Stress in Inflammatory Bowel Disease
Physiological Reactivity and Psychosocial Functioning in Pediatric Patients With Gastrointestinal Disease
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30322
- Children's Healthcare of Atlanta
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Atlanta, Georgia, United States, 30303
- Atlanta Metropolitan Area
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Atlanta, Georgia, United States, 30322
- Emory Children's Center Building
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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:
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Retention Rate
Time Frame: 6 weeks (End of treatment), and 2 months post treatment
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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.
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6 weeks (End of treatment), and 2 months post treatment
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Client Satisfaction Questionnaire (CSQ-8) Scores Following Biofeedback Enhanced Treatment
Time Frame: 6 weeks (End of treatment)
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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.
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6 weeks (End of treatment)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in the Children's Depression Inventory 2 (CDI-2) at Six Weeks Compared to Baseline
Time Frame: 6 weeks (End of treatment)
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Children's Depression Inventory 2 (CDI-2) is a child-report measure of physiological, behavioral, and emotional symptoms of depression.
It is a widely used tool for assessing depressive symptoms in children and adolescents.
It includes 28 items, each with three possible responses that reflect different levels of severity: 0 (absence of symptoms), 1 (mild or probable symptom), or 2 (definite symptom).
Raw scores are converted to t-scores ranging from 0 to 100, with a mean of 50 and a standard deviation of 10.
A decrease in the score indicates an improvement in depressive symptoms (depressive symptoms decrease over time).
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6 weeks (End of treatment)
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Change in the Children's Depression Inventory 2 (CDI-2) at 2 Months Post-treatment Compared to Baseline
Time Frame: 2 months post-Biofeedback Enhanced Treatment
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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).
Raw scores are converted to t-scores ranging from 0 to 100, with a mean of 50 and a standard deviation of 10.
A decrease in the score indicates an improvement in depressive symptoms (depressive symptoms decrease over time).
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2 months post-Biofeedback Enhanced Treatment
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Changes in the Behavior Assessment System for Children (BASC) Depression Parent Rating Scale at 6 Weeks
Time Frame: baseline, 6 weeks (End of treatment)
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Depressive symptoms were assessed using the 13-item Depression subscale of the Behavior Assessment System for Children, 3rd Edition (BASC-3).
The BASC-3 Parent Rating Scale (PRS) is a tool used to evaluate problem behaviors, including internalizing, externalizing, and adaptive behaviors.
Parents rate the frequency of these behaviors on a scale from 'Never' to 'Almost Always.' T-scores are used to compare responses to normative data for children of the same age and gender.
Raw scores are converted to t-scores ranging from 0 to 100, with a mean of 50 and a standard deviation of 10.
A decrease in the score indicates an improvement in depressive symptoms (depressive symptoms decrease over time).
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baseline, 6 weeks (End of treatment)
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Changes in the Behavior Assessment System for Children (BASC) Depression Parent Rating Scale at 2 Months After Completing Treatment Intervention
Time Frame: baseline, 2 months post-treatment
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Depressive symptoms were assessed using the 13-item Depression subscale of the Behavior Assessment System for Children, 3rd Edition (BASC-3).
The BASC-3 Parent Rating Scale (PRS) is a tool used to evaluate problem behaviors, including internalizing, externalizing, and adaptive behaviors.
Parents rate the frequency of these behaviors on a scale from 'Never' to 'Almost Always.' T-scores are used to compare responses to normative data for children of the same age and gender.
Raw scores are converted to t-scores ranging from 0 to 100, with a mean of 50 and a standard deviation of 10.
A decrease in the score indicates an improvement in depressive symptoms (depressive symptoms decrease over time).
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baseline, 2 months post-treatment
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Changes in the Screen for Child Anxiety Related Disorders (SCARED) Scores at 6 Weeks (End of Treatment)
Time Frame: baseline, 6 weeks (End of treatment)
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The Screen for Child Anxiety Related Disorders (SCARED) is a 41-item inventory rated on a 3-point Likert scale (0 "Not true or hardly ever true" to 2 "Very true or often true") used to screen for anxiety disorders.
It provides a Total score and scores across five domains: panic/somatic, separation anxiety, generalized anxiety, social anxiety, and school phobia.
The total score ranges from 0 to 82, with higher scores indicating greater anxiety.
A score of 25 or higher may suggest an anxiety disorder, while scores above 30 are more specific.
A decrease in score reflects symptom improvement.
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baseline, 6 weeks (End of treatment)
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Changes in Screen for Child Anxiety Related Disorders (SCARED) Scores in Both Groups at 2 Months After Completing Treatment
Time Frame: baseline, 2 months post treatment
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The Screen for Child Anxiety Related Disorders (SCARED) is a 41-item inventory rated on a 3-point Likert scale (0 "Not true or hardly ever true" to 2 "Very true or often true") used to screen for anxiety disorders.
It provides a Total score and scores across five domains: panic/somatic, separation anxiety, generalized anxiety, social anxiety, and school phobia.
The total score ranges from 0 to 82, with higher scores indicating greater anxiety.
A score of 25 or higher may suggest an anxiety disorder, while scores above 30 are more specific.
A decrease in score reflects symptom improvement.
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baseline, 2 months post treatment
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Changes in the Children's Somatic Symptoms Inventory (CSSI) 7-item (GI Subscale) After Completion of Biofeedback Enhanced Treatment
Time Frame: baseline, 6 weeks (End of treatment)
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Self-report of disease activity using the Children's Somatic Symptoms Inventory (CSSI) 7-item (GI Subscale), will be collected.
The GI symptom subscale includes items on nausea, constipation, diarrhea, abdominal pain, vomiting, bloating, and food-induced discomfort.
Each item asks the child to rate the frequency and intensity of symptoms over a specific period (e.g., "In the past week, how often have you felt stomachaches?").
Response options include: 0 - "Not at all"; 1 - "A little bit"; 2 - "Somewhat"; 3 - "Quite a bit"; 4 - "Very much."
Scores are summed to obtain a total score for gastrointestinal symptoms.
High scores, indicating frequent or intense gastrointestinal complaints, may suggest significant distress or a need for intervention.
A decrease in the score reflects symptom improvement.
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baseline, 6 weeks (End of treatment)
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Changes in the Children's Somatic Symptoms Inventory- (CSSI) 7-item (GI Subscale) at 2 Months After Completion of Treatment Intervention
Time Frame: baseline, 2 months post-treatment
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Self-report of disease activity using the Children's Somatic Symptoms Inventory-(CSSI) 7-item (GI Subscale) will be collected from parents and teens.
The GI symptom subscale includes items on nausea, constipation, diarrhea, abdominal pain, vomiting, bloating, and food-induced discomfort.
Each item asks the child to rate the frequency and intensity of symptoms over a specific period (e.g., "In the past week, how often have you felt stomachaches?").
Response options include: 0 - "Not at all"; 1 - "A little bit"; 2 - "Somewhat"; 3 - "Quite a bit"; 4 - "Very much."
Scores are summed to get a total gastrointestinal score.
High scores, indicating frequent or intense symptoms, may suggest significant distress or the need for intervention.
A decrease in score reflects symptom improvement.
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baseline, 2 months post-treatment
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Change in Autonomic Reactivity at 6 Weeks (End of Treatment)
Time Frame: baseline, 6 weeks (End of treatment)
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Autonomic reactivity will be measured using Heart Rate Variability (HRV) with the Inner Balance system by HeartMath. HRV will be assessed before treatment, post-treatment, and at follow-up. The mediation effect will be estimated using the difference in regression coefficients (β1 - β2). Adolescent HRV data was collected via the InnerBalance sensor during the pre-treatment (T1) and post-treatment (T2) assessments. The RR interval represents the time between heartbeats, while the NN interval normalizes this time, accounting for noise or artifacts. HRV measures, including the standard deviation of NN intervals (SDNN) and the root mean square of successive RR interval differences (RMSSD), are calculated from these intervals. Higher values of SDNN and RMSSD are considered more adaptive. |
baseline, 6 weeks (End of treatment)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Bonnie Reed, PhD, Emory University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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