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Level of Physical Activity and Fear Learning

Primary Purpose

Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sitting
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Generalized Anxiety Disorder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males and females ages 18-60
  • A primary diagnosis of a DSM-5 anxiety disorder (generalized anxiety disorder, panic disorder, social anxiety disorder)
  • Anxiety Sensitivity Index-3 score of ≥23 (i.e., high anxiety sensitivity)
  • Able and willing to provide informed consent

Exclusion Criteria:

  • Lifetime Bipolar Disorder or psychosis
  • Past 3 months substance use disorder or eating disorder
  • Current PTSD (past PTSD > 6 months prior to screening is allowed)
  • High risk for exercise according to the Physical Activity Readiness Questionnaire and American College of Sports Medicine guidelines with excluded active medical conditions including heart conditions, lung disease, bone/joint problems, or seizures
  • Women who are currently pregnant
  • Acute 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)
  • Benzodiazepine use
  • Current substance abuse or positive urine toxicology screen (recreational use of marijuana is permitted based on clinical assessment on the MINI structured diagnostic interview that it does not meet criteria for cannabis use disorder)
  • Stable psychiatric medications for at least 4 weeks prior to experimental procedures

Sites / Locations

  • NYU Langone HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Exercise Group

Seated group

Arm Description

Participants who will be randomized to moderate intensity exercise after extinction (Day 1)

Participants who will be randomized to sitting after extinction (Day 1)

Outcomes

Primary Outcome Measures

Skin Conductance Response (SCR)
SCR will be computed for each trial by subtracting the mean skin conductance level observed during the last two seconds of context presentation from the maximal skin conductance level reached during CS presentation. All SCR values will be square-root transformed prior to any statistical analyses. To evaluate extinction recall, an extinction retention index (ERI) will be computed for each individual using the following formula: 100 - (mean SCR to the first 4 CS+E trials during recall / maximum SCR reached during conditioning for this same cue) * 100
Heart rate (HR)
HR will be computed for each trial by collecting Heart rate measurements during the psychophysiological procedures.

Secondary Outcome Measures

Full Information

First Posted
January 20, 2022
Last Updated
June 18, 2023
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT05203731
Brief Title
Level of Physical Activity and Fear Learning
Official Title
The Role of Exercise in the Consolidation of Fear Extinction Learning in Adults With High Anxiety Sensitivity
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2023 (Actual)
Primary Completion Date
January 14, 2024 (Anticipated)
Study Completion Date
January 14, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The proposed experimental study will be the first to investigate whether exercise vs. sitting enhances consolidation of extinction learning in adults with high AS and anxiety disorders, and the mechanistic pathways of expectancy, affect, and key stress response markers.
Detailed Description
This is an experimental study (not a treatment study) aiming to examine the effects of acute exercise vs. sitting on fear extinction learning in a 2-day paradigm. 50 eligible (after screening) men and women ages 18-60 with high anxiety sensitivity (AS) and an anxiety disorder (generalized anxiety disorder, panic disorder, social anxiety disorder) will participate in a consecutive 2-day paradigm. Participants will be randomized to 1 of 2 conditions immediately following the emotional learning paradigm: 1) moderate intensity exercise (n=25) or 2) sitting(n=25), for 20 minutes. Day 2 will include testing of emotional learning. Primary outcomes are physiological arousal (skin conductance, heart rate) during Day 2 procedures. Mechanistic factors, including expected negative consequences of exercise, affect during exercise, threat/shock expectancy, and changes pre-post exercise in stress related neuroendocrine markers (cortisol and alpha-amylase) and their effects on extinction recall will be measured.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise Group
Arm Type
Experimental
Arm Description
Participants who will be randomized to moderate intensity exercise after extinction (Day 1)
Arm Title
Seated group
Arm Type
Sham Comparator
Arm Description
Participants who will be randomized to sitting after extinction (Day 1)
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Moderate intensity exercise (typically a brisk walk or light run) will occur for 20 minutes after the emotional learning procedures on Day 1.
Intervention Type
Behavioral
Intervention Name(s)
Sitting
Intervention Description
Sitting will occur for 20 minutes after the emotional learning procedures on Day 1.
Primary Outcome Measure Information:
Title
Skin Conductance Response (SCR)
Description
SCR will be computed for each trial by subtracting the mean skin conductance level observed during the last two seconds of context presentation from the maximal skin conductance level reached during CS presentation. All SCR values will be square-root transformed prior to any statistical analyses. To evaluate extinction recall, an extinction retention index (ERI) will be computed for each individual using the following formula: 100 - (mean SCR to the first 4 CS+E trials during recall / maximum SCR reached during conditioning for this same cue) * 100
Time Frame
Day 2 Visit
Title
Heart rate (HR)
Description
HR will be computed for each trial by collecting Heart rate measurements during the psychophysiological procedures.
Time Frame
Day 2 Visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females ages 18-60 A primary diagnosis of a DSM-5 anxiety disorder (generalized anxiety disorder, panic disorder, social anxiety disorder) Anxiety Sensitivity Index-3 score of ≥23 (i.e., high anxiety sensitivity) Able and willing to provide informed consent Exclusion Criteria: Lifetime Bipolar Disorder or psychosis Past 3 months substance use disorder or eating disorder Current PTSD (past PTSD > 6 months prior to screening is allowed) High risk for exercise according to the Physical Activity Readiness Questionnaire and American College of Sports Medicine guidelines with excluded active medical conditions including heart conditions, lung disease, bone/joint problems, or seizures Women who are currently pregnant Acute 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) Benzodiazepine use Current substance abuse or positive urine toxicology screen (recreational use of marijuana is permitted based on clinical assessment on the MINI structured diagnostic interview that it does not meet criteria for cannabis use disorder) Stable psychiatric medications for at least 4 weeks prior to experimental procedures
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristin Szuhany, MD
Phone
646-754-5161
Email
Kristin.szuhany@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Giselle Corneji
Email
Giselle.Cornejo@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin Szuhany, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristin Szuhany, MD
Phone
646-754-5161
Email
Kristin.szuhany@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Giselle Cornejo
Email
Giselle.Cornejo@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Kristin Szuhany, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This pilot study is not funded to support data sharing in a small pilot sample size. The Brain & Behavior Research Foundation (funder) does not require data sharing. However, individual requests for deidentified data will be considered in the future, if appropriate.

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Level of Physical Activity and Fear Learning

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