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Mind-Body Treatments for Concussion and Anxiety
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.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
Who is running the clinical trial?
Media Library
- I was diagnosed with a concussion within the last 10 weeks.I am currently having thoughts about harming myself.I am between 18 and 35 years old.I have participated in a mind-body or CBT treatment recently.My doctor expects my illness to get worse in the next 6 months.I have practiced mindfulness for over 45 minutes weekly in the last 3 months.I am willing and able to attend four 45-minute sessions and complete questionnaires.I have had a serious head injury or concussion in the last 2 years with symptoms lasting over 3 months.I have been on a stable dose of my mental health medication for at least 6 weeks.I experience significant anxiety symptoms.I have been on a stable dose of my mental health medication for 3 months.
- Group 1: TOR-C 2
- Group 2: TOR-C 1
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
Does this experiment accommodate geriatric patients?
"This research trial is accepting participants who are between the age of majority and 24."
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."
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."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
How responsive is this trial?
Typically responds via
Most responsive sites:
- Massachusetts General Hospital: < 48 hours
Average response time
- < 2 Days
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