At a glance
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Randomized Intervention Study of Mindfulness-Based Stress-Reduction to Improve the Quality of Life and Immune Regulation in Patients With Crohn's Disease
In Brief
A clinical study evaluating Cognitive behavioral mindfulness intervention and Cognitive behavioral mindfulness intervention after 3-month wait list for Crohn's Disease Colon. Completed, enrolled 142 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
The group that receives mindfulness-based stress reduction at their entry into the study will have 7 sequential sessions during 3 months, and later have a booster session in month 5
Wait-list control patients will get no intervention at the start of the study and instead will be contacted by study personal 7 times to care for the patient in order to control for the 7 sessions performed in the intervention group. After three months they will be offered mindfulness-based stress reduction as 8 sequential sessions.