Clinical trial NCT05524402: 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
Overall status: COMPLETED
Phase: NA
Conditions: MTBI - Mild Traumatic Brain Injury
Anxiety
Keywords: MTBI - Mild Traumatic Brain Injury
Anxiety
Mindfulness
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2022-09-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants Who Scored Above the Midpoint on Each Subscale of the Credibility and Expectancy Questionnaire (CEQ)
timeFrame: Baseline (0 Weeks)
measure: Number of Participants Who Scored Above the Midpoint on the Client Satisfaction Scale
timeFrame: Post-Test (4 Weeks)
measure: Feasibility of Recruitment
timeFrame: Baseline (0 Weeks)
measure: Acceptability of Treatment
timeFrame: Post-Test (4 Weeks)
measure: Adherence to Homework
timeFrame: Collected during intervention, an average of 4 weeks
measure: Therapist Adherence
timeFrame: Collected during intervention, an average of 4 weeks
measure: Feasibility of Assessments at Baseline
timeFrame: Baseline (0 Weeks)
measure: Feasibility of Assessments at Post-Test
timeFrame: Post-Test (4 Weeks)
measure: Feasibility of Assessments at Follow-up
timeFrame: Follow-up (12 Weeks)
measure: Adverse Events
timeFrame: Collected during intervention, an average of 4 weeks
Secondary outcomes:
measure: Numerical Rating Scale
timeFrame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
measure: Post-Concussion Symptom Scale (PCSS)
timeFrame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
measure: Generalized Anxiety Disorder Scale (GAD-7)
timeFrame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
measure: Hospital Anxiety And Depression Scale (HADS)
timeFrame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
measure: World Health Organization - Disability Assessment Schedule 2.0 (WHODAS)
timeFrame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
measure: Fear Avoidance Behavior After Traumatic Brain Injury (FAB-TBI)
timeFrame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
measure: Pain Catastophizing Scale (PCS)
timeFrame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
measure: Cognitive And Affective Mindfulness Scale-Revised (CAMS-R)
timeFrame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
measure: Behavioral Response To Illness (BRIQ) - Limiting Behaviors Subscale
timeFrame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
measure: Behavioral Response To Illness (BRIQ) - All-or-Nothing Subscale
timeFrame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jonathan Greenberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.