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

NCT ID: NCT02136745

Last Updated: 2014-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2011-07-31

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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. 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.

Group Type: EXPERIMENTAL

Relaxation Response Mind-Body Intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Branden Kuo

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brad Kuo, MD

Role: PRINCIPAL_INVESTIGATOR

MGH

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

Kuo B, Bhasin M, Jacquart J, Scult MA, Slipp L, Riklin EI, Lepoutre V, Comosa N, Norton BA, Dassatti A, Rosenblum J, Thurler AH, Surjanhata BC, Hasheminejad NN, Kagan L, Slawsby E, Rao SR, Macklin EA, Fricchione GL, Benson H, Libermann TA, Korzenik J, Denninger JW. Genomic and clinical effects associated with a relaxation response mind-body intervention in patients with irritable bowel syndrome and inflammatory bowel disease. PLoS One. 2015 Apr 30;10(4):e0123861. doi: 10.1371/journal.pone.0123861. eCollection 2015.

Reference Type: DERIVED

PMID: 25927528 (View on PubMed)

Other Identifiers

R01DP000339

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2009-P-000757/19

Identifier Type: -

Identifier Source: org_study_id