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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 is a NA study that has completed, run by Carnegie Mellon University. The registered enrollment target is 359 participants.

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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.

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

Sponsor

Carnegie Mellon University

37 total trials

What the Registry Record Tells You About NCT05083091

The ClinicalTrials.gov registry entry for NCT05083091 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 359 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Carnegie Mellon University, which has 37 total studies on file at ClinicalTrials.gov.

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

NCT05083091 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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