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NCT05083091 · ClinicalTrials.gov registry record · NA

Smartphone Training for Attention Regulation for IBS

A NA study, sponsored by Carnegie Mellon University.

Completed
Registry status
NA
Development phase
359
Enrollment target

NCT05083091: Completed NA study, sponsored by Carnegie Mellon University.

NCT05083091 is a NA study that has completed, run by Carnegie Mellon University. The registered enrollment target is 359 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05083091, a NA study, has completed, sponsored by Carnegie Mellon University.

COMPLETED
Registry status
NA
Development phase
359 participants
Enrollment target

Study 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.

Primary Outcome

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).

Interventions

  • BEHAVIORAL Mindfulness training
  • BEHAVIORAL Mindfulness and Attention Training
  • BEHAVIORAL Coping Condition

Trial Details

FieldValue
Enrollment Target 359 participants
Start Date 2022-03-01
Est. Completion 2025-02-14
Phase NA
Carnegie Mellon University

37 total trials

What the finished NCT05083091 record still lists

NCT05083091 is an interventional study that assigns participants to a tested intervention. The registered 359 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (74% lower).

The record links to 0 conditions, and to 3 interventions - of which Mindfulness training is the first listed.

NCT05083091 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05083091 about?

NCT05083091 is a clinical study titled "Smartphone Training for Attention Regulation for IBS". 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+A...

What is the current status of trial NCT05083091?

This trial is currently completed. It is a NA study. The enrollment target is 359 participants. The study started on 2022-03-01. Estimated completion is 2025-02-14.

What interventions are being tested in trial NCT05083091?

The interventions under investigation include: Mindfulness training (BEHAVIORAL), Mindfulness and Attention Training (BEHAVIORAL), Coping Condition (BEHAVIORAL).

Who is sponsoring clinical trial NCT05083091?

This trial is sponsored by Carnegie Mellon University, which has 37 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05083091's enrollment target sits among peer trials

359 288th of 2000 higher than 1,713 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05083091, the US trial registry maintained by the National Library of Medicine. NCT05083091 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.