Project Grant R01DK139653

Award Date 7/1/24
Completion Date 4/30/29
Dollars Obligated $1.4M
Federal Grant Program
93.847
Assistance Type
Project Grant
Place of Performance
Atlanta, GA 30329, USA
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A HEART RATE VARIABILITY BIOFEEDBACK ENHANCED BEHAVIORAL INTERVENTION TO IMPROVE PSYCHOLOGICAL AND DISEASE FUNCTIONING IN YOUTH WITH INFLAMMATORY BOWEL DISEASE (IBD) - PROJECT SUMMARY INFLAMMATORY BOWEL DISEASES (IBD), INCLUDING CROHN'S DISEASE AND ULCERATIVE COLITIS, ARE IMMUNE-MEDIATED GASTROINTESTINAL DISORDERS ASSOCIATED WITH CHRONIC MEDICAL AND PSYCHOSOCIAL DYSFUNCTION. IBD IS INCREASINGLY CONCEPTUALIZED AS A PRODUCT OF THE BIDIRECTIONAL COMMUNICATIONS BETWEEN THE CENTRAL NERVOUS SYSTEM, THE AUTONOMIC NERVOUS SYSTEM (ANS), AND THE GUT, REFERRED TO AS THE BRAIN-GUT AXIS. CONSISTENT WITH THIS MODEL, ADOLESCENTS WITH IBD DEMONSTRATE DYSFUNCTION OF THE ANS INDICATIVE OF A CHRONIC STRESS RESPONSE AND ARE AT INCREASED RISK FOR CHRONIC PSYCHOLOGICAL DISTRESS CHARACTERIZED BY ANXIETY AND DEPRESSION. TREATING ANS DYSFUNCTION HAS EMERGED AS A COMMON AND RELATIVELY EASY TO TREAT TARGET TO REDUCE PSYCHOLOGICAL SYMPTOMS AS WELL AS POTENTIALLY AMELIORATE THE DISEASE SYMPTOMS OF IBD. THROUGH OUR PRIOR WORK WITH PEDIATRIC IBD PATIENTS, WE HAVE DEMONSTRATED THAT HEART RATE VARIABILITY (HRV) IS A NON-INVASIVE, ACCEPTABLE, AND FEASIBLE MEASURE OF ANS FUNCTIONING THAT WE CAN RELIABLY ASSESS IN YOUTH WITH IBD AND TREAT THROUGH HRV BIOFEEDBACK. IN OUR PRIOR WORK, WE DEVELOPED AND EVALUATED THE FEASIBILITY, ACCEPTABILITY, AND PRELIMINARY EFFICACY OF A VIRTUALLY DELIVERED, GROUP-BASED HRV BIOFEEDBACK-ENHANCED COPING SKILLS TREATMENT PROGRAM FOR ADOLESCENTS DIAGNOSED WITH IBD (K23DK122115). THE GOAL OF THE PROPOSED WORK IS TO BUILD UPON COMPELLING PRELIMINARY FINDINGS TO TEST INTERVENTION EFFICACY VIA A RANDOMIZED WAITLIST-CONTROLLED TRIAL OF OUR HRV BIOFEEDBACK-ENHANCED COPING SKILLS TREATMENT PROGRAM IN A SAMPLE OF ADOLESCENTS AGES 13-18 DIAGNOSED WITH IBD AND WHO SCREEN POSITIVE FOR SYMPTOMS OF ANXIETY AND/OR DEPRESSION; N = 128. THE TREATMENT PROGRAM IS BASED ON EVIDENCE- BASED COGNITIVE BEHAVIORAL THERAPY TREATMENT PRINCIPLES AND USES HRV BIOFEEDBACK AS AN ADJUNCTIVE TREATMENT COMPONENT TO TREAT AUTONOMIC DYSFUNCTION. WITH R01 SUPPORT, OUR MULTIDISCIPLINARY TEAM OF EXPERTS IN BEHAVIORAL INTERVENTIONS INCORPORATING HRV BIOFEEDBACK, PEDIATRIC IBD, AND CLINICAL TRIAL DESIGN WILL DETERMINE IF TREATMENT (1) IMPROVES PSYCHOLOGICAL OUTCOMES AND (2) SYMPTOMS OF IBD INCLUDING REDUCTIONS IN DISEASE ACTIVITY AND INFLAMMATORY MARKERS, RELATIVE TO CONTROLS. FURTHER, WE WILL DETERMINE THE MECHANISTIC ROLE OF HRV ON PSYCHOLOGICAL AND IBD SYMPTOMS AS A FUNCTION OF TREATMENT. SUPPORT FOR A VIRTUALLY DELIVERED, HRV BIOFEEDBACK-ENHANCED COPING SKILLS TREATMENT PROGRAM FOR YOUTH WITH IBD TO ADDRESS PSYCHOLOGICAL OUTCOMES AND SYMPTOMS OF IBD WOULD PROVIDE A SCALABLE, INNOVATIVE TREATMENT OPTION FOR THE GROWING NUMBER OF AFFECTED PEDIATRIC PATIENTS. FURTHER, IF SUCCESSFUL, WE WILL DEMONSTRATE THAT HRV IS A MODIFIABLE BIOMARKER OF AUTONOMIC DYSFUNCTION RESPONSIVE TO BIOFEEDBACK TRAINING AND MECHANISTICALLY RESPONSIBLE FOR INTERVENTION EFFECTS ON PSYCHOLOGICAL AND CLINICAL OUTCOMES AS WELL AS MARKERS OF INFLAMMATION.

Posted 6/25/24, 12:00 AM