Monitor & Accept (MA-MBI) for Irritable Bowel Syndrome

N/A

Recruiting

Led By J. David Creswell, Ph.D.

Research Sponsored by Carnegie Mellon University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Indicate moderate to high levels of psychological distress over the past two weeks (composite score >5 on the Patient Health Questionnaire-4)

Be older than 18 years old

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upchange from baseline to 1-week post-intervention and 2-month follow-up

Awards & highlights

No Placebo-Only Group

Study Summary

This trial will compare the effectiveness of two different mindfulness-based interventions (MBIs) for treating irritable bowel syndrome (IBS), with a control group who will receive stress management training. The trial will use both clinician and patient assessed measures of IBS symptoms, as well asEcological Momentary Assessment to assess stress and symptoms in daily life.

Eligible Conditions

Irritable Bowel Syndrome

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Select...

You have been feeling very emotionally stressed or upset for the past two weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to 1-week post-intervention and 2-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to 1-week post-intervention and 2-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 1-week post-intervention and 2-month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in IBS Symptom Severity

Change in Microbiome Biology

Change in Self-Reported IBS Quality of Life

+8 more

Secondary outcome measures

Change in Gastrointestinal Symptom-Specific Anxiety

Change in Self-Reported Depressive Symptomatology

Change in Self-Reported Distress Tolerance

+5 more

Other outcome measures

Change in Self-Reported Treatment Expectancies

Self-Reported Diet

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Active Control

Group I: Monitor & Accept (MA-MBI)Active Control1 Intervention

14-day smartphone based mindfulness meditation attention monitoring and acceptance skills training intervention consisting of a 5-minute introductory video, a 20-minute audio-guided lesson, plus daily life homework practice (3-10 minutes) each day.

Group II: Coping Condition (CC)Active Control1 Intervention

14-day smartphone based training intervention focused on coping strategies consisting of a 5-minute introductory video, a 20-minute audio-guided lesson, plus daily life homework practice (3-10 minutes) each day.

Group III: Monitor Only (MO-MBI)Active Control1 Intervention

14-day smartphone based mindfulness meditation training intervention consisting of a 5-minute introductory video, a 20-minute audio-guided lesson, plus daily life homework practice (3-10 minutes) each day.

0 / 1Eligibility criteria met

Find a site

Who is running the clinical trial?

Carnegie Mellon UniversityLead Sponsor

72 Previous Clinical Trials

538,478 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,263 Previous Clinical Trials

4,200,553 Total Patients Enrolled

23 Trials studying Irritable Bowel Syndrome

3,267 Patients Enrolled for Irritable Bowel Syndrome

National Institutes of Health (NIH)NIH

2,611 Previous Clinical Trials

6,663,013 Total Patients Enrolled

4 Trials studying Irritable Bowel Syndrome

347 Patients Enrolled for Irritable Bowel Syndrome

Emily K Lindsay, Ph.D.Study Director

University of Pittsburgh

J. David Creswell, Ph.D.Principal Investigator

Carnegie Mellon University

1 Previous Clinical Trials

40 Total Patients Enrolled

Media Library

Mindfulness and Attention Training Clinical Trial Eligibility Overview. Trial Name: NCT05083091 — N/A

Irritable Bowel Syndrome Research Study Groups: Monitor & Accept (MA-MBI), Coping Condition (CC), Monitor Only (MO-MBI)

Irritable Bowel Syndrome Clinical Trial 2023: Mindfulness and Attention Training Highlights & Side Effects. Trial Name: NCT05083091 — N/A

Mindfulness and Attention Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT05083091 — N/A

Irritable Bowel Syndrome Patient Testimony for trial: Trial Name: NCT05083091 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any individuals being recruited for this trial at the moment?

"Affirmative. Clinicaltrials.gov confirms that this clinical trial, which was first announced on February 10th 2022, is still recruiting participants. Currently the study needs to enroll 325 patients from 1 site."

Answered by AI

What results is this research endeavor attempting to acquire?

"The primary objective of this research, which will be assessed over a post-intervention period, is to gauge Pain Tolerance following Cold Pressor Task. Additionally, the study seeks to measure Change in Self-Reported Loneliness with the UCLA Loneliness Scale (ranging from 20 - 80), Change in Self-Reported Mindfulness using The Five Facet Mindfulness Questionnaire (24 items) and finally Change in Self-Reported Perceived Stress through The 10 Item Perception Scale (0 - 40)."

Answered by AI

What is the cap on participants in this medical study?

"Affirmative. According to clinicaltrials.gov's records, this medical trial is currently seeking volunteers; it was initially posted on February 10th 2022 and last updated on August 16th 2022. A total of 325 people are needed for the study at one site."

Answered by AI