Live Video Mind-body Treatment to Prevent Persistent Symptoms Following mTBI

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05524402

Enrollment

Registered

2022-09-01

Start date

2022-10-15

Completion date

2024-07-12

Last updated

2025-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, MTBI - Mild Traumatic Brain Injury

Keywords

MTBI - Mild Traumatic Brain Injury, Anxiety, Mindfulness

Brief summary

Detailed description

The investigator aims to conduct a pilot randomized controlled trial to test the feasibility of two symptom management programs for college-age individuals with recent concussions and anxiety, TOR-C 1 and TOR-C 2. The investigator will assess the feasibility of recruitment procedures (screening, eligibility, and enrollment) and data collection as well as the feasibility, credibility, and acceptability of the programs (adherence, retention, fidelity, and satisfaction), following prespecified benchmarks. Both programs will be delivered virtually (Zoom). Each program will consist of four 45-minute sessions over the secure Zoom platform. Participants will receive a treatment manual. There are 3 assessment points consisting of self-report surveys: baseline, post program, and 3-month follow-up.

Interventions

BEHAVIORALTOR-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.

BEHAVIORALTOR-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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 35 Years

Healthy volunteers

Yes

Inclusion criteria

* Male and female outpatients, ages 18-35 * English fluency and literacy * Diagnosed with a concussion in the past 10 weeks * Owns a smartphone or computer with Internet access * Willingness and ability to participate in four 45-minute program sessions and answer remote questionnaires before, after, and 3-month following the program * Free of concurrent psychotropic or have been on stable dosage for at least 6 weeks * Clinically significant anxiety symptoms (score ≥ 5 on GAD-7 anxiety scale)

Exclusion criteria

* Previous history of moderate or severe TBI OR concussion in the past 2 years that resulted in symptoms lasting 3 months or more * Diagnosed with a medical illness expected to worsen in the next 6 months (e.g., malignancy) * Lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder * Current substance abuse or dependence and current substance use disorder * Current active self-reported suicidal ideation * Practice of mindfulness techniques for greater than 45 minutes per week within the last 3 months * Participation in a mind-body or CBT treatment in the past 3 months * Currently pregnant

Design outcomes

Primary

Measure	Time frame	Description
Adverse Events	Collected during intervention, an average of 4 weeks	Any self reported or observed negative events related to participation
Number of Participants Who Scored Above the Midpoint on Each Subscale of the Credibility and Expectancy Questionnaire (CEQ)	Baseline (0 Weeks)	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.
Number of Participants Who Scored Above the Midpoint on the Client Satisfaction Scale	Post-Test (4 Weeks)	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.
Feasibility of Recruitment	Baseline (0 Weeks)	Rate at which recruitment was possible
Acceptability of Treatment	Post-Test (4 Weeks)	Rate at which program was accepted, measured by attendance.
Adherence to Homework	Collected during intervention, an average of 4 weeks	Rate of participant's completion of homework assigned (practicing at least 1 program skill, 3 days/week on average) throughout the study.
Therapist Adherence	Collected during intervention, an average of 4 weeks	Rate of interventionist's delivering the programs by following the established session topics and practices
Feasibility of Assessments at Baseline	Baseline (0 Weeks)	Rate of participant's completion of self-report measures, with no measures missing
Feasibility of Assessments at Post-Test	Post-Test (4 Weeks)	Rate of participant's completion of self-report measures, with no measures missing
Feasibility of Assessments at Follow-up	Follow-up (12 Weeks)	Rate of participant's completion of self-report measures, with no measures missing

Secondary

Measure	Time frame	Description
Numerical Rating Scale	Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)	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.
Post-Concussion Symptom Scale (PCSS)	Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)	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.
Generalized Anxiety Disorder Scale (GAD-7)	Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)	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.
Hospital Anxiety And Depression Scale (HADS)	Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)	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.
World Health Organization - Disability Assessment Schedule 2.0 (WHODAS)	Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)	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).
Fear Avoidance Behavior After Traumatic Brain Injury (FAB-TBI)	Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)	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.
Pain Catastophizing Scale (PCS)	Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)	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).
Cognitive And Affective Mindfulness Scale-Revised (CAMS-R)	Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)	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
Behavioral Response To Illness (BRIQ) - Limiting Behaviors Subscale	Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)	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).
Behavioral Response To Illness (BRIQ) - All-or-Nothing Subscale	Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)	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.

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

Of the 51 eligible patients, 50 enrolled and were randomized.

Participants by arm

Arm	Count
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.	25
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.	25
Total	50

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	2	1
Overall Study	Withdrawal by Subject	3	1

Baseline characteristics

Characteristic	TOR-C 1	TOR-C 2	Total
Age, Continuous	23.64 years STANDARD_DEVIATION 4.83	23.28 years STANDARD_DEVIATION 4.56	23.45 years STANDARD_DEVIATION 4.61
Behavioral Response To Illness (BRIQ) - All-or-Nothing Subscale	11.64 units on a scale STANDARD_DEVIATION 5.3	12.84 units on a scale STANDARD_DEVIATION 5.24	12.24 units on a scale STANDARD_DEVIATION 5.25
Behavioral Response To Illness (BRIQ) - Limiting Behaviors Subscale	14.88 units on a scale STANDARD_DEVIATION 7.22	17.28 units on a scale STANDARD_DEVIATION 4.98	16.08 units on a scale STANDARD_DEVIATION 6.26
Cognitive And Affective Mindfulness Scale-Revised (CAMS-R)	29.31 units on a scale STANDARD_DEVIATION 5.39	27.24 units on a scale STANDARD_DEVIATION 5.05	28.28 units on a scale STANDARD_DEVIATION 5.28
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants	5 Participants	7 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants	19 Participants	42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	1 Participants	1 Participants
Fear Avoidance Behavior After Traumatic Brain Injury (FAB-TBI)	39.01 units on a scale STANDARD_DEVIATION 11.5	44.45 units on a scale STANDARD_DEVIATION 9.46	41.80 units on a scale STANDARD_DEVIATION 10.76
Generalized Anxiety Disorder Scale (GAD-7)	10.00 units on a scale STANDARD_DEVIATION 4.85	13.48 units on a scale STANDARD_DEVIATION 4.57	11.74 units on a scale STANDARD_DEVIATION 4.98
Hospital Anxiety And Depression Scale (HADS) - Anxiety Subscale	9.46 units on a scale STANDARD_DEVIATION 3.63	11.80 units on a scale STANDARD_DEVIATION 4.05	10.63 units on a scale STANDARD_DEVIATION 3.99
Hospital Anxiety And Depression Scale (HADS) - Depression Subscale	6.02 units on a scale STANDARD_DEVIATION 4.68	8.22 units on a scale STANDARD_DEVIATION 4.02	7.12 units on a scale STANDARD_DEVIATION 4.46
Numerical Rating Scale - At Rest	3.20 units on a scale STANDARD_DEVIATION 2.5	3.72 units on a scale STANDARD_DEVIATION 2.26	3.46 units on a scale STANDARD_DEVIATION 2.35
Numerical Rating Scale - During Activity	4.12 units on a scale STANDARD_DEVIATION 2.91	5.20 units on a scale STANDARD_DEVIATION 2.24	4.66 units on a scale STANDARD_DEVIATION 2.62
Pain Catastrophizing Scale (PCS)	17.13 units on a scale STANDARD_DEVIATION 14.26	20.64 units on a scale STANDARD_DEVIATION 14.78	18.92 units on a scale STANDARD_DEVIATION 14.48
Post-Concussion Symptom Scale	43.52 units on a scale STANDARD_DEVIATION 31.26	50.61 units on a scale STANDARD_DEVIATION 23.92	46.99 units on a scale STANDARD_DEVIATION 27.85
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	1 Participants	3 Participants	4 Participants
Race (NIH/OMB) Black or African American	1 Participants	1 Participants	2 Participants
Race (NIH/OMB) More than one race	2 Participants	0 Participants	2 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	21 Participants	21 Participants	42 Participants
Region of Enrollment United States	25 Participants	25 Participants	50 Participants
Sex: Female, Male Female	20 Participants	18 Participants	38 Participants
Sex: Female, Male Male	5 Participants	7 Participants	12 Participants
World Health Organization - Disability Assessment Schedule 2.0 (WHODAS)	13.47 units on a scale STANDARD_DEVIATION 9.96	16.29 units on a scale STANDARD_DEVIATION 8.8	14.88 units on a scale STANDARD_DEVIATION 9.41

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 25	0 / 25
other Total, other adverse events	0 / 25	0 / 25
serious Total, serious adverse events	0 / 25	0 / 25

Outcome results

Primary

Acceptability of Treatment

Rate at which program was accepted, measured by attendance.

Time frame: Post-Test (4 Weeks)

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
TOR-C 1	Acceptability of Treatment	21 Participants
TOR-C 2	Acceptability of Treatment	23 Participants

Primary

Adherence to Homework

Rate of participant's completion of homework assigned (practicing at least 1 program skill, 3 days/week on average) throughout the study.

Time frame: 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).

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
TOR-C 1	Adherence to Homework	16 Participants

Primary

Adverse Events

Any self reported or observed negative events related to participation

Time frame: Collected during intervention, an average of 4 weeks

Arm	Measure	Value (NUMBER)
TOR-C 1	Adverse Events	0 Adverse events related to participation
TOR-C 2	Adverse Events	0 Adverse events related to participation

Primary

Feasibility of Assessments at Baseline

Rate of participant's completion of self-report measures, with no measures missing

Time frame: Baseline (0 Weeks)

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
TOR-C 1	Feasibility of Assessments at Baseline	25 Participants
TOR-C 2	Feasibility of Assessments at Baseline	25 Participants

Primary

Feasibility of Assessments at Follow-up

Rate of participant's completion of self-report measures, with no measures missing

Time frame: Follow-up (12 Weeks)

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
TOR-C 1	Feasibility of Assessments at Follow-up	20 Participants
TOR-C 2	Feasibility of Assessments at Follow-up	23 Participants

Primary

Feasibility of Assessments at Post-Test

Rate of participant's completion of self-report measures, with no measures missing

Time frame: Post-Test (4 Weeks)

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
TOR-C 1	Feasibility of Assessments at Post-Test	22 Participants
TOR-C 2	Feasibility of Assessments at Post-Test	24 Participants

Primary

Feasibility of Recruitment

Rate at which recruitment was possible

Time frame: Baseline (0 Weeks)

Population: The proportion of eligible patients (n=54) who agree to participate (n=50).

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
TOR-C 1	Feasibility of Recruitment	50 Participants

Primary

Number of Participants Who Scored Above the Midpoint on Each Subscale 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.

Time frame: 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).

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
TOR-C 1	Number of Participants Who Scored Above the Midpoint on Each Subscale of the Credibility and Expectancy Questionnaire (CEQ)	Credibility Subscale	21 Participants
TOR-C 1	Number of Participants Who Scored Above the Midpoint on Each Subscale of the Credibility and Expectancy Questionnaire (CEQ)	Expectancy Subscale	16 Participants
TOR-C 2	Number of Participants Who Scored Above the Midpoint on Each Subscale of the Credibility and Expectancy Questionnaire (CEQ)	Credibility Subscale	23 Participants
TOR-C 2	Number of Participants Who Scored Above the Midpoint on Each Subscale of the Credibility and Expectancy Questionnaire (CEQ)	Expectancy Subscale	19 Participants

Primary

Number of Participants Who 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.

Time frame: Post-Test (4 Weeks)

Population: The proportion of participants that completed the post-test and scored above the midpoint on the Client Satisfaction Scale.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
TOR-C 1	Number of Participants Who Scored Above the Midpoint on the Client Satisfaction Scale	20 Participants
TOR-C 2	Number of Participants Who Scored Above the Midpoint on the Client Satisfaction Scale	20 Participants

Primary

Therapist Adherence

Rate of interventionist's delivering the programs by following the established session topics and practices

Time frame: 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.

Arm	Measure	Value (MEAN)	Dispersion
TOR-C 1	Therapist Adherence	96.30 percentage of adherence	Standard Deviation 0.6
TOR-C 2	Therapist Adherence	97.60 percentage of adherence	Standard Deviation 0.43

Secondary

Behavioral Response To Illness (BRIQ) - All-or-Nothing Subscale

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.

Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)