Exercise for Anxiety
Primary Purpose
Anxiety
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Titration to high intensity exercise (T-HIE)
Low intensity exercise prescription
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety
Eligibility Criteria
Inclusion Criteria
- Males and females ages 18-65
- Primary psychiatric diagnosis of generalized anxiety disorder (GAD), social anxiety disorder, or panic disorder
- Anxiety Sensitivity Index-3 score of ≥23 (i.e., high anxiety sensitivity)
- Currently sedentary (≤60 minutes of moderate intensity exercise per week for the past 3 months)
- Body mass index <40
- Able and willing to provide informed consent
Exclusion Criteria
- Lifetime history of Bipolar I or II or any psychotic disorder
- Bulimia or anorexia in the past 6 months
- Substance use disorder in the past 3 months
- Current PTSD (past PTSD is allowed)
- High current 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) consistent with a need for referral to higher level of care
Sites / Locations
- NYU Langone HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Titration to high intensity exercise
Low intensity exercise
Arm Description
Outcomes
Primary Outcome Measures
Change in Anxiety Sensitivity Index-3 (ASI-3) score
The ASI-3 is an 18-item measure of fear of anxiety sensations with three subscales (physical, cognitive, social concerns). The total score ranges from 0 (lowest anxiety sensitivity) to 72 (highest anxiety sensitivity).
Change in Clinical Global Impressions/Severity Scale score
A validated Clinical Global Impressions/Severity Scale (CGI) anchored for anxiety disorders measures overall functioning and clinical improvement. CGI-S is rated from 1 (least disordered) to 7 (most disordered).Scores of 1 or 2 on the CGI-I at post-treatment will represent significant response.
Secondary Outcome Measures
Engagement
Completion of exercise of any intensity (proportion of 75min assigned)
Adherence
Percentage of duration goals achieving target heart rate
Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) Score
14-item clinician-rated measure of severity of anxiety symptoms; The total score ranges from 0 (least severe anxiety symptoms) to 56 (most severe anxiety symptoms).
Work and Social Adjustment Scale (WSAS) Score
5 item self-report scale measing impairment in functioning with total score ranging from 0 (no impairment) to 40 (severe impairment).
Overall Anxiety Severity and Impairment Scale (OASIS) Score
A 5-item self-report scale measuring anxiety symptom severity and impairment due to anxiety; response items are coded from 0 to 4 and can be summed to obtain a total score range from 0 (least severity and impairment) to 20 (most severity and impairment).
Multidimensional Assessment of Interoceptive Awareness (MAIA-2) Score
A 37-item measure with 8 subscales assessing noticing bodily sensations, not distracting from bodily sensations, not worry about bodily sensations, attention regulation, emotional awareness (awareness of connection between emotions and bodily sensations), self-regulation of distress by body sensations, body listening, and trusting one's body.
Score on Montgomery-Asberg Depression Rating Scale (MADRS)
A 10-item clinician-rated measure of depression severity. Total score ranges from 0 (normal/no symptoms) to 60 (severe depression).
7 Day Physical Activity Recall Questionnaire (PAR) Score
interviewer-administered measure of self-reported weekly physical activity
Barriers Specific-Self-Efficacy Scale (BARSE) Score
13-item measure, will assess barriers to exercise and will be used as a covariate predicting exercise engagement
Physical Activity Enjoyment Scale (PACES)
18-item measure assessing enjoyment of exercise
Preferences for and Tolerance of the Intensity of Exercise Questionnaire (PRETIE-Q) Score
16-item measure assessing preferences for different exercise intensities, with strong ability to differentiate preferences for HIE vs. LIE.
Heartrate
Measured by the Fitbit Charge 3
Ecological Momentary Assessment (EMA) Score
Surveys will consist of five 0-100 Likert scale items assessing mood, anxiety, motivation, energy, and enjoyment.
Neuroeconomics willingness-to-pay (WTP) auction task adapted for exercise
will evaluate the subjective threshold between an option's anticipated value and its cost (maximum amount WTP for an expected outcome) and is based on the Becker-DeGroot-Marschak (BDM) auction task68, modified for exercise. Participants will have the opportunity to avoid exercising for a specific timeframe (e.g., 1min, 15min) at a specific intensity (low, moderate, high). The task will first be administered on paper (21-item questionnaire), which will be computerized in line with training aims.
Heartrate by Heartbeat Detection Task
Participants silently count their heartbeats for 6 trials of approximately 20-30 seconds (~5 minutes) while being monitored on an EKG to assess accuracy of reporting. This will assess interoceptive accuracy and will be used as a covariate at baseline and change with intervention will be assessed over time.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04638946
Brief Title
Exercise for Anxiety
Official Title
Optimizing Exercise for the Treatment of Anxiety
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2021 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
November 30, 2025 (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
Yes
5. Study Description
Brief Summary
90 sedentary adults with a primary anxiety disorder and high anxiety sensitivity will be randomized to either 8 weeks of 1) low intensity exercise, or 2) flexible titration to high intensity exercise (HIE). Blinded, validated clinician-rated and patient-rated outcomes will be assessed over treatment and at 1- and 3-month follow-up. To better understand what mechanisms influence decisions to exercise in the real-world, we will use of heart rate (HR) as an objective mechanistic target for exercise intensity, examine changes in valuation of exercise through a neuroeconomics task, examine changes in interoceptive sensitivity with a heartbeat detection task, and integrate of ecological momentary assessment (EMA) to measure effects of immediate changes in mood with exercise on anxiety outcomes and adherence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Titration to high intensity exercise
Arm Type
Experimental
Arm Title
Low intensity exercise
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Titration to high intensity exercise (T-HIE)
Intervention Description
All participants will receive psychoeducation regarding the rationale for using exercise as a strategy to create immediate changes in mood and anxiety. Participants will be instructed in basic motivational principles (e.g., breaking up goals into smaller parts, using rewards) based on information in Exercise for Mood and Anxiety. Participants will begin at low intensity with the goal of titrating to high intensity by 2 weeks prior to the end of trial (Week 6). If a participant achieves at least 70% of the duration goal at the target heart rate, he/she will be titrated to the next dose level (moderate intensity). This will continue until high intensity exercise is achieved. Prescription is based on heart rate reserve((maximum heart rate [220-age] - resting heart rate)*intensity percent - resting heart rate. Intensity percent lower/upper limits for moderate intensity are 40-59% and for high intensity are 60-84%.
Intervention Type
Behavioral
Intervention Name(s)
Low intensity exercise prescription
Intervention Description
All participants will receive psychoeducation regarding the rationale for using exercise as a strategy to create immediate changes in mood and anxiety. Participants will be instructed in basic motivational principles (e.g., breaking up goals into smaller parts, using rewards) based on information in Exercise for Mood and Anxiety. Prescription is based on heart rate reserve ((maximum heart rate [220-age] - resting heart rate)*30-39% (lower/upper limit of zone) - resting heart rate.
Primary Outcome Measure Information:
Title
Change in Anxiety Sensitivity Index-3 (ASI-3) score
Description
The ASI-3 is an 18-item measure of fear of anxiety sensations with three subscales (physical, cognitive, social concerns). The total score ranges from 0 (lowest anxiety sensitivity) to 72 (highest anxiety sensitivity).
Time Frame
Baseline, Week 8
Title
Change in Clinical Global Impressions/Severity Scale score
Description
A validated Clinical Global Impressions/Severity Scale (CGI) anchored for anxiety disorders measures overall functioning and clinical improvement. CGI-S is rated from 1 (least disordered) to 7 (most disordered).Scores of 1 or 2 on the CGI-I at post-treatment will represent significant response.
Time Frame
Baseline, Week 8
Secondary Outcome Measure Information:
Title
Engagement
Description
Completion of exercise of any intensity (proportion of 75min assigned)
Time Frame
Week 12, Week 20
Title
Adherence
Description
Percentage of duration goals achieving target heart rate
Time Frame
Week 8, Week 12, Week 20
Title
Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) Score
Description
14-item clinician-rated measure of severity of anxiety symptoms; The total score ranges from 0 (least severe anxiety symptoms) to 56 (most severe anxiety symptoms).
Time Frame
Week 1, Week 4, Week 8, Week 12, Week 20
Title
Work and Social Adjustment Scale (WSAS) Score
Description
5 item self-report scale measing impairment in functioning with total score ranging from 0 (no impairment) to 40 (severe impairment).
Time Frame
Week 1, Week 4, Week 8, Week 12, Week 20
Title
Overall Anxiety Severity and Impairment Scale (OASIS) Score
Description
A 5-item self-report scale measuring anxiety symptom severity and impairment due to anxiety; response items are coded from 0 to 4 and can be summed to obtain a total score range from 0 (least severity and impairment) to 20 (most severity and impairment).
Time Frame
Week 1, Week 4, Week 8, Week 12, Week 20
Title
Multidimensional Assessment of Interoceptive Awareness (MAIA-2) Score
Description
A 37-item measure with 8 subscales assessing noticing bodily sensations, not distracting from bodily sensations, not worry about bodily sensations, attention regulation, emotional awareness (awareness of connection between emotions and bodily sensations), self-regulation of distress by body sensations, body listening, and trusting one's body.
Time Frame
Week 1, Week 4, Week 8, Week 12, Week 20
Title
Score on Montgomery-Asberg Depression Rating Scale (MADRS)
Description
A 10-item clinician-rated measure of depression severity. Total score ranges from 0 (normal/no symptoms) to 60 (severe depression).
Time Frame
Week 1, Week 4, Week 8, Week 12, Week 20
Title
7 Day Physical Activity Recall Questionnaire (PAR) Score
Description
interviewer-administered measure of self-reported weekly physical activity
Time Frame
Weekly from Week 0 (screening) to Week 20
Title
Barriers Specific-Self-Efficacy Scale (BARSE) Score
Description
13-item measure, will assess barriers to exercise and will be used as a covariate predicting exercise engagement
Time Frame
Week 1, Week 4, Week 8, Week 12, Week 20
Title
Physical Activity Enjoyment Scale (PACES)
Description
18-item measure assessing enjoyment of exercise
Time Frame
Week 1, Week 4, Week 8, Week 12, Week 20
Title
Preferences for and Tolerance of the Intensity of Exercise Questionnaire (PRETIE-Q) Score
Description
16-item measure assessing preferences for different exercise intensities, with strong ability to differentiate preferences for HIE vs. LIE.
Time Frame
Week 1, Week 4, Week 8, Week 12, Week 20
Title
Heartrate
Description
Measured by the Fitbit Charge 3
Time Frame
Weekly from week 1 to week 20
Title
Ecological Momentary Assessment (EMA) Score
Description
Surveys will consist of five 0-100 Likert scale items assessing mood, anxiety, motivation, energy, and enjoyment.
Time Frame
Weekly from week 1 to week 20
Title
Neuroeconomics willingness-to-pay (WTP) auction task adapted for exercise
Description
will evaluate the subjective threshold between an option's anticipated value and its cost (maximum amount WTP for an expected outcome) and is based on the Becker-DeGroot-Marschak (BDM) auction task68, modified for exercise. Participants will have the opportunity to avoid exercising for a specific timeframe (e.g., 1min, 15min) at a specific intensity (low, moderate, high). The task will first be administered on paper (21-item questionnaire), which will be computerized in line with training aims.
Time Frame
Week 1, Week 4, Week 8, Week 12, Week 20
Title
Heartrate by Heartbeat Detection Task
Description
Participants silently count their heartbeats for 6 trials of approximately 20-30 seconds (~5 minutes) while being monitored on an EKG to assess accuracy of reporting. This will assess interoceptive accuracy and will be used as a covariate at baseline and change with intervention will be assessed over time.
Time Frame
Week 1, Week 4, Week 8, Week 12, Week 20
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Males and females ages 18-65
Primary psychiatric diagnosis of generalized anxiety disorder (GAD), social anxiety disorder, or panic disorder
Anxiety Sensitivity Index-3 score of ≥23 (i.e., high anxiety sensitivity)
Currently sedentary (≤60 minutes of moderate intensity exercise per week for the past 3 months)
Body mass index <40
Able and willing to provide informed consent
Exclusion Criteria
Lifetime history of Bipolar I or II or any psychotic disorder
Bulimia or anorexia in the past 6 months
Substance use disorder in the past 3 months
Current PTSD (past PTSD is allowed)
High current 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) consistent with a need for referral to higher level of care
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristin Szuhany, PhD
Phone
646-754-5161
Email
Kristin.szuhany@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Giselle Cornejo
Email
Giselle.Cornejo@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin Szuhany, PhD
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, PhD
First Name & Middle Initial & Last Name & Degree
Giselle Cornejo
Email
Giselle.Cornejo@nyulangone.org
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to the PI. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
beginning 9 months and ending 36 months following article publication
IPD Sharing Access Criteria
Requests may be directed to the PI
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Exercise for Anxiety
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