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

Mass General Brigham

Status: Completed

Conditions: Irritable Bowel Syndrome; Inflammatory Bowel Disease

Treatments: Behavioral: Relaxation Response Mind-Body Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02136745

R01DP000339 (U.S. NIH Grant/Contract)

2009-P-000757/19

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with documented IBS (confirmed by the Rome III diagnostic criteria for 6 months) or IBD (upper limit for Harvey-Bradshaw index [HBI] = 20, upper limit of simple clinical colitis activity index [SCCAI] = 18) by their primary care provider or gastroenterologist
• 18-75 years old
• Fluent in English

Exclusion criteria

• Patients with IBS were excluded if they had abdominal surgery in the past 5 years (with the exception of appendectomy, cholecystectomy) or documentation of GI motility disorder.
• Patients with IBD were excluded if they used NSAIDS chronically, were on a prednisone dose ≥20 mg/day, or if surgery was anticipated in the 10-weeks following enrollment.
• Current evidence of duodenal ulcer, gastric ulcer, diverticulitis, esophagitis or infectious gastroenteritis, or any acute gastrointestinal process, as well as if concurrent total parental nutrition or tube feeding were being used.
• Recent (within the last 4-weeks) changes in IBS/IBD medications, planned changes in diet, or current use of steroids
• Currently pregnant or attempting to become pregnant
• Currently (>3-weeks) practicing Tai Chi, meditation, yoga, individual mind/body based psychotherapy or counseling,
• Initiated psychotherapy within the last 8-weeks
• Using psychotropic medications (except at stable doses for at least 12-weeks),
• Has an untreated psychiatric disorder

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Relaxation Response Mind-Body Intervention

Experimental group

Description:

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. 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.

Treatment:

Behavioral: Relaxation Response Mind-Body Intervention