An Online Mindfulness-Based Intervention for Psychological Distress Associated with Inflammatory Bowel Disease: A Feasibility Trial of the Mind4IBD Program
- Conditions
- Inflammatory Bowel DiseaseCrohn's DiseaseUlcerative ColitisOral and Gastrointestinal - Inflammatory bowel diseaseAlternative and Complementary Medicine - Other alternative and complementary medicineOral and Gastrointestinal - Crohn's diseaseOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
- Registration Number
- ACTRN12623000383662
- Lead Sponsor
- Deakin University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
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
; - 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
- 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. ; - 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Feasibility of recruitment and retention assessed based on descriptive study data. This will be based on study recruitment records. [ Upon intervention completion (6 weeks post baseline).];Acceptability of the intervention based on levels of satisfaction measured through numeric rating scale and qualitative open ended survey responses regarding the intervention. These survey measures have been designed specifically for this study. [ Upon intervention completion (6 weeks post baseline). ];Feasibility of recruitment and retention assessed based on descriptive study data. This will be based on study recruitment records. [ Upon intervention completion (6 weeks post baseline).];Acceptability of the intervention based on levels of satisfaction measured through numeric rating scale and qualitative open ended survey responses regarding the intervention. These survey measures have been designed specifically for this study. [ Upon intervention completion (6 weeks post baseline). ]
- Secondary Outcome Measures
Name Time Method