Exercise for Anxiety
- Conditions
- Anxiety
- Interventions
- Behavioral: Titration to high intensity exercise (T-HIE)Behavioral: Low intensity exercise prescription
- Registration Number
- NCT04638946
- Lead Sponsor
- NYU Langone Health
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Titration to high intensity exercise Titration to high intensity exercise (T-HIE) - Low intensity exercise Low intensity exercise prescription -
- Primary Outcome Measures
Name Time Method Change in Anxiety Sensitivity Index-3 (ASI-3) score Baseline, Week 8 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 Baseline, Week 8 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
Name Time Method Work and Social Adjustment Scale (WSAS) Score Week 1, Week 4, Week 8, Week 12, Week 20 5 item self-report scale measing impairment in functioning with total score ranging from 0 (no impairment) to 40 (severe impairment).
7 Day Physical Activity Recall Questionnaire (PAR) Score Weekly from Week 0 (screening) to Week 20 interviewer-administered measure of self-reported weekly physical activity
Preferences for and Tolerance of the Intensity of Exercise Questionnaire (PRETIE-Q) Score Week 1, Week 4, Week 8, Week 12, Week 20 16-item measure assessing preferences for different exercise intensities, with strong ability to differentiate preferences for HIE vs. LIE.
Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) Score Week 1, Week 4, Week 8, Week 12, Week 20 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).
Barriers Specific-Self-Efficacy Scale (BARSE) Score Week 1, Week 4, Week 8, Week 12, Week 20 13-item measure, will assess barriers to exercise and will be used as a covariate predicting exercise engagement
Engagement Week 12, Week 20 Completion of exercise of any intensity (proportion of 75min assigned)
Adherence Week 8, Week 12, Week 20 Percentage of duration goals achieving target heart rate
Multidimensional Assessment of Interoceptive Awareness (MAIA-2) Score Week 1, Week 4, Week 8, Week 12, Week 20 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.
Ecological Momentary Assessment (EMA) Score Weekly from week 1 to week 20 Surveys will consist of five 0-100 Likert scale items assessing mood, anxiety, motivation, energy, and enjoyment.
Overall Anxiety Severity and Impairment Scale (OASIS) Score Week 1, Week 4, Week 8, Week 12, Week 20 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).
Score on Montgomery-Asberg Depression Rating Scale (MADRS) Week 1, Week 4, Week 8, Week 12, Week 20 A 10-item clinician-rated measure of depression severity. Total score ranges from 0 (normal/no symptoms) to 60 (severe depression).
Physical Activity Enjoyment Scale (PACES) Week 1, Week 4, Week 8, Week 12, Week 20 18-item measure assessing enjoyment of exercise
Heartrate Weekly from week 1 to week 20 Measured by the Fitbit Charge 3
Neuroeconomics willingness-to-pay (WTP) auction task adapted for exercise Week 1, Week 4, Week 8, Week 12, Week 20 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 Week 1, Week 4, Week 8, Week 12, Week 20 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.
Trial Locations
- Locations (1)
NYU Langone Health
🇺🇸New York, New York, United States