Stress in Inflammatory Bowel Disease

Physiological Reactivity and Psychosocial Functioning in Pediatric Patients With Gastrointestinal Disease

This is a prospective, assessment-based study to examine the relationship between psychophysiological functioning and psychological symptoms in youth newly diagnosed with inflammatory bowel disease (IBD) compared to healthy controls.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases; Psychological
• Intervention / Treatment: Behavioral: Biofeedback Enhanced Treatment

Detailed Description

Detailed Description: Similar to other chronic stressors, diagnosis with a chronic illness places youth at risk of adverse psychosocial outcomes. Inflammatory bowel diseases (IBD), Crohn's disease, ulcerative colitis, and indeterminate colitis are chronic, immune-mediated diseases of the gastrointestinal tract characterized by unpredictable remissions of disease activity followed by relapses of symptoms. Although some research has found higher levels of disease activity to relate to greater depressive symptoms, the overall relationship between disease activity and emotional functioning has been mixed, suggesting that additional individual differences need to be considered in addition to illness-related factors when predicting emotional outcomes. Increased risk for developing anxiety disorders and depression has been documented in youth with IBD. Individual differences in physiological reactivity may affect patients' risk for developing psychosocial difficulties within the context of chronic stress. Additional risk factors for the development of psychosocial difficulties need to be identified to identify moderators of outcomes above and beyond disease activity.

Individual differences in physiological reactivity may affect patients' risk for developing psychosocial difficulties within the context of chronic stress. Physiological reactivity, which broadly refers to bodily reactions in response to a stressor, varies with regards to intensity and threshold for activation between individuals.

In youth affected by non-medical chronic stress (e.g., family conflict, trauma history), measures of autonomic dysfunction have been used to explain why some individuals have worse psychological and physical outcomes compared to others exposed to similar levels of chronic stress. Results support autonomic dysfunction as a vulnerability factor for adjustment problems within the context of chronic environmental stress.

The aim of the current study is to test whether differences in psychophysiological reactivity serve as risk factors in the relationship between clinical disease activity in youth newly diagnosed with IBD and psychosocial adjustment problems. The relationship between psychophysiological reactivity and psychosocial adjustment problems in youth with IBD will be compared to healthy controls. Youth participants with IBD will be enrolled in a coping skills treatment to test the effectiveness of a cognitive-behavioral intervention including biofeedback to reduce anxiety and depression and disease symptoms. The research team will conduct a pilot intervention targeting autonomic dysfunction through biofeedback enhanced coping skills treatment delivered virtually over 6-sessions.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Children's Healthcare of Atlanta
    • Atlanta, Georgia, United States, 30303
      • Atlanta Metropolitan Area
    • Atlanta, Georgia, United States, 30322
      • Emory Children's Center Building

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosed with biopsy-confirmed IBD
• Ages 13 through 18 years inclusive
• English fluency for parent and child participants.
• Accompanied by at least 1 parent/guardian who is willing to participate
• Positive depression or anxiety symptom screen using the patient health questionnaire (PHQ-9) or Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Anxiety measures

Exclusion Criteria:

• Previous diagnosis of intellectual disability
• Autism spectrum disorder.
• Parent is unwilling to participate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biofeedback Enhanced Treatment; 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 each. Sessions will include brief, daily homework to facilitate mastery that is developmentally tailored to youth (e.g., practice skills with support from phone or tablet apps). Groups will meet approximately every week for 6 weeks. Advanced Ph.D. students in clinical psychology and Principal Investigator will deliver the treatment protocol. They will complete questionnaires before and after each session to measure autonomic reactivity in response to stress induction and coping strategies.	Behavioral: Biofeedback Enhanced Treatment; The intervention involves 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 each. Sessions will include brief, daily homework to facilitate mastery that is developmentally tailored to youth (e.g., practice skills with support from phone or tablet apps). Groups will meet approximately every week for 6 weeks. Advanced Ph.D. students in clinical psychology and Principal Investigator will deliver the treatment protocol. Participants will complete questionnaires before and after each session to measure autonomic reactivity, lifetime stress, depression, anxiety in response to stress induction, and coping strategies.; Other Names: Behavioral Intervention
No Intervention: Wait-list control; Participants randomized to the wait-list control group will complete the same measures of lifetime stress, autonomic reactivity, depression, anxiety. The identical treatment will be offered to control participants after the 6-week time point.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the retention rate	Measures including consent rates, completion/retention rates will be summarized using counts and percentages or means and standard deviations, as appropriate.	Baseline, 6 weeks (End of treatment), and 2 months post treatment
Changes in treatment satisfaction	Treatment satisfaction ratings will be summarized using counts and percentages or means and standard deviations, as appropriate.	6 weeks (End of treatment) and 2 months post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in clinical scores (depression) will be summarized within groups at each study time-point.	Children's Depression Inventory 2 (CDI-2). The CDI 2 is a child-report measure of physiological, behavioral, and emotional symptoms of depression. The full-length CDI 2: Self-Report (CDI 2:SR) is a 28-item assessment that yields a Total Score, two-scale scores, and four subscale scores. For each item, the respondent is presented with three choices that correspond to three levels of symptomatology: 0 (absence of symptoms), 1 (mild or probable symptom), or 2 (definite symptom). A total score of ≥ 60 may indicate concerns for depression. An estimation of the mediation effect will be calculated using the difference in the regression coefficients (β1-β2)	baseline, 6 weeks (End of treatment), and 2 months post treatment
Changes in scores (anxiety disorders) will be summarized within groups at each study time-point.	The Screen for Child Anxiety Related Disorders (SCARED). The SCARED is a 41-item inventory rated on a 3-point Likert-type scale used to screen for anxiety disorders. The SCARED offers a Total score as well as five symptom domains: panic/somatic, separation anxiety, generalized anxiety, social anxiety, and school phobia. The SCARED is a screening measure and not a diagnostic of anxiety disorders. That being said, the authors provide cut scores for each scored domain that may be indicative of an anxiety disorder. A total score of ≥ 25 may indicate an anxiety disorder, and for each of the subscales, a score of 7 may indicate Panic Disorder, a score of 9 may indicate Generalized anxiety, a score of 8 may indicate Social Phobia, and a score of 3 may indicate significant school avoidance. An estimation of the mediation effect will be calculated using the difference in the regression coefficients (β1-β2).	baseline, 6 weeks (End of treatment), and 2 months post treatment
Changes in clinical scores (clinical symptoms) will be summarized within groups at each study time-point.	Self-report of disease activity using the Children's Somatic Symptoms Inventory- 24 (CSSI), GI Module will be collected. The GI symptom subscale includes items referring to nausea, constipation, diarrhea, abdominal pain, vomiting, feeling bloated, and food making you sick. The GI symptoms subscale has shown sensitivity to treatment. An estimation of the mediation effect will be calculated using the difference in the regression coefficients (β1-β2)	baseline, 6 weeks (End of treatment), and 2 months post treatment
Changes in autonomic reactivity will be summarized within groups at each study time-point.	Autonomic reactivity will be measured using Heart rate variability, measured using the Inner Balance system designed by HeartMath. Measures of heart rate variability will be taken before treatment, post-treatment, and follow-up. An estimation of the mediation effect will be calculated using the difference in the regression coefficients (β1-β2)	baseline, 6 weeks (End of treatment), and 2 months post treatment

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Children's Healthcare of Atlanta
• Investigators: Principal Investigator: Bonnie Reed, PhD, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2022
• Primary Completion (Actual): January 13, 2024
• Study Completion (Actual): January 13, 2024

Study Registration Dates

• First Submitted: December 9, 2021
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (Actual): January 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Systemic inflammation; skin conductance reactivity
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: IRB00085974; 5K23DK122115-02 (U.S. NIH Grant/Contract); 1R03DK136975-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The research team will share individual participant data that underlie the results reported in a published article, after deidentification (text, tables, figures, and appendices)
• IPD Sharing Time Frame: The research team will share the data beginning 6 months and ending 36 months following article publication.
• IPD Sharing Access Criteria: The research team will share the data with researchers, who provide a methodologically sound proposal. Data will be shared to achieve aims in the approved proposal All requests and proposals should be directed to ebreed@emory.edu up to 36 months following article publication.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No