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Completed

NCT Number: NCT05202418

Stress in Inflammatory Bowel Disease

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.

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Key information

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atlanta Metropolitan Area, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Behavioral Intervention

Primary outcomes

  1. Retention Rate

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

    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.

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

    Time frame: 6 weeks (End of 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.

Secondary outcomes

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

    Time frame: 6 weeks (End of treatment)

    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).

  2. 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

    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).

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

    Time frame: baseline, 6 weeks (End of treatment)

    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).

  4. 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

    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).

  5. 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)

    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.

  6. 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

    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.

  7. 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)

    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.

  8. 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

    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.

  9. Change in Autonomic Reactivity at 6 Weeks (End of Treatment)

    Time frame: baseline, 6 weeks (End of treatment)

    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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Children's Healthcare of Atlanta
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Physiological Reactivity and Psychosocial Functioning in Pediatric Patients With Gastrointestinal Disease

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 21, 2022
Registry last updated
Apr 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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