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Completed

NCT Number: NCT05524402

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

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).

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Key information

Conditions

MTBI - Mild Traumatic Brain Injury Anxiety Anxiety Disorders Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Mental Disorders Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02129, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TOR-C 1

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

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.

Primary outcomes

  1. Number of Participants Who Scored Above the Midpoint on Each Subscale of the Credibility and Expectancy Questionnaire (CEQ)

    Time frame: Baseline (0 Weeks)

    Assessed using the Credibility and Expectancy Questionnaire (CEQ) which asks the participant indicate how much they believe, right now, that the intervention they will receive will help manage their concussion and related worry. Possible scores on both the credibility and expectancy subscales range from 3 to 27 and have a midpoint score of 14. The number of participants that scored at or above 14 on the credibility and/or expectancy subscales are reported below.

  2. Number of Participants Who Scored Above the Midpoint on the Client Satisfaction Scale

    Time frame: Post-Test (4 Weeks)

    Measured using the Client Satisfaction Scale which assess participants' satisfaction with participation in the study. The score range is 0-12. Higher scores indicate greater satisfaction.

  3. Feasibility of Recruitment

    Time frame: Baseline (0 Weeks)

    Rate at which recruitment was possible

  4. Acceptability of Treatment

    Time frame: Post-Test (4 Weeks)

    Rate at which program was accepted, measured by attendance.

  5. Adherence to Homework

    Time frame: Collected during intervention, an average of 4 weeks

    Rate of participant's completion of homework assigned (practicing at least 1 program skill, 3 days/week on average) throughout the study.

  6. Therapist Adherence

    Time frame: Collected during intervention, an average of 4 weeks

    Rate of interventionist's delivering the programs by following the established session topics and practices

  7. Feasibility of Assessments at Baseline

    Time frame: Baseline (0 Weeks)

    Rate of participant's completion of self-report measures, with no measures missing

  8. Feasibility of Assessments at Post-Test

    Time frame: Post-Test (4 Weeks)

    Rate of participant's completion of self-report measures, with no measures missing

  9. Feasibility of Assessments at Follow-up

    Time frame: Follow-up (12 Weeks)

    Rate of participant's completion of self-report measures, with no measures missing

  10. Adverse Events

    Time frame: Collected during intervention, an average of 4 weeks

    Any self reported or observed negative events related to participation

Secondary outcomes

  1. Numerical Rating Scale

    Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)

    Rate of a participant's pain at rest and with activity using a Likert scale with 0 being no pain and 10 being worst possible pain.

  2. Post-Concussion Symptom Scale (PCSS)

    Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)

    The PCSS measures post-concussion symptoms on a 1-6-point Linkert scale. Higher scores represent greater symptom severity and total scores can range from 22 to132 points.

  3. Generalized Anxiety Disorder Scale (GAD-7)

    Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)

    7-item questionnaire measuring symptoms of anxiety within the past 2 weeks on a scale of 0 to 3. Total scores range from 0 to 21 and higher scores indicate more symptoms of anxiety.

  4. Hospital Anxiety And Depression Scale (HADS)

    Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)

    Measures symptoms of emotional distress and estimates diagnoses. The scale has 14 items, 7 assess anxiety and 7 depression. Scores range from 0-21 on each subscale, wtih higher scores indicating more symptoms. Scores greater than 8 indicate clinically significant symptoms.

  5. World Health Organization - Disability Assessment Schedule 2.0 (WHODAS)

    Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)

    The WHODAS 2.0 measures level of functioning in six domains: cognition, mobility, self-care, getting along, life activities, and participation. Each item is on the scale is measured 0-4, with total scores ranging from 0 to 48. Higher scores indicate more disability (worse outcomes).

  6. Fear Avoidance Behavior After Traumatic Brain Injury (FAB-TBI)

    Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)

    A 16-item questionnaire assessing beliefs about how work and physical activities affect mTBI symptoms, and whether they should be avoided on a scale of 0 to 3. Total scores range from 0 to 48 and higher scores represent higher fear avoidance.

  7. Pain Catastophizing Scale (PCS)

    Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)

    A 13-item questionnaire assessing one's tendency to focus on pain-related thoughts and feel helpless and hopeless due to pain on a scale of 0 to 4. Total scores range from 0 to 25 and higher scores indicate higher pain catastrophizing (worse outcomes).

  8. Cognitive And Affective Mindfulness Scale-Revised (CAMS-R)

    Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)

    Rate of a participant's broad conceptualization of mindfulness, items range from 1-4 and scores range from 12-48, with higher values reflecting higher levels of mindfulness

  9. Behavioral Response To Illness (BRIQ) - Limiting Behaviors Subscale

    Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)

    A 7-item subscale of the BRIQ measuring "limiting behaviors" (frequency of inactivity). This subscale is rated on a scale of 0 to 4, with total scores ranging from 0 to 28. Higher scores indicate more limiting behavior (worse outcomes).

  10. Behavioral Response To Illness (BRIQ) - All-or-Nothing Subscale

    Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)

    A 6-item subscale of the BRIQ measuring "all or nothing behaviors" (tendency for overexertion). This subscale is rated on a scale of 0 to 4, with higher scores indicating more all or nothing behavior. Total scores on this subscale range from 0 to 24.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 1, 2022
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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