Clinical trial NCT05202418: Stress in Inflammatory Bowel Disease
Official title: Physiological Reactivity and Psychosocial Functioning in Pediatric Patients With Gastrointestinal Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Psychological
Keywords: skin conductance reactivity
Systemic inflammation
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Children's Healthcare of Atlanta
First posted: 2022-01-21
Enrollment: 53
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 developing psychosocial challenges 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 current study aims 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.

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.

Primary outcomes:
measure: Retention Rate
timeFrame: 6 weeks (End of treatment), and 2 months post treatment
measure: Client Satisfaction Questionnaire (CSQ-8) Scores Following Biofeedback Enhanced Treatment
timeFrame: 6 weeks (End of treatment)
Secondary outcomes:
measure: Change in the Children's Depression Inventory 2 (CDI-2) at Six Weeks Compared to Baseline
timeFrame: 6 weeks (End of treatment)
measure: Change in the Children's Depression Inventory 2 (CDI-2) at 2 Months Post-treatment Compared to Baseline
timeFrame: 2 months post-Biofeedback Enhanced Treatment
measure: Changes in the Behavior Assessment System for Children (BASC) Depression Parent Rating Scale at 6 Weeks
timeFrame: baseline, 6 weeks (End of treatment)
measure: Changes in the Behavior Assessment System for Children (BASC) Depression Parent Rating Scale at 2 Months After Completing Treatment Intervention
timeFrame: baseline, 2 months post-treatment
measure: Changes in the Screen for Child Anxiety Related Disorders (SCARED) Scores at 6 Weeks (End of Treatment)
timeFrame: baseline, 6 weeks (End of treatment)
measure: Changes in Screen for Child Anxiety Related Disorders (SCARED) Scores in Both Groups at 2 Months After Completing Treatment
timeFrame: baseline, 2 months post treatment
measure: Changes in the Children's Somatic Symptoms Inventory (CSSI) 7-item (GI Subscale) After Completion of Biofeedback Enhanced Treatment
timeFrame: baseline, 6 weeks (End of treatment)
measure: Changes in the Children's Somatic Symptoms Inventory- (CSSI) 7-item (GI Subscale) at 2 Months After Completion of Treatment Intervention
timeFrame: baseline, 2 months post-treatment
measure: Change in Autonomic Reactivity at 6 Weeks (End of Treatment)
timeFrame: baseline, 6 weeks (End of treatment)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Atlanta Metropolitan Area
state: Georgia
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Atlanta
country: United States
facility: Emory Children's Center Building
state: Georgia
Study officials:
affiliation: Emory University
name: Bonnie Reed, PhD
role: PRINCIPAL_INVESTIGATOR
References: