An Efficacy Trial of The Toolkit for Optimal Recovery After Concussion
NCT07923864, Not applicable, Not yet recruiting, Massachusetts General Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | An Efficacy Trial of The Toolkit for Optimal Recovery After Concussion | ClinicalTrials.gov |
| NCT number | NCT07923864 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 260 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Massachusetts General Hospital | ClinicalTrials.gov |
| Conditions | Concussion (Diagnosis), Mild Traumatic Brain Injury, Post Concussion Symptoms, Anxiety | ClinicalTrials.gov |
| Interventions | Toolkit for Optimal Recovery after Concussion (TOR-C), Health Enhancement after Concussion (HE-C) | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Post-Concussion Symptom Scale (PCSS) | Baseline (week 0), post-test (week 4), 6-month follow-up (week 28) | 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. | ClinicalTrials.gov |
| Secondary | Generalized Anxiety Disorder scale (GAD-7) | Baseline (week 0), post-test (week 4), 6-month follow-up (week 28) | Measures the severity of anxiety symptoms. (Also used at screening, where a score ≥5 is required for eligibility.) | ClinicalTrials.gov |
| Secondary | Patient Health Questionnaire-9 (PHQ-9) | Baseline (week 0), post-test (week 4), 6-month follow-up (week 28) | Measures the severity of depression symptoms. | ClinicalTrials.gov |
| Secondary | Fear Avoidance Behavior after Traumatic Brain Injury (FAB-TBI) | Baseline (week 0), post-test (week 4), 6-month follow-up (week 28) | Measures fear-avoidance behavior, i.e., avoiding activities out of fear they will worsen symptoms. A core mechanism in the fear-avoidance model. | ClinicalTrials.gov |
| Secondary | Symptom Catastrophizing Scale | Baseline (week 0), post-test (week 4), 6-month follow-up (week 28) | Measures the tendency to catastrophize concussion symptoms (magnifying, ruminating on, or feeling helpless about them). | ClinicalTrials.gov |
| Secondary | Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) | Baseline (week 0), post-test (week 4), 6-month follow-up (week 28) | Measures mindfulness, i.e., present-moment awareness and acceptance of thoughts and feelings. | ClinicalTrials.gov |
| Secondary | Behavioral Response to Illness Questionnaire (BRIQ): Limiting behavior subscale | Baseline (week 0), post-test (week 4), 6-month follow-up (week 28) | Measures the tendency to limit or avoid various activities in response to medical conditions | ClinicalTrials.gov |
| Secondary | Pittsburgh Sleep Quality Index (PSQI) | Baseline (week 0), post-test (week 4), 6-month follow-up (week 28) | An exploratory outcome which measures sleep quality over the past month. | ClinicalTrials.gov |
| Secondary | PROMIS Cognitive Function | Baseline (week 0), post-test (week 4), 6-month follow-up (week 28) | An exploratory outcome which measures self-reported cognitive function (e.g., perceived problems with memory, attention, and thinking). | ClinicalTrials.gov |
| Secondary | WHO Disability Assessment Schedule (WHODAS 2.0; 12-item version) | Baseline (week 0), post-test (week 4), 6-month follow-up (week 28) | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 3
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)