Live Video Mind-body Treatment to Prevent Persistent Symptoms Following mTBI
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Number of Participants Who Scored Above the Midpoint on Each Subscale of the Credibility and Expectancy Questionnaire (CEQ)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
Intervention: TOR-C 1 (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.
Intervention: TOR-C 2 (Behavioral)
Outcomes
Primary Outcomes
Number of Participants Who Scored Above the Midpoint on Each Subscale of the Credibility and Expectancy Questionnaire (CEQ)
Time Frame: Baseline (0 Weeks)
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.
Number of Participants Who Scored Above the Midpoint on the Client Satisfaction Scale
Time Frame: Post-Test (4 Weeks)
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.
Feasibility of Recruitment
Time Frame: Baseline (0 Weeks)
Rate at which recruitment was possible
Acceptability of Treatment
Time Frame: Post-Test (4 Weeks)
Rate at which program was accepted, measured by attendance.
Adherence to Homework
Time Frame: Collected during intervention, an average of 4 weeks
Rate of participant's completion of homework assigned (practicing at least 1 program skill, 3 days/week on average) throughout the study.
Therapist Adherence
Time Frame: Collected during intervention, an average of 4 weeks
Rate of interventionist's delivering the programs by following the established session topics and practices
Feasibility of Assessments at Baseline
Time Frame: Baseline (0 Weeks)
Rate of participant's completion of self-report measures, with no measures missing
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
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
Adverse Events
Time Frame: Collected during intervention, an average of 4 weeks
Any self reported or observed negative events related to participation
Secondary Outcomes
- Numerical Rating Scale(Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks))
- Post-Concussion Symptom Scale (PCSS)(Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks))
- Generalized Anxiety Disorder Scale (GAD-7)(Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks))
- Hospital Anxiety And Depression Scale (HADS)(Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks))
- World Health Organization - Disability Assessment Schedule 2.0 (WHODAS)(Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks))
- Fear Avoidance Behavior After Traumatic Brain Injury (FAB-TBI)(Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks))
- Pain Catastophizing Scale (PCS)(Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks))
- Cognitive And Affective Mindfulness Scale-Revised (CAMS-R)(Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks))
- Behavioral Response To Illness (BRIQ) - Limiting Behaviors Subscale(Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks))
- Behavioral Response To Illness (BRIQ) - All-or-Nothing Subscale(Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks))
Investigators
Jonathan Greenberg
Principal Investigator
Massachusetts General Hospital