Smartphone Training for Attention Regulation for IBS

NCT05083091 | Completed

• 1 other identifier: 1R01DK128114-01
• Study Type: interventional
• Target: 359
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

IBS

Outcome Measures

Primary Outcomes (11)

• Change in IBS Symptom Severity

  The Irritable Bowel Syndrome Severity Scoring System (IBS-SSS), queries patients on the severity and occurrence of abdominal pain, bloating, tightness, and bowel habits, and IBS life interference over the previous ten days. Scores are totaled (0-500 range) to obtain a composite IBS severity score, with the scale demonstrating acceptable clinical sensitivity to change (50 point changes indicate clinical improvement).

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

• IBS Symptom Improvement

  The Clinical Global Impressions Scale (CGI-I), a one-item 7-point measure, evaluates improvement in overall clinical condition (1= very much improved since the initiation of the treatment to 7=very much worse since the initiation of the treatment).

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

• Change in Self-Reported Symptom-Related Psychological Outcomes

  The Brief Symptom Inventory 18-item is a self-report measure used to assess psychological problems in adults. The scale asks patients to rate how bothered they were by symptoms on a 5-point scale (1=not at all bothered to 5= extremely bothered). Therefore, total scores can range from 18 to 90, with a higher score indicating greater distress.

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

• Change in Self-Reported IBS Quality of Life

  The Irritable Bowel Syndrome Quality of Life (IBS-QOL) is a 34-item scale that measures quality of life specific to IBS. The scores are transformed to a 0-100 scale, with higher scores corresponding to better IBS specific quality of life.

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

• Change in Microbiome Biology

  Gut microbiome diversity evaluated using shotgun metagenomic sequencing for stool samples

  Change from baseline to 1-week post-intervention

• Change in Self-Reported Perceptions of Stress

  Evaluated using Ecological Momentary Assessment using the items "Right now, how much stress are you experiencing or feeling?" (1=no stress to 7 = extremely severe stress); "Since the last survey, did you experience any feelings of stress?" (yes/no).

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

• Change in Self-Reported Perceptions of IBS Distress

  Evaluated using Ecological Momentary Assessment using the items "Right now, how severe are your IBS symptoms right now? (1=no symptoms to 7=extremely severe symptoms); "Right now, how much are your IBS symptoms interfering with your life right now?" (1=not at all to 7=extremely); "Right now, my IBS symptoms are causing me distress" (1=no distress to 7= extremely severe distress).

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

• Change in Self-Reported Perceptions of IBS Distress During Bowel Movements

  Evaluated using Event-Triggered Ecological Momentary Assessment. Measures their perceptions of distress in the minutes leading up to sitting on the toilet ("how distressed did you feel in the ten minutes leading up to sitting on the toilet? 1=not at all distressed to 7= extremely distressed) and during the bowel movement attempt ("how distressed did you feel while sitting on the toilet? 1=not at all distressed to 7= extremely distressed).

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

• Pain Tolerance following Cold Pressor Task

  Evaluated by length of time (in minutes, seconds, and milliseconds) participant's hand is under water, where the maximum amount of time is 5 minutes, 0 seconds, 0 milliseconds. Measures the degree of pain/discomfort that can be withstood by the participants following completion of their assigned intervention condition. Differences will be analyzed across the three different arms (i.e., MA, MO, and CC) of the study.

  Differences across all three conditions collected at post-intervention

• Sensation Intensity Rating following Cold Pressor Task

  Evaluated using a Likert-type scale on a single item ("how intense are the sensations for you at the moment?", 1=no sensations, 10=most intense sensations) every 30 seconds, measures the degree of intense sensations felt following completion of participant's assigned intervention condition. Differences will be analyzed across the three different arms (i.e., MA, MO, and CC) of the study.

  Differences across all three conditions collected at post-intervention

• Distress Rating following Cold Pressor Task

  Evaluated using a Likert-type scale on a single item ("how distressed are you by the sensations at the moment?", 1=no distress, 10=worse distress) every 30 seconds, measures the degree of distress tolerance that can be withstood by participants following completion of participant's assigned intervention condition. Differences will be analyzed across the three different arms (i.e., MA, MO, and CC) of the study.

  Differences across all three conditions collected at post-intervention

Secondary Outcomes (8)

• Change in Self-Reported Perceived Stress

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

• Change in Self-Reported Depressive Symptomatology

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

• Change in Self-Reported Mindfulness

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

• Change in Self-Reported Loneliness

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

• Change in Self-Reported Distress Tolerance

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

Other Outcomes (2)

• Self-Reported Diet

  Change from baseline to 1-week post-intervention

• Change in Self-Reported Treatment Expectancies

  Change from baseline to 1-week post-intervention

Study Arms (3)

Monitor & Accept (MA-MBI)

ACTIVE COMPARATOR

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.

Behavioral: Mindfulness and Attention Training

Monitor Only (MO-MBI)

ACTIVE COMPARATOR

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.

Behavioral: Mindfulness training

Coping Condition (CC)

ACTIVE COMPARATOR

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.

Behavioral: Coping Condition

Interventions

Mindfulness and Attention Training BEHAVIORAL

Guided mindfulness meditation with attention monitoring and acceptance skills training

Also known as: MA-MBI

Monitor & Accept (MA-MBI)

Mindfulness training BEHAVIORAL

Guided mindfulness meditation, no attention monitoring or acceptance skills training

Also known as: MO-MBI

Monitor Only (MO-MBI)

Coping Condition BEHAVIORAL

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

Also known as: CC

Coping Condition (CC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Rome IV IBS diagnosis
• Indicate moderate to high levels of psychological distress over the past two weeks (composite score \>=4 on the Patient Health Questionnaire-4)
• Willingness to provide assessments of bowel symptoms and complete study measures (including smartphone assessments)
• Willingness/availability to be randomized and participate in all study activities

You may not qualify if:

• Non-English speaking
• Report a new diagnosis of a (non-acute) medical or psychiatric condition requiring treatment within the last 3 months
• Have a history of diagnosed IBD or gastrointestinal malignancies.
• Begun any new treatments for IBS in the four weeks prior to baseline
• Currently pregnant
• Had a colonoscopy within 2 weeks of enrolling in the study or within the first 4 weeks of study procedures
• CGI Interview Only: Is a patient of Dr. David Levinthal
• As they will be visiting our laboratory on campus, participants will now be required to show proof of COVID-19 vaccination to participate in the study. Participants must also show proof of a booster shot, if they do not have one, they will be asked to wear a mask at in-person sessions to participate. Moving forward, we will continue to follow CMU COVID protocols.

Sponsors & Collaborators

• Carnegie Mellon University: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Carnegie Mellon University

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (45)

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MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• J. David Creswell, Ph.D.

  Carnegie Mellon University

  PRINCIPAL INVESTIGATOR

• Emily K Lindsay, Ph.D.

  University of Pittsburgh

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: All study investigators and the participant (excluding the independent unblinded statistician and unblinded project manager(s)), will be blinded to condition assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychology, Principal Investigator

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: October 19, 2021
• Study Start: March 1, 2022
• Primary Completion: February 14, 2025
• Study Completion: February 14, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The study team agrees to deposit outcome data into the ICPSR repository three years after the end of the grant period.
• Access Criteria: The study team agrees that they will identify where the data will be available and how to access the data in any publications and presentations that they author or co-author, as well as acknowledge the repository and funding source in any publications and presentations. The study team will be using the ICPSR, an NIH-funded repository with policies and procedures in place to provide data access to qualified researchers, fully consistent with NIH data sharing policies, applicable laws, and regulations.

Locations

US (1)