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

NCT02136745 | Completed

• 2 other identifiers: 2009-P-000757/19R01DP000339
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Keywords

Irritable Bowel Syndrome; Inflammatory Bowel Disease; mind body; intervention; group; Relaxation Response; genomic effects

Outcome Measures

Primary Outcomes (3)

• IBS Quality of Life

  The IBS Quality of Life (IBS-QOL) is a validated disease-specific instruments to assess the disease-specific impact of the intervention. The IBS-QOL is a self-reported quality of life (QOL) measure containing 34 questions specific to IBS that is used to assess the impact of IBS and its treatment on QOL.

  Change from Baseline (week 0), Mid-intervention (week 5), Post-intervention (week 10), and Short-term Follow-up (week 13)

• IBS Symptom Severity Index

  The IBS Symptom Severity Index (SSI) is a validated disease-specific instruments to assess the disease-specific impact of the intervention. The IBS SSI is a widely used questionnaire measuring IBS-related pain frequency, severity of pain, bloating, bowel habit dissatisfaction and interference with daily life and extra-colonic symptoms on a visual analogue scale.

  Change between Baseline (week 0), Mid-intervention (week 5), Post-intervention (week 10), and Short-term Follow-up (week 13)

• IBD Questionnaire

  The IBD Questionnaire (IBD-Q) is a validated disease-specific instruments to assess the disease-specific impact of the intervention. The IBD-Q is designed to measure the effects of inflammatory bowel disease on daily function and quality of life.

  Change between Baseline (week 0), Mid-intervention (week 5), Post-intervention (week 10), and Short-term Follow-up (week 13)

Secondary Outcomes (5)

• State-Trait Anxiety Inventory (STAI)

  Change between Baseline (week 0), Mid-intervention (week 5), Post-intervention (week 10), and Short-term Follow-up (week 13)

• Pain Catastrophizing Scale

  Change between Baseline (week 0), Mid-intervention (week 5), Post-intervention (week 10), and Short-term Follow-up (week 13)

• Brief Pain Inventory

  Change between Baseline (week 0), Mid-intervention (week 5), Post-intervention (week 10), and Short-term Follow-up (week 13)

• erythrocyte sedimentation rate

  Change between Baseline (week 0) and Post-intervention (week 10)

• C-reactive protein

  Change between Baseline (week 0) and Post-intervention (week-10)

Other Outcomes (1)

• Genetic Expression

  Change between Baseline (week 0) and Post-Intervention (week 10)

Study Arms (1)

Relaxation Response Mind-Body Intervention

EXPERIMENTAL

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.

Behavioral: Relaxation Response Mind-Body Intervention

Interventions

Relaxation Response Mind-Body Intervention 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.

Relaxation Response Mind-Body Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years old
• Fluent in English

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 25927528 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis

Study Officials

• Brad Kuo, MD

  MGH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: May 8, 2014
• First Posted: May 13, 2014
• Study Start: May 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: May 13, 2014

Record last verified: 2014-05

Locations

US (1)