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Mind-Body Treatments for Concussion and Anxiety

N/A
Waitlist Available
Led By Jonathan Greenberg, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (0 weeks), post-test (4 weeks), follow-up (12 weeks)
Awards & highlights

Study Summary

This trial will test two different programs to help manage anxiety in college-age individuals who have recently had a concussion. The trial will assess how easy it is to recruit participants and collect data, as well as how well the programs work.

Who is the study for?
This trial is for college-age individuals (18-35) who have had a concussion within the last 10 weeks and are experiencing anxiety. Participants must be fluent in English, able to use a smartphone or computer with internet, and not on varying psychotropic drugs. Those with severe TBI history, certain psychiatric conditions, substance abuse issues, recent mind-body treatment practices or current pregnancy cannot join.Check my eligibility
What is being tested?
The study tests two virtual programs delivered via Zoom—TOR-C 1 and TOR-C 2—for managing symptoms after mild traumatic brain injury (mTBI). It focuses on feasibility of recruitment, data collection procedures and the acceptability of these programs among young adults with concussions.See study design
What are the potential side effects?
Since this trial involves mind-body treatments rather than medication, traditional side effects like those seen with drugs may not apply. However, participants might experience discomfort or emotional distress related to engaging in treatment sessions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~collected during intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and collected during intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability of treatment
Adherence to homework
Adverse Events
+7 more
Secondary outcome measures
Behavioral Response To Illness (BRIQ)
Cognitive And Affective Mindfulness Scale-Revised (CAMS-R)
Fear Avoidance Behavior After Traumatic Brain Injury (FAB-TBI)
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TOR-C 1Experimental Treatment1 Intervention
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.
Group II: TOR-C 2Active Control1 Intervention
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.

Who is running the clinical trial?

National Center for Complementary and Integrative Health (NCCIH)NIH
831 Previous Clinical Trials
668,883 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,305 Total Patients Enrolled
Jonathan Greenberg, PhDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
52 Total Patients Enrolled

Media Library

TOR-C 1 Clinical Trial Eligibility Overview. Trial Name: NCT05524402 — N/A
Concussion Research Study Groups: TOR-C 2, TOR-C 1
Concussion Clinical Trial 2023: TOR-C 1 Highlights & Side Effects. Trial Name: NCT05524402 — N/A
TOR-C 1 2023 Treatment Timeline for Medical Study. Trial Name: NCT05524402 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings for participants to join this research project?

"According to the clinicaltrials.gov database, recruitment for this trial has ceased as the last update was on October 5th 2022. Despite that, there are still 706 other trials actively seeking participants at present."

Answered by AI

Does this experiment accommodate geriatric patients?

"This research trial is accepting participants who are between the age of majority and 24."

Answered by AI

What goals is this research attempting to achieve?

"This trial's primary outcome is to ascertain the feasibility of recruitment, and secondary objectives include measuring participants' Behavioral Response To Illness (BRIQ), Generalized Anxiety Disorder (GAD-7), and Cognitive And Affective Mindfulness Scale-Revised (CAMS-R) scores over a four week period. The BRIQ scale ranges from 0 to 4, GAD-7 measures anxiety symptoms on a 0 to 3 spectrum, while CAMS-R assesses mindfulness based off values between 12 to 48."

Answered by AI

Does my medical profile qualify me to participate in this research?

"This trial requires 50 participants, aged 18-24 and suffering from anxiety. The further prerequisites are males and females who have experienced a concussion in the last 10 weeks, own an Internet connected device such as a smartphone or laptop, English fluency and literacy, readiness to partake for four 45 minutes sessions of programs along with answering remote questionnaires prior to treatment initiation, post completion and 3 months after program conclusion; additionally those applying must not be concurrently taking any psychotropic medications or has been on stable dosage for at least three months."

Answered by AI

Who else is applying?

What state do they live in?
New Mexico
What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. Massachusetts General Hospital: < 48 hours
Average response time
  • < 2 Days
~7 spots leftby Aug 2024