Generalized Anxiety DisorderNCT05203731
Level of Physical Activity and Fear Learning
A study testing Exercise and Sitting in people with Generalized Anxiety Disorder and Social Anxiety Disorder, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder
- What is being tested?
- Exercise and Sitting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2023to 19 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Exercise in the Consolidation of Fear Extinction Learning in Adults With High Anxiety Sensitivity
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.
Read the 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.
- Being tested
- Exercise, Sitting
- Medical subject headings
- Generalized Anxiety Disorder, Phobia, Social, Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Moderate intensity exercise (typically a brisk walk or light run) will occur for 20 minutes after the emotional learning procedures on Day 1.
SittingBehavioural
Sitting will occur for 20 minutes after the emotional learning procedures on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | Participants who will be randomized to moderate intensity exercise after extinction (Day 1) Receives: Behavioral: Exercise |
| Seated group | Sham comparator | Participants who will be randomized to sitting after extinction (Day 1) Receives: Behavioral: Sitting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 2 Visit
Heart rate (HR)
HR will be computed for each trial by collecting Heart rate measurements during the psychophysiological procedures.
Measured: Day 2 Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start31 Jan 2023
- Primary completion19 Mar 2025
- Study completion19 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristin Szuhany, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203731
- Sponsor's protocol ID
- 21-01657
- Status last verified
- Feb 2026
- First submitted
- 20 Jan 2022
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Exercise in the Consolidation of Fear Extinction Learning in Adults With High Anxiety Sensitivity
- ClinicalTrials.gov ID
- NCT05203731
- Acronym / sponsor ID
- 21-01657
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 19 Mar 2025 (actual)
- Study completion
- 19 Mar 2025 (actual)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Behavioral: ExerciseParticipants who will be randomized to moderate intensity exercise after extinction (Day 1) |
| Seated group | Sham comparator | Behavioral: SittingParticipants who will be randomized to sitting after extinction (Day 1) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseModerate intensity exercise (typically a brisk walk or light run) will occur for 20 minutes after the emotional learning procedures on Day 1. | Behavioural | Exercise Group |
| SittingSitting will occur for 20 minutes after the emotional learning procedures on Day 1. | Behavioural | Seated group |
Primary outcome
Skin Conductance Response (SCR)
Time frame: Day 2 Visit
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)
Time frame: Day 2 Visit
HR will be computed for each trial by collecting Heart rate measurements during the psychophysiological procedures.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin Szuhany, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Sitting in people with Generalized Anxiety Disorder and Social Anxiety Disorder, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin Conductance Response (SCR) (time frame: Day 2 Visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.