Trial Outcomes & Findings for Mindfulness-Based Stress Reduction for Bowel Symptoms: Collection of Pilot Survey Data (NCT NCT00880256)

Results Overview

The Irritable Bowel Severity Scoring System (IBSSS) provides a measure of the severity of IBS. The measure consists of five questions, which assess severity of abdominal pain, number of days with abdominal pain in past 10 days, severity of abdominal distension, satisfaction with bowel habits, and impact of IBS on life in general. The score on each of the 5 questions ranges from 0 to 100, and the scores are summed with a range of total possible scores from 0 to 500. Higher scores reflect more severe IBS. Total score was used in the analyses.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

93 participants

Primary outcome timeframe

6 months

Results posted on

2012-02-27

Participant Flow

During a 17-month period, we enrolled 93 patients who were referred or self-referred themselves to the Mindfulness-Based Stress Reduction (MBSR) program at VA Puget Sound.

Participant milestones

Participant milestones
Measure	MBSR Patients who undergo mindfulness-based stress reduction will fill out measures of IBS severity before and after the mindfulness course.
Overall Study STARTED	93
Overall Study COMPLETED	65
Overall Study NOT COMPLETED	28

Reasons for withdrawal

Reasons for withdrawal
Measure	MBSR Patients who undergo mindfulness-based stress reduction will fill out measures of IBS severity before and after the mindfulness course.
Overall Study Lost to Follow-up	28

Baseline Characteristics

Mindfulness-Based Stress Reduction for Bowel Symptoms: Collection of Pilot Survey Data

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MBSR n=93 Participants Patients who undergo mindfulness-based stress reduction will fill out measures of IBS severity before and after the mindfulness course.
Age Continuous	51 years STANDARD_DEVIATION 10.6 • n=93 Participants
Sex: Female, Male Female	24 Participants n=93 Participants
Sex: Female, Male Male	69 Participants n=93 Participants

PRIMARY outcome

Timeframe: 6 months

Population: We compared scores at baseline, 2-month, and 6-month time points, using t-tests. A two-sided P value of less than 0.05 was considered statistically significant. The standardized mean difference (Cohen's d effect size) from baseline to 2-months, and baseline to 6-months was calculated for each variable.

The Irritable Bowel Severity Scoring System (IBSSS) provides a measure of the severity of IBS. The measure consists of five questions, which assess severity of abdominal pain, number of days with abdominal pain in past 10 days, severity of abdominal distension, satisfaction with bowel habits, and impact of IBS on life in general. The score on each of the 5 questions ranges from 0 to 100, and the scores are summed with a range of total possible scores from 0 to 500. Higher scores reflect more severe IBS. Total score was used in the analyses.

Outcome measures

Outcome measures
Measure	Mindfulness-Based Stress Reduction (MBSR) n=65 Participants Patients who undergo mindfulness-based stress reduction will fill out measures of IBS severity before and after the mindfulness course.
IBS (Irritable Bowel Syndrome) Symptom Severity Score (Total Score) IBS (IBS) symptoms	256.9 units on a scale Standard Deviation 90.6
IBS (Irritable Bowel Syndrome) Symptom Severity Score (Total Score) Irritable Bowel Syndrome Quality of LIfe (QOL)	84.4 units on a scale Standard Deviation 20.6

SECONDARY outcome

Timeframe: 6 months

Population: All participants who completed at 6 months were included

The IBS-QOL is a disease specific Quality-of-Life Measure for IBS. IBS-QOL has been shown have a high level of content validity and to be responsive to change, and has been used in several outcome studies and clinical drug trials throughout the world. It consists of 34 questions that assess the influence of bowel habits on daily life. The response to each question is rated on a 5-point scale. A lower score indicates worse bowel-related quality of life. The summed total score is transformed to a 0-100 scale ranging from 0 (poor quality of life) to 100 (maximum quality of life).

Outcome measures

Outcome measures
Measure	Mindfulness-Based Stress Reduction (MBSR) n=65 Participants Patients who undergo mindfulness-based stress reduction will fill out measures of IBS severity before and after the mindfulness course.
Irritable Bowel Syndrome (IBS) Quality of Life	224.3 units on a scale Standard Deviation 96.3

Adverse Events

MBSR

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. David Kearney

VA Puget Sound Health Care System

Phone: 206-764-2285

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place