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Stress in Inflammatory Bowel Disease

Primary Purpose

Inflammatory Bowel Diseases, Psychological

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biofeedback Enhanced Treatment
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Inflammatory Bowel Diseases focused on measuring skin conductance reactivity, Systemic inflammation

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with biopsy-confirmed IBD
  • Ages 8 through 17 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.

Sites / Locations

  • Atlanta Metropolitan AreaRecruiting
  • Children's Healthcare of AtlantaRecruiting
  • Emory Children's Center BuildingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Biofeedback Enhanced Treatment

Wait-list control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Changes in the retention rate
Measures including consent rates, completion/retention rates will be summarized using counts and percentages or means and standard deviations, as appropriate.
Changes in treatment satisfaction
Treatment satisfaction ratings will be summarized using counts and percentages or means and standard deviations, as appropriate.

Secondary Outcome Measures

Changes in clinical scores (depression) will be summarized within groups at each study time-point.
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). A total score of ≥ 60 may indicate concerns for depression. An estimation of the mediation effect will be calculated using the difference in the regression coefficients (β1-β2)
Changes in scores (anxiety disorders) will be summarized within groups at each study time-point.
The Screen for Child Anxiety Related Disorders (SCARED). The SCARED is a 41-item inventory rated on a 3-point Likert-type scale used to screen for anxiety disorders. The SCARED offers a Total score as well as five symptom domains: panic/somatic, separation anxiety, generalized anxiety, social anxiety, and school phobia. The SCARED is a screening measure and not a diagnostic of anxiety disorders. That being said, the authors provide cut scores for each scored domain that may be indicative of an anxiety disorder. A total score of ≥ 25 may indicate an anxiety disorder, and for each of the subscales, a score of 7 may indicate Panic Disorder, a score of 9 may indicate Generalized anxiety, a score of 8 may indicate Social Phobia, and a score of 3 may indicate significant school avoidance. An estimation of the mediation effect will be calculated using the difference in the regression coefficients (β1-β2).
Changes in clinical scores (clinical symptoms) will be summarized within groups at each study time-point.
Self-report of disease activity using the Children's Somatic Symptoms Inventory- 24 (CSSI), GI Module will be collected. The GI symptom subscale includes items referring to nausea, constipation, diarrhea, abdominal pain, vomiting, feeling bloated, and food making you sick. The GI symptoms subscale has shown sensitivity to treatment. An estimation of the mediation effect will be calculated using the difference in the regression coefficients (β1-β2)
Changes in autonomic reactivity will be summarized within groups at each study time-point.
Autonomic reactivity will be measured using Heart rate variability, measured using the Inner Balance system designed by HeartMath. Measures of heart rate variability will be taken before treatment, post-treatment, and follow-up. An estimation of the mediation effect will be calculated using the difference in the regression coefficients (β1-β2)

Full Information

First Posted
December 9, 2021
Last Updated
May 1, 2023
Sponsor
Emory University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Children's Healthcare of Atlanta
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1. Study Identification

Unique Protocol Identification Number
NCT05202418
Brief Title
Stress in Inflammatory Bowel Disease
Official Title
Physiological Reactivity and Psychosocial Functioning in Pediatric Patients With Gastrointestinal Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 27, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Children's Healthcare of Atlanta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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 the development of psychosocial difficulties 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 aim of the current study is 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Psychological
Keywords
skin conductance reactivity, Systemic inflammation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Biofeedback Enhanced Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait-list control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Biofeedback Enhanced Treatment
Other Intervention Name(s)
Behavioral Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in the retention rate
Description
Measures including consent rates, completion/retention rates will be summarized using counts and percentages or means and standard deviations, as appropriate.
Time Frame
Baseline, 6 weeks (End of treatment), and 2 months post treatment
Title
Changes in treatment satisfaction
Description
Treatment satisfaction ratings will be summarized using counts and percentages or means and standard deviations, as appropriate.
Time Frame
6 weeks (End of treatment) and 2 months post treatment
Secondary Outcome Measure Information:
Title
Changes in clinical scores (depression) will be summarized within groups at each study time-point.
Description
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). A total score of ≥ 60 may indicate concerns for depression. An estimation of the mediation effect will be calculated using the difference in the regression coefficients (β1-β2)
Time Frame
baseline, 6 weeks (End of treatment), and 2 months post treatment
Title
Changes in scores (anxiety disorders) will be summarized within groups at each study time-point.
Description
The Screen for Child Anxiety Related Disorders (SCARED). The SCARED is a 41-item inventory rated on a 3-point Likert-type scale used to screen for anxiety disorders. The SCARED offers a Total score as well as five symptom domains: panic/somatic, separation anxiety, generalized anxiety, social anxiety, and school phobia. The SCARED is a screening measure and not a diagnostic of anxiety disorders. That being said, the authors provide cut scores for each scored domain that may be indicative of an anxiety disorder. A total score of ≥ 25 may indicate an anxiety disorder, and for each of the subscales, a score of 7 may indicate Panic Disorder, a score of 9 may indicate Generalized anxiety, a score of 8 may indicate Social Phobia, and a score of 3 may indicate significant school avoidance. An estimation of the mediation effect will be calculated using the difference in the regression coefficients (β1-β2).
Time Frame
baseline, 6 weeks (End of treatment), and 2 months post treatment
Title
Changes in clinical scores (clinical symptoms) will be summarized within groups at each study time-point.
Description
Self-report of disease activity using the Children's Somatic Symptoms Inventory- 24 (CSSI), GI Module will be collected. The GI symptom subscale includes items referring to nausea, constipation, diarrhea, abdominal pain, vomiting, feeling bloated, and food making you sick. The GI symptoms subscale has shown sensitivity to treatment. An estimation of the mediation effect will be calculated using the difference in the regression coefficients (β1-β2)
Time Frame
baseline, 6 weeks (End of treatment), and 2 months post treatment
Title
Changes in autonomic reactivity will be summarized within groups at each study time-point.
Description
Autonomic reactivity will be measured using Heart rate variability, measured using the Inner Balance system designed by HeartMath. Measures of heart rate variability will be taken before treatment, post-treatment, and follow-up. An estimation of the mediation effect will be calculated using the difference in the regression coefficients (β1-β2)
Time Frame
baseline, 6 weeks (End of treatment), and 2 months post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bonney Reed, PhD
Phone
404-727-8312
Email
ebreed@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bonnie Reed, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atlanta Metropolitan Area
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bonney Reed, PhD
Facility Name
Children's Healthcare of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bonney Reed, PhD
Email
ebreed@emory.edu
Facility Name
Emory Children's Center Building
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bonney Reed, PhD
Email
ebreed@emory.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The research team will share individual participant data that underlie the results reported in a published article, after deidentification (text, tables, figures, and appendices)
IPD Sharing Time Frame
The research team will share the data beginning 6 months and ending 36 months following article publication.
IPD Sharing 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.

Learn more about this trial

Stress in Inflammatory Bowel Disease

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