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

Mass General Brigham

Status: Completed

Conditions: MTBI - Mild Traumatic Brain Injury; Anxiety

Treatments: Behavioral: TOR-C 1; Behavioral: TOR-C 2

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05524402

K23AT010653-01A1 (U.S. NIH Grant/Contract)

2022P001521

Details and patient eligibility

About

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).

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

TOR-C 1

Experimental group

Description:

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 delivered over live video with weekly sessions and home practice.

Treatment:

Behavioral: TOR-C 1

TOR-C 2

Active Comparator group

Description:

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.

Treatment:

Behavioral: TOR-C 2