Inflammatory Bowel DiseasesNCT05202418
Stress in Inflammatory Bowel Disease
A study testing Biofeedback Enhanced Treatment in people with Inflammatory Bowel Diseases and Psychological, run by Emory University at 3 sites in United States.
Trial summary
This is a prospective, assessment-based study to examine the relationship between psychophysiological functioning and psychological symptoms in youth newly diagnosed with inflammatory bowel disease (IBD) compared to healthy controls. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Psychological
- What is being tested?
- Biofeedback Enhanced Treatment
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Feb 2022to 13 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed with biopsy-confirmed IBD
- Ages 13 through 18 years inclusive
- English fluency for parent and child participants.
- Accompanied by at least 1 parent/guardian who is willing to participate
- Positive depression or anxiety symptom screen using the patient health questionnaire (PHQ-9) or Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Anxiety measures
Who cannot join
- Previous diagnosis of intellectual disability
- Autism spectrum disorder.
- Parent is unwilling to participate.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Atlanta Metropolitan Area
Atlanta, Georgia, 30303
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
Emory Children's Center Building
Atlanta, Georgia, 30322
About this study
Official title: Physiological Reactivity and Psychosocial Functioning in Pediatric Patients With Gastrointestinal Disease
This is a prospective, assessment-based study to examine the relationship between psychophysiological functioning and psychological symptoms in youth newly diagnosed with inflammatory bowel disease (IBD) compared to healthy controls.
Read the detailed description
Similar to other chronic stressors, diagnosis with a chronic illness places youth at risk of adverse psychosocial outcomes. Inflammatory bowel diseases (IBD), Crohn's disease, ulcerative colitis, and indeterminate colitis are chronic, immune-mediated diseases of the gastrointestinal tract characterized by unpredictable remissions of disease activity followed by relapses of symptoms. Although some research has found higher levels of disease activity to relate to greater depressive symptoms, the overall relationship between disease activity and emotional functioning has been mixed, suggesting that additional individual differences need to be considered in addition to illness-related factors when predicting emotional outcomes. Increased risk for developing anxiety disorders and depression has been documented in youth with IBD. Individual differences in physiological reactivity may affect patients' risk for developing psychosocial difficulties within the context of chronic stress. Additional risk factors for developing psychosocial challenges need to be identified to identify moderators of outcomes above and beyond disease activity.
Individual differences in physiological reactivity may affect patients' risk for developing psychosocial difficulties within the context of chronic stress. Physiological reactivity, which broadly refers to bodily reactions in response to a stressor, varies with regards to intensity and threshold for activation between individuals.
In youth affected by non-medical chronic stress (e.g., family conflict, trauma history), measures of autonomic dysfunction have been used to explain why some individuals have worse psychological and physical outcomes compared to others exposed to similar levels of chronic stress. Results support autonomic dysfunction as a vulnerability factor for adjustment problems within the context of chronic environmental stress.
The current study aims to test whether differences in psychophysiological reactivity serve as risk factors in the relationship between clinical disease activity in youth newly diagnosed with IBD and psychosocial adjustment problems. The relationship between psychophysiological reactivity and psychosocial adjustment problems in youth with IBD will be compared to healthy controls. Youth participants with IBD will be enrolled in a coping skills treatment to test the effectiveness of a cognitive-behavioral intervention including biofeedback to reduce anxiety and depression and disease symptoms. The research team will conduct a pilot intervention targeting autonomic dysfunction through biofeedback-enhanced coping skills treatment delivered virtually over 6-sessions.
- Conditions
- Inflammatory Bowel Diseases, Psychological
- Being tested
- Biofeedback Enhanced Treatment
- Keywords
- skin conductance reactivity, Systemic inflammation
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofeedback Enhanced TreatmentBehavioural
Also called Behavioral Intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Biofeedback Enhanced Treatment |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 weeks (End of treatment)
Secondary outcomes (9)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, 6 weeks (End of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start27 Feb 2022
- Primary completion13 Jan 2024
- Study completion13 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Children's Healthcare of Atlanta
- Responsible party
- Principal investigator, Bonney Reed, Emory University
- Investigators
- Bonnie Reed, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05202418
- Sponsor's protocol ID
- IRB00085974
- Other IDs
- 5K23DK122115-02, 1R03DK136975-01
- Status last verified
- Apr 2025
- First submitted
- 9 Dec 2021
- Last updated
- 22 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research team will share individual participant data that underlie the results reported in a published article, after deidentification (text, tables, figures, and appendices)
Publications
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.
PubMed 41486461
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Reactivity and Psychosocial Functioning in Pediatric Patients With Gastrointestinal Disease
- ClinicalTrials.gov ID
- NCT05202418
- Acronym / sponsor ID
- IRB00085974
- Conditions
- Inflammatory Bowel Diseases, Psychological
- Keywords
- skin conductance reactivity, Systemic inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Children's Healthcare of Atlanta
- Study start
- 27 Feb 2022 (actual)
- Primary completion
- 13 Jan 2024 (actual)
- Study completion
- 13 Jan 2024 (actual)
- First posted
- 21 Jan 2022 (actual)
- Results
- Posted 22 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, assessment-based study to examine the relationship between psychophysiological functioning and psychological symptoms in youth newly diagnosed with inflammatory bowel disease (IBD) compared to healthy controls.
Detailed description
Similar to other chronic stressors, diagnosis with a chronic illness places youth at risk of adverse psychosocial outcomes. Inflammatory bowel diseases (IBD), Crohn's disease, ulcerative colitis, and indeterminate colitis are chronic, immune-mediated diseases of the gastrointestinal tract characterized by unpredictable remissions of disease activity followed by relapses of symptoms. Although some research has found higher levels of disease activity to relate to greater depressive symptoms, the overall relationship between disease activity and emotional functioning has been mixed, suggesting that additional individual differences need to be considered in addition to illness-related factors when predicting emotional outcomes. Increased risk for developing anxiety disorders and depression has been documented in youth with IBD. Individual differences in physiological reactivity may affect patients' risk for developing psychosocial difficulties within the context of chronic stress. Additional risk factors for developing psychosocial challenges need to be identified to identify moderators of outcomes above and beyond disease activity.
Individual differences in physiological reactivity may affect patients' risk for developing psychosocial difficulties within the context of chronic stress. Physiological reactivity, which broadly refers to bodily reactions in response to a stressor, varies with regards to intensity and threshold for activation between individuals.
In youth affected by non-medical chronic stress (e.g., family conflict, trauma history), measures of autonomic dysfunction have been used to explain why some individuals have worse psychological and physical outcomes compared to others exposed to similar levels of chronic stress. Results support autonomic dysfunction as a vulnerability factor for adjustment problems within the context of chronic environmental stress.
The current study aims to test whether differences in psychophysiological reactivity serve as risk factors in the relationship between clinical disease activity in youth newly diagnosed with IBD and psychosocial adjustment problems. The relationship between psychophysiological reactivity and psychosocial adjustment problems in youth with IBD will be compared to healthy controls. Youth participants with IBD will be enrolled in a coping skills treatment to test the effectiveness of a cognitive-behavioral intervention including biofeedback to reduce anxiety and depression and disease symptoms. The research team will conduct a pilot intervention targeting autonomic dysfunction through biofeedback-enhanced coping skills treatment delivered virtually over 6-sessions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biofeedback Enhanced Treatment | Experimental | Behavioral: Biofeedback Enhanced TreatmentParticipants 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. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Diagnosed with biopsy-confirmed IBD
- Ages 13 through 18 years inclusive
- English fluency for parent and child participants.
- Accompanied by at least 1 parent/guardian who is willing to participate
- Positive depression or anxiety symptom screen using the patient health questionnaire (PHQ-9) or Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Anxiety measures
Key exclusion criteria (3 listed)
- Previous diagnosis of intellectual disability
- Autism spectrum disorder.
- Parent is unwilling to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biofeedback Enhanced TreatmentAlso: Behavioral InterventionThe 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. | Behavioural | Biofeedback Enhanced Treatment |
Primary outcome
Retention Rate
Time frame: 6 weeks (End of treatment), and 2 months post treatment
Retention rates will be summarized using the number of individuals who gave consent to participate in the trial, who completed 6 weeks of the intervention they were randomized to, as well as the count of participants completing the Post-Treatment assessment 2 months after finishing 6 weeks of Biofeedback Enhanced Treatment.
Client Satisfaction Questionnaire (CSQ-8) Scores Following Biofeedback Enhanced Treatment
Time frame: 6 weeks (End of treatment)
Acceptability of the Biofeedback Enhanced Treatment was assessed using adolescent- and parent-reported program satisfaction ratings on the Client Satisfaction Questionnaire (CSQ-8). Adolescents and parents completed this 8-item survey on a 4-point scale, with total scores ranging from 8 to 32; higher scores indicated greater satisfaction. Each group completed the questionnaire 6 weeks after finishing the Biofeedback Enhanced Treatment. No survey was provided to participants during the waitlist phase, as no treatment was administered during the waiting period.
9 secondary outcomes
Change in the Children's Depression Inventory 2 (CDI-2) at Six Weeks Compared to Baseline
Time frame: 6 weeks (End of treatment)
Change in the Children's Depression Inventory 2 (CDI-2) at 2 Months Post-treatment Compared to Baseline
Time frame: 2 months post-Biofeedback Enhanced Treatment
Changes in the Behavior Assessment System for Children (BASC) Depression Parent Rating Scale at 6 Weeks
Time frame: 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
Time frame: baseline, 2 months post-treatment
Changes in the Screen for Child Anxiety Related Disorders (SCARED) Scores at 6 Weeks (End of Treatment)
Time frame: baseline, 6 weeks (End of treatment)
Changes in Screen for Child Anxiety Related Disorders (SCARED) Scores in Both Groups at 2 Months After Completing Treatment
Time frame: baseline, 2 months post treatment
Changes in the Children's Somatic Symptoms Inventory (CSSI) 7-item (GI Subscale) After Completion of Biofeedback Enhanced Treatment
Time frame: baseline, 6 weeks (End of treatment)
Changes in the Children's Somatic Symptoms Inventory- (CSSI) 7-item (GI Subscale) at 2 Months After Completion of Treatment Intervention
Time frame: baseline, 2 months post-treatment
Change in Autonomic Reactivity at 6 Weeks (End of Treatment)
Time frame: baseline, 6 weeks (End of treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41486461Younginer 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.
- Individual participant dataSharing planned: Yes. The research team will share individual participant data that underlie the results reported in a published article, after deidentification (text, tables, figures, and appendices)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bonnie Reed, PhD principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback Enhanced Treatment in people with Inflammatory Bowel Diseases and Psychological, run by Emory University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention Rate (time frame: 6 weeks (End of treatment), and 2 months post treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05202418, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.