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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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MTBI - Mild Traumatic Brain Injury, Anxiety

Intervention / Treatment
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* Behavioral: TOR-C 1
* Behavioral: TOR-C 2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TOR-C 1<br>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. | Behavioral: TOR-C 1<br>* 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.<br>|
| Active Comparator: TOR-C 2<br>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: TOR-C 2<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Credibility and Expectancy Questionnaire | The survey asks that the participant indicates how much they believe, right now, that the intervention they will receive will help manage their concussion and related worry. | Baseline (0 Weeks) | 
| Client Satisfaction Score | This measure will assess participants' satisfaction with participation in the study. The score range is 0-12. Higher scores indicate greater satisfaction. | Post-Test (4 Weeks) | 
| Feasibility of recruitment | Rate at which recruitment was possible | Baseline (0 Weeks) | 
| Acceptability of treatment | Rate at which program was accepted, measured by attendance. | Post-Test (4 Weeks) | 
| Adherence to homework | Rate of participant's completion of homework assigned throughout the study. | Collected during intervention | 
| Therapist adherence | Rate of interventionist's delivering the programs by following the established session topics and skills. | Collected during intervention | 
| Feasibility of assessments at Baseline | Rate of participant's completion of self-report measures, with no measures missing | Baseline (0 Weeks) | 
| Feasibility of assessments at Post-Test | Rate of participant's completion of self-report measures, with no measures missing | Post-Test (4 Weeks) | 
| Feasibility of assessments at Follow-up | Rate of participant's completion of self-report measures, with no measures missing | Follow-up (12 Weeks) | 
| Adverse Events | Any self reported or observed negative events related to participation | Collected during intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Rating Scale | 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. | Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks) | 
| Post-Concussion Symptom Scale | Rate post-concussion symptoms on a 7-point Likert scale | Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks) | 
| Generalized Anxiety Disorder (GAD-7) | 7-item questionnaire measuring anxiety Measures symptoms of anxiety within the past 2 weeks on a scale of 0 to 3. Higher scores indicate more symptoms of anxiety | Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks) | 
| Hospital Anxiety And Depression Scale (HADS) | 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. | Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks) | 
| Who Disability Assessment Schedule 2.0 (WHODAS) | The WHODAS measures level of functioning in six domains: cognition, mobility, self-care, getting along, life activities, and participation. Each question on the scale is measured 0-4, with higher scores indicating more disability. | Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks) | 
| Fear Avoidance Behavior After Traumatic Brain Injury (FAB-TBI) | 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. Higher scores represent higher fear avoidance. | Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks) | 
| Pain Catastophizing Scale (PCS) | 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. Higher scores indicate higher pain catastrophizing. | Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks) | 
| Cognitive And Affective Mindfulness Scale-Revised (CAMS-R) | 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 | Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks) | 
| Behavioral Response To Illness (BRIQ) | A 13-item measure consisting of a limiting behaviors subscale (frequency of inactivity) and an all or nothing behavior subscale (tendency for overexertion). Both subscales are rated on a scale of 0 to 4, with higher scores indicating more limiting and all or nothing behavior. | Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MTBI - Mild Traumatic Brain Injury, Anxiety, Mindfulness