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

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02136745
• Other study ID #: 2009-P-000757/19
• Secondary ID: R01DP000339
• Status: Completed
• Phase: N/A
• First received: May 8, 2014
• Last updated: May 9, 2014
• Start date: May 2009
• Est. completion date: July 2011

Study information

• Verified date: May 2014
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Irritable Bowel Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Genetic Expression	Blood was collected in PAXgene (Qiagen) tubes for transcriptional expression profiling.	Change between Baseline (week 0) and Post-Intervention (week 10)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Secondary	State-Trait Anxiety Inventory (STAI)	To measure symptoms common to IBS and IBD, the State-Trait Anxiety Inventory (STAI-Y) was administered at each assessment. The STAI is a widely used instrument for measuring anxiety in adults. It differentiates between the temporary condition of "state anxiety" and the more general and long-standing quality of "trait anxiety".	Change between Baseline (week 0), Mid-intervention (week 5), Post-intervention (week 10), and Short-term Follow-up (week 13)	No
Secondary	Pain Catastrophizing Scale	To measure symptoms common to IBS and IBD, the Pain Catastrophizing Scale (PCS) was administered at each assessment. The PCS is widely used to assess cognitive and affective responses to pain and to evaluate pain management program outcomes.	Change between Baseline (week 0), Mid-intervention (week 5), Post-intervention (week 10), and Short-term Follow-up (week 13)	No
Secondary	Brief Pain Inventory	To measure symptoms common to IBS and IBD the Brief Pain Inventory (BPI) was administered at each assessment. The BPI allows patients to rate the severity of their pain (BPI-S) and the degree to which their pain interferes with common dimensions of feeling and function (BPI-I).	Change between Baseline (week 0), Mid-intervention (week 5), Post-intervention (week 10), and Short-term Follow-up (week 13)	No
Secondary	erythrocyte sedimentation rate	Blood was collected for erythrocyte sedimentation rate (ESR) as measures of inflammation.	Change between Baseline (week 0) and Post-intervention (week 10)	No
Secondary	C-reactive protein	Blood was collected for C-reactive protein (CRP) assays as measures of inflammation.	Change between Baseline (week 0) and Post-intervention (week-10)	No