Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT05202418
Status:
COMPLETED
Last Update Posted:
2025-04-22
First Post:
2021-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Stress in Inflammatory Bowel Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001521', 'term': 'Behavior Therapy'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ebreed@emory.edu', 'phone': '404-727-8312', 'title': 'Dr. Bonney Reed', 'organization': 'Emory University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event information was collected from the time consent was given to participate in the study through 2 months post-treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Biofeedback Enhanced Treatment', 'description': 'Participants will engage in biofeedback-enhanced, cognitive-behavioral coping skills treatment. Sessions will include brief, daily homework assignments tailored to youth (e.g., using apps for skill practice). Participants will complete pre- and post-session questionnaires to assess autonomic reactivity, lifetime stress, depression, anxiety, and coping strategies in response to stress induction.\n\nBiofeedback Enhanced Treatment: 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, 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 the 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.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Wait-list Control', '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.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Retention Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Biofeedback Enhanced Treatment', 'description': 'Participants will engage in biofeedback-enhanced, cognitive-behavioral coping skills treatment. Sessions will include brief, daily homework assignments tailored to youth (e.g., using apps for skill practice). Participants will complete pre- and post-session questionnaires to assess autonomic reactivity, lifetime stress, depression, anxiety, and coping strategies in response to stress induction.\n\nBiofeedback Enhanced Treatment: 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, 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 the 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.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Participants randomized to the wait-list control group will complete the same measures of lifetime stress, autonomic reactivity, depression, and anxiety. The intervention was offered to control participants after the 6-week time point, and all 2-month follow-up surveys and assessments were completed only after finishing the Biofeedback Enhanced Treatment.'}], 'classes': [{'title': 'Retention at 6 weeks (End of treatment)', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Retention at 2 months post-treatment', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks (End of treatment), and 2 months post treatment', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Client Satisfaction Questionnaire (CSQ-8) Scores Following Biofeedback Enhanced Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Biofeedback Enhanced Treatment and Waitlist Control After Completing Treatment', 'description': 'All participants randomized to either the Biofeedback Enhanced Treatment group or the Waitlist Control group were evaluated and analyzed together after completing treatment within their respective periods.'}], 'classes': [{'title': 'Child Report at 6 weeks (End of treatment)', 'categories': [{'measurements': [{'value': '28.02', 'spread': '2.90', 'groupId': 'OG000'}]}]}, {'title': 'Parent Report at 6 weeks (End of treatment)', 'categories': [{'measurements': [{'value': '28.73', 'spread': '3.18', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks (End of treatment)', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Satisfaction data applies only to the Biofeedback Enhanced Treatment (BET), as the control group did not receive treatment during the first 6 weeks. Satisfaction was assessed after both groups had completed their treatments, and the data were combined for analysis. These results include data from participants who completed the Biofeedback Enhanced Treatment and the satisfaction surveys 6 weeks post-treatment (BET), with data from both groups analyzed after treatment completion.'}, {'type': 'SECONDARY', 'title': "Change in the Children's Depression Inventory 2 (CDI-2) at Six Weeks Compared to Baseline", 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Biofeedback Enhanced Treatment', 'description': 'Participants will engage in biofeedback-enhanced, cognitive-behavioral coping skills treatment. Sessions will include brief, daily homework assignments tailored to youth (e.g., using apps for skill practice). Participants will complete pre- and post-session questionnaires to assess autonomic reactivity, lifetime stress, depression, anxiety, and coping strategies in response to stress induction.\n\nBiofeedback Enhanced Treatment: 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, 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 the 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.'}, {'id': 'OG001', 'title': 'Wait-list Control', '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.99', 'groupId': 'OG000', 'lowerLimit': '-4.49', 'upperLimit': '0.47'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-2.18', 'upperLimit': '2.18'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks (End of treatment)', 'description': "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).", 'unitOfMeasure': 'T-score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who completed the baseline survey.'}, {'type': 'SECONDARY', 'title': "Change in the Children's Depression Inventory 2 (CDI-2) at 2 Months Post-treatment Compared to Baseline", 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Biofeedback Enhanced Treatment and Waitlist Control After Completing Treatment', 'description': 'All participants randomized to either the Biofeedback Enhanced Treatment group or the Waitlist Control group were evaluated and analyzed together after completing the treatment within their respective periods. Both groups were combined for analysis at the 2-month follow-up after each group completed the Biofeedback Enhanced Treatment in different periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.17', 'groupId': 'OG000', 'lowerLimit': '-6.63', 'upperLimit': '-1.71'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 months post-Biofeedback Enhanced Treatment', '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). 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).", 'unitOfMeasure': 'T-score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The results include data from participants in both groups after completing the Biofeedback Enhanced Treatment. No 2-month follow-up data were collected from the control group during the waiting period, as they received the intervention at 6 weeks. Data were collected 2 months after completing the treatment in each group, and these were combined for analysis, as specified in the protocol, which outlines that the changes will be summarized within groups.'}, {'type': 'SECONDARY', 'title': 'Changes in the Behavior Assessment System for Children (BASC) Depression Parent Rating Scale at 6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Biofeedback Enhanced Treatment', 'description': 'Participants will engage in biofeedback-enhanced, cognitive-behavioral coping skills treatment. Sessions will include brief, daily homework assignments tailored to youth (e.g., using apps for skill practice). Participants will complete pre- and post-session questionnaires to assess autonomic reactivity, lifetime stress, depression, anxiety, and coping strategies in response to stress induction.\n\nBiofeedback Enhanced Treatment: 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, 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 the 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.'}, {'id': 'OG001', 'title': 'Wait-list Control', '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.64', 'groupId': 'OG000', 'lowerLimit': '-7.21', 'upperLimit': '-0.07'}, {'value': '0.44', 'groupId': 'OG001', 'lowerLimit': '-2.88', 'upperLimit': '3.76'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 weeks (End of treatment)', 'description': "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).", 'unitOfMeasure': 'T-score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in the Behavior Assessment System for Children (BASC) Depression Parent Rating Scale at 2 Months After Completing Treatment Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Biofeedback Enhanced Treatment and Waitlist Control After Completing Treatment', 'description': 'All participants randomized to either the Biofeedback Enhanced Treatment group or the Waitlist Control group were evaluated and analyzed together after completing the treatment within their respective periods. Both groups were combined for analysis at the 2-month follow-up after each group completed the Biofeedback Enhanced Treatment in different periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.60', 'groupId': 'OG000', 'lowerLimit': '-7.06', 'upperLimit': '-2.15'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 2 months post-treatment', 'description': "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).", 'unitOfMeasure': 'T-score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The results include data from participants in both groups after completing the Biofeedback Enhanced Treatment. No 2-month follow-up data were collected from the control group during the waiting period, as they received the intervention at 6 weeks. Data were collected 2 months after completing the treatment in each group, and these were combined for analysis, as specified in the protocol, which outlines that the changes will be summarized within groups.'}, {'type': 'SECONDARY', 'title': 'Changes in the Screen for Child Anxiety Related Disorders (SCARED) Scores at 6 Weeks (End of Treatment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Biofeedback Enhanced Treatment', 'description': 'Participants will engage in biofeedback-enhanced, cognitive-behavioral coping skills treatment. Sessions will include brief, daily homework assignments tailored to youth (e.g., using apps for skill practice). Participants will complete pre- and post-session questionnaires to assess autonomic reactivity, lifetime stress, depression, anxiety, and coping strategies in response to stress induction.\n\nBiofeedback Enhanced Treatment: 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, 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 the 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.'}, {'id': 'OG001', 'title': 'Wait-list Control', '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.'}], 'classes': [{'title': 'Child Report at 6 weeks (End of treatment)', 'categories': [{'measurements': [{'value': '-5.05', 'groupId': 'OG000', 'lowerLimit': '-9.69', 'upperLimit': '-.04'}, {'value': '-0.67', 'groupId': 'OG001', 'lowerLimit': '-4.8', 'upperLimit': '3.47'}]}]}, {'title': 'Parent Report 6 weeks (End of treatment)', 'categories': [{'measurements': [{'value': '-1.87', 'groupId': 'OG000', 'lowerLimit': '-5.87', 'upperLimit': '2.13'}, {'value': '-1.84', 'groupId': 'OG001', 'lowerLimit': '-5.53', 'upperLimit': '1.85'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 weeks (End of treatment)', 'description': '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.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in Screen for Child Anxiety Related Disorders (SCARED) Scores in Both Groups at 2 Months After Completing Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Biofeedback Enhanced Treatment and Waitlist Control After Completing Treatment', 'description': 'All participants randomized to either the Biofeedback Enhanced Treatment group or the Waitlist Control group were evaluated and analyzed together after completing the treatment within their respective periods. Both groups were combined for analysis at the 2-month follow-up after each group completed the Biofeedback Enhanced Treatment in different periods.'}], 'classes': [{'title': 'Child Report at 2 months post treatment (End of treatment)', 'categories': [{'measurements': [{'value': '-4.28', 'groupId': 'OG000', 'lowerLimit': '-7.14', 'upperLimit': '-1.42'}]}]}, {'title': 'Parent Report at 2 months post treatment', 'categories': [{'measurements': [{'value': '-1.87', 'groupId': 'OG000', 'lowerLimit': '-5.87', 'upperLimit': '2.13'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 2 months post treatment', 'description': '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.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The results include data from participants in both groups after completing the Biofeedback Enhanced Treatment. No 2-month follow-up data were collected from the control group during the waiting period, as they received the intervention at 6 weeks. Data were collected 2 months after completing the treatment in each group, and these were combined for analysis, as specified in the protocol, which outlines that the changes will be summarized within groups.'}, {'type': 'SECONDARY', 'title': "Changes in the Children's Somatic Symptoms Inventory (CSSI) 7-item (GI Subscale) After Completion of Biofeedback Enhanced Treatment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Biofeedback Enhanced Treatment', 'description': 'Participants will engage in biofeedback-enhanced, cognitive-behavioral coping skills treatment. Sessions will include brief, daily homework assignments tailored to youth (e.g., using apps for skill practice). Participants will complete pre- and post-session questionnaires to assess autonomic reactivity, lifetime stress, depression, anxiety, and coping strategies in response to stress induction.\n\nBiofeedback Enhanced Treatment: 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, 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 the 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.'}, {'id': 'OG001', 'title': 'Wait-list Control', '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.'}], 'classes': [{'title': 'Child Report at 6 weeks (End of treatment)', 'categories': [{'measurements': [{'value': '-1.29', 'groupId': 'OG000', 'lowerLimit': '-2.91', 'upperLimit': '0.32'}, {'value': '0.56', 'groupId': 'OG001', 'lowerLimit': '-0.88', 'upperLimit': '1.99'}]}]}, {'title': 'Parent Report at 6 weeks (End of treatment)', 'categories': [{'measurements': [{'value': '-2.79', 'groupId': 'OG000', 'lowerLimit': '-4.53', 'upperLimit': '-1.04'}, {'value': '-0.12', 'groupId': 'OG001', 'lowerLimit': '-1.73', 'upperLimit': '1.49'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 weeks (End of treatment)', 'description': '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.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Changes in the Children's Somatic Symptoms Inventory- (CSSI) 7-item (GI Subscale) at 2 Months After Completion of Treatment Intervention", 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Biofeedback Enhanced Treatment and Waitlist Control After Completing Treatment Intervention', 'description': 'All participants randomized to either the Biofeedback Enhanced Treatment group or the Waitlist Control group were evaluated and analyzed together after completing the treatment within their respective periods. Both groups were combined for analysis at the 2-month follow-up after each group completed the Biofeedback Enhanced Treatment in different periods.'}], 'classes': [{'title': 'Child Report at 2 months post-treatment(End of treatment)', 'categories': [{'measurements': [{'value': '0.62', 'groupId': 'OG000', 'lowerLimit': '-0.69', 'upperLimit': '1.94'}]}]}, {'title': 'Parent Report at 2 months post-treatment (End of treatment)', 'categories': [{'measurements': [{'value': '-0.01', 'groupId': 'OG000', 'lowerLimit': '-1.27', 'upperLimit': '1.25'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 2 months post-treatment', 'description': '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.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The results include data from participants in both groups after completing the Biofeedback Enhanced Treatment. No 2-month follow-up data were collected from the control group during the waiting period, as they received the intervention at 6 weeks. Data were collected 2 months after completing the treatment in each group, and these were combined for analysis, as specified in the protocol, which outlines that the changes will be summarized within groups.'}, {'type': 'SECONDARY', 'title': 'Change in Autonomic Reactivity at 6 Weeks (End of Treatment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Biofeedback Enhanced Treatment', 'description': 'Participants will engage in biofeedback-enhanced, cognitive-behavioral coping skills treatment. Sessions will include brief, daily homework assignments tailored to youth (e.g., using apps for skill practice). Participants will complete pre- and post-session questionnaires to assess autonomic reactivity, lifetime stress, depression, anxiety, and coping strategies in response to stress induction.\n\nBiofeedback Enhanced Treatment: 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, 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 the 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.'}, {'id': 'OG001', 'title': 'Wait-list Control', '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.'}], 'classes': [{'title': 'SDNN at 6 weeks (End of treatment)', 'categories': [{'measurements': [{'value': '15.6', 'groupId': 'OG000', 'lowerLimit': '-2.12', 'upperLimit': '33.32'}, {'value': '16.74', 'groupId': 'OG001', 'lowerLimit': '0.99', 'upperLimit': '32.49'}]}]}, {'title': 'RMSSD at 6 weeks (End of treatment)', 'categories': [{'measurements': [{'value': '-4.09', 'groupId': 'OG000', 'lowerLimit': '-27.64', 'upperLimit': '19.47'}, {'value': '16.02', 'groupId': 'OG001', 'lowerLimit': '-4.86', 'upperLimit': '36.91'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 weeks (End of treatment)', 'description': '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.\n\nThe 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.', 'unitOfMeasure': 'milliseconds (ms)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Biofeedback Enhanced Treatment', 'description': 'Participants will engage in biofeedback-enhanced, cognitive-behavioral coping skills treatment. Sessions will include brief, daily homework assignments tailored to youth (e.g., using apps for skill practice). Participants will complete pre- and post-session questionnaires to assess autonomic reactivity, lifetime stress, depression, anxiety, and coping strategies in response to stress induction.\n\nBiofeedback Enhanced Treatment: 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, 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 the 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.'}, {'id': 'FG001', 'title': 'Wait-list Control', 'description': 'Participants randomized to the wait-list control group will complete the same measures of lifetime stress, autonomic reactivity, depression, and anxiety. The intervention was offered to control participants after the 6-week time point, and all 2-month follow-up surveys and assessments were completed only after finishing the Biofeedback Enhanced Treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'For participants randomized to the treatment group, clinical assessments, including study questionnaires and the HRV assessment, were conducted at baseline (within 1 week before starting treatment), at the end of treatment (6 weeks after baseline), and all other assessments were completed 14 weeks after baseline to capture the 2-month follow-up after treatment.', 'groupId': 'FG000', 'numSubjects': '26'}, {'comment': 'Participants randomized to the waitlist control group completed the same assessment protocol at the time of randomization (Baseline) and again 6 weeks later.', 'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'comment': 'The biofeedback enhancement intervention was administered after 6 weeks. After completing the Biofeedback Enhanced Treatment, participants completed satisfaction and HRV assessments at the 6-week and 2-month follow-up points, after finishing the treatment.', 'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': "Participants were recruited from Children's Healthcare of Atlanta (CHOA) at Egleston in Atlanta, Georgia, USA. Participant enrollment began on February 27, 2022, and 3 rounds of treatment and paired waitlist groups were held. All follow-ups were complete by January 13, 2024.", 'preAssignmentDetails': 'Participants in the waitlist control group completed lifetime stress, autonomic reactivity, depression, and anxiety surveys at baseline and 6 weeks. A 2-month follow-up was not conducted during the waitlist period, as the biofeedback intervention was given after 6 weeks. After completing the Biofeedback Enhanced Treatment, participants took part in the 2-month follow-up assessments. All 2-month follow-up data were then combined and analyzed for both groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Biofeedback Enhanced Treatment', 'description': 'Participants will engage in biofeedback-enhanced, cognitive-behavioral coping skills treatment. Sessions will include brief, daily homework assignments tailored to youth (e.g., using apps for skill practice). Participants will complete pre- and post-session questionnaires to assess autonomic reactivity, lifetime stress, depression, anxiety, and coping strategies in response to stress induction.\n\nBiofeedback Enhanced Treatment: 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, 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 the 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.'}, {'id': 'BG001', 'title': 'Wait-list Control', 'description': 'Participants randomized to the wait-list control group will complete the same measures of lifetime stress, autonomic reactivity, depression, and anxiety. The intervention was offered to control participants after the 6-week time point, and all 2-month follow-up surveys and assessments were completed only after finishing the Biofeedback Enhanced Treatment.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.58', 'spread': '1.38', 'groupId': 'BG000'}, {'value': '15.37', 'spread': '1.45', 'groupId': 'BG001'}, {'value': '15.00', 'spread': '1.46', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Inflammatory Bowel Disease (IBD) Diagnosis', 'classes': [{'title': "Crohn's Disease", 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': 'Ulcerative Colitis', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Indeterminate Colitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Time since diagnosis', 'classes': [{'categories': [{'measurements': [{'value': '2.88', 'spread': '2.57', 'groupId': 'BG000'}, {'value': '3.53', 'spread': '2.80', 'groupId': 'BG001'}, {'value': '3.22', 'spread': '2.69', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Estimated household yearly income before taxes', 'classes': [{'title': '$25,000 to $49,999', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': '$50,000 to $74,999', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': '$75,000 to $99,999', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': '$100,000 to $124,999', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': '$125,000 to $149,999', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Above $150,000', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Caregiver relationship to the child', 'classes': [{'title': 'Mother', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': 'Father', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-04-21', 'size': 415946, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-11-12T15:57', 'hasProtocol': True}, {'date': '2023-08-19', 'size': 355155, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-03-06T11:57', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-01-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-03', 'studyFirstSubmitDate': '2021-12-09', 'resultsFirstSubmitDate': '2024-12-19', 'studyFirstSubmitQcDate': '2022-01-20', 'lastUpdatePostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-03', 'studyFirstPostDateStruct': {'date': '2022-01-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retention Rate', 'timeFrame': '6 weeks (End of treatment), and 2 months post treatment', 'description': '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.'}, {'measure': 'Client Satisfaction Questionnaire (CSQ-8) Scores Following Biofeedback Enhanced Treatment', 'timeFrame': '6 weeks (End of treatment)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': "Change in the Children's Depression Inventory 2 (CDI-2) at Six Weeks Compared to Baseline", 'timeFrame': '6 weeks (End of treatment)', 'description': "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)."}, {'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', '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). 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)."}, {'measure': 'Changes in the Behavior Assessment System for Children (BASC) Depression Parent Rating Scale at 6 Weeks', 'timeFrame': 'baseline, 6 weeks (End of treatment)', 'description': "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)."}, {'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', 'description': "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)."}, {'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)', 'description': '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.'}, {'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', 'description': '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.'}, {'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)', 'description': '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.'}, {'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', 'description': '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.'}, {'measure': 'Change in Autonomic Reactivity at 6 Weeks (End of Treatment)', 'timeFrame': 'baseline, 6 weeks (End of treatment)', 'description': '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.\n\nThe 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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['skin conductance reactivity', 'Systemic inflammation'], 'conditions': ['Inflammatory Bowel Diseases', 'Psychological']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nIndividual 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.\n\nIn 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with biopsy-confirmed IBD\n* Ages 13 through 18 years inclusive\n* English fluency for parent and child participants.\n* Accompanied by at least 1 parent/guardian who is willing to participate\n* Positive depression or anxiety symptom screen using the patient health questionnaire (PHQ-9) or Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Anxiety measures\n\nExclusion Criteria:\n\n* Previous diagnosis of intellectual disability\n* Autism spectrum disorder.\n* Parent is unwilling to participate.'}, 'identificationModule': {'nctId': 'NCT05202418', 'briefTitle': 'Stress in Inflammatory Bowel Disease', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Physiological Reactivity and Psychosocial Functioning in Pediatric Patients With Gastrointestinal Disease', 'orgStudyIdInfo': {'id': 'IRB00085974'}, 'secondaryIdInfos': [{'id': '5K23DK122115-02', 'link': 'https://reporter.nih.gov/quickSearch/5K23DK122115-02', 'type': 'NIH'}, {'id': '1R03DK136975-01', 'link': 'https://reporter.nih.gov/quickSearch/1R03DK136975-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biofeedback Enhanced Treatment', '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.', 'interventionNames': ['Behavioral: Biofeedback Enhanced Treatment']}, {'type': 'NO_INTERVENTION', 'label': 'Wait-list control', '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.'}], 'interventions': [{'name': 'Biofeedback Enhanced Treatment', 'type': 'BEHAVIORAL', 'otherNames': ['Behavioral 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.', 'armGroupLabels': ['Biofeedback Enhanced Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Metropolitan Area', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Healthcare of Atlanta", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Emory Children's Center Building", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Bonnie Reed, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'The research team will share the data beginning 6 months and ending 36 months following article publication.', 'ipdSharing': 'YES', '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)', 'accessCriteria': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, {'name': "Children's Healthcare of Atlanta", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Bonney Reed', 'investigatorAffiliation': 'Emory University'}}}}