NCT05524402

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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).

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.

Conditions

• MTBI - Mild Traumatic Brain Injury
• Anxiety

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2022-10-15
• Primary completion: 2024-07-12
• Completion: 2024-07-12
• First posted: 2022-09-01
• Last updated: 2025-03-20
• Results posted: 2025-03-20

Locations

1 site across 1 country: United States