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| ID | Type | Description | Link |
|---|---|---|---|
| K23AT010653-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TOR-C 1 | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Scored Above the Midpoint on Each Subscale of the Credibility and Expectancy Questionnaire (CEQ) | 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. | Baseline (0 Weeks) |
| Number of Participants Who Scored Above the Midpoint on the Client Satisfaction Scale | 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. | Post-Test (4 Weeks) |
| Feasibility of Recruitment | Rate at which recruitment was possible | Baseline (0 Weeks) |
| Acceptability of Treatment | Rate at which program was accepted, measured by attendance. | Post-Test (4 Weeks) |
| Adherence to Homework | Rate of participant's completion of homework assigned (practicing at least 1 program skill, 3 days/week on average) throughout the study. | Collected during intervention, an average of 4 weeks |
| Therapist Adherence | Rate of interventionist's delivering the programs by following the established session topics and practices |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks) |
| Post-Concussion Symptom Scale (PCSS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Greenberg, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02129 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33443484 | Background | 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. | |
| 39505248 | Derived | Greenberg J, Levey NS, Becker M, Yeh GY, Giacino JT, Iverson G, Silverberg ND, Parker RA, Vranceanu AM. Feasibility Randomized Controlled Trial of the Toolkit for Optimal Recovery After Concussion: A Live Video Program to Prevent Persistent Concussion Symptoms in Young Adults With Anxiety. Arch Phys Med Rehabil. 2025 Apr;106(4):527-536. doi: 10.1016/j.apmr.2024.10.011. Epub 2024 Nov 5. |
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Of the 51 eligible patients, 50 enrolled and were randomized.
Subjects were recruited via provider and self-referrals from the MGH Sports Concussion Clinic and Emergency Department, as well as concussion clinics nationwide, college health resources (e.g., sports medicine centers), relevant public social media sites (e.g., Facebook), Research Invitations via Patient Gateway after identifying potential participants through Research Patient Database Registry (RPDR) queries, and MGB Rally.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline analysis population is same as indicated in "Participant Flow".
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Scored Above the Midpoint on Each Subscale of the Credibility and Expectancy Questionnaire (CEQ) | 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. | The total of participants (separated by condition) that scored above the midline on the credibility and expectancy subscales of the Credibility and Expectancy Questionnaire (CEQ). | Posted | Count of Participants | Participants | Baseline (0 Weeks) |
|
Adverse event data were collected from the time of enrollment (0 weeks) through the follow-up assessment (3 months)
Adverse Event Monitoring: Throughout the study, subjects were monitored for the occurrence of adverse/other events. Lack of effect of treatment is not considered an event. All adverse events will be reported on an adverse event form. The Principle Investigator had the responsibility of reporting serious adverse events (death, life-threatening illness or injury, serious injury, or permanent disability) to PHRC within 24-72 hours of notification.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jonathan Greenberg | Massachusetts General Hospital | 617-643-9402 | jgreenberg5@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 22, 2024 | Aug 28, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 22, 2024 | Aug 28, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 26, 2024 | Aug 28, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
| 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. |
|
| Collected during intervention, an average of 4 weeks |
| Feasibility of Assessments at Baseline | Rate of participant's completion of self-report measures, with no measures missing | Baseline (0 Weeks) |
| Feasibility of Assessments at Post-Test | Rate of participant's completion of self-report measures, with no measures missing | Post-Test (4 Weeks) |
| Feasibility of Assessments at Follow-up | Rate of participant's completion of self-report measures, with no measures missing | Follow-up (12 Weeks) |
| Adverse Events | Any self reported or observed negative events related to participation | Collected during intervention, an average of 4 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. |
| Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks) |
| Generalized Anxiety Disorder Scale (GAD-7) | 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. | Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks) |
| 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. | Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks) |
| World Health Organization - Disability Assessment Schedule 2.0 (WHODAS) | 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). | Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks) |
| 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. Total scores range from 0 to 48 and higher scores represent higher fear avoidance. | Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks) |
| 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. Total scores range from 0 to 25 and higher scores indicate higher pain catastrophizing (worse outcomes). | Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks) |
| 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 | Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks) |
| Behavioral Response To Illness (BRIQ) - Limiting Behaviors Subscale | 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). | Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks) |
| Behavioral Response To Illness (BRIQ) - All-or-Nothing Subscale | 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. | Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks) |
| BG001 | 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. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Numerical Rating Scale - During Activity | Rate of pain during activity using a Likert scale with 0 being no pain and 10 being worst possible pain. | Mean | Standard Deviation | units on a scale |
|
| Post-Concussion Symptom Scale | Rate post-concussion symptoms on a 1 to 6-point Likert scale. Total scores range from 22 to 132, with higher scores indicating worse concussion symptoms. | Mean | Standard Deviation | units on a scale |
|
| Generalized Anxiety Disorder Scale (GAD-7) | 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. | Mean | Standard Deviation | units on a scale |
|
| Hospital Anxiety And Depression Scale (HADS) - Anxiety Subscale | 7-item anxiety subscale of the Hospital Anxiety and Depression Scale. Scores range from 0-21, with higher scores indicating more symptoms. Scores greater than 8 indicate clinically significant symptoms. | Mean | Standard Deviation | units on a scale |
|
| World Health Organization - Disability Assessment Schedule 2.0 (WHODAS) | 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). | Mean | Standard Deviation | units on a scale |
|
| 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. Total scores range from 0 to 48 and higher scores represent higher fear avoidance. | Mean | Standard Deviation | units on a scale |
|
| Pain Catastrophizing 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. Total scores range from 0 to 25 and higher scores indicate higher pain catastrophizing (worse outcomes). | Mean | Standard Deviation | units on a scale |
|
| Cognitive And Affective Mindfulness Scale-Revised (CAMS-R) | Measures participant's broad conceptualization of mindfulness, items range from 1-4 and total scores range from 12-48, with higher values reflecting higher levels of mindfulness | Mean | Standard Deviation | units on a scale |
|
| Behavioral Response To Illness (BRIQ) - All-or-Nothing Subscale | 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. | Mean | Standard Deviation | units on a scale |
|
| Hospital Anxiety And Depression Scale (HADS) - Depression Subscale | 7-item depression subscale of the Hospital Anxiety and Depression Scale. Scores range from 0-21, with higher scores indicating more symptoms. Scores greater than 8 indicate clinically significant symptoms. | Mean | Standard Deviation | units on a scale |
|
| Behavioral Response To Illness (BRIQ) - Limiting Behaviors Subscale | 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). | Mean | Standard Deviation | units on a scale |
|
| Numerical Rating Scale - At Rest | Participant's pain at rest using a Likert scale with 0 being no pain and 10 being worst possible pain. Higher scores indicate worse pain severity. | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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. 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. |
|
|
| Primary | Number of Participants Who Scored Above the Midpoint on the Client Satisfaction Scale | 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. | The proportion of participants that completed the post-test and scored above the midpoint on the Client Satisfaction Scale. | Posted | Count of Participants | Participants | Post-Test (4 Weeks) |
|
|
|
| Primary | Feasibility of Recruitment | Rate at which recruitment was possible | The proportion of eligible patients (n=54) who agree to participate (n=50). | Posted | Count of Participants | Participants | Baseline (0 Weeks) |
|
|
|
| Primary | Acceptability of Treatment | Rate at which program was accepted, measured by attendance. | Posted | Count of Participants | Participants | Post-Test (4 Weeks) |
|
|
|
| Primary | Adherence to Homework | Rate of participant's completion of homework assigned (practicing at least 1 program skill, 3 days/week on average) throughout the study. | Sample represents the number of TOR-C1 program completers (i.e., those who attended at least 3 of 4 program sessions). | Posted | Count of Participants | Participants | Collected during intervention, an average of 4 weeks |
|
|
|
| Primary | Therapist Adherence | Rate of interventionist's delivering the programs by following the established session topics and practices | 20% (n=10) of session recordings for each condition were randomly selected for clinician fidelity checks. The clinician is evaluated on the degree to which they delivered session content as intended with adequate clinical skills. Each subcomponent in each session is scored on a 1-5 point scale. The overall average score for the randomly selected TOR-C1 and TOR-C2 sessions is then assessed to produce an average percent of therapist adherence for each intervention. | Posted | Mean | Standard Deviation | percentage of adherence | Collected during intervention, an average of 4 weeks | Program Sessions | Program Sessions |
|
|
|
| Primary | Feasibility of Assessments at Baseline | Rate of participant's completion of self-report measures, with no measures missing | Posted | Count of Participants | Participants | Baseline (0 Weeks) |
|
|
|
| Primary | Feasibility of Assessments at Post-Test | Rate of participant's completion of self-report measures, with no measures missing | Posted | Count of Participants | Participants | Post-Test (4 Weeks) |
|
|
|
| Primary | Feasibility of Assessments at Follow-up | Rate of participant's completion of self-report measures, with no measures missing | Posted | Count of Participants | Participants | Follow-up (12 Weeks) |
|
|
|
| Primary | Adverse Events | Any self reported or observed negative events related to participation | Posted | Number | Adverse events related to participation | Collected during intervention, an average of 4 weeks |
|
|
|
| Secondary | 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. | Analysis population consists of measure completers (subject to change at each assessment point) | Posted | Mean | Standard Deviation | units on a scale | Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks) |
|
|
|
| Secondary | Post-Concussion Symptom Scale (PCSS) | 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. | Analysis population consists of measure completers (subject to change at each assessment point) | Posted | Mean | Standard Deviation | score on a scale | Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks) |
|
|
|
| Secondary | Generalized Anxiety Disorder Scale (GAD-7) | 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. | Analysis population consists of measure completers (subject to change at each assessment point) | Posted | Mean | Standard Deviation | score on a scale | Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks) |
|
|
|
| Secondary | 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. | Analysis population consists of measure completers (subject to change at each assessment point) | Posted | Mean | Standard Deviation | score on a scale | Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks) |
|
|
|
| Secondary | World Health Organization - Disability Assessment Schedule 2.0 (WHODAS) | 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). | Analysis population consists of measure completers (subject to change at each assessment point) | Posted | Mean | Standard Deviation | score on a scale | Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks) |
|
|
|
| Secondary | 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. Total scores range from 0 to 48 and higher scores represent higher fear avoidance. | Analysis population consists of measure completers (subject to change at each assessment point) | Posted | Mean | Standard Deviation | score on a scale | Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks) |
|
|
|
| Secondary | 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. Total scores range from 0 to 25 and higher scores indicate higher pain catastrophizing (worse outcomes). | Analysis population consists of measure completers (subject to change at each assessment point) | Posted | Mean | Standard Deviation | score on a scale | Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks) |
|
|
|
| Secondary | 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 | Analysis population consists of measure completers (subject to change at each assessment point) | Posted | Mean | Standard Deviation | score on a scale | Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks) |
|
|
|
| Secondary | Behavioral Response To Illness (BRIQ) - Limiting Behaviors Subscale | 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). | Analysis population consists of measure completers (subject to change at each assessment point) | Posted | Mean | Standard Deviation | score on a scale | Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks) |
|
|
|
| Secondary | Behavioral Response To Illness (BRIQ) - All-or-Nothing Subscale | 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. | Analysis population consists of measure completers (subject to change at each assessment point) | Posted | Mean | Standard Deviation | units on a scale | Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks) |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | 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. 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. | 0 | 25 | 0 | 25 | 0 | 25 |
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D001523 | Mental Disorders |
| Baseline - At rest |
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| Post-Test - During activity |
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| Post-Test - At rest |
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| Follow-Up - During activity |
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| Follow-Up - At rest |
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| Post-Test |
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| Follow-Up |
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| Post-Test |
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| Follow-Up |
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| Baseline - Depression |
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| Post-Test - Anxiety |
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| Post-Test - Depression |
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| Follow-Up - Anxiety |
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| Follow-Up - Depression |
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| Post-Test |
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| Follow-Up |
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| Post-Test |
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| Follow-Up |
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| Pose-Test |
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| Follow-Up |
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| Post-Test |
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| Follow-Up |
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| Post-Test |
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| Follow-Up |
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| Post-Test |
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| Follow-Up |
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