Anxiety
Conditions
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.
Interventions
BEHAVIORALTitration 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%.
BEHAVIORALLow 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.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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). |
| 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). |
| 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). |
| 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. |
| 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). |
| 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 |
| 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 |
| Physical Activity Enjoyment Scale (PACES) | Week 1, Week 4, Week 8, Week 12, Week 20 | 18-item measure assessing enjoyment of exercise |
| 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. |
| Heartrate | Weekly from week 1 to week 20 | Measured by the Fitbit Charge 3 |
| 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. |
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKristin Szuhany, PhD
NYU Langone Health
Outcome results
None listed