N/A
N=53
Stress in Inflammatory Bowel Disease
Inflammatory Bowel Diseases · Psychological
Bottom Line
View on ClinicalTrials.gov: NCT05202418 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Retention Rate — 23; 25; 19; 22 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Biofeedback Enhanced Treatment (Behavioral)
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Retention Rate |
23; 25; 19; 22 | — |
| PRIMARY Client Satisfaction Questionnaire (CSQ-8) Scores Following Biofeedback Enhanced Treatment |
28.02; 28.73 | — |
| SECONDARY Change in the Children's Depression Inventory 2 (CDI-2) at Six Weeks Compared to Baseline |
-1.99; 0.00 | — |
| SECONDARY Change in the Children's Depression Inventory 2 (CDI-2) at 2 Months Post-treatment Compared to Baseline |
-4.17 | — |
| SECONDARY Changes in the Behavior Assessment System for Children (BASC) Depression Parent Rating Scale at 6 Weeks |
-3.64; 0.44 | — |
| SECONDARY Changes in the Behavior Assessment System for Children (BASC) Depression Parent Rating Scale at 2 Months After Completing Treatment Intervention |
-4.60 | — |
| SECONDARY Changes in the Screen for Child Anxiety Related Disorders (SCARED) Scores at 6 Weeks (End of Treatment) |
-5.05; -0.67; -1.87; -1.84 | — |
| SECONDARY Changes in Screen for Child Anxiety Related Disorders (SCARED) Scores in Both Groups at 2 Months After Completing Treatment |
-4.28; -1.87 | — |
| SECONDARY Changes in the Children's Somatic Symptoms Inventory (CSSI) 7-item (GI Subscale) After Completion of Biofeedback Enhanced Treatment |
-1.29; 0.56; -2.79; -0.12 | — |
| SECONDARY Changes in the Children's Somatic Symptoms Inventory- (CSSI) 7-item (GI Subscale) at 2 Months After Completion of Treatment Intervention |
0.62; -0.01 | — |
| SECONDARY Change in Autonomic Reactivity at 6 Weeks (End of Treatment) |
15.6; 16.74; -4.09; 16.02 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT05202418). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.