Live Video Mind-body Treatment to Prevent Persistent Symptoms Following mTBI

Anxiety Clinical Trial

Official title:

Live Video Mind-body Treatment to Prevent Persistent Symptoms Following mTBI

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05524402
• Other study ID #: 2022P001521
• Secondary ID: K23AT010653-01A1
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 15, 2022
• Est. completion date: August 1, 2024

Study information

• Verified date: March 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• MTBI - Mild Traumatic Brain Injury

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Credibility and Expectancy Questionnaire	The survey asks that the participant indicates how much they believe, right now, that the intervention they will receive will help manage their concussion and related worry.	Baseline (0 Weeks)
Primary	Client Satisfaction Score	This measure will assess participants' satisfaction with participation in the study. The score range is 0-12. Higher scores indicate greater satisfaction.	Post-Test (4 Weeks)
Primary	Feasibility of recruitment	Rate at which recruitment was possible	Baseline (0 Weeks)
Primary	Acceptability of treatment	Rate at which program was accepted, measured by attendance.	Post-Test (4 Weeks)
Primary	Adherence to homework	Rate of participant's completion of homework assigned throughout the study.	Collected during intervention
Primary	Therapist adherence	Rate of interventionist's delivering the programs by following the established session topics and skills.	Collected during intervention
Primary	Feasibility of assessments at Baseline	Rate of participant's completion of self-report measures, with no measures missing	Baseline (0 Weeks)
Primary	Feasibility of assessments at Post-Test	Rate of participant's completion of self-report measures, with no measures missing	Post-Test (4 Weeks)
Primary	Feasibility of assessments at Follow-up	Rate of participant's completion of self-report measures, with no measures missing	Follow-up (12 Weeks)
Primary	Adverse Events	Any self reported or observed negative events related to participation	Collected during intervention
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.	Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
Secondary	Post-Concussion Symptom Scale	Rate post-concussion symptoms on a 7-point Likert scale	Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
Secondary	Generalized Anxiety Disorder (GAD-7)	7-item questionnaire measuring anxiety Measures symptoms of anxiety within the past 2 weeks on a scale of 0 to 3. Higher scores indicate more symptoms of anxiety	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.	Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
Secondary	Who Disability Assessment Schedule 2.0 (WHODAS)	The WHODAS measures level of functioning in six domains: cognition, mobility, self-care, getting along, life activities, and participation. Each question on the scale is measured 0-4, with higher scores indicating more disability.	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. Higher scores represent higher fear avoidance.	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. Higher scores indicate higher pain catastrophizing.	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	Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)
Secondary	Behavioral Response To Illness (BRIQ)	A 13-item measure consisting of a "limiting behaviors" subscale (frequency of inactivity) and an "all or nothing behavior" subscale (tendency for overexertion). Both subscales are rated on a scale of 0 to 4, with higher scores indicating more limiting and all or nothing behavior.	Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)