N/A
N=50
Live Video Mind-body Treatment to Prevent Persistent Symptoms Following mTBI
MTBI - Mild Traumatic Brain Injury · Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT05524402 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Number of Participants Who Scored Above the Midpoint on Each Subscale of the Credibility and Expectancy Questionnaire (CEQ) — 21; 23; 16; 19 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TOR-C 1 (Behavioral); TOR-C 2 (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Scored Above the Midpoint on Each Subscale of the Credibility and Expectancy Questionnaire (CEQ) |
21; 23; 16; 19 | — |
| PRIMARY Number of Participants Who Scored Above the Midpoint on the Client Satisfaction Scale |
20; 20 | — |
| PRIMARY Feasibility of Recruitment |
50 | — |
| PRIMARY Acceptability of Treatment |
21; 23 | — |
| PRIMARY Adherence to Homework |
16 | — |
| PRIMARY Therapist Adherence |
96.30; 97.60 | — |
| PRIMARY Feasibility of Assessments at Baseline |
25; 25 | — |
| PRIMARY Feasibility of Assessments at Post-Test |
22; 24 | — |
| PRIMARY Feasibility of Assessments at Follow-up |
20; 23 | — |
| PRIMARY Adverse Events |
0; 0 | — |
| SECONDARY Numerical Rating Scale |
4.12; 5.20; 3.20; 3.72; 1.91; 3.50 | — |
| SECONDARY Post-Concussion Symptom Scale (PCSS) |
43.52; 50.61; 12.50; 29.08; 11.65; 23.13 | — |
| SECONDARY Generalized Anxiety Disorder Scale (GAD-7) |
10.00; 13.48; 5.00; 7.92; 3.85; 6.74 | — |
| SECONDARY Hospital Anxiety And Depression Scale (HADS) |
9.46; 11.80; 6.02; 8.22; 7.81; 8.79 | — |
| SECONDARY World Health Organization - Disability Assessment Schedule 2.0 (WHODAS) |
13.47; 16.29; 5.61; 9.83; 3.10; 7.61 | — |
| SECONDARY Fear Avoidance Behavior After Traumatic Brain Injury (FAB-TBI) |
39.01; 44.45; 24.51; 36.02; 24.20; 31.35 | — |
| SECONDARY Pain Catastophizing Scale (PCS) |
17.13; 20.64; 8.44; 14.46; 7.80; 13.22 | — |
| SECONDARY Cognitive And Affective Mindfulness Scale-Revised (CAMS-R) |
29.31; 27.24; 33.68; 30.21; 33.65; 31.13 | — |
| SECONDARY Behavioral Response To Illness (BRIQ) - Limiting Behaviors Subscale |
14.88; 17.28; 6.14; 11.00; 4.99; 9.83 | — |
| SECONDARY Behavioral Response To Illness (BRIQ) - All-or-Nothing Subscale |
11.64; 12.84; 8.19; 10.79; 7.16; 9.52 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT05524402). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.