Live Video Mind-body Treatment to Prevent Persistent Symptoms Following mTBI
2 other identifiers
interventional
50
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2022
CompletedFirst Posted
Study publicly available on registry
September 1, 2022
CompletedStudy Start
First participant enrolled
October 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 12, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 12, 2024
CompletedResults Posted
Study results publicly available
March 20, 2025
CompletedMarch 20, 2025
March 1, 2025
1.7 years
August 17, 2022
October 31, 2024
March 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
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 Outcomes (10)
Numerical Rating Scale
Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
Post-Concussion Symptom Scale (PCSS)
Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
Generalized Anxiety Disorder Scale (GAD-7)
Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
Hospital Anxiety And Depression Scale (HADS)
Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
World Health Organization - Disability Assessment Schedule 2.0 (WHODAS)
Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
- +5 more secondary outcomes
Study Arms (2)
TOR-C 1
EXPERIMENTALTOR-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
ACTIVE COMPARATORTOR-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.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02129, United States
Related Publications (2)
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.
PMID: 33443484BACKGROUNDGreenberg J, Levey NS, Becker M, Yeh GY, Giacino JT, Iverson G, Silverberg ND, Parker RA, Vranceanu AM. Feasibility Randomized Controlled Trial of the Toolkit for Optimal Recovery After Concussion: A Live Video Program to Prevent Persistent Concussion Symptoms in Young Adults With Anxiety. Arch Phys Med Rehabil. 2025 Apr;106(4):527-536. doi: 10.1016/j.apmr.2024.10.011. Epub 2024 Nov 5.
PMID: 39505248DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jonathan Greenberg
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan Greenberg, PhD
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 17, 2022
First Posted
September 1, 2022
Study Start
October 15, 2022
Primary Completion
July 12, 2024
Study Completion
July 12, 2024
Last Updated
March 20, 2025
Results First Posted
March 20, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share