease;ulcerative colitis; depression stress anxiety inflammatory bowel disease Crohn disease ulcerative colitis;Mental Health - Depression;Oral and Gastrointestinal - Inflammatory bowel disease;Mental Health - Anxiety;Mental Health - Other mental health disorders;Oral and Gastrointestinal - Crohn's disease
Interventions 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 to complete the ACT modules.
Participant Information
Sponsor University of Auckland
City -
Country/Region New Zealand
Enrollment Criteria
Sex Requirement ALL
Age Requirement ADULT, ELDER, OLDER_ADULT
Study Design
Study Type Interventional
Phase Not Available
Time Information
Start Date 2025-04-24
Primary Completion Date 2024-05-14
Completion Date 2023-06-21