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OpenTrials
Completed

NCT Number: NCT03819426

Walking or High Intensity Exercise for Anxiety

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Low Intensity Exercise Intervention

Behavioral

Those in the walking intervention will be instructed to take walks below a brisk pace (low intensity) to improve mood

High Intensity Intervention

Behavioral

Instructed in high intensity interval training techniques and will be provided videos to follow for implementation of intervention at home that will include short bursts of high energy

Primary outcomes

  1. Efficacy of HIIT measured by Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q-SF)

    Time frame: Week 1

    Scoring involves summing only the first 14 items to yield a raw total score. The last two items are not included in the total score but are stand alone items. The raw score ranges from 14 to 70.

  2. Efficacy of HIIT measured by Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q-SF)

    Time frame: Week 10

    Scoring involves summing only the first 14 items to yield a raw total score. The last two items are not included in the total score but are stand alone items. The raw score ranges from 14 to 70.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 28, 2019
Registry last updated
Sep 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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