Exercise for Anxiety

Anxiety Clinical Trial

Official title:

Optimizing Exercise for the Treatment of Anxiety

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04638946
• Other study ID #: 20-01348
• Status: Recruiting
• Phase: N/A
• Start date: June 30, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: NYU Langone Health
• Contact: Kristin Szuhany, PhD
• Phone: 646-754-5161
• Email: Kristin.szuhany[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Behavioral:
• Titration to high intensity exercise (T-HIE)
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%.
• Low intensity exercise prescription
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.

Locations

Country	Name	City	State
United States	NYU Langone Health	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	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).	Baseline, Week 8
Primary	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.	Baseline, Week 8
Secondary	Engagement	Completion of exercise of any intensity (proportion of 75min assigned)	Week 12, Week 20
Secondary	Adherence	Percentage of duration goals achieving target heart rate	Week 8, Week 12, Week 20
Secondary	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).	Week 1, Week 4, Week 8, Week 12, Week 20
Secondary	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).	Week 1, Week 4, Week 8, Week 12, Week 20
Secondary	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).	Week 1, Week 4, Week 8, Week 12, Week 20
Secondary	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.	Week 1, Week 4, Week 8, Week 12, Week 20
Secondary	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).	Week 1, Week 4, Week 8, Week 12, Week 20
Secondary	7 Day Physical Activity Recall Questionnaire (PAR) Score	interviewer-administered measure of self-reported weekly physical activity	Weekly from Week 0 (screening) to Week 20
Secondary	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	Week 1, Week 4, Week 8, Week 12, Week 20
Secondary	Physical Activity Enjoyment Scale (PACES)	18-item measure assessing enjoyment of exercise	Week 1, Week 4, Week 8, Week 12, Week 20
Secondary	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.	Week 1, Week 4, Week 8, Week 12, Week 20
Secondary	Heartrate	Measured by the Fitbit Charge 3	Weekly from week 1 to week 20
Secondary	Ecological Momentary Assessment (EMA) Score	Surveys will consist of five 0-100 Likert scale items assessing mood, anxiety, motivation, energy, and enjoyment.	Weekly from week 1 to week 20
Secondary	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.	Week 1, Week 4, Week 8, Week 12, Week 20
Secondary	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.	Week 1, Week 4, Week 8, Week 12, Week 20