Walking or High Intensity Exercise for Anxiety

Not Applicable

Completed

• Conditions: Generalized Anxiety Disorder; Panic Disorder; Social Anxiety
• Interventions: Behavioral: Low Intensity Exercise Intervention; Behavioral: High Intensity Intervention

• Registration Number: NCT03819426
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-29
• Study Start: 2018-12-11
• Study First Submitted QC: 2019-01-25
• Study First Posted: 2019-01-28
• Primary Completion: 2020-07-29
• Study Completion: 2020-07-29
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-25
• Last Update Posted: 2020-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Walking	Low Intensity Exercise Intervention	This intervention will be demonstrated during Session 1. Participants will be shown the appropriate walking intensity (low intensity; i.e., approximately 50% of maximum heart rate (220-age) or lower) by interventionist. Interventionist will observe participant engaging in walking at appropriate intensity level for 15 minutes. Walking intervention (for 15 minutes) will also be observed during Session 4 and 8.
High Intensity Interval Training	High Intensity Intervention	Participants will be shown the appropriate techniques and intensity (high intensity; i.e., 70-90% of maximum heart rate (220-age) with a verified online youtube video. Participants will be provided with this video and other options that can be followed to complete 15 minute HIIT interventions at home. Interventionist will observe participant engaging in HIIT for 15 minutes. HIIT intervention (for 15 minutes) will also be observed during Session 4 and 8.

Primary Outcome Measures

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

Trial Locations

Locations (1)

NYU Langone; 🇺🇸 New York, New York, United States