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Brain scans reveal how mindfulness and therapy calm Kids' tummy troubles

NCT ID NCT03518216

Knowledge-focused Sponsor: Michigan State University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at how a behavioral treatment called ADAPT affects brain activity in children aged 11–16 with functional abdominal pain and anxiety. The treatment combines mindfulness meditation and cognitive behavioral therapy over six sessions, delivered remotely. Researchers used fMRI scans to see changes in brain connections related to pain and emotion. The goal was to understand how the treatment works in the brain, not to test if it cures the condition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ADAPT (Aim to Decrease Anxiety and Pain Treatment) – a remotely delivered behavioral intervention combining mindfulness meditation and cognitive behavioral therapy
What this could lead to
If successful, this could help design more targeted non-drug treatments for children with functional abdominal pain and anxiety.
What could go wrong
This is a small, early-stage study (49 participants) focused on understanding brain changes, not on proving the treatment works. Results may not apply to all children.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

49 people

The number who actually took part.

Started

Jul 2018

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

11 to 16 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria * Children (boys and girls) between 11 and 16 years of age and their parent/primary caregiver. * Meets criteria for FAPD based on physician diagnosis of FAPD and ROME IV FAPD criteria * Meets criteria for presence of clinically significant anxiety (based on the Generalized Anxiety Disorders-7 \[GAD-7\] cut-off score ≥10). * Sufficient English language ability necessary to complete study measures and protocol. Exclusion Criteria * Children with significant medical condition(s) with an identifiable organic cause including those that may include abdominal pain symptoms (e.g., Inflammatory Bowel Diseases). * Children with a documented developmental delays, autism spectrum disorder, a previously diagnosed thought disorder (i.e., psychosis), or bipolar disorder. * Significant visual, hearing, or speech impairment. * Organic brain injury. * Participants who are currently in psychological therapy for pain or anxiety. * Participants with severe depressive symptoms (cut-score ≥20) on the Patient Health Questionnaire 9 \[PHQ-9\] or active suicidal ideation. * Exclusionary criteria specific to the fMRI component of the study: * Participants with an implant such as a cochlear implant device, a pacemaker or neurostimulator containing electrical circuitry or generating magnetic signals. Participants with any significant ferrous material in their body that could pose the potential for harm in the fMRI environment or cause signal suppression of key regions (i.e. orthodontia). * Female participants who report current/suspected pregnancy. * Participants with evidence of claustrophobia.

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Conditions

The condition(s) this trial relates to.

anxiety anxiety disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anxiety Functional abdominal pain syndrome

Contacts and locations

Locations

  • Michigan State University

    Grand Rapids, Michigan, 49503, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.