None listed
Conditions
Brief summary
IBD populations experience 2-3 times higher rates of mental health comorbidities in comparison to healthy individuals. Researchers have investigated mental health as contributing to the pathogenies of IBD, finding a significant two-way gut-brain relationship. Mindfulness-based interventions (MBI’s) have been examined as a psychotherapy for IBD. MBI’s aim to foster non-judgmental awareness of emotions, thoughts, and behavior, to support self-regulation. A recent systematic review found MBI’s to be effective in improving IBD biopsychosocial outcomes, including CRP, stress and HRQoL, concluding that MBI’s may be a useful adjuvant therapy in IBD care, with further trials warranted. The review highlighted several limitations providing considerations for the current trial including; trials utilizing unselected participants without psychological distress, no trial utilizing an online intervention, and lack of interventions adapted to IBD. This study aims to evaluate the feasibility and preliminary efficacy of a 6-week online MIND4IBD program, adapted for individuals with IBD, experiencing psychological distress.
Interventions
The MIND4IBD Intervention: Mindfulness is commonly defined as “paying attention in a particular way, on purpose, in the present moment and non-judgmentally to the unfolding of experience moment by moment”. Mindfulness has also been defined as a “mental engagement that introduces a space in-between one’s perception and response, which helps to regulate how an individual relates to that experience rather than attempting to change the experience themselves”. Ultimately mindfulness-based interventio
The MIND4IBD Intervention: Mindfulness is commonly defined as “paying attention in a particular way, on purpose, in the present moment and non-judgmentally to the unfolding of experience moment by moment”. Mindfulness has also been defined as a “mental engagement that introduces a space in-between one’s perception and response, which helps to regulate how an individual relates to that experience rather than attempting to change the experience themselves”. Ultimately mindfulness-based interventions aim to foster non-judgmental awareness of emotions, thoughts, and behaviour, supporting individuals to respond to their experiences in more adaptive ways, instead of reacting in an automatic habitual pattern. The core components of MBI’s typically include psychoeducation, mindfulness meditation, and mindfulness activities. Our intervention is consistent with the core principles and components of mindfulness. Our intervention is also tailored to people with Inflammatory Bowel Disease (IBD) in several ways. Research has shown that people with IBD experience unique disease related worries related to concerns surrounding QoL (e.g., travelling, toilet frequency), unpredictability (of flares in symptoms), the symptoms themselves (e.g., fatigue, pain), and treatment concerns (e.g., medication side effects). The intervention will incorporate these unique disease related worries within intervention modules themselves. We will also provide psychoeducation surrounding the brain-gut connection in IBD. Our 6-week MIND4IBD intervention includes six fully scripted modules, each addressing different mindfulness themes or principles. All modules are self-led and delivered wholly online via a website, and include written material, video and/or voice recordings. Participants are asked to complete one module a week over 6-weeks, with modules lasting no longer than 30 minutes. As the intervention is delivered through a website, website analytics will be used to monitor adherence to the intervention. The contents of the modules will include an introduction to mindfulness, stress reduction using mindfulness, relating to emotions mindfully, mindful self-compassion, communicating mindfully, and living mindfully.
Sponsors
Deakin University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Adults aged 18 years or older. - Diagnosis of IBD (including Ulcerative Colitis or Crohn's Disease subtypes). IBD diagnosis needs to be established by a health professional using standard criteria. Participants will need to provide evidence of their diagnosis, this can include a letter from a doctor (e.g., GP or Gastroenterologist), results of endoscopy, or any other medical document confirming their diagnosis. Screening for this will take place after consent has been obtained and evidence will be destroyed after verifying participants study eligibility. - Evidence of moderate to high psychological distress. This will be verified by a score between 16-29 on K10. Screening for distress will take place after consent has been obtained. - Able to communicate in English. - Access to the internet to participate in the online intervention. - Live in Australia
Exclusion criteria
- No/low psychological distress (represented by scores <16 on K10) or very high psychological distress (represented by scores >29 on K10). It is anticipated that participants with more severe distress would require a more intensive therapeutic approach before benefiting from the current intervention. These participants will receive a message embedded in the Qualtrics screening process to indicate they are not eligible to participate in the study due to screening for severe distress, and it will be recommended that they seek additional support from other appropriate providers. In the same manner participants with no distress will also receive a message stating that they are not eligible to participate in the study due to screening for no distress.
Outcome results
None listed