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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

Baseline (0 Weeks)

Results posted on

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

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

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

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

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

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

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

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 weeks

Population: 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

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 weeks

Population: 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

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

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

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

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 weeks

Any self reported or observed negative events related to participation

Outcome measures

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

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

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

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

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

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

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

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

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

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

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) - All-or-Nothing Subscale
Baseline
11.64 units on a scale
Standard Deviation 5.30
12.84 units on a scale
Standard Deviation 5.24
Behavioral Response To Illness (BRIQ) - All-or-Nothing Subscale
Post-Test
8.19 units on a scale
Standard Deviation 5.79
10.79 units on a scale
Standard Deviation 4.90
Behavioral Response To Illness (BRIQ) - All-or-Nothing Subscale
Follow-Up
7.16 units on a scale
Standard Deviation 4.95
9.52 units on a scale
Standard Deviation 6.81

Adverse Events

TOR-C 1

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

TOR-C 2

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jonathan Greenberg

Massachusetts General Hospital

Phone: 617-643-9402

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place