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Not yet recruitingNCT07923864Updated Nov 9, 2026

An Efficacy Trial of The Toolkit for Optimal Recovery After Concussion

An interventional study of Toolkit for Optimal Recovery after Concussion (TOR-C) and Health Enhancement after Concussion (HE-C) in Concussion (Diagnosis), Mild Traumatic Brain Injury and Post Concussion Symptoms, sponsored by Massachusetts General Hospital. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-11-09.

Primary conditionPost-Concussion SyndromeRegistry: Brain ConcussionReclassifiedWhy we changed it
Registry
Brain Concussion — the first condition term the registry derived for this study.
ClinicalTrials.gg
Post-Concussion Syndrome
Why
  1. The study's listed conditions name Post-Concussion Syndrome, a narrower term within Brain Concussion.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Prevention

Updated Nov 9, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
260
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study summary

The goal of this study is to test the efficacy of the Toolkit for Optimal Recovery after Concussion (TOR-C), a brief live-video mind-body program. aiming to prevent chronic concussion symptoms and optimize recovery.

02

Conditions studied

  • Concussion (Diagnosis)
  • Mild Traumatic Brain Injury
  • Post Concussion Symptoms
  • Anxiety

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Keywords

  • Mind-body Intervention
  • Concussion
  • Mild traumatic Brain Injury
  • Psychoeducation
03

In context

Post-Concussion Syndrome Reclassified

141 studies on the registry are indexed under Post-Concussion Syndrome; 34 are open to participants now.

This study's planned enrollment of 260 is above the median of 52 across 114 interventional studies indexed under Post-Concussion Syndrome.

Browse Post-Concussion Syndrome studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.

Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.

Compared within Post-Concussion Syndrome, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Brain Concussion. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Sustained a concussion 3-10 weeks earlier
  2. At least mild anxiety symptoms (score ≥ 5 on GAD-7 anxiety scale)
  3. Age 18-35
  4. English fluency and literacy
  5. Ability and willingness to participate in study procedures, assessments, and intervention
  6. Access to a smartphone or computer with internet access
  7. Cleared for participation by clinic/study staff

Exclusion criteria

Exclusion Criteria:

  1. Participation in mind-body or CBT treatment in the past 3 months
  2. Concussion in the past 2 years that resulted in symptoms lasting 3 months or more / current or previous complicated or moderate/severe TBI
  3. Practice of mindfulness techniques > 45 minutes/week in the past 3 months
  4. Change in psychotropic medications (e.g., antidepressant, anxiolytics) in the past 6 weeks
  5. Uncontrolled bipolar disorder, psychosis, active substance dependence, self reported current active suicidal ideation with plan and/or intent
  6. Pregnancy
  7. Serious comorbidity expected to worsen in the next 6 months
  8. Secondary gains that may bias motivation (e.g., pending disability claim)
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
260 participants (estimated)

Study arms

  • Experimental
    Toolkit for Optimal Recovery after Concussion (TOR-C)

    A 4-week mind-body program delivered via live video (Zoom) 1:1 with a clinician delivering mind-body and cognitive-behavioral skills.

    Behavioral: Toolkit for Optimal Recovery after Concussion (TOR-C)

  • Active comparator
    Health Enhancement after Concussion (HE-C)

    A 4-week program delivered via live video (Zoom) 1:1 with a clinician delivering psychoeducation and information about healthy living after a concussion

    Behavioral: Health Enhancement after Concussion (HE-C)

Interventions

  • BehavioralToolkit for Optimal Recovery after Concussion (TOR-C)

    TOR-C is a brief behavioral mind-body program delivered remotely via live video over four weekly 45-minute sessions, with approximately 10 minutes of daily home practice. It targets anxiety and fear-avoidance factors to prevent chronic concussion symptoms, combining mind-body skills (e.g., mindfulness, deep breathing, acceptance), light cognitive-behavioral skills, skills for gradual return to activity, and concussion psychoeducation.

  • BehavioralHealth Enhancement after Concussion (HE-C)

    HE-C is an attention-matched active control program delivered remotely via live video over four weekly 45-minute sessions, with approximately 10 minutes of daily home practice. It provides general health education after concussion (e.g., sleep, nutrition, physical activity) without the specific skills included in TOR-C.

06

What researchers measure

Primary outcomes

  1. Post-Concussion Symptom Scale (PCSS)

    Measures the severity of concussion symptoms (e.g., headache, fatigue, dizziness, difficulty concentrating). This is the study's primary outcome; efficacy is judged mainly on reducing these symptoms.

    Time frame: Baseline (week 0), post-test (week 4), 6-month follow-up (week 28)

Secondary outcomes

  1. Generalized Anxiety Disorder scale (GAD-7)

    Measures the severity of anxiety symptoms. (Also used at screening, where a score ≥5 is required for eligibility.)

    Time frame: Baseline (week 0), post-test (week 4), 6-month follow-up (week 28)

  2. Patient Health Questionnaire-9 (PHQ-9)

    Measures the severity of depression symptoms.

    Time frame: Baseline (week 0), post-test (week 4), 6-month follow-up (week 28)

  3. Fear Avoidance Behavior after Traumatic Brain Injury (FAB-TBI)

    Measures fear-avoidance behavior, i.e., avoiding activities out of fear they will worsen symptoms. A core mechanism in the fear-avoidance model.

    Time frame: Baseline (week 0), post-test (week 4), 6-month follow-up (week 28)

  4. Symptom Catastrophizing Scale

    Measures the tendency to catastrophize concussion symptoms (magnifying, ruminating on, or feeling helpless about them).

    Time frame: Baseline (week 0), post-test (week 4), 6-month follow-up (week 28)

  5. Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)

    Measures mindfulness, i.e., present-moment awareness and acceptance of thoughts and feelings.

    Time frame: Baseline (week 0), post-test (week 4), 6-month follow-up (week 28)

  6. Behavioral Response to Illness Questionnaire (BRIQ): Limiting behavior subscale

    Measures the tendency to limit or avoid various activities in response to medical conditions

    Time frame: Baseline (week 0), post-test (week 4), 6-month follow-up (week 28)

  7. Pittsburgh Sleep Quality Index (PSQI)

    An exploratory outcome which measures sleep quality over the past month.

    Time frame: Baseline (week 0), post-test (week 4), 6-month follow-up (week 28)

  8. PROMIS Cognitive Function

    An exploratory outcome which measures self-reported cognitive function (e.g., perceived problems with memory, attention, and thinking).

    Time frame: Baseline (week 0), post-test (week 4), 6-month follow-up (week 28)

  9. WHO Disability Assessment Schedule (WHODAS 2.0; 12-item version)

    It is 12-item measure of health-related functioning and disability across daily activities (e.g., cognition, mobility, self-care, social participation) over the past 30 days, with higher scores indicating greater disability.

    Time frame: Baseline (week 0), post-test (week 4), 6-month follow-up (week 28)

07

Study locations

1 site
08

References and documents

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. PubMed 33443484 ↗
  • Greenberg 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. PubMed 39505248 ↗
  • Becker ME, Stratton Levey N, Yeh GY, Giacino J, Iverson G, Silverberg N, Parker RA, McKinnon E, Siravo C, Shah P, Vranceanu AM, Greenberg J. Preliminary Feasibility of a Novel Mind-Body Program to Prevent Persistent Concussion Symptoms Among Young Adults With Anxiety: Nonrandomized Open Pilot Study. JMIR Form Res. 2024 Nov 8;8:e64540. doi: 10.2196/64540. PubMed 39514283 ↗

Individual participant data

Plan to share: Yes — We plan to share our study protocol, analysis plan, data dictionary, and de-identified data from all measures described under "outcome measures"

Supporting information: Study protocol, Statistical analysis plan

Time frame: Data from this study will be deposited into the Vivli database no later than one year of the completion of the funded project period

Access criteria: Interested parties can create an account in the Vivli Database and submit a request to access study data

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07923864
Responsible party
Jonathan Greenberg (Associate Professor / Research Staff Psychologist, Massachusetts General Hospital) — Principal investigator
First posted
Nov 9, 2026
Start date
Jun 2027 (estimated)
Primary completion
Dec 2030 (estimated)
Completion
Dec 2030 (estimated)
Last update
Nov 9, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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