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

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ClinicalTrials.gov Identifier: NCT02136745
Recruitment Status : Completed
First Posted : May 13, 2014
Last Update Posted : May 13, 2014
Sponsor:
Information provided by (Responsible Party):
Branden Kuo, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Inflammatory Bowel Disease Behavioral: Relaxation Response Mind-Body Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Arm Intervention/treatment
Experimental: 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.
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.




Primary Outcome Measures :
  1. IBS Quality of Life [ Time Frame: Change from Baseline (week 0), Mid-intervention (week 5), Post-intervention (week 10), and Short-term Follow-up (week 13) ]
    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.

  2. IBS Symptom Severity Index [ Time Frame: Change between Baseline (week 0), Mid-intervention (week 5), Post-intervention (week 10), and Short-term Follow-up (week 13) ]
    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.

  3. IBD Questionnaire [ Time Frame: Change between Baseline (week 0), Mid-intervention (week 5), Post-intervention (week 10), and Short-term Follow-up (week 13) ]
    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 :
  1. State-Trait Anxiety Inventory (STAI) [ Time Frame: Change between Baseline (week 0), Mid-intervention (week 5), Post-intervention (week 10), and Short-term Follow-up (week 13) ]
    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".

  2. Pain Catastrophizing Scale [ Time Frame: Change between Baseline (week 0), Mid-intervention (week 5), Post-intervention (week 10), and Short-term Follow-up (week 13) ]
    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.

  3. Brief Pain Inventory [ Time Frame: Change between Baseline (week 0), Mid-intervention (week 5), Post-intervention (week 10), and Short-term Follow-up (week 13) ]
    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).

  4. erythrocyte sedimentation rate [ Time Frame: Change between Baseline (week 0) and Post-intervention (week 10) ]
    Blood was collected for erythrocyte sedimentation rate (ESR) as measures of inflammation.

  5. C-reactive protein [ Time Frame: Change between Baseline (week 0) and Post-intervention (week-10) ]
    Blood was collected for C-reactive protein (CRP) assays as measures of inflammation.


Other Outcome Measures:
  1. Genetic Expression [ Time Frame: Change between Baseline (week 0) and Post-Intervention (week 10) ]
    Blood was collected in PAXgene (Qiagen) tubes for transcriptional expression profiling.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02136745


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Brad Kuo, MD MGH
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Branden Kuo, Dr., Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02136745    
Other Study ID Numbers: 2009-P-000757/19
R01DP000339 ( U.S. NIH Grant/Contract )
First Posted: May 13, 2014    Key Record Dates
Last Update Posted: May 13, 2014
Last Verified: May 2014
Keywords provided by Branden Kuo, Massachusetts General Hospital:
Irritable Bowel Syndrome
Inflammatory Bowel Disease
mind body
intervention
group
Relaxation Response
genomic effects
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Colonic Diseases, Functional
Colonic Diseases