Trial Outcomes & Findings for Live Video Mind-body Treatment to Prevent Persistent Symptoms Following mTBI (NCT NCT05524402)
NCT ID: NCT05524402
Last Updated: 2025-03-20
Results Overview
Assessed using the Credibility and Expectancy Questionnaire (CEQ) which asks the participant indicate how much they believe, right now, that the intervention they will receive will help manage their concussion and related worry. Possible scores on both the credibility and expectancy subscales range from 3 to 27 and have a midpoint score of 14. The number of participants that scored at or above 14 on the credibility and/or expectancy subscales are reported below.
COMPLETED
NA
50 participants
Baseline (0 Weeks)
2025-03-20
Participant Flow
Subjects were recruited via provider and self-referrals from the MGH Sports Concussion Clinic and Emergency Department, as well as concussion clinics nationwide, college health resources (e.g., sports medicine centers), relevant public social media sites (e.g., Facebook), Research Invitations via Patient Gateway after identifying potential participants through Research Patient Database Registry (RPDR) queries, and MGB Rally.
Of the 51 eligible patients, 50 enrolled and were randomized.
Participant milestones
| Measure |
TOR-C 1
TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.
TOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.
|
TOR-C 2
TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
TOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
Post-Test (4 Weeks)
|
22
|
24
|
|
Overall Study
Follow-Up (12 Weeks)
|
20
|
23
|
|
Overall Study
COMPLETED
|
20
|
23
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
TOR-C 1
TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.
TOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.
|
TOR-C 2
TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
TOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
Baseline Characteristics
Live Video Mind-body Treatment to Prevent Persistent Symptoms Following mTBI
Baseline characteristics by cohort
| Measure |
TOR-C 1
n=25 Participants
TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.
TOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.
|
TOR-C 2
n=25 Participants
TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
TOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
23.64 years
STANDARD_DEVIATION 4.83 • n=5 Participants
|
23.28 years
STANDARD_DEVIATION 4.56 • n=7 Participants
|
23.45 years
STANDARD_DEVIATION 4.61 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Numerical Rating Scale - During Activity
|
4.12 units on a scale
STANDARD_DEVIATION 2.91 • n=5 Participants
|
5.20 units on a scale
STANDARD_DEVIATION 2.24 • n=7 Participants
|
4.66 units on a scale
STANDARD_DEVIATION 2.62 • n=5 Participants
|
|
Post-Concussion Symptom Scale
|
43.52 units on a scale
STANDARD_DEVIATION 31.26 • n=5 Participants
|
50.61 units on a scale
STANDARD_DEVIATION 23.92 • n=7 Participants
|
46.99 units on a scale
STANDARD_DEVIATION 27.85 • n=5 Participants
|
|
Generalized Anxiety Disorder Scale (GAD-7)
|
10.00 units on a scale
STANDARD_DEVIATION 4.85 • n=5 Participants
|
13.48 units on a scale
STANDARD_DEVIATION 4.57 • n=7 Participants
|
11.74 units on a scale
STANDARD_DEVIATION 4.98 • n=5 Participants
|
|
Hospital Anxiety And Depression Scale (HADS) - Anxiety Subscale
|
9.46 units on a scale
STANDARD_DEVIATION 3.63 • n=5 Participants
|
11.80 units on a scale
STANDARD_DEVIATION 4.05 • n=7 Participants
|
10.63 units on a scale
STANDARD_DEVIATION 3.99 • n=5 Participants
|
|
World Health Organization - Disability Assessment Schedule 2.0 (WHODAS)
|
13.47 units on a scale
STANDARD_DEVIATION 9.96 • n=5 Participants
|
16.29 units on a scale
STANDARD_DEVIATION 8.80 • n=7 Participants
|
14.88 units on a scale
STANDARD_DEVIATION 9.41 • n=5 Participants
|
|
Fear Avoidance Behavior After Traumatic Brain Injury (FAB-TBI)
|
39.01 units on a scale
STANDARD_DEVIATION 11.50 • n=5 Participants
|
44.45 units on a scale
STANDARD_DEVIATION 9.46 • n=7 Participants
|
41.80 units on a scale
STANDARD_DEVIATION 10.76 • n=5 Participants
|
|
Pain Catastrophizing Scale (PCS)
|
17.13 units on a scale
STANDARD_DEVIATION 14.26 • n=5 Participants
|
20.64 units on a scale
STANDARD_DEVIATION 14.78 • n=7 Participants
|
18.92 units on a scale
STANDARD_DEVIATION 14.48 • n=5 Participants
|
|
Cognitive And Affective Mindfulness Scale-Revised (CAMS-R)
|
29.31 units on a scale
STANDARD_DEVIATION 5.39 • n=5 Participants
|
27.24 units on a scale
STANDARD_DEVIATION 5.05 • n=7 Participants
|
28.28 units on a scale
STANDARD_DEVIATION 5.28 • n=5 Participants
|
|
Behavioral Response To Illness (BRIQ) - All-or-Nothing Subscale
|
11.64 units on a scale
STANDARD_DEVIATION 5.30 • n=5 Participants
|
12.84 units on a scale
STANDARD_DEVIATION 5.24 • n=7 Participants
|
12.24 units on a scale
STANDARD_DEVIATION 5.25 • n=5 Participants
|
|
Hospital Anxiety And Depression Scale (HADS) - Depression Subscale
|
6.02 units on a scale
STANDARD_DEVIATION 4.68 • n=5 Participants
|
8.22 units on a scale
STANDARD_DEVIATION 4.02 • n=7 Participants
|
7.12 units on a scale
STANDARD_DEVIATION 4.46 • n=5 Participants
|
|
Behavioral Response To Illness (BRIQ) - Limiting Behaviors Subscale
|
14.88 units on a scale
STANDARD_DEVIATION 7.22 • n=5 Participants
|
17.28 units on a scale
STANDARD_DEVIATION 4.98 • n=7 Participants
|
16.08 units on a scale
STANDARD_DEVIATION 6.26 • n=5 Participants
|
|
Numerical Rating Scale - At Rest
|
3.20 units on a scale
STANDARD_DEVIATION 2.50 • n=5 Participants
|
3.72 units on a scale
STANDARD_DEVIATION 2.26 • n=7 Participants
|
3.46 units on a scale
STANDARD_DEVIATION 2.35 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (0 Weeks)Population: The total of participants (separated by condition) that scored above the midline on the credibility and expectancy subscales of the Credibility and Expectancy Questionnaire (CEQ).
Assessed using the Credibility and Expectancy Questionnaire (CEQ) which asks the participant indicate how much they believe, right now, that the intervention they will receive will help manage their concussion and related worry. Possible scores on both the credibility and expectancy subscales range from 3 to 27 and have a midpoint score of 14. The number of participants that scored at or above 14 on the credibility and/or expectancy subscales are reported below.
Outcome measures
| Measure |
TOR-C 1
n=25 Participants
TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.
TOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.
|
TOR-C 2
n=25 Participants
TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
TOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
|
|---|---|---|
|
Number of Participants Who Scored Above the Midpoint on Each Subscale of the Credibility and Expectancy Questionnaire (CEQ)
Credibility Subscale
|
21 Participants
|
23 Participants
|
|
Number of Participants Who Scored Above the Midpoint on Each Subscale of the Credibility and Expectancy Questionnaire (CEQ)
Expectancy Subscale
|
16 Participants
|
19 Participants
|
PRIMARY outcome
Timeframe: Post-Test (4 Weeks)Population: The proportion of participants that completed the post-test and scored above the midpoint on the Client Satisfaction Scale.
Measured using the Client Satisfaction Scale which assess participants' satisfaction with participation in the study. The score range is 0-12. Higher scores indicate greater satisfaction.
Outcome measures
| Measure |
TOR-C 1
n=21 Participants
TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.
TOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.
|
TOR-C 2
n=23 Participants
TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
TOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
|
|---|---|---|
|
Number of Participants Who Scored Above the Midpoint on the Client Satisfaction Scale
|
20 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: Baseline (0 Weeks)Population: The proportion of eligible patients (n=54) who agree to participate (n=50).
Rate at which recruitment was possible
Outcome measures
| Measure |
TOR-C 1
n=54 Participants
TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.
TOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.
|
TOR-C 2
TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
TOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
|
|---|---|---|
|
Feasibility of Recruitment
|
50 Participants
|
—
|
PRIMARY outcome
Timeframe: Post-Test (4 Weeks)Rate at which program was accepted, measured by attendance.
Outcome measures
| Measure |
TOR-C 1
n=25 Participants
TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.
TOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.
|
TOR-C 2
n=25 Participants
TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
TOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
|
|---|---|---|
|
Acceptability of Treatment
|
21 Participants
|
23 Participants
|
PRIMARY outcome
Timeframe: Collected during intervention, an average of 4 weeksPopulation: Sample represents the number of TOR-C1 program completers (i.e., those who attended at least 3 of 4 program sessions).
Rate of participant's completion of homework assigned (practicing at least 1 program skill, 3 days/week on average) throughout the study.
Outcome measures
| Measure |
TOR-C 1
n=21 Participants
TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.
TOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.
|
TOR-C 2
TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
TOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
|
|---|---|---|
|
Adherence to Homework
|
16 Participants
|
—
|
PRIMARY outcome
Timeframe: Collected during intervention, an average of 4 weeksPopulation: 20% (n=10) of session recordings for each condition were randomly selected for clinician fidelity checks. The clinician is evaluated on the degree to which they delivered session content as intended with adequate clinical skills. Each subcomponent in each session is scored on a 1-5 point scale. The overall average score for the randomly selected TOR-C1 and TOR-C2 sessions is then assessed to produce an average percent of therapist adherence for each intervention.
Rate of interventionist's delivering the programs by following the established session topics and practices
Outcome measures
| Measure |
TOR-C 1
n=10 Program Sessions
TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.
TOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.
|
TOR-C 2
n=10 Program Sessions
TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
TOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
|
|---|---|---|
|
Therapist Adherence
|
96.30 percentage of adherence
Standard Deviation 0.60
|
97.60 percentage of adherence
Standard Deviation 0.43
|
PRIMARY outcome
Timeframe: Baseline (0 Weeks)Rate of participant's completion of self-report measures, with no measures missing
Outcome measures
| Measure |
TOR-C 1
n=25 Participants
TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.
TOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.
|
TOR-C 2
n=25 Participants
TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
TOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
|
|---|---|---|
|
Feasibility of Assessments at Baseline
|
25 Participants
|
25 Participants
|
PRIMARY outcome
Timeframe: Post-Test (4 Weeks)Rate of participant's completion of self-report measures, with no measures missing
Outcome measures
| Measure |
TOR-C 1
n=25 Participants
TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.
TOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.
|
TOR-C 2
n=25 Participants
TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
TOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
|
|---|---|---|
|
Feasibility of Assessments at Post-Test
|
22 Participants
|
24 Participants
|
PRIMARY outcome
Timeframe: Follow-up (12 Weeks)Rate of participant's completion of self-report measures, with no measures missing
Outcome measures
| Measure |
TOR-C 1
n=25 Participants
TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.
TOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.
|
TOR-C 2
n=25 Participants
TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
TOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
|
|---|---|---|
|
Feasibility of Assessments at Follow-up
|
20 Participants
|
23 Participants
|
PRIMARY outcome
Timeframe: Collected during intervention, an average of 4 weeksAny self reported or observed negative events related to participation
Outcome measures
| Measure |
TOR-C 1
n=25 Participants
TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.
TOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.
|
TOR-C 2
n=25 Participants
TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
TOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
|
|---|---|---|
|
Adverse Events
|
0 Adverse events related to participation
|
0 Adverse events related to participation
|
SECONDARY outcome
Timeframe: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)Population: Analysis population consists of measure completers (subject to change at each assessment point)
Rate of a participant's pain at rest and with activity using a Likert scale with 0 being no pain and 10 being worst possible pain.
Outcome measures
| Measure |
TOR-C 1
n=25 Participants
TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.
TOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.
|
TOR-C 2
n=25 Participants
TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
TOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
|
|---|---|---|
|
Numerical Rating Scale
Baseline - During activity
|
4.12 units on a scale
Standard Deviation 2.91
|
5.20 units on a scale
Standard Deviation 2.24
|
|
Numerical Rating Scale
Baseline - At rest
|
3.20 units on a scale
Standard Deviation 2.50
|
3.72 units on a scale
Standard Deviation 2.26
|
|
Numerical Rating Scale
Post-Test - At rest
|
1.45 units on a scale
Standard Deviation 1.30
|
2.38 units on a scale
Standard Deviation 1.74
|
|
Numerical Rating Scale
Follow-Up - During activity
|
1.40 units on a scale
Standard Deviation 2.01
|
2.35 units on a scale
Standard Deviation 2.10
|
|
Numerical Rating Scale
Follow-Up - At rest
|
1.15 units on a scale
Standard Deviation 1.46
|
1.43 units on a scale
Standard Deviation 1.24
|
|
Numerical Rating Scale
Post-Test - During activity
|
1.91 units on a scale
Standard Deviation 1.57
|
3.50 units on a scale
Standard Deviation 2.27
|
SECONDARY outcome
Timeframe: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)Population: Analysis population consists of measure completers (subject to change at each assessment point)
The PCSS measures post-concussion symptoms on a 1-6-point Linkert scale. Higher scores represent greater symptom severity and total scores can range from 22 to132 points.
Outcome measures
| Measure |
TOR-C 1
n=25 Participants
TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.
TOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.
|
TOR-C 2
n=25 Participants
TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
TOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
|
|---|---|---|
|
Post-Concussion Symptom Scale (PCSS)
Baseline
|
43.52 score on a scale
Standard Deviation 31.26
|
50.61 score on a scale
Standard Deviation 23.92
|
|
Post-Concussion Symptom Scale (PCSS)
Post-Test
|
12.50 score on a scale
Standard Deviation 7.57
|
29.08 score on a scale
Standard Deviation 24.05
|
|
Post-Concussion Symptom Scale (PCSS)
Follow-Up
|
11.65 score on a scale
Standard Deviation 11.26
|
23.13 score on a scale
Standard Deviation 24.12
|
SECONDARY outcome
Timeframe: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)Population: Analysis population consists of measure completers (subject to change at each assessment point)
7-item questionnaire measuring symptoms of anxiety within the past 2 weeks on a scale of 0 to 3. Total scores range from 0 to 21 and higher scores indicate more symptoms of anxiety.
Outcome measures
| Measure |
TOR-C 1
n=25 Participants
TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.
TOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.
|
TOR-C 2
n=25 Participants
TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
TOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
|
|---|---|---|
|
Generalized Anxiety Disorder Scale (GAD-7)
Baseline
|
10.00 score on a scale
Standard Deviation 4.85
|
13.48 score on a scale
Standard Deviation 4.57
|
|
Generalized Anxiety Disorder Scale (GAD-7)
Post-Test
|
5.00 score on a scale
Standard Deviation 3.82
|
7.92 score on a scale
Standard Deviation 5.27
|
|
Generalized Anxiety Disorder Scale (GAD-7)
Follow-Up
|
3.85 score on a scale
Standard Deviation 3.70
|
6.74 score on a scale
Standard Deviation 6.45
|
SECONDARY outcome
Timeframe: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)Population: Analysis population consists of measure completers (subject to change at each assessment point)
Measures symptoms of emotional distress and estimates diagnoses. The scale has 14 items, 7 assess anxiety and 7 depression. Scores range from 0-21 on each subscale, wtih higher scores indicating more symptoms. Scores greater than 8 indicate clinically significant symptoms.
Outcome measures
| Measure |
TOR-C 1
n=25 Participants
TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.
TOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.
|
TOR-C 2
n=25 Participants
TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
TOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
|
|---|---|---|
|
Hospital Anxiety And Depression Scale (HADS)
Baseline - Anxiety
|
9.46 score on a scale
Standard Deviation 3.63
|
11.80 score on a scale
Standard Deviation 4.05
|
|
Hospital Anxiety And Depression Scale (HADS)
Baseline - Depression
|
6.02 score on a scale
Standard Deviation 4.68
|
8.22 score on a scale
Standard Deviation 4.02
|
|
Hospital Anxiety And Depression Scale (HADS)
Post-Test - Anxiety
|
7.81 score on a scale
Standard Deviation 4.22
|
8.79 score on a scale
Standard Deviation 4.35
|
|
Hospital Anxiety And Depression Scale (HADS)
Post-Test - Depression
|
3.73 score on a scale
Standard Deviation 3.63
|
5.13 score on a scale
Standard Deviation 2.63
|
|
Hospital Anxiety And Depression Scale (HADS)
Follow-Up - Anxiety
|
6.80 score on a scale
Standard Deviation 3.97
|
8.39 score on a scale
Standard Deviation 5.22
|
|
Hospital Anxiety And Depression Scale (HADS)
Follow-Up - Depression
|
2.10 score on a scale
Standard Deviation 2.59
|
5.12 score on a scale
Standard Deviation 2.96
|
SECONDARY outcome
Timeframe: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)Population: Analysis population consists of measure completers (subject to change at each assessment point)
The WHODAS 2.0 measures level of functioning in six domains: cognition, mobility, self-care, getting along, life activities, and participation. Each item is on the scale is measured 0-4, with total scores ranging from 0 to 48. Higher scores indicate more disability (worse outcomes).
Outcome measures
| Measure |
TOR-C 1
n=25 Participants
TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.
TOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.
|
TOR-C 2
n=25 Participants
TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
TOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
|
|---|---|---|
|
World Health Organization - Disability Assessment Schedule 2.0 (WHODAS)
Post-Test
|
5.61 score on a scale
Standard Deviation 6.32
|
9.83 score on a scale
Standard Deviation 8.30
|
|
World Health Organization - Disability Assessment Schedule 2.0 (WHODAS)
Baseline
|
13.47 score on a scale
Standard Deviation 9.96
|
16.29 score on a scale
Standard Deviation 8.80
|
|
World Health Organization - Disability Assessment Schedule 2.0 (WHODAS)
Follow-Up
|
3.10 score on a scale
Standard Deviation 3.01
|
7.61 score on a scale
Standard Deviation 8.60
|
SECONDARY outcome
Timeframe: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)Population: Analysis population consists of measure completers (subject to change at each assessment point)
A 16-item questionnaire assessing beliefs about how work and physical activities affect mTBI symptoms, and whether they should be avoided on a scale of 0 to 3. Total scores range from 0 to 48 and higher scores represent higher fear avoidance.
Outcome measures
| Measure |
TOR-C 1
n=24 Participants
TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.
TOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.
|
TOR-C 2
n=25 Participants
TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
TOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
|
|---|---|---|
|
Fear Avoidance Behavior After Traumatic Brain Injury (FAB-TBI)
Baseline
|
39.01 score on a scale
Standard Deviation 11.50
|
44.45 score on a scale
Standard Deviation 9.46
|
|
Fear Avoidance Behavior After Traumatic Brain Injury (FAB-TBI)
Post-Test
|
24.51 score on a scale
Standard Deviation 7.78
|
36.02 score on a scale
Standard Deviation 12.02
|
|
Fear Avoidance Behavior After Traumatic Brain Injury (FAB-TBI)
Follow-Up
|
24.20 score on a scale
Standard Deviation 9.80
|
31.35 score on a scale
Standard Deviation 12.19
|
SECONDARY outcome
Timeframe: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)Population: Analysis population consists of measure completers (subject to change at each assessment point)
A 13-item questionnaire assessing one's tendency to focus on pain-related thoughts and feel helpless and hopeless due to pain on a scale of 0 to 4. Total scores range from 0 to 25 and higher scores indicate higher pain catastrophizing (worse outcomes).
Outcome measures
| Measure |
TOR-C 1
n=25 Participants
TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.
TOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.
|
TOR-C 2
n=25 Participants
TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
TOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
|
|---|---|---|
|
Pain Catastophizing Scale (PCS)
Baseline
|
17.13 score on a scale
Standard Deviation 14.26
|
20.64 score on a scale
Standard Deviation 14.78
|
|
Pain Catastophizing Scale (PCS)
Pose-Test
|
8.44 score on a scale
Standard Deviation 9.37
|
14.46 score on a scale
Standard Deviation 13.41
|
|
Pain Catastophizing Scale (PCS)
Follow-Up
|
7.80 score on a scale
Standard Deviation 9.57
|
13.22 score on a scale
Standard Deviation 5.82
|
SECONDARY outcome
Timeframe: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)Population: Analysis population consists of measure completers (subject to change at each assessment point)
Rate of a participant's broad conceptualization of mindfulness, items range from 1-4 and scores range from 12-48, with higher values reflecting higher levels of mindfulness
Outcome measures
| Measure |
TOR-C 1
n=25 Participants
TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.
TOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.
|
TOR-C 2
n=25 Participants
TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
TOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
|
|---|---|---|
|
Cognitive And Affective Mindfulness Scale-Revised (CAMS-R)
Post-Test
|
33.68 score on a scale
Standard Deviation 6.71
|
30.21 score on a scale
Standard Deviation 6.74
|
|
Cognitive And Affective Mindfulness Scale-Revised (CAMS-R)
Baseline
|
29.31 score on a scale
Standard Deviation 5.39
|
27.24 score on a scale
Standard Deviation 5.05
|
|
Cognitive And Affective Mindfulness Scale-Revised (CAMS-R)
Follow-Up
|
33.65 score on a scale
Standard Deviation 4.80
|
31.13 score on a scale
Standard Deviation 5.82
|
SECONDARY outcome
Timeframe: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)Population: Analysis population consists of measure completers (subject to change at each assessment point)
A 7-item subscale of the BRIQ measuring "limiting behaviors" (frequency of inactivity). This subscale is rated on a scale of 0 to 4, with total scores ranging from 0 to 28. Higher scores indicate more limiting behavior (worse outcomes).
Outcome measures
| Measure |
TOR-C 1
n=25 Participants
TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.
TOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.
|
TOR-C 2
n=25 Participants
TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
TOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
|
|---|---|---|
|
Behavioral Response To Illness (BRIQ) - Limiting Behaviors Subscale
Baseline
|
14.88 score on a scale
Standard Deviation 7.22
|
17.28 score on a scale
Standard Deviation 4.98
|
|
Behavioral Response To Illness (BRIQ) - Limiting Behaviors Subscale
Post-Test
|
6.14 score on a scale
Standard Deviation 5.58
|
11.00 score on a scale
Standard Deviation 6.41
|
|
Behavioral Response To Illness (BRIQ) - Limiting Behaviors Subscale
Follow-Up
|
4.99 score on a scale
Standard Deviation 4.30
|
9.83 score on a scale
Standard Deviation 7.21
|
SECONDARY outcome
Timeframe: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)Population: Analysis population consists of measure completers (subject to change at each assessment point)
A 6-item subscale of the BRIQ measuring "all or nothing behaviors" (tendency for overexertion). This subscale is rated on a scale of 0 to 4, with higher scores indicating more all or nothing behavior. Total scores on this subscale range from 0 to 24.
Outcome measures
| Measure |
TOR-C 1
n=25 Participants
TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.
TOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.
|
TOR-C 2
n=25 Participants
TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
TOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
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Behavioral Response To Illness (BRIQ) - All-or-Nothing Subscale
Baseline
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11.64 units on a scale
Standard Deviation 5.30
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12.84 units on a scale
Standard Deviation 5.24
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Behavioral Response To Illness (BRIQ) - All-or-Nothing Subscale
Post-Test
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8.19 units on a scale
Standard Deviation 5.79
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10.79 units on a scale
Standard Deviation 4.90
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Behavioral Response To Illness (BRIQ) - All-or-Nothing Subscale
Follow-Up
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7.16 units on a scale
Standard Deviation 4.95
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9.52 units on a scale
Standard Deviation 6.81
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Adverse Events
TOR-C 1
TOR-C 2
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place