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

Study Overview
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Brief Summary
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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.

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

Conditions
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Irritable Bowel Syndrome, Inflammatory Bowel Disease

Intervention / Treatment
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* Behavioral: Relaxation Response Mind-Body Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Relaxation Response Mind-Body Intervention<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intervention, Irritable Bowel Syndrome, Inflammatory Bowel Disease, mind body, group, Relaxation Response, genomic effects