NYU Langone Health
New York, 10016, United States
Location status: Recruiting
NCT Number: NCT07340281
The overarching objective is to examine the brain-based biological mechanistic pathway by which exercise exerts anxiolytic effects. The investigators will measure brain-derived markers of mitochondrial metabolism (acetyl-L-carnitine [LAC]) and inflammation (interleukin-6 [IL-6]) using innovative technology to isolate neuronal exosomes.
Interested in participating?
Request Info18 year–50 year
All sexes
Interventional
Not applicable
New York, 10016, United States
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
For both participant groups: To be eligible to participate in this study, an individual must meet all of the following criteria:
For anxiety disorder participant group, an individual must also meet:
Exclusion criteria
Non-psychiatric controls who meet the following criteria will be excluded from participation in this study:
Exercise intervention is delivered in weekly individual sessions virtually for the 4-week intervention period. Sessions range from 25-45 minutes. The sessions serve as touch base points to review exercise for the week, plan for the coming week, problem-solve obstacles, and discuss various motivational strategies to help with an exercise routine. Participants are prescribed 150 minutes of moderate intensity exercise per week to be completed at home.
Time frame: Week 4
Levels of LAC isolated from neuronal exosomes from plasma blood draws.
Time frame: Week 4
Levels of IL-6 isolated from neuronal exosomes from plasma blood draws.
Time frame: Up to Week 4
Information collected via Fitbit.
Time frame: Baseline, Week 2, Week 4
Measurement of total weekly metabolic equivalent of task (MET)-hours.
Time frame: Baseline, Week 2, Week 4
OASIS is a 5-item assessment of anxiety severity and impairment over the past week; each item is rated on a Likert scale from 0-4. The total score is the sum of responses and ranges from 0-20; higher scores indicate greater anxiety severity and impairment.
Time frame: Baseline, Week 2, Week 4
ASI-3 is an 18-item assessment of anxiety severity over the past week; each item is rated on a Likert scale from 0-4. The total score is the sum of responses and ranges from 0-72; higher scores indicate greater anxiety severity.
Time frame: Baseline, Week 2, Week 4
QIDS is a 16-item assessment of depressive symptomatology; each item is rated on a Likert scale from 0-3. The total score is the sum of responses from each of the 9 domains and ranges from 0-27; higher scores indicate greater severity of depressive symptomatology.
Time frame: Baseline, Week 2, Week 4
PSS is a 10-item assessment of perceived stress; each item is rated on a scale from 0-4. The score is the sum of responses ranges from 0 to 40 with higher scores indicating higher perceived stress.
Time frame: Baseline, Week 2, Week 4
CTQ is a 28-item assessment of childhood trauma. The scale comprises five sub-scales; the score to each subscale ranges from 5-25; the total score is the sum of the sub-scales and ranges from 25-125; higher scores indicate more frequent/severe childhood trauma experiences.
Time frame: Baseline, Week 2, Week 4
ISI is a 7-item assessment of insomnia; each item is rated on a scale from 0-4. The total score is the sum of responses and ranges from 0-28; higher scores indicate greater insomnia severity.
Time frame: Baseline, Week 2, Week 4
IPAQ is an assessment of overall activity levels; the total score is expressed as METs (Metabolic Equivalents), a unit representing energy cost, where 1 MET is resting energy expenditure.
Time frame: Baseline, Week 2, Week 4
Contact information is provided by the study sponsor or research team.
NYU Langone Health
Other
Examining Novel Biomarkers of Neuroplasticity Associated With Exercise in Adults With Anxiety Disorders
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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