Clinical trial NCT03819426: Walking or High Intensity Exercise for Anxiety
Official title: Walking or High Intensity Exercise for Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Generalized Anxiety Disorder
Panic Disorder
Social Anxiety
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2019-01-28
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: After an initial phone screen process, approximately 50 participants will be enrolled and evaluated/screened in person after consenting to achieve 30 eligible participants with a principal diagnosis of GAD, panic disorder, or social anxiety disorder and high anxiety sensitivity (Anxiety Sensitivity Index score =20). Participants will be given a choice of either high intensity interval training (HIIT) or walking interventions, which will be completed over the course of 8 weeks. The goal of the study is to 1) obtain pilot data comparing the efficacy of HIIT vs. walking for effects on psychiatric, functioning and immune outcomes, 2) to identify adherence levels given the choice of exercise intensity, and 3) to identify proportion of individuals opting for each intervention. Results from this pilot study will be used to inform future grant applications including a K award.


Eligibility criteria: Inclusion Criteria:

* Anxiety Sensitivity Index score of ≥20 (i.e., high anxiety sensitivity)
* Primary psychiatric diagnosis of generalized anxiety disorder (GAD), social anxiety disorder, or panic disorder
* Currently sedentary (≤60 minutes of moderate intensity exercise per week for the past 3 months)
* Able and willing to provide informed consent

Exclusion Criteria:

* Lifetime history of Bipolar I or II or any psychotic disorder
* Meets criteria for bulimia or anorexia in the past 6 months
* Meets criteria for substance use disorder in the past 3 months
* High current suicide risk as indicated by a score of ≥4 on the C-SSRS
* Risk for exercise according to Physical Activity Readiness Questionnaire with excluded 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
* Participation in concurrent evidence-based therapy (e.g., cognitive behavioral therapy) targeting anxiety or depression (supportive therapy and couples therapy are allowed)
* Participants on psychiatric medication must be on a stable dose for ≥8 weeks prior to participation
* Current substance abuse or positive urine toxic screen (recreational use of marijuana is permitted based on clinical assessment on the MINI that it does not meet criteria for cannabis use disorder)

Primary outcomes:
measure: Efficacy of HIIT measured by Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q-SF)
timeFrame: Week 1
measure: Efficacy of HIIT measured by Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q-SF)
timeFrame: Week 10
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone
state: New York
Study officials:
affiliation: NYU Langone
name: Kristin Szuhany, PhD
role: PRINCIPAL_INVESTIGATOR
References: