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Specialty Medical Homes for IBD and Behavioral Health Conditions

N/A
Waitlist Available
Led By Eva Szigethy, MD, PhD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Behavioral health symptoms mild to severe, defined as a score of >= 6 on the Personal Health Questionnaire 4 (PHQ4)
Inflammatory Bowel Disease Diagnosis of Crohn's or Ulcerative Colitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up compare at baseline, 6-month and 12-month for any changes
Awards & highlights

Study Summary

This trial will compare two care strategies for people with IBD and BH, including in-person and technology-supported care. Data will be collected over time through self-report, interviews, and electronic health records.

Who is the study for?
This trial is for individuals with Inflammatory Bowel Disease (IBD), such as Crohn's or Ulcerative Colitis, who also have mild to severe behavioral health symptoms. Participants must score at least a 6 on the PHQ4 questionnaire. People without a smartphone or those unable to speak, read, or understand English well enough are not eligible.Check my eligibility
What is being tested?
The study compares two strategies for managing IBD and behavioral health: in-person supported care versus technology-supported care. It uses a randomized design and collects both quantitative data (like self-reports) and qualitative data (such as interviews).See study design
What are the potential side effects?
Since this trial focuses on care strategies rather than medications, it does not list specific side effects like drug trials do. However, participants may experience stress or discomfort related to the interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have mild to severe behavioral health symptoms.
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I have been diagnosed with Crohn's disease or Ulcerative Colitis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~compare at baseline, 6-month and 12-month for any changes
This trial's timeline: 3 weeks for screening, Varies for treatment, and compare at baseline, 6-month and 12-month for any changes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Behavioral Health Symptom Severity
Inflammatory Bowel Disease Symptom Severity
Inflammatory Bowel Disease Symptom Severity-HBI
+1 more
Secondary outcome measures
Functional Impairment
Health Care Utilization
Inflammatory Bowel Diseases
+1 more

Trial Design

2Treatment groups
Active Control
Group I: TEAM-care as usual approachActive Control1 Intervention
Patients will be triaged based on their physical health (PH) and behavioral health (BH) complexity to determine the frequency of in-person visits and how much of these visits will be devoted to medical versus BH issues
Group II: TECH-telehealth approachActive Control1 Intervention
Each patient will have an initial face-to-face visit with the core treatment team described above and undergo the same triage process to determine their PH/BH care needs. Each TECH patient will participate in one face-to-face treatment team visit per year unless more frequent visits are deemed to be medically necessary; however, all other interactions will be conducted via technology-supported modalities

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,731 Previous Clinical Trials
16,306,778 Total Patients Enrolled
Mount Sinai Hospital, New YorkOTHER
34 Previous Clinical Trials
890,940 Total Patients Enrolled
The Cleveland ClinicOTHER
1,034 Previous Clinical Trials
1,364,767 Total Patients Enrolled

Media Library

TEAM Clinical Trial Eligibility Overview. Trial Name: NCT03985800 — N/A
Inflammatory Bowel Disease Research Study Groups: TEAM-care as usual approach, TECH-telehealth approach
Inflammatory Bowel Disease Clinical Trial 2023: TEAM Highlights & Side Effects. Trial Name: NCT03985800 — N/A
TEAM 2023 Treatment Timeline for Medical Study. Trial Name: NCT03985800 — N/A
~79 spots leftby Feb 2025
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