Generalized Anxiety DisorderNCT03819426
Walking or High Intensity Exercise for Anxiety
A study testing Low Intensity Exercise Intervention and High Intensity Intervention in people with Generalized Anxiety Disorder and Panic Disorder, run by NYU Langone Health at 1 site in United States.
Trial summary
After an initial phone screen process, approximately 50 participants will be enrolled and evaluated/screened in person after consenting to achieve 30 eligible participants with a principal diagnosis of GAD, panic disorder, or social anxiety disorder and high anxiety sensitivity (Anxiety Sensitivity Index score =20). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Generalized Anxiety Disorder, Panic Disorder, Social Anxiety
- What is being tested?
- Low Intensity Exercise Intervention and High Intensity Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2018to 29 Jul 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Anxiety Sensitivity Index score of ≥20 (i.e., high anxiety sensitivity)
- Primary psychiatric diagnosis of generalized anxiety disorder (GAD), social anxiety disorder, or panic disorder
- Currently sedentary (≤60 minutes of moderate intensity exercise per week for the past 3 months)
- Able and willing to provide informed consent
Who cannot join
- Lifetime history of Bipolar I or II or any psychotic disorder
- Meets criteria for bulimia or anorexia in the past 6 months
- Meets criteria for substance use disorder in the past 3 months
- High current suicide risk as indicated by a score of ≥4 on the C-SSRS
- Risk for exercise according to Physical Activity Readiness Questionnaire with excluded medical conditions including heart conditions, lung disease, bone/joint problems, or seizures
- Women who are currently pregnant or plan to become pregnant during the duration of the study
Show all 9Show fewer
- Participation in concurrent evidence-based therapy (e.g., cognitive behavioral therapy) targeting anxiety or depression (supportive therapy and couples therapy are allowed)
- Participants on psychiatric medication must be on a stable dose for ≥8 weeks prior to participation
- Current substance abuse or positive urine toxic screen (recreational use of marijuana is permitted based on clinical assessment on the MINI that it does not meet criteria for cannabis use disorder)
Trial locations and contacts
1 site in 1 country.
About this study
After an initial phone screen process, approximately 50 participants will be enrolled and evaluated/screened in person after consenting to achieve 30 eligible participants with a principal diagnosis of GAD, panic disorder, or social anxiety disorder and high anxiety sensitivity (Anxiety Sensitivity Index score =20). Participants will be given a choice of either high intensity interval training (HIIT) or walking interventions, which will be completed over the course of 8 weeks. The goal of the study is to 1) obtain pilot data comparing the efficacy of HIIT vs. walking for effects on psychiatric, functioning and immune outcomes, 2) to identify adherence levels given the choice of exercise intensity, and 3) to identify proportion of individuals opting for each intervention. Results from this pilot study will be used to inform future grant applications including a K award.
- Conditions
- Generalized Anxiety Disorder, Panic Disorder, Social Anxiety
- Being tested
- Low Intensity Exercise Intervention, High Intensity Intervention
- Medical subject headings
- Generalized Anxiety Disorder, Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Intensity Exercise InterventionBehavioural
Those in the walking intervention will be instructed to take walks below a brisk pace (low intensity) to improve mood
High Intensity InterventionBehavioural
Instructed in high intensity interval training techniques and will be provided videos to follow for implementation of intervention at home that will include short bursts of high energy
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Interval Training | Experimental | Participants will be shown the appropriate techniques and intensity (high intensity; i.e., 70-90% of maximum heart rate (220-age) with a verified online youtube video. Participants will be provided with this video and other options that can be followed to complete 15 minute HIIT interventions at home. Interventionist will observe participant engaging in HIIT for 15 minutes. HIIT intervention (for 15 minutes) will also be observed during Session 4 and 8. Receives: Behavioral: High Intensity Intervention |
| Walking | Experimental | This intervention will be demonstrated during Session 1. Participants will be shown the appropriate walking intensity (low intensity; i.e., approximately 50% of maximum heart rate (220-age) or lower) by interventionist. Interventionist will observe participant engaging in walking at appropriate intensity level for 15 minutes. Walking intervention (for 15 minutes) will also be observed during Session 4 and 8. Receives: Behavioral: Low Intensity Exercise Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of HIIT measured by Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q-SF)
Scoring involves summing only the first 14 items to yield a raw total score. The last two items are not included in the total score but are stand alone items. The raw score ranges from 14 to 70.
Measured: Week 1
Efficacy of HIIT measured by Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q-SF)
Scoring involves summing only the first 14 items to yield a raw total score. The last two items are not included in the total score but are stand alone items. The raw score ranges from 14 to 70.
Measured: Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start11 Dec 2018
- Primary completion29 Jul 2020
- Study completion29 Jul 2020
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristin Szuhany, PhD, Principal investigator, NYU Langone
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03819426
- Sponsor's protocol ID
- 18-01277
- Status last verified
- Sep 2020
- First submitted
- 29 Oct 2018
- Last updated
- 28 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Any requests for data will be considered on a case by case basis given the pilot nature of this project. As this is a pilot study, there will not be sufficient data for systematic sharing. Means of participant data will be shared on clinicaltrials.gov.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Walking or High Intensity Exercise for Anxiety
- ClinicalTrials.gov ID
- NCT03819426
- Acronym / sponsor ID
- 18-01277
- Conditions
- Generalized Anxiety Disorder, Panic Disorder, Social Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 11 Dec 2018 (actual)
- Primary completion
- 29 Jul 2020 (actual)
- Study completion
- 29 Jul 2020 (actual)
- First posted
- 28 Jan 2019 (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.
After an initial phone screen process, approximately 50 participants will be enrolled and evaluated/screened in person after consenting to achieve 30 eligible participants with a principal diagnosis of GAD, panic disorder, or social anxiety disorder and high anxiety sensitivity (Anxiety Sensitivity Index score =20). Participants will be given a choice of either high intensity interval training (HIIT) or walking interventions, which will be completed over the course of 8 weeks. The goal of the study is to 1) obtain pilot data comparing the efficacy of HIIT vs. walking for effects on psychiatric, functioning and immune outcomes, 2) to identify adherence levels given the choice of exercise intensity, and 3) to identify proportion of individuals opting for each intervention. Results from this pilot study will be used to inform future grant applications including a K award.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Intensity Interval Training | Experimental | Behavioral: High Intensity InterventionParticipants will be shown the appropriate techniques and intensity (high intensity; i.e., 70-90% of maximum heart rate (220-age) with a verified online youtube video. Participants will be provided with this video and other options that can be followed to complete 15 minute HIIT interventions at home. Interventionist will observe participant engaging in HIIT for 15 minutes. HIIT intervention (for 15 minutes) will also be observed during Session 4 and 8. |
| Walking | Experimental | Behavioral: Low Intensity Exercise InterventionThis intervention will be demonstrated during Session 1. Participants will be shown the appropriate walking intensity (low intensity; i.e., approximately 50% of maximum heart rate (220-age) or lower) by interventionist. Interventionist will observe participant engaging in walking at appropriate intensity level for 15 minutes. Walking intervention (for 15 minutes) will also be observed during Session 4 and 8. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Anxiety Sensitivity Index score of ≥20 (i.e., high anxiety sensitivity)
- Primary psychiatric diagnosis of generalized anxiety disorder (GAD), social anxiety disorder, or panic disorder
- Currently sedentary (≤60 minutes of moderate intensity exercise per week for the past 3 months)
- Able and willing to provide informed consent
Key exclusion criteria (9 listed)
- Lifetime history of Bipolar I or II or any psychotic disorder
- Meets criteria for bulimia or anorexia in the past 6 months
- Meets criteria for substance use disorder in the past 3 months
- High current suicide risk as indicated by a score of ≥4 on the C-SSRS
- Risk for exercise according to Physical Activity Readiness Questionnaire with excluded medical conditions including heart conditions, lung disease, bone/joint problems, or seizures
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 |
|---|---|---|
| Low Intensity Exercise InterventionThose in the walking intervention will be instructed to take walks below a brisk pace (low intensity) to improve mood | Behavioural | Walking |
| High Intensity InterventionInstructed in high intensity interval training techniques and will be provided videos to follow for implementation of intervention at home that will include short bursts of high energy | Behavioural | High Intensity Interval Training |
Primary outcome
Efficacy of HIIT measured by Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q-SF)
Time frame: Week 1
Scoring involves summing only the first 14 items to yield a raw total score. The last two items are not included in the total score but are stand alone items. The raw score ranges from 14 to 70.
Efficacy of HIIT measured by Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q-SF)
Time frame: Week 10
Scoring involves summing only the first 14 items to yield a raw total score. The last two items are not included in the total score but are stand alone items. The raw score ranges from 14 to 70.
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 28 Sep 2020.
- Individual participant dataSharing planned: Yes. Any requests for data will be considered on a case by case basis given the pilot nature of this project. As this is a pilot study, there will not be sufficient data for systematic sharing. Means of participant data will be shared on clinicaltrials.gov.
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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, PhD principal investigator
NYU Langone
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Intensity Exercise Intervention and High Intensity Intervention in people with Generalized Anxiety Disorder and Panic 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 28 Sep 2020. 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. 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?
Efficacy of HIIT measured by Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q-SF) (time frame: Week 1). 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 28 Sep 2020; AzTrials last refreshed its copy on 30 Oct 2026.