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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
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 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.
Massachusetts General Hospital
Boston, Massachusetts, United States
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.
Time frame: 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.
Time frame: Post-Test (4 Weeks)
Feasibility of Recruitment
Rate at which recruitment was possible
Time frame: Baseline (0 Weeks)
Acceptability of Treatment
Rate at which program was accepted, measured by attendance.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Baseline (0 Weeks)
Feasibility of Assessments at Post-Test
Rate of participant's completion of self-report measures, with no measures missing
Time frame: Post-Test (4 Weeks)
Feasibility of Assessments at Follow-up
Rate of participant's completion of self-report measures, with no measures missing
Time frame: Follow-up (12 Weeks)
Adverse Events
Any self reported or observed negative events related to participation
Time frame: Collected during intervention, an average of 4 weeks
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.
Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
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Time frame: 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).
Time frame: 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
Time frame: 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).
Time frame: 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.
Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)