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

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).

Study Overview

• Status: Completed
• Conditions: Anxiety; MTBI - Mild Traumatic Brain Injury
• Intervention / Treatment: Behavioral: TOR-C 1; Behavioral: TOR-C 2

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02129
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 24 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Active Comparator: 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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (0 Weeks)
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.	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 (practicing at least 1 program skill, 3 days/week on average) throughout the study.	Collected during intervention, an average of 4 weeks
Therapist Adherence	Rate of interventionist's delivering the programs by following the established session topics and practices	Collected during intervention, an average of 4 weeks
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, an average of 4 weeks

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)
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)
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)
Post-Concussion Symptom Scale (PCSS)	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.	Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
Generalized Anxiety Disorder Scale (GAD-7)	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.	Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
World Health Organization - Disability Assessment Schedule 2.0 (WHODAS)	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).	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. Total scores range from 0 to 48 and 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. Total scores range from 0 to 25 and higher scores indicate higher pain catastrophizing (worse outcomes).	Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
Behavioral Response To Illness (BRIQ) - Limiting Behaviors Subscale	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).	Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
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.	Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Jonathan Greenberg, PhD, Massachusetts General Hospital

Publications and helpful links

General Publications

• Greenberg J, Singh T, Iverson GL, Silverberg ND, Macklin EA, Parker RA, Giacino JT, Yeh GY, Vranceanu AM. A Live Video Mind-Body Treatment to Prevent Persistent Symptoms Following Mild Traumatic Brain Injury: Protocol for a Mixed Methods Study. JMIR Res Protoc. 2021 Jan 14;10(1):e25746. doi: 10.2196/25746.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2022
• Primary Completion (Actual): July 12, 2024
• Study Completion (Actual): July 12, 2024

Study Registration Dates

• First Submitted: August 17, 2022
• First Submitted That Met QC Criteria: August 29, 2022
• First Posted (Actual): September 1, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 3, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Anxiety; Mindfulness; MTBI - Mild Traumatic Brain Injury
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries, Traumatic; Brain Injuries; Brain Concussion
• Other Study ID Numbers: 2022P001521; K23AT010653-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No