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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-15

Study Completion Date

2024-07-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Medical and Resource Facilitation Intervention After Traumatic Brain Injury

NCT03429322

Brain Injuries, Traumatic Family Physician's Role

COMPLETED NA

TBI Care: Collaborative Care for Pain After Traumatic Brain Injury (TBI)

NCT03523923

Brain Injuries, Traumatic Chronic Pain Post-Traumatic Headache

COMPLETED NA

Metacognitive Therapy for Post-concussive Symptoms After Mild Traumatic Brain Injury

NCT02690584

Brain Injuries Post-Concussive Symptom Post-Concussive Syndrome

COMPLETED NA

Mindfulness-Based Intervention for Mild Traumatic Brain Injury

NCT05105802

Concussion, Mild

COMPLETED NA

CORE (Cognitive Optimization Through Rehabilitation and Education) Study

NCT06859996

Mild Traumatic Brain Injury; Concussion

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

MTBI - Mild Traumatic Brain Injury Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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 delivered over live video with weekly sessions and home practice.

Group Type EXPERIMENTAL

TOR-C 1

Intervention Type BEHAVIORAL

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 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.

Group Type ACTIVE_COMPARATOR

TOR-C 2

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes