Clinical trial NCT02136745: 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
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Inflammatory Bowel Disease
Keywords: Irritable Bowel Syndrome
Inflammatory Bowel Disease
mind body
intervention
group
Relaxation Response
genomic effects
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2014-05-13
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: IBS Quality of Life
timeFrame: Change from Baseline (week 0), Mid-intervention (week 5), Post-intervention (week 10), and Short-term Follow-up (week 13)
measure: IBS Symptom Severity Index
timeFrame: Change between Baseline (week 0), Mid-intervention (week 5), Post-intervention (week 10), and Short-term Follow-up (week 13)
measure: IBD Questionnaire
timeFrame: Change between Baseline (week 0), Mid-intervention (week 5), Post-intervention (week 10), and Short-term Follow-up (week 13)
Secondary outcomes:
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: Change between Baseline (week 0), Mid-intervention (week 5), Post-intervention (week 10), and Short-term Follow-up (week 13)
measure: Pain Catastrophizing Scale
timeFrame: Change between Baseline (week 0), Mid-intervention (week 5), Post-intervention (week 10), and Short-term Follow-up (week 13)
measure: Brief Pain Inventory
timeFrame: Change between Baseline (week 0), Mid-intervention (week 5), Post-intervention (week 10), and Short-term Follow-up (week 13)
measure: erythrocyte sedimentation rate
timeFrame: Change between Baseline (week 0) and Post-intervention (week 10)
measure: C-reactive protein
timeFrame: Change between Baseline (week 0) and Post-intervention (week-10)
Other outcomes:
measure: Genetic Expression
timeFrame: Change between Baseline (week 0) and Post-Intervention (week 10)
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: MGH
name: Brad Kuo, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.