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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

No Placebo-Only Group

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.

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).

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ compare at baseline, 6-month and 12-month for any changes

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Behavioral Health Symptom Severity

Inflammatory Bowel Disease Symptom Severity

Inflammatory Bowel Disease Symptom Severity-HBI

+1 more

Secondary study objectives

Functional Impairment

Health Care Utilization

Inflammatory Bowel Diseases

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 2Eligibility criteria met