Stress in Inflammatory Bowel Disease

NCT05202418 | Completed Results

• 3 other identifiers: IRB000859745K23DK122115-021R03DK136975-01
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 3

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.

Conditions

Inflammatory Bowel Diseases; Psychological

Keywords

skin conductance reactivity; Systemic inflammation

Outcome Measures

Primary Outcomes (2)

• Retention Rate

  Retention rates will be summarized using the number of individuals who gave consent to participate in the trial, who completed 6 weeks of the intervention they were randomized to, as well as the count of participants completing the Post-Treatment assessment 2 months after finishing 6 weeks of Biofeedback Enhanced Treatment.

  6 weeks (End of treatment), and 2 months post treatment

• Client Satisfaction Questionnaire (CSQ-8) Scores Following Biofeedback Enhanced Treatment

  Acceptability of the Biofeedback Enhanced Treatment was assessed using adolescent- and parent-reported program satisfaction ratings on the Client Satisfaction Questionnaire (CSQ-8). Adolescents and parents completed this 8-item survey on a 4-point scale, with total scores ranging from 8 to 32; higher scores indicated greater satisfaction. Each group completed the questionnaire 6 weeks after finishing the Biofeedback Enhanced Treatment. No survey was provided to participants during the waitlist phase, as no treatment was administered during the waiting period.

  6 weeks (End of treatment)

Secondary Outcomes (9)

• Change in the Children's Depression Inventory 2 (CDI-2) at Six Weeks Compared to Baseline

  6 weeks (End of treatment)

• Change in the Children's Depression Inventory 2 (CDI-2) at 2 Months Post-treatment Compared to Baseline

  2 months post-Biofeedback Enhanced Treatment

• Changes in the Behavior Assessment System for Children (BASC) Depression Parent Rating Scale at 6 Weeks

  baseline, 6 weeks (End of treatment)

• Changes in the Behavior Assessment System for Children (BASC) Depression Parent Rating Scale at 2 Months After Completing Treatment Intervention

  baseline, 2 months post-treatment

• Changes in the Screen for Child Anxiety Related Disorders (SCARED) Scores at 6 Weeks (End of Treatment)

  baseline, 6 weeks (End of treatment)

Study Arms (2)

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 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

Wait-list control

NO INTERVENTION

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.

Interventions

Biofeedback Enhanced Treatment BEHAVIORAL

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.

Also known as: Behavioral Intervention

Biofeedback Enhanced Treatment

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Emory University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Children's Healthcare of Atlanta: collaborator

Study Sites (3)

Atlanta Metropolitan Area

Atlanta, Georgia, 30303, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Emory Children's Center Building

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

• Younginer ST, Westbrook A, Buzenski J, Dykes C, Kugathasan S, Talmadge C, Reed B. Health-related quality of life in youth with chronic gastrointestinal disease following a biofeedback enhanced cognitive behavioral therapy intervention: A randomized controlled trial. J Pediatr Gastroenterol Nutr. 2026 Jan 4. doi: 10.1002/jpn3.70333. Online ahead of print.

  PMID: 41486461 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Bonney Reed
• Organization: Emory University

ebreed@emory.edu

404-727-8312

Study Officials

• Bonnie Reed, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: January 21, 2022
• Study Start: February 27, 2022
• Primary Completion: January 13, 2024
• Study Completion: January 13, 2024
• Last Updated: April 22, 2025
• Results First Posted: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (3)