Inflammatory Bowel DiseasesNCT06537258
Heart Rate Variability and Inflammatory Bowel Disease
A study testing Biofeedback Enhanced Treatment in people with Inflammatory Bowel Diseases, run by Emory University at 3 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Biofeedback Enhanced Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 3 sitesUnited States
- Study dates
- 6 Feb 2025to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Atlanta Metropolitan Area
Atlanta, Georgia, 30303
Bonney Reed, PhD, ebreed@emory.edu
- Recruiting
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
Bonney Reed, PhD, ebreed@emory.edu
Bonney Reed, PhD
- Recruiting
Center for Advanced Pediatrics
Atlanta, Georgia, 30329
Bonney Reed, PhD, ebreed@emory.edu
Bonney Reed, PhD
About this study
Official title: A Heart Rate Variability Biofeedback Enhanced Behavioral Intervention to Improve Psychological and Disease Functioning in Youth With Inflammatory Bowel Disease (IBD)
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. Participants will be randomized to biofeedback enhanced treatment or wait-list control.
Read the detailed description
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).
Patients are youth ages 13-18 recruited through IBD clinics at Children's Healthcare of Atlanta. Enrollment will include up to 128 children with at least 1 parent. This study will last 7-months and will have 4 in person study visits, lasting about 1 hour each, as well as 6 virtual treatment sessions lasting about 45 minutes each.
Study procedures will include surveys, chart/record review, blood sampling, and non-invasive assessments of psychophysiological functioning. Stool samples will be collected and stored. Informed consent and assent will be obtained in-person or remote signed.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Biofeedback Enhanced Treatment
- Keywords
- cognitive behavioral therapy, heart rate variability
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofeedback Enhanced TreatmentBehavioural
Also called biofeedback cognitive behaviorally based coping skills treatment
At all 4 assessment points (T1-T4), HRV will be measured using the ECG module of the mobile MindWare system at a sampling rate of 500 Hz, and a Skin Conductance Response (SCR) will be collected at a sampling rate of 10 Hz using eSense for iPad. Electrodes to assess SCR and HRV will be attached to patients during an ~10-minute period.
A 5-minute initial baseline assessment will occur first followed by three 5-minute stress trials.
Stress tasks will be audio recorded to measure study fidelity, and participants will be asked to rate their subjective level of stress with each trial. At all assessment points (T1-T4), participants will be provided with stool collection kits to collect a stool sample within 3 days of the laboratory psychophysiological assessment.
At all assessment points (T1-T4), a blood draw of approximately 3 ml of blood will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback Enhanced Treatment | Experimental | Participants in this group will participate in biofeedback enhanced cognitive behaviorally based coping skills treatment. Treatment will consist of a 6-visit group intervention conducted online, via Emory zoom. Groups will include 5-8 patients. Groups will meet approximately each week for 6 weeks. Patients will also rate their disease symptoms and measures of clinical disease activity will be collected via chart review. Clinical assessments will occur at baseline within 1 week prior to starting treatment (T1), at treatment end or 6 weeks after baseline (T2), 14 weeks after baseline to capture 2-month follow-up after treatment (T3) and at 26 weeks after baseline (T4). Receives: Behavioral: Biofeedback Enhanced Treatment |
| Wait-list control | No intervention | Participants randomized to the waitlist control group will complete the same assessment protocol at the time of randomization (Baseline) and again 6 weeks later. They will then be invited to begin treatment and will repeat the assessments at posttest and again at 14 and 26-week follow-up (for a total of 5 assessments). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in psychological distress
A continuous composite measure of stress, anxiety, and depression. Which will be analyzed continuously to evaluate for a significant mean difference between randomized groups at study endpoint (6-weeks). Scores range from 0 to 63, with higher scores indicating greater distress.
Measured: Baseline, 6 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start6 Feb 2025
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bonney Reed, Emory University
- Investigators
- Bonney Reed, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537258
- Sponsor's protocol ID
- STUDY00007611
- Other IDs
- R01DK139653-01, 2025P009521
- Status last verified
- Mar 2026
- First submitted
- 1 Aug 2024
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared with Researchers who provide a methodologically sound proposal. The research team will share individual participant data that underlie the results reported in a published article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Heart Rate Variability Biofeedback Enhanced Behavioral Intervention to Improve Psychological and Disease Functioning in Youth With Inflammatory Bowel Disease (IBD)
- ClinicalTrials.gov ID
- NCT06537258
- Acronym / sponsor ID
- STUDY00007611
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- cognitive behavioral therapy, heart rate variability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Participants will be randomized to biofeedback enhanced treatment or wait-list control.
Detailed description
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).
Patients are youth ages 13-18 recruited through IBD clinics at Children's Healthcare of Atlanta. Enrollment will include up to 128 children with at least 1 parent. This study will last 7-months and will have 4 in person study visits, lasting about 1 hour each, as well as 6 virtual treatment sessions lasting about 45 minutes each.
Study procedures will include surveys, chart/record review, blood sampling, and non-invasive assessments of psychophysiological functioning. Stool samples will be collected and stored. Informed consent and assent will be obtained in-person or remote signed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biofeedback Enhanced Treatment | Experimental | Behavioral: Biofeedback Enhanced TreatmentParticipants in this group will participate in biofeedback enhanced cognitive behaviorally based coping skills treatment. Treatment will consist of a 6-visit group intervention conducted online, via Emory zoom. Groups will include 5-8 patients. Groups will meet approximately each week for 6 weeks. Patients will also rate their disease symptoms and measures of clinical disease activity will be collected via chart review. Clinical assessments will occur at baseline within 1 week prior to starting treatment (T1), at treatment end or 6 weeks after baseline (T2), 14 weeks after baseline to capture 2-month follow-up after treatment (T3) and at 26 weeks after baseline (T4). |
| Wait-list control | No intervention | –Participants randomized to the waitlist control group will complete the same assessment protocol at the time of randomization (Baseline) and again 6 weeks later. They will then be invited to begin treatment and will repeat the assessments at posttest and again at 14 and 26-week follow-up (for a total of 5 assessments). |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biofeedback Enhanced TreatmentAlso: biofeedback cognitive behaviorally based coping skills treatmentAt all 4 assessment points (T1-T4), HRV will be measured using the ECG module of the mobile MindWare system at a sampling rate of 500 Hz, and a Skin Conductance Response (SCR) will be collected at a sampling rate of 10 Hz using eSense for iPad. Electrodes to assess SCR and HRV will be attached to patients during an ~10-minute period. A 5-minute initial baseline assessment will occur first followed by three 5-minute stress trials. Stress tasks will be audio recorded to measure study fidelity, and participants will be asked to rate their subjective level of stress with each trial. At all assessment points (T1-T4), participants will be provided with stool collection kits to collect a stool sample within 3 days of the laboratory psychophysiological assessment. At all assessment points (T1-T4), a blood draw of approximately 3 ml of blood will be collected. | Behavioural | Biofeedback Enhanced Treatment |
Primary outcome
Changes in psychological distress
Time frame: Baseline, 6 weeks post-intervention
A continuous composite measure of stress, anxiety, and depression. Which will be analyzed continuously to evaluate for a significant mean difference between randomized groups at study endpoint (6-weeks). Scores range from 0 to 63, with higher scores indicating greater distress.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: Yes. Data will be shared with Researchers who provide a methodologically sound proposal. The research team will share individual participant data that underlie the results reported in a published article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bonney Reed, PhD principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback Enhanced Treatment in people with Inflammatory Bowel Diseases, run by Emory University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bonney Reed, PhD (404-727-8312, ebreed@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in psychological distress (time frame: Baseline, 6 weeks post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.