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

Not Applicable

Completed

Conditions: Anxiety
MTBI - Mild Traumatic Brain Injury

Interventions: Behavioral: TOR-C 1
Behavioral: TOR-C 2

Registration Number: NCT05524402

Lead Sponsor: Massachusetts General Hospital

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 50

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TOR-C 1	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 2	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.

Primary Outcome Measures

Name	Time	Method
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
Adverse Events	Collected during intervention, an average of 4 weeks	Any self reported or observed negative events related to participation

Secondary Outcome Measures

Name	Time	Method
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.