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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23DK122115-02 | U.S. NIH Grant/Contract | View source | |
| 1R03DK136975-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Children's Healthcare of Atlanta | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biofeedback Enhanced Treatment | Experimental | 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. |
|
| Wait-list control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Retention Rate | 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. | 6 weeks (End of treatment), and 2 months post treatment |
| Client Satisfaction Questionnaire (CSQ-8) Scores Following Biofeedback Enhanced 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. | 6 weeks (End of treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Children's Depression Inventory 2 (CDI-2) at Six Weeks Compared to Baseline | Children's Depression Inventory 2 (CDI-2) is a child-report measure of physiological, behavioral, and emotional symptoms of depression. It is a widely used tool for assessing depressive symptoms in children and adolescents. It includes 28 items, each with three possible responses that reflect different levels of severity: 0 (absence of symptoms), 1 (mild or probable symptom), or 2 (definite symptom). Raw scores are converted to t-scores ranging from 0 to 100, with a mean of 50 and a standard deviation of 10. A decrease in the score indicates an improvement in depressive symptoms (depressive symptoms decrease over time). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bonnie Reed, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlanta Metropolitan Area | Atlanta | Georgia | 30303 | United States | ||
| Children's Healthcare of Atlanta |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41486461 | Derived | Younginer ST, Westbrook A, Buzenski J, Dykes C, Kugathasan S, Talmadge C, Reed B. Health-related quality of life in youth with chronic gastrointestinal disease following a biofeedback enhanced cognitive behavioral therapy intervention: A randomized controlled trial. J Pediatr Gastroenterol Nutr. 2026 Mar;82(3):672-683. doi: 10.1002/jpn3.70333. Epub 2026 Jan 4. |
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The research team will share individual participant data that underlie the results reported in a published article, after deidentification (text, tables, figures, and appendices)
The research team will share the data beginning 6 months and ending 36 months following article publication.
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.
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Biofeedback Enhanced Treatment | 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. Biofeedback 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. |
| FG001 | Wait-list Control | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Biofeedback Enhanced Treatment | 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. Biofeedback 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Retention Rate | 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. | Posted | Count of Participants | Participants | 6 weeks (End of treatment), and 2 months post treatment |
|
Adverse event information was collected from the time consent was given to participate in the study through 2 months post-treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Biofeedback Enhanced Treatment | 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. Biofeedback 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bonney Reed | Emory University | 404-727-8312 | ebreed@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 21, 2023 | Nov 12, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 19, 2023 | Mar 6, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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|
|
| 6 weeks (End of treatment) |
| Change in the Children's Depression Inventory 2 (CDI-2) at 2 Months Post-treatment Compared to Baseline | 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). | 2 months post-Biofeedback Enhanced Treatment |
| Changes in the Behavior Assessment System for Children (BASC) Depression Parent Rating Scale at 6 Weeks | 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). | baseline, 6 weeks (End of treatment) |
| Changes in the Behavior Assessment System for Children (BASC) Depression Parent Rating Scale at 2 Months After Completing Treatment Intervention | 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). | baseline, 2 months post-treatment |
| Changes in the Screen for Child Anxiety Related Disorders (SCARED) Scores at 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. | baseline, 6 weeks (End of treatment) |
| Changes in Screen for Child Anxiety Related Disorders (SCARED) Scores in Both Groups at 2 Months After Completing 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. | baseline, 2 months post treatment |
| Changes in the Children's Somatic Symptoms Inventory (CSSI) 7-item (GI Subscale) After Completion of Biofeedback Enhanced 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. | baseline, 6 weeks (End of treatment) |
| Changes in the Children's Somatic Symptoms Inventory- (CSSI) 7-item (GI Subscale) at 2 Months After Completion of Treatment Intervention | 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. | baseline, 2 months post-treatment |
| Change in Autonomic Reactivity at 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. | baseline, 6 weeks (End of treatment) |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Emory Children's Center Building | Atlanta | Georgia | 30322 | United States |
| BG001 | Wait-list Control | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Inflammatory Bowel Disease (IBD) Diagnosis | Count of Participants | Participants |
|
| Time since diagnosis | Mean | Standard Deviation | years |
|
| Estimated household yearly income before taxes | Count of Participants | Participants |
|
| Caregiver relationship to the child | Count of Participants | Participants |
|
| OG001 | Wait-list Control | 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. |
|
|
| Primary | Client Satisfaction Questionnaire (CSQ-8) Scores Following Biofeedback Enhanced 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks (End of treatment) |
|
|
|
| Secondary | Change in the Children's Depression Inventory 2 (CDI-2) at Six Weeks Compared to Baseline | 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). | This analysis includes participants who completed the baseline survey. | Posted | Mean | 95% Confidence Interval | T-score | 6 weeks (End of treatment) |
|
|
|
| Secondary | Change in the Children's Depression Inventory 2 (CDI-2) at 2 Months Post-treatment Compared to Baseline | 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). | 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. | Posted | Mean | 95% Confidence Interval | T-score | 2 months post-Biofeedback Enhanced Treatment |
|
|
|
| Secondary | Changes in the Behavior Assessment System for Children (BASC) Depression Parent Rating Scale at 6 Weeks | 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). | Posted | Mean | 95% Confidence Interval | T-score | baseline, 6 weeks (End of treatment) |
|
|
|
| Secondary | Changes in the Behavior Assessment System for Children (BASC) Depression Parent Rating Scale at 2 Months After Completing Treatment Intervention | 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). | 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. | Posted | Mean | 95% Confidence Interval | T-score | baseline, 2 months post-treatment |
|
|
|
| Secondary | Changes in the Screen for Child Anxiety Related Disorders (SCARED) Scores at 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. | Posted | Mean | 95% Confidence Interval | Score on a scale | baseline, 6 weeks (End of treatment) |
|
|
|
| Secondary | Changes in Screen for Child Anxiety Related Disorders (SCARED) Scores in Both Groups at 2 Months After Completing 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. | 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. | Posted | Mean | 95% Confidence Interval | Score on a scale | baseline, 2 months post treatment |
|
|
|
| Secondary | Changes in the Children's Somatic Symptoms Inventory (CSSI) 7-item (GI Subscale) After Completion of Biofeedback Enhanced 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. | Posted | Mean | 95% Confidence Interval | Score on a scale | baseline, 6 weeks (End of treatment) |
|
|
|
| Secondary | Changes in the Children's Somatic Symptoms Inventory- (CSSI) 7-item (GI Subscale) at 2 Months After Completion of Treatment Intervention | 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. | 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. | Posted | Mean | 95% Confidence Interval | Score on a scale | baseline, 2 months post-treatment |
|
|
|
| Secondary | Change in Autonomic Reactivity at 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. | Posted | Mean | 95% Confidence Interval | milliseconds (ms) | baseline, 6 weeks (End of treatment) |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Wait-list Control | Participants randomized to the wait-list control group will complete the same measures of lifetime stress, autonomic reactivity, depression, anxiety. The identical treatment will be offered to control participants after the 6-week time point. | 0 | 27 | 0 | 27 | 0 | 27 |
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