NCT02136745

Effects of Relaxation Response Mind-body Intervention in Patients With IBS and IBD

Genomic and Clinical Effects Associated With a Relaxation Response Mind-Body Intervention in Patients With Irritable Bowel Syndrome and Inflammatory Bowel Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

In this pilot study, the investigators examined whether a relaxation response mind-body intervention could be effectively delivered to mixed groups of IBS and IBD patients and determined the effects of the intervention on quality of life, inflammatory markers, and gene expression using transcriptional profiling.

Conditions

• Irritable Bowel Syndrome
• Inflammatory Bowel Disease

Interventions

Type	Name	Description
BEHAVIORAL	Relaxation Response Mind-Body Intervention	The Relaxation Response Mind-Body Intervention (RR-MBI) involved a 9-week group program conducted by a nurse practitioner or psychologist skilled in MBI, which included a GI-specific session conducted by a physician. The groups met once weekly for 1.5 hours. Three consecutive, mixed-disorder groups, ranging in size from 10 to 18 participants each. The program was multidimensional and included daily elicitation of the RR using a variety of methods (including breath focus, single-pointed focus, imagery, contemplation, yoga, and mindful awareness); cognitive reappraisal skills, health enhancing behaviors, and the promotion of optimism and acceptance. Throughout the course of treatment, participants were asked to elicit the RR at home each day for 15-20 minutes.

Timeline

• Start date: 2009-05-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2014-05-13
• Last updated: 2014-05-13

Locations

1 site across 1 country: United States