Stress in Inflammatory Bowel Disease

• ClinicalTrials.gov Identifier: NCT05202418
• Recruitment Status: Recruiting
• First Posted: January 21, 2022
• Last Update Posted: May 3, 2023
• Sponsor: Emory University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Children's Healthcare of Atlanta
• Information provided by (Responsible Party): Bonney Reed, Emory University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Inflammatory Bowel Diseases; Psychological	Behavioral: Biofeedback Enhanced Treatment	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Physiological Reactivity and Psychosocial Functioning in Pediatric Patients With Gastrointestinal Disease
• Actual Study Start Date: February 27, 2022
• Estimated Primary Completion Date: February 2024
• Estimated Study Completion Date: June 2024

Arms and Interventions

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 Name: 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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Changes in clinical scores (depression) will be summarized within groups at each study time-point. [ Time Frame: baseline, 6 weeks (End of treatment), and 2 months post treatment ]
   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)
2. Changes in scores (anxiety disorders) will be summarized within groups at each study time-point. [ Time Frame: baseline, 6 weeks (End of treatment), and 2 months post treatment ]
   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).
3. Changes in clinical scores (clinical symptoms) will be summarized within groups at each study time-point. [ Time Frame: baseline, 6 weeks (End of treatment), and 2 months post treatment ]
   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)
4. Changes in autonomic reactivity will be summarized within groups at each study time-point. [ Time Frame: baseline, 6 weeks (End of treatment), and 2 months post treatment ]
   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)

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Contacts

Contact: Bonney Reed, PhD; 404-727-8312; ebreed@emory.edu

Locations

United States, Georgia

Atlanta Metropolitan Area; Recruiting

Atlanta, Georgia, United States, 30303

Contact: Bonney Reed, PhD

Children's Healthcare of Atlanta; Recruiting

Atlanta, Georgia, United States, 30322

Contact: Bonney Reed, PhD ebreed@emory.edu

Emory Children's Center Building; Recruiting

Atlanta, Georgia, United States, 30322

Contact: Bonney Reed, PhD ebreed@emory.edu

Sponsors and Collaborators

Emory University

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Children's Healthcare of Atlanta

Investigators

• Principal Investigator: Bonnie Reed, PhD; Emory University

More Information

• Responsible Party: Bonney Reed, Assistant Professor, Emory University
• ClinicalTrials.gov Identifier: NCT05202418
• Other Study ID Numbers: IRB00085974; 5K23DK122115-02 ( U.S. NIH Grant/Contract )
• First Posted: January 21, 2022
• Last Update Posted: May 3, 2023
• Last Verified: May 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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)
• Supporting Materials: Study Protocol
• Time Frame: The research team will share the data beginning 6 months and ending 36 months following article publication.
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bonney Reed, Emory University:

skin conductance reactivity; Systemic inflammation

Additional relevant MeSH terms:

Intestinal Diseases; Inflammatory Bowel Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis