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

March 18, 2024 updated by: Jonathan Greenberg, Massachusetts General Hospital
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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02129
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 24 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Credibility and Expectancy Questionnaire
Time Frame: Baseline (0 Weeks)
The survey asks that the participant indicates how much they believe, right now, that the intervention they will receive will help manage their concussion and related worry.
Baseline (0 Weeks)
Client Satisfaction Score
Time Frame: Post-Test (4 Weeks)
This measure will assess participants' satisfaction with participation in the study. The score range is 0-12. Higher scores indicate greater satisfaction.
Post-Test (4 Weeks)
Feasibility of recruitment
Time Frame: Baseline (0 Weeks)
Rate at which recruitment was possible
Baseline (0 Weeks)
Acceptability of treatment
Time Frame: Post-Test (4 Weeks)
Rate at which program was accepted, measured by attendance.
Post-Test (4 Weeks)
Adherence to homework
Time Frame: Collected during intervention
Rate of participant's completion of homework assigned throughout the study.
Collected during intervention
Therapist adherence
Time Frame: Collected during intervention
Rate of interventionist's delivering the programs by following the established session topics and skills.
Collected during intervention
Feasibility of assessments at Baseline
Time Frame: Baseline (0 Weeks)
Rate of participant's completion of self-report measures, with no measures missing
Baseline (0 Weeks)
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
Post-Test (4 Weeks)
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
Follow-up (12 Weeks)
Adverse Events
Time Frame: Collected during intervention
Any self reported or observed negative events related to participation
Collected during intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
Post-Concussion Symptom Scale
Time Frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
Rate post-concussion symptoms on a 7-point Likert scale
Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
Generalized Anxiety Disorder (GAD-7)
Time Frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
7-item questionnaire measuring anxiety Measures symptoms of anxiety within the past 2 weeks on a scale of 0 to 3. Higher scores indicate more symptoms of anxiety
Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
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.
Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
Who Disability Assessment Schedule 2.0 (WHODAS)
Time Frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
The WHODAS measures level of functioning in six domains: cognition, mobility, self-care, getting along, life activities, and participation. Each question on the scale is measured 0-4, with higher scores indicating more disability.
Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
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. Higher scores represent higher fear avoidance.
Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
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. Higher scores indicate higher pain catastrophizing.
Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
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
Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
Behavioral Response To Illness (BRIQ)
Time Frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
A 13-item measure consisting of a "limiting behaviors" subscale (frequency of inactivity) and an "all or nothing behavior" subscale (tendency for overexertion). Both subscales are rated on a scale of 0 to 4, with higher scores indicating more limiting and all or nothing behavior.
Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Jonathan Greenberg, PhD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2022

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

August 17, 2022

First Submitted That Met QC Criteria

August 29, 2022

First Posted (Actual)

September 1, 2022

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022P001521
  • K23AT010653-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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