Trial Outcomes & Findings for Fibromyalgia Integrative Training for Adolescents With Juvenile Fibromyalgia (NCT NCT03268421)

Last Updated: 2025-02-14

Results Overview

Functional Disability Inventory (FDI) is a validated 15-item self-report measure, developed to assess perceived difficulty in the performance of daily activities in home, school, recreational, and social domains due to pain. Total sum scores are calculated and range from 0 - 60, with higher scores indicating greater functional disability. Clinical reference points are: No/Minimal disability (0 to 12), Mild disability (13 to 20), Moderate disability (21 to 29) and Severe disability (≥30). For this primary outcome, data from this questionnaire was used to compare baseline response to 3 month follow up to examine whether a reduction in disability occurs. The main outcome measure for this comparison is the difference in baseline and primary endpoint (3 month) FDI scores for each of the three interventions (FIT Teens, CBT, and GAE).

Recruitment status

COMPLETED

Study phase

Target enrollment

389 participants

Primary outcome timeframe

Baseline to 3 month follow up (primary endpoint) and 6, 9 and 12 month follow-up

Results posted on

2025-02-14

Participant Flow

Due to the group-based nature of the study, potential participants completed their baseline (T1) assessment and then waited up to 4 weeks before treatment assignment. A potential participant would be excluded from the study prior to treatment assignment for the reasons of screen-fails, no longer interested in the study, starting a disallowed treatment, or are lost to contact.

Participant milestones

Participant milestones
Measure	Fibromyalgia Integrative Training for Teens Fibromyalgia Integrative Training for Teens (FIT Teens) is a combined cognitive behavioral therapy and neuromuscular training.	Cognitive Behavioral Therapy Cognitive Behavioral Therapy (CBT) is a psychological pain coping skills training program.	Graded Aerobic Exercise Graded aerobic exercise (GAE) is a circuit-training exercise program with short intervals of aerobic exercise interspersed with brief rest breaks.
Overall Study STARTED	103	110	104
Overall Study Completed Primary Endpoint	87	93	79
Overall Study COMPLETED	83	89	72
Overall Study NOT COMPLETED	20	21	32

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fibromyalgia Integrative Training for Adolescents With Juvenile Fibromyalgia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fibromyalgia Integrative Training for Teens n=103 Participants Fibromyalgia Integrative Training for Teens (FIT Teens) is a combined cognitive behavioral therapy and neuromuscular training.	Cognitive Behavioral Therapy n=110 Participants Cognitive Behavioral Therapy (CBT) is a psychological pain coping skills training program.	Graded Aerobic Exercise n=104 Participants Graded aerobic exercise (GAE) is a circuit-training exercise program with short intervals of aerobic exercise interspersed with brief rest breaks.	Total n=317 Participants Total of all reporting groups
Age, Categorical <=18 years	103 Participants n=5 Participants	110 Participants n=7 Participants	104 Participants n=5 Participants	317 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	15.73 years STANDARD_DEVIATION 1.49 • n=5 Participants	15.61 years STANDARD_DEVIATION 1.61 • n=7 Participants	15.96 years STANDARD_DEVIATION 1.47 • n=5 Participants	15.76 years STANDARD_DEVIATION 1.53 • n=4 Participants
Sex: Female, Male Female	98 Participants n=5 Participants	97 Participants n=7 Participants	99 Participants n=5 Participants	294 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	13 Participants n=7 Participants	5 Participants n=5 Participants	23 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	11 Participants n=7 Participants	9 Participants n=5 Participants	25 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	98 Participants n=5 Participants	99 Participants n=7 Participants	95 Participants n=5 Participants	292 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	18 Participants n=4 Participants
Race (NIH/OMB) White	85 Participants n=5 Participants	92 Participants n=7 Participants	90 Participants n=5 Participants	267 Participants n=4 Participants
Race (NIH/OMB) More than one race	8 Participants n=5 Participants	8 Participants n=7 Participants	6 Participants n=5 Participants	22 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment Canada	0 participants n=5 Participants	3 participants n=7 Participants	0 participants n=5 Participants	3 participants n=4 Participants
Region of Enrollment United States	103 participants n=5 Participants	107 participants n=7 Participants	104 participants n=5 Participants	314 participants n=4 Participants
Functional Disability Inventory (FDI)	25.73 units on a scale STANDARD_DEVIATION 8.67 • n=5 Participants	24.05 units on a scale STANDARD_DEVIATION 7.95 • n=7 Participants	25.95 units on a scale STANDARD_DEVIATION 8.33 • n=5 Participants	25.22 units on a scale STANDARD_DEVIATION 5.84 • n=4 Participants
Pain Intensity (VAS)	5.71 units on a scale STANDARD_DEVIATION 1.30 • n=5 Participants	5.93 units on a scale STANDARD_DEVIATION 1.34 • n=7 Participants	5.88 units on a scale STANDARD_DEVIATION 1.26 • n=5 Participants	5.84 units on a scale STANDARD_DEVIATION 1.30 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline to 3 month follow up (primary endpoint) and 6, 9 and 12 month follow-up

Outcome measures

Outcome measures
Measure	Fibromyalgia Integrative Training for Teens n=103 Participants Fibromyalgia Integrative Training for Teens (FIT Teens) is a combined cognitive behavioral therapy and neuromuscular training.	Cognitive Behavioral Therapy n=110 Participants Cognitive Behavioral Therapy (CBT) is a psychological pain coping skills training program.	Graded Aerobic Exercise n=104 Participants Graded aerobic exercise (GAE) is a circuit-training exercise program with short intervals of aerobic exercise interspersed with brief rest breaks.
Functional Disability Inventory Baseline	25.78 score on a scale Interval 24.08 to 27.48	24.10 score on a scale Interval 22.31 to 25.89	25.96 score on a scale Interval 23.88 to 28.03
Functional Disability Inventory 3-month endpoint	21.83 score on a scale Interval 20.19 to 23.48	21.65 score on a scale Interval 19.86 to 23.43	24.70 score on a scale Interval 22.6 to 26.8
Functional Disability Inventory 6-month endpoint	21.26 score on a scale Interval 19.49 to 23.02	21.01 score on a scale Interval 19.09 to 22.93	23.34 score on a scale Interval 20.88 to 25.8
Functional Disability Inventory 9-month endpoint	21.56 score on a scale Interval 19.46 to 23.66	20.71 score on a scale Interval 18.54 to 22.88	23.37 score on a scale Interval 20.82 to 25.92
Functional Disability Inventory 12-month endpoint	21.02 score on a scale Interval 18.71 to 23.33	20.15 score on a scale Interval 18.08 to 22.21	21.22 score on a scale Interval 18.56 to 23.87

SECONDARY outcome

Timeframe: Baseline to 3 month follow up (primary endpoint) and 6, 9 and 12 month follow-up

Pain intensity was measured using the Visual Analog Scale (VAS), which is a validated measure of pain intensity in children and adolescents. Participants were shown a line with the written anchors of "no pain" and "pain as bad as I can imagine" on either end. The line represents a 0-10 scale, where higher scores are representative of higher pain intensity with a score of 4-6 indicating at least moderate pain levels and a score of 7-10 indicating severe pain levels. This measure was completed daily for one week and scores averaged over that time. For this secondary outcome, data from this measure were used to compare baseline response to 3 month follow up to examine whether a reduction in pain intensity occurred.

Outcome measures

Outcome measures
Measure	Fibromyalgia Integrative Training for Teens n=103 Participants Fibromyalgia Integrative Training for Teens (FIT Teens) is a combined cognitive behavioral therapy and neuromuscular training.	Cognitive Behavioral Therapy n=110 Participants Cognitive Behavioral Therapy (CBT) is a psychological pain coping skills training program.	Graded Aerobic Exercise n=104 Participants Graded aerobic exercise (GAE) is a circuit-training exercise program with short intervals of aerobic exercise interspersed with brief rest breaks.
Pain Intenstiy Baseline	5.71 units on a scale Interval 5.48 to 5.94	5.93 units on a scale Interval 5.66 to 6.21	5.88 units on a scale Interval 5.58 to 6.18
Pain Intenstiy 6-month endpoint	5.27 units on a scale Interval 4.8 to 5.74	5.19 units on a scale Interval 4.76 to 5.62	5.42 units on a scale Interval 4.9 to 5.94
Pain Intenstiy 9-month endpoint	5.07 units on a scale Interval 4.64 to 5.5	5.13 units on a scale Interval 4.73 to 5.54	5.45 units on a scale Interval 4.92 to 5.98
Pain Intenstiy 3-month endpoint	5.29 units on a scale Interval 4.78 to 5.79	5.41 units on a scale Interval 4.95 to 5.87	5.44 units on a scale Interval 4.98 to 5.91
Pain Intenstiy 12-month endpoint	4.91 units on a scale Interval 4.46 to 5.35	4.88 units on a scale Interval 4.48 to 5.28	5.18 units on a scale Interval 4.7 to 5.66

Adverse Events

Fibromyalgia Integrative Training for Teens

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Cognitive Behavioral Therapy

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Graded Aerobic Exercise

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Fibromyalgia Integrative Training for Teens n=103 participants at risk Fibromyalgia Integrative Training for Teens (FIT Teens) is a combined cognitive behavioral therapy and neuromuscular training.	Cognitive Behavioral Therapy n=110 participants at risk Cognitive Behavioral Therapy (CBT) is a psychological pain coping skills training program.	Graded Aerobic Exercise n=104 participants at risk Graded aerobic exercise (GAE) is a circuit-training exercise program with short intervals of aerobic exercise interspersed with brief rest breaks.
Cardiac disorders Chest pain	0.00% 0/103 • Adverse events were collected beginning at time of consent through the final endpoint (12-months post treatment end), approximately 14 months total. General clinicaltrials.gov definitions apply; however, body systems vary to align with common AEs reported in this population. Our systematic approach for the assessment of AEs included asking participants about changes in their health at each assessment visit. Coordinators also received alerts through EMRs when participants were in the ER. Additionally, AEs could be spontaneously reported during treatment sessions. AEs considered possibly, likely or definitely related are reported here.	0.91% 1/110 • Number of events 1 • Adverse events were collected beginning at time of consent through the final endpoint (12-months post treatment end), approximately 14 months total. General clinicaltrials.gov definitions apply; however, body systems vary to align with common AEs reported in this population. Our systematic approach for the assessment of AEs included asking participants about changes in their health at each assessment visit. Coordinators also received alerts through EMRs when participants were in the ER. Additionally, AEs could be spontaneously reported during treatment sessions. AEs considered possibly, likely or definitely related are reported here.	0.00% 0/104 • Adverse events were collected beginning at time of consent through the final endpoint (12-months post treatment end), approximately 14 months total. General clinicaltrials.gov definitions apply; however, body systems vary to align with common AEs reported in this population. Our systematic approach for the assessment of AEs included asking participants about changes in their health at each assessment visit. Coordinators also received alerts through EMRs when participants were in the ER. Additionally, AEs could be spontaneously reported during treatment sessions. AEs considered possibly, likely or definitely related are reported here.
Cardiac disorders Tachycardia/palpitations	0.00% 0/103 • Adverse events were collected beginning at time of consent through the final endpoint (12-months post treatment end), approximately 14 months total. General clinicaltrials.gov definitions apply; however, body systems vary to align with common AEs reported in this population. Our systematic approach for the assessment of AEs included asking participants about changes in their health at each assessment visit. Coordinators also received alerts through EMRs when participants were in the ER. Additionally, AEs could be spontaneously reported during treatment sessions. AEs considered possibly, likely or definitely related are reported here.	0.00% 0/110 • Adverse events were collected beginning at time of consent through the final endpoint (12-months post treatment end), approximately 14 months total. General clinicaltrials.gov definitions apply; however, body systems vary to align with common AEs reported in this population. Our systematic approach for the assessment of AEs included asking participants about changes in their health at each assessment visit. Coordinators also received alerts through EMRs when participants were in the ER. Additionally, AEs could be spontaneously reported during treatment sessions. AEs considered possibly, likely or definitely related are reported here.	0.96% 1/104 • Number of events 1 • Adverse events were collected beginning at time of consent through the final endpoint (12-months post treatment end), approximately 14 months total. General clinicaltrials.gov definitions apply; however, body systems vary to align with common AEs reported in this population. Our systematic approach for the assessment of AEs included asking participants about changes in their health at each assessment visit. Coordinators also received alerts through EMRs when participants were in the ER. Additionally, AEs could be spontaneously reported during treatment sessions. AEs considered possibly, likely or definitely related are reported here.
Endocrine disorders Fatigue	0.97% 1/103 • Number of events 1 • Adverse events were collected beginning at time of consent through the final endpoint (12-months post treatment end), approximately 14 months total. General clinicaltrials.gov definitions apply; however, body systems vary to align with common AEs reported in this population. Our systematic approach for the assessment of AEs included asking participants about changes in their health at each assessment visit. Coordinators also received alerts through EMRs when participants were in the ER. Additionally, AEs could be spontaneously reported during treatment sessions. AEs considered possibly, likely or definitely related are reported here.	0.00% 0/110 • Adverse events were collected beginning at time of consent through the final endpoint (12-months post treatment end), approximately 14 months total. General clinicaltrials.gov definitions apply; however, body systems vary to align with common AEs reported in this population. Our systematic approach for the assessment of AEs included asking participants about changes in their health at each assessment visit. Coordinators also received alerts through EMRs when participants were in the ER. Additionally, AEs could be spontaneously reported during treatment sessions. AEs considered possibly, likely or definitely related are reported here.	0.00% 0/104 • Adverse events were collected beginning at time of consent through the final endpoint (12-months post treatment end), approximately 14 months total. General clinicaltrials.gov definitions apply; however, body systems vary to align with common AEs reported in this population. Our systematic approach for the assessment of AEs included asking participants about changes in their health at each assessment visit. Coordinators also received alerts through EMRs when participants were in the ER. Additionally, AEs could be spontaneously reported during treatment sessions. AEs considered possibly, likely or definitely related are reported here.
Gastrointestinal disorders Abdominal pain	0.00% 0/103 • Adverse events were collected beginning at time of consent through the final endpoint (12-months post treatment end), approximately 14 months total. General clinicaltrials.gov definitions apply; however, body systems vary to align with common AEs reported in this population. Our systematic approach for the assessment of AEs included asking participants about changes in their health at each assessment visit. Coordinators also received alerts through EMRs when participants were in the ER. Additionally, AEs could be spontaneously reported during treatment sessions. AEs considered possibly, likely or definitely related are reported here.	0.00% 0/110 • Adverse events were collected beginning at time of consent through the final endpoint (12-months post treatment end), approximately 14 months total. General clinicaltrials.gov definitions apply; however, body systems vary to align with common AEs reported in this population. Our systematic approach for the assessment of AEs included asking participants about changes in their health at each assessment visit. Coordinators also received alerts through EMRs when participants were in the ER. Additionally, AEs could be spontaneously reported during treatment sessions. AEs considered possibly, likely or definitely related are reported here.	0.96% 1/104 • Number of events 1 • Adverse events were collected beginning at time of consent through the final endpoint (12-months post treatment end), approximately 14 months total. General clinicaltrials.gov definitions apply; however, body systems vary to align with common AEs reported in this population. Our systematic approach for the assessment of AEs included asking participants about changes in their health at each assessment visit. Coordinators also received alerts through EMRs when participants were in the ER. Additionally, AEs could be spontaneously reported during treatment sessions. AEs considered possibly, likely or definitely related are reported here.
Musculoskeletal and connective tissue disorders Extremity pain	3.9% 4/103 • Number of events 5 • Adverse events were collected beginning at time of consent through the final endpoint (12-months post treatment end), approximately 14 months total. General clinicaltrials.gov definitions apply; however, body systems vary to align with common AEs reported in this population. Our systematic approach for the assessment of AEs included asking participants about changes in their health at each assessment visit. Coordinators also received alerts through EMRs when participants were in the ER. Additionally, AEs could be spontaneously reported during treatment sessions. AEs considered possibly, likely or definitely related are reported here.	3.6% 4/110 • Number of events 4 • Adverse events were collected beginning at time of consent through the final endpoint (12-months post treatment end), approximately 14 months total. General clinicaltrials.gov definitions apply; however, body systems vary to align with common AEs reported in this population. Our systematic approach for the assessment of AEs included asking participants about changes in their health at each assessment visit. Coordinators also received alerts through EMRs when participants were in the ER. Additionally, AEs could be spontaneously reported during treatment sessions. AEs considered possibly, likely or definitely related are reported here.	8.7% 9/104 • Number of events 9 • Adverse events were collected beginning at time of consent through the final endpoint (12-months post treatment end), approximately 14 months total. General clinicaltrials.gov definitions apply; however, body systems vary to align with common AEs reported in this population. Our systematic approach for the assessment of AEs included asking participants about changes in their health at each assessment visit. Coordinators also received alerts through EMRs when participants were in the ER. Additionally, AEs could be spontaneously reported during treatment sessions. AEs considered possibly, likely or definitely related are reported here.
Musculoskeletal and connective tissue disorders Generalized weakness/pain	0.97% 1/103 • Number of events 1 • Adverse events were collected beginning at time of consent through the final endpoint (12-months post treatment end), approximately 14 months total. General clinicaltrials.gov definitions apply; however, body systems vary to align with common AEs reported in this population. Our systematic approach for the assessment of AEs included asking participants about changes in their health at each assessment visit. Coordinators also received alerts through EMRs when participants were in the ER. Additionally, AEs could be spontaneously reported during treatment sessions. AEs considered possibly, likely or definitely related are reported here.	0.91% 1/110 • Number of events 1 • Adverse events were collected beginning at time of consent through the final endpoint (12-months post treatment end), approximately 14 months total. General clinicaltrials.gov definitions apply; however, body systems vary to align with common AEs reported in this population. Our systematic approach for the assessment of AEs included asking participants about changes in their health at each assessment visit. Coordinators also received alerts through EMRs when participants were in the ER. Additionally, AEs could be spontaneously reported during treatment sessions. AEs considered possibly, likely or definitely related are reported here.	1.9% 2/104 • Number of events 2 • Adverse events were collected beginning at time of consent through the final endpoint (12-months post treatment end), approximately 14 months total. General clinicaltrials.gov definitions apply; however, body systems vary to align with common AEs reported in this population. Our systematic approach for the assessment of AEs included asking participants about changes in their health at each assessment visit. Coordinators also received alerts through EMRs when participants were in the ER. Additionally, AEs could be spontaneously reported during treatment sessions. AEs considered possibly, likely or definitely related are reported here.
Musculoskeletal and connective tissue disorders Sprain/strain	0.00% 0/103 • Adverse events were collected beginning at time of consent through the final endpoint (12-months post treatment end), approximately 14 months total. General clinicaltrials.gov definitions apply; however, body systems vary to align with common AEs reported in this population. Our systematic approach for the assessment of AEs included asking participants about changes in their health at each assessment visit. Coordinators also received alerts through EMRs when participants were in the ER. Additionally, AEs could be spontaneously reported during treatment sessions. AEs considered possibly, likely or definitely related are reported here.	0.91% 1/110 • Number of events 1 • Adverse events were collected beginning at time of consent through the final endpoint (12-months post treatment end), approximately 14 months total. General clinicaltrials.gov definitions apply; however, body systems vary to align with common AEs reported in this population. Our systematic approach for the assessment of AEs included asking participants about changes in their health at each assessment visit. Coordinators also received alerts through EMRs when participants were in the ER. Additionally, AEs could be spontaneously reported during treatment sessions. AEs considered possibly, likely or definitely related are reported here.	1.9% 2/104 • Number of events 2 • Adverse events were collected beginning at time of consent through the final endpoint (12-months post treatment end), approximately 14 months total. General clinicaltrials.gov definitions apply; however, body systems vary to align with common AEs reported in this population. Our systematic approach for the assessment of AEs included asking participants about changes in their health at each assessment visit. Coordinators also received alerts through EMRs when participants were in the ER. Additionally, AEs could be spontaneously reported during treatment sessions. AEs considered possibly, likely or definitely related are reported here.
Nervous system disorders Dizziness	0.97% 1/103 • Number of events 1 • Adverse events were collected beginning at time of consent through the final endpoint (12-months post treatment end), approximately 14 months total. General clinicaltrials.gov definitions apply; however, body systems vary to align with common AEs reported in this population. Our systematic approach for the assessment of AEs included asking participants about changes in their health at each assessment visit. Coordinators also received alerts through EMRs when participants were in the ER. Additionally, AEs could be spontaneously reported during treatment sessions. AEs considered possibly, likely or definitely related are reported here.	0.00% 0/110 • Adverse events were collected beginning at time of consent through the final endpoint (12-months post treatment end), approximately 14 months total. General clinicaltrials.gov definitions apply; however, body systems vary to align with common AEs reported in this population. Our systematic approach for the assessment of AEs included asking participants about changes in their health at each assessment visit. Coordinators also received alerts through EMRs when participants were in the ER. Additionally, AEs could be spontaneously reported during treatment sessions. AEs considered possibly, likely or definitely related are reported here.	0.00% 0/104 • Adverse events were collected beginning at time of consent through the final endpoint (12-months post treatment end), approximately 14 months total. General clinicaltrials.gov definitions apply; however, body systems vary to align with common AEs reported in this population. Our systematic approach for the assessment of AEs included asking participants about changes in their health at each assessment visit. Coordinators also received alerts through EMRs when participants were in the ER. Additionally, AEs could be spontaneously reported during treatment sessions. AEs considered possibly, likely or definitely related are reported here.
Nervous system disorders Headache	0.00% 0/103 • Adverse events were collected beginning at time of consent through the final endpoint (12-months post treatment end), approximately 14 months total. General clinicaltrials.gov definitions apply; however, body systems vary to align with common AEs reported in this population. Our systematic approach for the assessment of AEs included asking participants about changes in their health at each assessment visit. Coordinators also received alerts through EMRs when participants were in the ER. Additionally, AEs could be spontaneously reported during treatment sessions. AEs considered possibly, likely or definitely related are reported here.	0.00% 0/110 • Adverse events were collected beginning at time of consent through the final endpoint (12-months post treatment end), approximately 14 months total. General clinicaltrials.gov definitions apply; however, body systems vary to align with common AEs reported in this population. Our systematic approach for the assessment of AEs included asking participants about changes in their health at each assessment visit. Coordinators also received alerts through EMRs when participants were in the ER. Additionally, AEs could be spontaneously reported during treatment sessions. AEs considered possibly, likely or definitely related are reported here.	0.96% 1/104 • Number of events 1 • Adverse events were collected beginning at time of consent through the final endpoint (12-months post treatment end), approximately 14 months total. General clinicaltrials.gov definitions apply; however, body systems vary to align with common AEs reported in this population. Our systematic approach for the assessment of AEs included asking participants about changes in their health at each assessment visit. Coordinators also received alerts through EMRs when participants were in the ER. Additionally, AEs could be spontaneously reported during treatment sessions. AEs considered possibly, likely or definitely related are reported here.
Nervous system disorders Heat syncope	0.97% 1/103 • Number of events 1 • Adverse events were collected beginning at time of consent through the final endpoint (12-months post treatment end), approximately 14 months total. General clinicaltrials.gov definitions apply; however, body systems vary to align with common AEs reported in this population. Our systematic approach for the assessment of AEs included asking participants about changes in their health at each assessment visit. Coordinators also received alerts through EMRs when participants were in the ER. Additionally, AEs could be spontaneously reported during treatment sessions. AEs considered possibly, likely or definitely related are reported here.	0.00% 0/110 • Adverse events were collected beginning at time of consent through the final endpoint (12-months post treatment end), approximately 14 months total. General clinicaltrials.gov definitions apply; however, body systems vary to align with common AEs reported in this population. Our systematic approach for the assessment of AEs included asking participants about changes in their health at each assessment visit. Coordinators also received alerts through EMRs when participants were in the ER. Additionally, AEs could be spontaneously reported during treatment sessions. AEs considered possibly, likely or definitely related are reported here.	0.00% 0/104 • Adverse events were collected beginning at time of consent through the final endpoint (12-months post treatment end), approximately 14 months total. General clinicaltrials.gov definitions apply; however, body systems vary to align with common AEs reported in this population. Our systematic approach for the assessment of AEs included asking participants about changes in their health at each assessment visit. Coordinators also received alerts through EMRs when participants were in the ER. Additionally, AEs could be spontaneously reported during treatment sessions. AEs considered possibly, likely or definitely related are reported here.
Psychiatric disorders Increased emotional distress	3.9% 4/103 • Number of events 4 • Adverse events were collected beginning at time of consent through the final endpoint (12-months post treatment end), approximately 14 months total. General clinicaltrials.gov definitions apply; however, body systems vary to align with common AEs reported in this population. Our systematic approach for the assessment of AEs included asking participants about changes in their health at each assessment visit. Coordinators also received alerts through EMRs when participants were in the ER. Additionally, AEs could be spontaneously reported during treatment sessions. AEs considered possibly, likely or definitely related are reported here.	2.7% 3/110 • Number of events 4 • Adverse events were collected beginning at time of consent through the final endpoint (12-months post treatment end), approximately 14 months total. General clinicaltrials.gov definitions apply; however, body systems vary to align with common AEs reported in this population. Our systematic approach for the assessment of AEs included asking participants about changes in their health at each assessment visit. Coordinators also received alerts through EMRs when participants were in the ER. Additionally, AEs could be spontaneously reported during treatment sessions. AEs considered possibly, likely or definitely related are reported here.	3.8% 4/104 • Number of events 4 • Adverse events were collected beginning at time of consent through the final endpoint (12-months post treatment end), approximately 14 months total. General clinicaltrials.gov definitions apply; however, body systems vary to align with common AEs reported in this population. Our systematic approach for the assessment of AEs included asking participants about changes in their health at each assessment visit. Coordinators also received alerts through EMRs when participants were in the ER. Additionally, AEs could be spontaneously reported during treatment sessions. AEs considered possibly, likely or definitely related are reported here.
Skin and subcutaneous tissue disorders Rash	0.97% 1/103 • Number of events 1 • Adverse events were collected beginning at time of consent through the final endpoint (12-months post treatment end), approximately 14 months total. General clinicaltrials.gov definitions apply; however, body systems vary to align with common AEs reported in this population. Our systematic approach for the assessment of AEs included asking participants about changes in their health at each assessment visit. Coordinators also received alerts through EMRs when participants were in the ER. Additionally, AEs could be spontaneously reported during treatment sessions. AEs considered possibly, likely or definitely related are reported here.	0.91% 1/110 • Number of events 1 • Adverse events were collected beginning at time of consent through the final endpoint (12-months post treatment end), approximately 14 months total. General clinicaltrials.gov definitions apply; however, body systems vary to align with common AEs reported in this population. Our systematic approach for the assessment of AEs included asking participants about changes in their health at each assessment visit. Coordinators also received alerts through EMRs when participants were in the ER. Additionally, AEs could be spontaneously reported during treatment sessions. AEs considered possibly, likely or definitely related are reported here.	0.96% 1/104 • Number of events 1 • Adverse events were collected beginning at time of consent through the final endpoint (12-months post treatment end), approximately 14 months total. General clinicaltrials.gov definitions apply; however, body systems vary to align with common AEs reported in this population. Our systematic approach for the assessment of AEs included asking participants about changes in their health at each assessment visit. Coordinators also received alerts through EMRs when participants were in the ER. Additionally, AEs could be spontaneously reported during treatment sessions. AEs considered possibly, likely or definitely related are reported here.

Additional Information

Susmita Kashikar-Zuck, PhD

Cincinnati Children's Hospital

Phone: 513-636-6337

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place