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New treatment option for Inflammatory Bowel Diseases
Official title Heart Rate Variability and Inflammatory Bowel Disease
ClinicalTrials.gov ID: NCT06537258
What this study is testing
- What it's testing
- The goals of this study are to test the effectiveness of a virtually delivered, group-based coping skills treatment program incorporating heart rate variability biofeedback to target autonomic dysfunction in youth diagnosed with inflammatory bowel disease (IBD). The investigators will enroll participants with IBD in a biofeedback enhanced cognitive behaviorally based coping skills treatment.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 13 to 18
You may be able to join if
- Diagnosis with biopsy-confirmed IBD for at least 4 months,
- ages 13 through 18 years inclusive,
- speak English,
- enrolling with at least 1 parent/guardian who is willing to participate by completing surveys,
- positive depression or anxiety screens using the PHQ-4, - access to home internet to participate in virtual intervention,
You likely can't join if
- previous diagnosis of developmental disabilities that require full-time special education or that impair the ability to respond to treatment,
- diagnosis with any other chronic disease (e.g., diabetes, epilepsy, etc.),
- diagnosis of abnormal thyroid function,
- treatment with any drug with known autonomic cardiovascular influences including beta-blockers, central sympatholytic agents, or antidepressants.
See the full eligibility criteria
- Diagnosis with biopsy-confirmed IBD for at least 4 months,
- ages 13 through 18 years inclusive,
- speak English,
- enrolling with at least 1 parent/guardian who is willing to participate by completing surveys,
- positive depression or anxiety screens using the PHQ-4, - access to home internet to participate in virtual intervention,
- youth and parent agree to the conditions of study participation, including randomization, participation in intervention, and follow-up assessments,
- youth is medically approved to engage in normal daily activities (e.g., attend school, extracurricular activities)
- previous diagnosis of developmental disabilities that require full-time special education or that impair the ability to respond to treatment,
- diagnosis with any other chronic disease (e.g., diabetes, epilepsy, etc.),
- diagnosis of abnormal thyroid function,
- treatment with any drug with known autonomic cardiovascular influences including beta-blockers, central sympatholytic agents, or antidepressants.
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 13 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.