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Recruiting NCT07340281

Biomarkers for Exercise

No phase Interventional Anxiety Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exercise Intervention.
Who it may be relevant to
Registry conditions: Anxiety Disorders. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Acetyl-L-carnitine (LAC) Levels [Time frame: Week 4]
  • Interleukin-6 (IL-6) Levels [Time frame: Week 4]
Secondary outcome measures (10)
  • Continuously measured moderate/vigorous minutes of exercise [Time frame: Up to Week 4]
  • 7-Day Physical Activity Recall [Time frame: Baseline, Week 2, Week 4]
  • Overall Anxiety Severity and Impairment Scale (OASIS) [Time frame: Baseline, Week 2, Week 4]
  • Anxiety Sensitivity Index (ASI-3) Score [Time frame: Baseline, Week 2, Week 4]
  • Quick Inventory of Depressive Symptomatology (QIDS) Score [Time frame: Baseline, Week 2, Week 4]
  • Perceived Stress Scale (PSS) Score [Time frame: Baseline, Week 2, Week 4]
  • Childhood Trauma Questionnaire [Time frame: Baseline, Week 2, Week 4]
  • Insomnia Severity Index (ISI) Score [Time frame: Baseline, Week 2, Week 4]
  • International Physical Activity Questionnaire (IPAQ) Score [Time frame: Baseline, Week 2, Week 4]
  • Body Mass Index (BMI) [Time frame: Baseline, Week 2, Week 4]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT07340281 · 25-01561

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗