Back to resultsLive Video Mind-body Treatment to Prevent Persistent Symptoms Following mTBI
Primary Purpose
MTBI - Mild Traumatic Brain Injury, Anxiety
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TOR-C 1
TOR-C 2
Sponsored by
About this trial
This is an interventional treatment trial for MTBI - Mild Traumatic Brain Injury focused on measuring MTBI - Mild Traumatic Brain Injury, Anxiety, Mindfulness
Eligibility Criteria
Inclusion Criteria:
- Male and female outpatients, ages 18-24
- 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 3 months
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 yoga/meditation, or other mind body techniques that elicit the RR, once per week for 45min or more within the last 3 months
- Participation in a mind-body or CBT treatment in the past 3 months
- Currently pregnant
Sites / Locations
- Massachusetts General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TOR-C 1
TOR-C 2
Arm 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.
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.
Outcomes
Primary Outcome Measures
Credibility and Expectancy Questionnaire
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.
Client Satisfaction Score
This measure will assess participants' satisfaction with participation in the study. The score range is 0-12. Higher scores indicate greater satisfaction.
Feasibility of recruitment
Rate at which recruitment was possible
Acceptability of treatment
Rate at which program was accepted, measured by attendance.
Adherence to homework
Rate of participant's completion of homework assigned throughout the study.
Therapist adherence
Rate of interventionist's delivering the programs by following the established session topics and skills.
Feasibility of assessments at Baseline
Rate of participant's completion of self-report measures, with no measures missing
Feasibility of assessments at Post-Test
Rate of participant's completion of self-report measures, with no measures missing
Feasibility of assessments at Follow-up
Rate of participant's completion of self-report measures, with no measures missing
Adverse Events
Any self reported or observed negative events related to participation
Secondary Outcome Measures
Numerical Rating Scale
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.
Post-Concussion Symptom Scale
Rate post-concussion symptoms on a 7-point Likert scale
Generalized Anxiety Disorder (GAD-7)
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
Hospital Anxiety And Depression Scale (HADS)
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.
Who Disability Assessment Schedule 2.0 (WHODAS)
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.
Fear Avoidance Behavior After Traumatic Brain Injury (FAB-TBI)
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.
Pain Catastophizing Scale (PCS)
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.
Cognitive And Affective Mindfulness Scale-Revised (CAMS-R)
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
Behavioral Response To Illness (BRIQ)
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.
Full Information
NCT ID
NCT05524402
First Posted
August 17, 2022
Last Updated
August 21, 2023
Sponsor
Massachusetts General Hospital
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT05524402
Brief Title
Live Video Mind-body Treatment to Prevent Persistent Symptoms Following mTBI
Official Title
Live Video Mind-body Treatment to Prevent Persistent Symptoms Following mTBI
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2022 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MTBI - Mild Traumatic Brain Injury, Anxiety
Keywords
MTBI - Mild Traumatic Brain Injury, Anxiety, Mindfulness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TOR-C 1
Arm Type
Experimental
Arm 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.
Arm Title
TOR-C 2
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
TOR-C 1
Intervention 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 with weekly sessions and home practice.
Intervention Type
Behavioral
Intervention Name(s)
TOR-C 2
Intervention 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.
Primary Outcome Measure Information:
Title
Credibility and Expectancy Questionnaire
Description
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.
Time Frame
Baseline (0 Weeks)
Title
Client Satisfaction Score
Description
This measure will assess participants' satisfaction with participation in the study. The score range is 0-12. Higher scores indicate greater satisfaction.
Time Frame
Post-Test (4 Weeks)
Title
Feasibility of recruitment
Description
Rate at which recruitment was possible
Time Frame
Baseline (0 Weeks)
Title
Acceptability of treatment
Description
Rate at which program was accepted, measured by attendance.
Time Frame
Post-Test (4 Weeks)
Title
Adherence to homework
Description
Rate of participant's completion of homework assigned throughout the study.
Time Frame
Collected during intervention
Title
Therapist adherence
Description
Rate of interventionist's delivering the programs by following the established session topics and skills.
Time Frame
Collected during intervention
Title
Feasibility of assessments at Baseline
Description
Rate of participant's completion of self-report measures, with no measures missing
Time Frame
Baseline (0 Weeks)
Title
Feasibility of assessments at Post-Test
Description
Rate of participant's completion of self-report measures, with no measures missing
Time Frame
Post-Test (4 Weeks)
Title
Feasibility of assessments at Follow-up
Description
Rate of participant's completion of self-report measures, with no measures missing
Time Frame
Follow-up (12 Weeks)
Title
Adverse Events
Description
Any self reported or observed negative events related to participation
Time Frame
Collected during intervention
Secondary Outcome Measure Information:
Title
Numerical Rating Scale
Description
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.
Time Frame
Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
Title
Post-Concussion Symptom Scale
Description
Rate post-concussion symptoms on a 7-point Likert scale
Time Frame
Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
Title
Generalized Anxiety Disorder (GAD-7)
Description
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
Time Frame
Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
Title
Hospital Anxiety And Depression Scale (HADS)
Description
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.
Time Frame
Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
Title
Who Disability Assessment Schedule 2.0 (WHODAS)
Description
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.
Time Frame
Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
Title
Fear Avoidance Behavior After Traumatic Brain Injury (FAB-TBI)
Description
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.
Time Frame
Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
Title
Pain Catastophizing Scale (PCS)
Description
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.
Time Frame
Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
Title
Cognitive And Affective Mindfulness Scale-Revised (CAMS-R)
Description
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
Time Frame
Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
Title
Behavioral Response To Illness (BRIQ)
Description
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.
Time Frame
Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan Greenberg, PhD
Phone
617-643-9402
Email
jgreenberg5@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Nadine Levey, BA
Phone
6177248431
Email
nlevey@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Greenberg, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Greenberg, PhD
Phone
617-643-9602
Email
jgreenberg5@mgh.harvard.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33443484
Citation
Greenberg J, Singh T, Iverson GL, Silverberg ND, Macklin EA, Parker RA, Giacino JT, Yeh GY, Vranceanu AM. A Live Video Mind-Body Treatment to Prevent Persistent Symptoms Following Mild Traumatic Brain Injury: Protocol for a Mixed Methods Study. JMIR Res Protoc. 2021 Jan 14;10(1):e25746. doi: 10.2196/25746.
Results Reference
background
Learn more about this trial
Live Video Mind-body Treatment to Prevent Persistent Symptoms Following mTBI
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