An interventional study of Biofeedback Enhanced Treatment in Inflammatory Bowel Diseases and Psychological, sponsored by Emory University. Completed at 3 sites in United States. Open to participants aged 13 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-04-22.
Sponsored by Emory University · Not applicable, Interventional, and Supportive care
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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Exclusion Criteria:
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.
Behavioral: Biofeedback Enhanced Treatment
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.
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.
Also known as: Behavioral Intervention
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.
Time frame: 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.
Time frame: 6 weeks (End of treatment)
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).
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
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).
Time frame: 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).
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
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).
Time frame: 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.
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
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.
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
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.
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
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.
Time frame: 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.
Time frame: baseline, 6 weeks (End of treatment)
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.
| Milestone | Biofeedback Enhanced Treatment | Wait-list Control |
|---|---|---|
| Started | 26 | 27 |
| Completed | 23 | 25 |
| Not completed | 3 | 2 |
| Withdrew: Withdrawal by subject | 2 | 1 |
| Withdrew: Lost to follow-up | 1 | 1 |
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.
| Participants | Biofeedback Enhanced Treatment | Wait-list Control |
|---|---|---|
| Retention at 6 weeks (End of treatment) | 23 | 25 |
| Retention at 2 months post-treatment | 19 | 22 |
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.
| score on a scale | Biofeedback Enhanced Treatment and Waitlist Control After Completing Treatment |
|---|---|
| Child Report at 6 weeks (End of treatment) | 28.02 ± 2.90 |
| Parent Report at 6 weeks (End of treatment) | 28.73 ± 3.18 |
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).
| T-score | Biofeedback Enhanced Treatment | Wait-list Control |
|---|---|---|
| Change in the Children's Depression Inventory 2 (CDI-2) at Six Weeks Compared to Baseline | -1.99 (-4.49 to 0.47) | 0.00 (-2.18 to 2.18) |
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).
| T-score | Biofeedback Enhanced Treatment and Waitlist Control After Completing Treatment |
|---|---|
| Change in the Children's Depression Inventory 2 (CDI-2) at 2 Months Post-treatment Compared to Baseline | -4.17 (-6.63 to -1.71) |
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).
| T-score | Biofeedback Enhanced Treatment | Wait-list Control |
|---|---|---|
| Changes in the Behavior Assessment System for Children (BASC) Depression Parent Rating Scale at 6 Weeks | -3.64 (-7.21 to -0.07) | 0.44 (-2.88 to 3.76) |
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).
| T-score | Biofeedback Enhanced Treatment and Waitlist Control After Completing Treatment |
|---|---|
| Changes in the Behavior Assessment System for Children (BASC) Depression Parent Rating Scale at 2 Months After Completing Treatment Intervention | -4.60 (-7.06 to -2.15) |
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.
| Score on a scale | Biofeedback Enhanced Treatment | Wait-list Control |
|---|---|---|
| Child Report at 6 weeks (End of treatment) | -5.05 (-9.69 to -.04) | -0.67 (-4.8 to 3.47) |
| Parent Report 6 weeks (End of treatment) | -1.87 (-5.87 to 2.13) | -1.84 (-5.53 to 1.85) |
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.
| Score on a scale | Biofeedback Enhanced Treatment and Waitlist Control After Completing Treatment |
|---|---|
| Child Report at 2 months post treatment (End of treatment) | -4.28 (-7.14 to -1.42) |
| Parent Report at 2 months post treatment | -1.87 (-5.87 to 2.13) |
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.
| Score on a scale | Biofeedback Enhanced Treatment | Wait-list Control |
|---|---|---|
| Child Report at 6 weeks (End of treatment) | -1.29 (-2.91 to 0.32) | 0.56 (-0.88 to 1.99) |
| Parent Report at 6 weeks (End of treatment) | -2.79 (-4.53 to -1.04) | -0.12 (-1.73 to 1.49) |
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.
| Score on a scale | Biofeedback Enhanced Treatment and Waitlist Control After Completing Treatment Intervention |
|---|---|
| Child Report at 2 months post-treatment(End of treatment) | 0.62 (-0.69 to 1.94) |
| Parent Report at 2 months post-treatment (End of treatment) | -0.01 (-1.27 to 1.25) |
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.
| milliseconds (ms) | Biofeedback Enhanced Treatment | Wait-list Control |
|---|---|---|
| SDNN at 6 weeks (End of treatment) | 15.6 (-2.12 to 33.32) | 16.74 (0.99 to 32.49) |
| RMSSD at 6 weeks (End of treatment) | -4.09 (-27.64 to 19.47) | 16.02 (-4.86 to 36.91) |
Collected over Adverse event information was collected from the time consent was given to participate in the study through 2 months post-treatment.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Biofeedback Enhanced Treatment | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| Wait-list Control | 0/27 (0%) | 0/27 (0%) | 0/27 (0%) |
| Age, Continuous(years) | Biofeedback Enhanced Treatment | Wait-list Control | Total |
|---|---|---|---|
| Mean | 14.58 ± 1.38 | 15.37 ± 1.45 | 15.00 ± 1.46 |
| Sex: Female, Male(Participants) | Biofeedback Enhanced Treatment | Wait-list Control | Total |
|---|---|---|---|
| Female | 17 | 14 | 31 |
| Male | 7 | 13 | 20 |
| Ethnicity (NIH/OMB)(Participants) | Biofeedback Enhanced Treatment | Wait-list Control | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 24 | 26 | 50 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Biofeedback Enhanced Treatment | Wait-list Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 2 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 1 | 2 | 3 |
| White | 23 | 22 | 45 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Biofeedback Enhanced Treatment | Wait-list Control | Total |
|---|---|---|---|
| United States | 24 | 27 | 51 |
| Inflammatory Bowel Disease (IBD) Diagnosis(Participants) | Biofeedback Enhanced Treatment | Wait-list Control | Total |
|---|---|---|---|
| Crohn's Disease | 16 | 20 | 36 |
| Ulcerative Colitis | 8 | 6 | 14 |
| Indeterminate Colitis | 0 | 1 | 1 |
| Time since diagnosis(years) | Biofeedback Enhanced Treatment | Wait-list Control | Total |
|---|---|---|---|
| Mean | 2.88 ± 2.57 | 3.53 ± 2.80 | 3.22 ± 2.69 |
| Estimated household yearly income before taxes(Participants) | Biofeedback Enhanced Treatment | Wait-list Control | Total |
|---|---|---|---|
| $25,000 to $49,999 | 2 | 0 | 2 |
| $50,000 to $74,999 | 3 | 1 | 4 |
| $75,000 to $99,999 | 2 | 5 | 7 |
| $100,000 to $124,999 | 6 | 4 | 10 |
| $125,000 to $149,999 | 1 | 4 | 5 |
| Above $150,000 | 10 | 11 | 21 |
| Not Reported | 1 | 1 | 2 |
1 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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)
Supporting information: Study protocol
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Emory University