Mindfulness-Based Stress-Reduction in Patients With Crohn's Disease (NCT05085925) | Clinical Trial Compass
CompletedNot Applicable
Mindfulness-Based Stress-Reduction in Patients With Crohn's Disease
Israel142 participantsStarted 2018-06-13
Plain-language summary
A randomized controlled study which aims to improve the quality of life of Crohn's disease adult patients suffering from mild to moderate level of symptoms. Patients will be randomized to Intervention or Wait-List groups and will undergo eight Cognitive Behavioral and Mindfulness, one on one, sessions with a social worker via SkypeTM. The Intervention group will receive intervention upon recruitment while the Wait-List group will receive the same intervention after 3 months. Clinical, biological and psycho-social data will be collected at four time points over the 12-months of the study.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Willingness to participate and commit to a one-year process
* Age 18-75 years
* Hebrew-speaking
* Proven diagnosis of mild/moderate Crohn's disease
* At least 3 months post-diagnosis
Exclusion Criteria:
* Crohn's disease that is severe (HBI \>16) or in remission (HBI\<5)
* Ulcerative colitis, IBD unclassified
* Planned surgery or surgery in last 6 months
* Psychiatric disease
* Psychotropic medication
* Alcohol or drug dependency
* Pregnancy
* Significant or poorly controlled comorbidity
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Crohn's disease specific health-related quality of life
Timeframe: Measured at baseline, 3-months, 6-months, 12-months
2
Change in general health profile
Timeframe: Measured at baseline, 3-months, 6-months, 12-months
3
Change in utility weights
Timeframe: Measured at baseline, 3-months, 6-months, 12-months