Clinical trial NCT04638946: Exercise for Anxiety
Official title: Optimizing Exercise for the Treatment of Anxiety
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-11-20
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Change in Anxiety Sensitivity Index-3 (ASI-3) score
timeFrame: Baseline, Week 8
measure: Change in Clinical Global Impressions/Severity Scale score
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Engagement
timeFrame: Week 12, Week 20
measure: Adherence
timeFrame: Week 8, Week 12, Week 20
measure: Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) Score
timeFrame: Week 1, Week 4, Week 8, Week 12, Week 20
measure: Work and Social Adjustment Scale (WSAS) Score
timeFrame: Week 1, Week 4, Week 8, Week 12, Week 20
measure: Overall Anxiety Severity and Impairment Scale (OASIS) Score
timeFrame: Week 1, Week 4, Week 8, Week 12, Week 20
measure: Multidimensional Assessment of Interoceptive Awareness (MAIA-2) Score
timeFrame: Week 1, Week 4, Week 8, Week 12, Week 20
measure: Score on Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Week 1, Week 4, Week 8, Week 12, Week 20
measure: 7 Day Physical Activity Recall Questionnaire (PAR) Score
timeFrame: Weekly from Week 0 (screening) to Week 20
measure: Barriers Specific-Self-Efficacy Scale (BARSE) Score
timeFrame: Week 1, Week 4, Week 8, Week 12, Week 20
measure: Physical Activity Enjoyment Scale (PACES)
timeFrame: Week 1, Week 4, Week 8, Week 12, Week 20
measure: Preferences for and Tolerance of the Intensity of Exercise Questionnaire (PRETIE-Q) Score
timeFrame: Week 1, Week 4, Week 8, Week 12, Week 20
measure: Heartrate
timeFrame: Weekly from week 1 to week 20
measure: Ecological Momentary Assessment (EMA) Score
timeFrame: Weekly from week 1 to week 20
measure: Neuroeconomics willingness-to-pay (WTP) auction task adapted for exercise
timeFrame: Week 1, Week 4, Week 8, Week 12, Week 20
measure: Heartrate by Heartbeat Detection Task
timeFrame: Week 1, Week 4, Week 8, Week 12, Week 20
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Kristin Szuhany, PhD
role: PRINCIPAL_INVESTIGATOR
References: