Back to resultsEffects of Relaxation Response Mind-body Intervention in Patients With IBS and IBD
Primary Purpose
Irritable Bowel Syndrome, Inflammatory Bowel Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Relaxation Response Mind-Body Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Irritable Bowel Syndrome, Inflammatory Bowel Disease, mind body, intervention, group, Relaxation Response, genomic effects
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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Relaxation Response Mind-Body Intervention
Arm 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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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".
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.
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).
erythrocyte sedimentation rate
Blood was collected for erythrocyte sedimentation rate (ESR) as measures of inflammation.
C-reactive protein
Blood was collected for C-reactive protein (CRP) assays as measures of inflammation.
Full Information
NCT ID
NCT02136745
First Posted
May 8, 2014
Last Updated
May 9, 2014
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02136745
Brief Title
Effects of Relaxation Response Mind-body Intervention in Patients With IBS and IBD
Official Title
Genomic and Clinical Effects Associated With a Relaxation Response Mind-Body Intervention in Patients With Irritable Bowel Syndrome and Inflammatory Bowel Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome, Inflammatory Bowel Disease
Keywords
Irritable Bowel Syndrome, Inflammatory Bowel Disease, mind body, intervention, group, Relaxation Response, genomic effects
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Relaxation Response Mind-Body Intervention
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Relaxation Response Mind-Body Intervention
Intervention 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. 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.
Primary Outcome Measure Information:
Title
IBS Quality of Life
Description
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.
Time Frame
Change from Baseline (week 0), Mid-intervention (week 5), Post-intervention (week 10), and Short-term Follow-up (week 13)
Title
IBS Symptom Severity Index
Description
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.
Time Frame
Change between Baseline (week 0), Mid-intervention (week 5), Post-intervention (week 10), and Short-term Follow-up (week 13)
Title
IBD Questionnaire
Description
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.
Time Frame
Change between Baseline (week 0), Mid-intervention (week 5), Post-intervention (week 10), and Short-term Follow-up (week 13)
Secondary Outcome Measure Information:
Title
State-Trait Anxiety Inventory (STAI)
Description
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".
Time Frame
Change between Baseline (week 0), Mid-intervention (week 5), Post-intervention (week 10), and Short-term Follow-up (week 13)
Title
Pain Catastrophizing Scale
Description
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.
Time Frame
Change between Baseline (week 0), Mid-intervention (week 5), Post-intervention (week 10), and Short-term Follow-up (week 13)
Title
Brief Pain Inventory
Description
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).
Time Frame
Change between Baseline (week 0), Mid-intervention (week 5), Post-intervention (week 10), and Short-term Follow-up (week 13)
Title
erythrocyte sedimentation rate
Description
Blood was collected for erythrocyte sedimentation rate (ESR) as measures of inflammation.
Time Frame
Change between Baseline (week 0) and Post-intervention (week 10)
Title
C-reactive protein
Description
Blood was collected for C-reactive protein (CRP) assays as measures of inflammation.
Time Frame
Change between Baseline (week 0) and Post-intervention (week-10)
Other Pre-specified Outcome Measures:
Title
Genetic Expression
Description
Blood was collected in PAXgene (Qiagen) tubes for transcriptional expression profiling.
Time Frame
Change between Baseline (week 0) and Post-Intervention (week 10)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brad Kuo, MD
Organizational Affiliation
MGH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25927528
Citation
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. Erratum In: PLoS One. 2017 Feb 21;12 (2):e0172872.
Results Reference
derived
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Effects of Relaxation Response Mind-body Intervention in Patients With IBS and IBD
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