CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
TOR-C 1 +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05524402
NCT05524402N/ACompleted

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

Massachusetts General Hospital·interventional·Posted Sep 1, 2022·Updated Mar 20, 2025

In Brief

A clinical study evaluating TOR-C 1 and TOR-C 2 for MTBI - Mild Traumatic Brain Injury and Anxiety. Completed, enrolled 50 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2023202420252026
First PostedSep 1, 2022
Enrollment StartOct 15, 2022
Primary CompletionJul 12, 2024
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 3.8 years ago

Interventions

TOR-C 1behavioral

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 2behavioral

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.