Exercise for Anxiety

NYU Langone Health

Status: Enrolling

Conditions: Anxiety

Treatments: Behavioral: Titration to high intensity exercise (T-HIE); Behavioral: Low intensity exercise prescription

Study type: Interventional

Funder types: Other

Identifiers

NCT04638946

20-01348

Details and patient eligibility

About

90 sedentary adults with a primary anxiety disorder and high anxiety sensitivity will be randomized to either 8 weeks of 1) low intensity exercise, or 2) flexible titration to high intensity exercise (HIE). Blinded, validated clinician-rated and patient-rated outcomes will be assessed over treatment and at 1- and 3-month follow-up. To better understand what mechanisms influence decisions to exercise in the real-world, we will use of heart rate (HR) as an objective mechanistic target for exercise intensity, examine changes in valuation of exercise through a neuroeconomics task, examine changes in interoceptive sensitivity with a heartbeat detection task, and integrate of ecological momentary assessment (EMA) to measure effects of immediate changes in mood with exercise on anxiety outcomes and adherence.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Males and females ages 18-65
• Primary psychiatric diagnosis of generalized anxiety disorder (GAD), social anxiety disorder, or panic disorder
• Anxiety Sensitivity Index-3 score of ≥23 (i.e., high anxiety sensitivity)
• Currently sedentary (≤60 minutes of moderate intensity exercise per week for the past 3 months)
• Body mass index <40
• Able and willing to provide informed consent

Exclusion Criteria

• Lifetime history of Bipolar I or II or any psychotic disorder
• Bulimia or anorexia in the past 6 months
• Substance use disorder in the past 3 months
• Current PTSD (past PTSD is allowed)
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Titration to high intensity exercise

Experimental group

Treatment:

Behavioral: Titration to high intensity exercise (T-HIE)

Low intensity exercise

Active Comparator group

Treatment:

Behavioral: Low intensity exercise prescription