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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK139653-01 | U.S. NIH Grant/Contract | View source | |
| 2025P009521 | Other Identifier | Emory IRB |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biofeedback Enhanced Treatment | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 6 weeks post-intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bonney Reed, PhD | Contact | 404-727-8312 | ebreed@emory.edu |
| Name | Affiliation | Role |
|---|---|---|
| Bonney Reed, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlanta Metropolitan Area | Recruiting | Atlanta | Georgia | 30303 | United States |
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).
Beginning 3 months and ending 36 months following article publication.
Proposals should be directed to ebreed@emory.edu To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website, Vivli.
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| Children's Healthcare of Atlanta | Recruiting | Atlanta | Georgia | 30322 | United States |
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| Center for Advanced Pediatrics | Recruiting | Atlanta | Georgia | 30329 | United States |
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