Biomarkers for Exercise

Examining Novel Biomarkers of Neuroplasticity Associated With Exercise in Adults With Anxiety Disorders

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.

Study Overview

• Status: Recruiting
• Conditions: Anxiety Disorders
• Intervention / Treatment: Behavioral: Exercise Intervention

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristin Szuhany, PhD; Phone Number: 646-754-5161; Email: Kristin.szuhany@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

For both participant groups: To be eligible to participate in this study, an individual must meet all of the following criteria:

• Between 18-50 years of age
• Currently sedentary (≤60 minutes of moderate intensity exercise per week for the past 3 months)
• Capable and willing to provide informed consent

For anxiety disorder participant group, an individual must also meet:

• Primary psychiatric diagnosis of generalized anxiety disorder (GAD), social anxiety disorder, or panic disorder

Exclusion Criteria:

• Lifetime history of Bipolar I or II or any psychotic disorder
• Bulimia or anorexia in the past 3 months
• Alcohol or substance use disorder in the past 3 months
• Current major depressive disorder (past is allowed)
• Current neurologic disorder
• High current suicide risk (active suicidal ideation with plan and intent) as indicated by a score of ≥4 on the Columbia Suicide Severity Rating Scale (C-SSRS) consistent with a need for referral to higher level of care
• Participation in concurrent evidence-based therapy (e.g., cognitive behavioral therapy) targeting anxiety and/or depression (supportive therapy and couples therapy are allowed)
• Risk for exercise according to the Physical Activity Readiness Questionnaire with excluded active medical conditions including heart conditions, lung disease, bone/joint problems, or seizures
• Women who are currently pregnant or plan to become pregnant during the duration of the study
• current psychiatric medication
• Current substance abuse or positive urine toxicology screen (recreational use of marijuana is permitted based on clinical assessment on the MINI structured diagnostic interview that it does not meet criteria for cannabis use disorder)
• Active infection

Non-psychiatric controls who meet the following criteria will be excluded from participation in this study:

• Current psychiatric condition assessed by the MINI

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Individuals with Anxiety Disorder; All participants will complete the 4-week exercise intervention in which they'll be prescribed 150 minutes of moderate intensity exercise per week at home, which will be measured using Fitbits.	Behavioral: Exercise Intervention; 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.
Active Comparator: Control Individuals; All participants will complete the 4-week exercise intervention in which they'll be prescribed 150 minutes of moderate intensity exercise per week at home, which will be measured using Fitbits.	Behavioral: Exercise Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acetyl-L-carnitine (LAC) Levels	Levels of LAC isolated from neuronal exosomes from plasma blood draws.	Week 4
Interleukin-6 (IL-6) Levels	Levels of IL-6 isolated from neuronal exosomes from plasma blood draws.	Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continuously measured moderate/vigorous minutes of exercise	Information collected via Fitbit.	Up to Week 4
7-Day Physical Activity Recall	Measurement of total weekly metabolic equivalent of task (MET)-hours.	Baseline, Week 2, Week 4
Overall Anxiety Severity and Impairment Scale (OASIS)	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.	Baseline, Week 2, Week 4
Anxiety Sensitivity Index (ASI-3) Score	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.	Baseline, Week 2, Week 4
Quick Inventory of Depressive Symptomatology (QIDS) Score	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.	Baseline, Week 2, Week 4
Perceived Stress Scale (PSS) Score	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.	Baseline, Week 2, Week 4
Childhood Trauma Questionnaire	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.	Baseline, Week 2, Week 4
Insomnia Severity Index (ISI) Score	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.	Baseline, Week 2, Week 4
International Physical Activity Questionnaire (IPAQ) Score	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.	Baseline, Week 2, Week 4
Body Mass Index (BMI)		Baseline, Week 2, Week 4

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Kristin Szuhany, PhD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): January 15, 2028

Study Registration Dates

• First Submitted: January 6, 2026
• First Submitted That Met QC Criteria: January 6, 2026
• First Posted (Actual): January 14, 2026

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 25-01561

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Deidentified data will be made available if requested.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No