Walking or High Intensity Exercise for Anxiety

Generalized Anxiety Disorder Clinical Trial

Official title:

Walking or High Intensity Exercise for Anxiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03819426
• Other study ID #: 18-01277
• Status: Completed
• Phase: N/A
• Start date: December 11, 2018
• Est. completion date: July 29, 2020

Study information

• Verified date: September 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: July 29, 2020
• Est. primary completion date: July 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Generalized Anxiety Disorder
• Panic Disorder
• Social Anxiety

Intervention

Behavioral:
• Low Intensity Exercise Intervention
Those in the walking intervention will be instructed to take walks below a brisk pace (low intensity) to improve mood
• High Intensity Intervention
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

Locations

Country	Name	City	State
United States	NYU Langone	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of HIIT measured by Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q-SF)	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.	Week 1
Primary	Efficacy of HIIT measured by Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q-SF)	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.	Week 10