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Can a team approach help IBD patients with anxiety and depression?

NCT ID NCT03985800

Disease control Sponsor: University of Pittsburgh 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested two team-based care models for 657 adults with inflammatory bowel disease (Crohn's or ulcerative colitis) who also had mild to severe behavioral health symptoms. One model used in-person visits with a team including a gastroenterologist, nurse, nutritionist, and mental health specialist. The other used telemedicine and digital tools instead of in-person care. The goal was to see if these approaches could reduce IBD and behavioral health symptoms and improve quality of life.

What this could mean

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

Active substance
team-based care (in-person or telemedicine) with behavioral health support
What this could lead to
If successful, this could show that integrated medical and behavioral health care improves symptoms and quality of life for people with IBD.
What could go wrong
This is a completed comparative effectiveness study, not a treatment trial. Results may not apply to all patients or settings, and the interventions are complex to implement widely.

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

657 people

The number who actually took part.

Started

Jul 2019

Finished

Mar 2025

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

18 to 60 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: * Inflammatory Bowel Disease Diagnosis of Crohn's or Ulcerative Colitis. Behavioral health symptoms mild to severe, defined as a score of \>= 6 on the Personal Health Questionnaire 4 (PHQ4) Exclusion Criteria: * Lack of smart phone, and/or are unable to speak, read or understand English at the minimum-required level.

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Conditions

The condition(s) this trial relates to.

Behavioral Symptoms Crohn disease inflammatory bowel disease ulcerative colitis

As listed by the trial registrant

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

Behavioral symptoms Inflammatory bowel disease

Contacts and locations

Locations

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

More trials for these conditions

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