Smartphone Training for Attention Regulation for IBS

Summary

In the largest and most well-controlled randomized control trial of mindfulness-based interventions (MBIs) training in irritable bowel syndrome (IBS) to-date (N=360), the investigators will evaluate whether a smartphone MBI program (with attention monitoring and acceptance skills training; Monitor+Accept, MA-MBI) reduces daily life stress and IBS symptoms at post-treatment and two-month follow-up, relative to a matched MBI program with acceptance skills training removed (training in attention monitoring skills only; Monitor Only, MO-MBI) or to an active stress management training control group (Coping Control, CC). Participants will not only provide clinician and patient assessed measures of IBS symptoms at the three time points, but they will also provide sensitive experience sampling assessments (using Ecological Momentary Assessment) of their stress and symptoms in daily life at each time point. Finally, as an exploratory aim, participants will provide stool samples at baseline and post-intervention to provide the first ever test of whether MBIs can alter the gut microbiome in IBS. We will also conduct a sub-study that will include completion of a cold-water challenge performance task to test individuals' distress tolerance.

Conditions

• Irritable Bowel Syndrome

Interventions

BEHAVIORAL

Mindfulness and Attention Training

Guided mindfulness meditation with attention monitoring and acceptance skills training

BEHAVIORAL

Mindfulness training

Guided mindfulness meditation, no attention monitoring or acceptance skills training

BEHAVIORAL

Coping Condition

Guided training focused on coping effectiveness strategies, no monitoring or acceptance instruction

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

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

  collaborator NIH

• Carnegie Mellon University

  lead OTHER

Principal Investigators

• J. David Creswell, Ph.D. · Carnegie Mellon University

• Emily K Lindsay, Ph.D. · University of Pittsburgh

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-01

Primary Completion

2025-02-14

Completion

2025-02-14

Countries

• United States

Study Locations