Generalized Anxiety DisorderNCT01912287
GATE: Generalized Anxiety - A Treatment Evaluation
A study testing Cognitive Behavioral Therapy, Stress Education and Yoga in people with Generalized Anxiety Disorder, run by NYU Langone Health at 2 sites in United States.
Trial summary
The purpose of this randomized study is to examine the comparative efficacy of yoga, cognitive behavioral therapy, and stress education, a previously employed control condition, for patients with Generalized Anxiety Disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Cognitive Behavioral Therapy, Stress Education and Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 226 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2013to 25 Oct 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female outpatients > 18 years of age with a primary psychiatric diagnosis of generalized anxiety disorder
- Clinical Global Impression-Severity scale (CGI-S) score of 4 or higher
- Off concurrent psychotropic medication for at least 2 weeks prior to initiation of randomized treatment, OR stable on current medication for a minimum of 6 weeks and willing to maintain a stable dose
- Willingness and ability to perform the yoga intervention and to comply with the requirements of the study protocol.
- For women of childbearing potential, willingness to use a reliable form of birth control
Who cannot join
- Patients unable to understand study procedures and participate in the informed consent process.
- Pregnancy as assessed by pregnancy test at screen or lack of use approved methods birth control for women of childbearing age
- Women who are planning to become pregnant
- Serious medical illness or instability for which hospitalization may be likely within the next year
- Significant current suicidal ideation or suicidal behaviors within the past 6 months (assessed with the Beck Depression Inventory-II [BDI-II])
- History of head trauma causing loss of consciousness, or seizure disorder resulting in ongoing cognitive impairment
Show all 13Show fewer
- Posttraumatic stress disorder, substance use disorder, eating disorder, or organic mental disorder within the past 6 months
- Lifetime history of psychotic disorder, bipolar disorder, or developmental disorder
- Significant personality dysfunction likely to interfere with study participation (assessed during the clinical interview)
- Prior experience with (more than 5 Yoga classes or CBT sessions within the last 3 years) and/or current practice of mindbody techniques (e.g., yoga, meditation, Tai-Chi, etc) or cognitive behavioral therapy (CBT)
- Concomitant therapy for generalized anxiety disorder (GAD) (any therapy)
- Physical conditions that might cause injury from yoga (pregnancy, physical injuries and musculoskeletal problems)
- Cognitive impairment (MOCA<21)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston University
Boston, Massachusetts, 02215
About this study
The purpose of this randomized study is to examine the comparative efficacy of yoga, cognitive behavioral therapy, and stress education, a previously employed control condition, for patients with Generalized Anxiety Disorder.
Read the detailed description
We are currently conducting a treatment study to reduce stress and anxiety in people with generalized anxiety disorder (GAD). This study will not use a medication, but instead will involve weekly stress reduction classes that use different strategies to reduce anxiety. The study involves having a formal psychiatric interview, filling out questionnaires, ECGs, saliva samples, a urine test for drugs of abuse, and study visits over 12 weeks. Each study visit will take a few hours. Qualified participants will be compensated for time and travel.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Cognitive Behavioral Therapy, Stress Education, Yoga
- Keywords
- Generalized Anxiety Disorder, GAD, Yoga, CBT
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Also called CBT
CBT focused on Generalized Anxiety Disorder (12 sessions)
Stress EducationBehavioural
Also called SE
Active control group (12 sessions)
YogaBehavioural
Also called Kundalini Yoga
12 sessions, mindfulness components
| Study group | Role | What they receive |
|---|---|---|
| Yoga | Experimental | The yoga intervention will apply Kundalini Yoga practices as taught by Yogi Bhajan. This is a well-known, accessible style of practice in the U.S. that incorporates all of the traditional components of yoga including physical postures and exercises, breathing techniques, relaxation exercises and meditation practices. It is a safe style of yoga that is registered with the Yoga Alliance that is readily and routinely adapted for therapeutic purposes. The 12-week yoga intervention will consist of 12 group classes and assigned daily home practice led by qualified and certified yoga instructors. Each group yoga session will include physical postures/exercises, breathing techniques, meditation and deep relaxation practice that are all easy to learn and do not require extensive practice or athletic ability to perform. Receives: Behavioral: Yoga |
| Cognitive Behavioral Therapy (CBT) | Active comparator | The 12 session CBT treatment will be based on the standardized protocol developed at one of our centers (CARD) and widely available [88]. This protocol is comprised of four primary treatment modules including cognitive restructuring, progressive muscle relaxation, worry exposures, and in vivo exposure exercises. The initial sessions describe the cognitive behavioral model of worry and GAD. Each session consists of a different "lesson." These lessons initially cover basic information about the nature of the anxiety and worry, the possible function and negative consequences of worrying, the maladaptive and paradoxical effects of attempting to control and suppress one's thoughts, the basic cognitive errors of probability overestimation and catastrophic thinking, adaptive strategies to deal with worries, such as problem solving, worry exposure, which may involve exploring and exposing the patient to negative images and scenarios that might be behind some of the worrisome thoughts. Receives: Behavioral: Cognitive Behavioral Therapy |
| Stress Education | Sham comparator | SE will also include 12 weeks of group and home practice sessions. SE will control for attention from instructors, expectancy effects, and group support effects, Stress Education (SE) will be employed as an active control intervention. SE is currently used in NIH-funded protocols at the Benson-Henry Institute for Mind-Body Medicine at MGH. In this condition, participants will be provided with detailed and extensive information about stress and health, but will not receive any CBT, yoga, or other mind-body training techniques. Receives: Behavioral: Stress Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With Treatment Response
Treatment response is a dichotomous outcome coded 0=no treatment response, 1= treatment response. This treatment response coding was derived from the Clinical Global Impression-Improvement (CGI-I) measure. The CGI-I is a clinician administered instrument that assesses level of symptom change across the course of treatment. The CGI-I ranges from 1 to 7, with lower scores indicating greater improvement. Our treatment response outcome variable was coded 0 if CGI-I was 3 or more. Treatment response was coded 1 if CGI-I was rated 1 (very much improved) or 2 (much improved).
Measured: Biweekly from weeks 0 through 12
Secondary outcomes (1)
Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A)
Measured: Weeks 0, 6 , 12 and 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study startDec 2013
- Primary completion29 Apr 2019
- Study completion25 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Naomi M Simon, MD, MSc, Principal investigator, NYU Langone HealthStefan G Hofmann, PhD, Principal investigator, Boston UniversityEric Bui, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912287
- Sponsor's protocol ID
- s17-00526
- Other IDs
- 1R01AT007258-01A1
- Status last verified
- Jun 2020
- First submitted
- 29 Jul 2013
- Last updated
- 22 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Keltz S, Quintana L, Szuhany KL, Adhikari S, Twi-Yeboah A, Baker AW, Khalsa SBS, Hoge E, Bui E, Hoeppner SS, Rosenfield D, Hofmann SG, Simon NM. Impact of homework engagement on treatment response to group cognitive-behavioral therapy, yoga, and stress education for generalized anxiety disorder. Cogn Behav Ther. 2025 Nov 18:1-12. doi: 10.1080/16506073.2025.2589392. Online ahead of print.
PubMed 41252645Hoge EA, Simon NM, Szuhany K, Feldman B, Rosenfield D, Hoeppner S, Jennings E, Khalsa SB, Hofmann SG. Comparing Kundalini Yoga, cognitive behavioral therapy, and stress education for generalized anxiety disorder: Anxiety and depression symptom outcomes. Psychiatry Res. 2023 Sep;327:115362. doi: 10.1016/j.psychres.2023.115362. Epub 2023 Aug 6.
PubMed 37598625Szuhany KL, Adhikari S, Chen A, Lubin RE, Jennings E, Rassaby M, Eakley R, Brown ML, Suzuki R, Barthel AL, Rosenfield D, Hoeppner SS, Khalsa SB, Bui E, Hofmann SG, Simon NM. Impact of preference for yoga or cognitive behavioral therapy in patients with generalized anxiety disorder on treatment outcomes and engagement. J Psychiatr Res. 2022 Sep;153:109-115. doi: 10.1016/j.jpsychires.2022.07.008. Epub 2022 Jul 5.
PubMed 35810600Simon NM, Hofmann SG, Rosenfield D, Hoeppner SS, Hoge EA, Bui E, Khalsa SBS. Efficacy of Yoga vs Cognitive Behavioral Therapy vs Stress Education for the Treatment of Generalized Anxiety Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Jan 1;78(1):13-20. doi: 10.1001/jamapsychiatry.2020.2496.
PubMed 32805013
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GATE: Generalized Anxiety - A Treatment Evaluation
- ClinicalTrials.gov ID
- NCT01912287
- Acronym / sponsor ID
- s17-00526
- Conditions
- Generalized Anxiety Disorder
- Keywords
- Generalized Anxiety Disorder, GAD, Yoga, CBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Dec 2013
- Primary completion
- 29 Apr 2019 (actual)
- Study completion
- 25 Oct 2019 (actual)
- First posted
- 31 Jul 2013 (estimated)
- Results
- Posted 22 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this randomized study is to examine the comparative efficacy of yoga, cognitive behavioral therapy, and stress education, a previously employed control condition, for patients with Generalized Anxiety Disorder.
Detailed description
We are currently conducting a treatment study to reduce stress and anxiety in people with generalized anxiety disorder (GAD). This study will not use a medication, but instead will involve weekly stress reduction classes that use different strategies to reduce anxiety. The study involves having a formal psychiatric interview, filling out questionnaires, ECGs, saliva samples, a urine test for drugs of abuse, and study visits over 12 weeks. Each study visit will take a few hours. Qualified participants will be compensated for time and travel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Yoga | Experimental | Behavioral: YogaThe yoga intervention will apply Kundalini Yoga practices as taught by Yogi Bhajan. This is a well-known, accessible style of practice in the U.S. that incorporates all of the traditional components of yoga including physical postures and exercises, breathing techniques, relaxation exercises and meditation practices. It is a safe style of yoga that is registered with the Yoga Alliance that is readily and routinely adapted for therapeutic purposes. The 12-week yoga intervention will consist of 12 group classes and assigned daily home practice led by qualified and certified yoga instructors. Each group yoga session will include physical postures/exercises, breathing techniques, meditation and deep relaxation practice that are all easy to learn and do not require extensive practice or athletic ability to perform. |
| Cognitive Behavioral Therapy (CBT) | Active comparator | Behavioral: Cognitive Behavioral TherapyThe 12 session CBT treatment will be based on the standardized protocol developed at one of our centers (CARD) and widely available [88]. This protocol is comprised of four primary treatment modules including cognitive restructuring, progressive muscle relaxation, worry exposures, and in vivo exposure exercises. The initial sessions describe the cognitive behavioral model of worry and GAD. Each session consists of a different "lesson." These lessons initially cover basic information about the nature of the anxiety and worry, the possible function and negative consequences of worrying, the maladaptive and paradoxical effects of attempting to control and suppress one's thoughts, the basic cognitive errors of probability overestimation and catastrophic thinking, adaptive strategies to deal with worries, such as problem solving, worry exposure, which may involve exploring and exposing the patient to negative images and scenarios that might be behind some of the worrisome thoughts. |
| Stress Education | Sham comparator | Behavioral: Stress EducationSE will also include 12 weeks of group and home practice sessions. SE will control for attention from instructors, expectancy effects, and group support effects, Stress Education (SE) will be employed as an active control intervention. SE is currently used in NIH-funded protocols at the Benson-Henry Institute for Mind-Body Medicine at MGH. In this condition, participants will be provided with detailed and extensive information about stress and health, but will not receive any CBT, yoga, or other mind-body training techniques. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female outpatients > 18 years of age with a primary psychiatric diagnosis of generalized anxiety disorder
- Clinical Global Impression-Severity scale (CGI-S) score of 4 or higher
- Off concurrent psychotropic medication for at least 2 weeks prior to initiation of randomized treatment, OR stable on current medication for a minimum of 6 weeks and willing to maintain a stable dose
- Willingness and ability to perform the yoga intervention and to comply with the requirements of the study protocol.
- For women of childbearing potential, willingness to use a reliable form of birth control
Key exclusion criteria (13 listed)
- Patients unable to understand study procedures and participate in the informed consent process.
- Pregnancy as assessed by pregnancy test at screen or lack of use approved methods birth control for women of childbearing age
- Women who are planning to become pregnant
- Serious medical illness or instability for which hospitalization may be likely within the next year
- Significant current suicidal ideation or suicidal behaviors within the past 6 months (assessed with the Beck Depression Inventory-II [BDI-II])
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 |
|---|---|---|
| Cognitive Behavioral TherapyAlso: CBTCBT focused on Generalized Anxiety Disorder (12 sessions) | Behavioural | Cognitive Behavioral Therapy (CBT) |
| Stress EducationAlso: SEActive control group (12 sessions) | Behavioural | Stress Education |
| YogaAlso: Kundalini Yoga12 sessions, mindfulness components | Behavioural | Yoga |
Primary outcome
Proportion of Participants With Treatment Response
Time frame: Biweekly from weeks 0 through 12
Treatment response is a dichotomous outcome coded 0=no treatment response, 1= treatment response. This treatment response coding was derived from the Clinical Global Impression-Improvement (CGI-I) measure. The CGI-I is a clinician administered instrument that assesses level of symptom change across the course of treatment. The CGI-I ranges from 1 to 7, with lower scores indicating greater improvement. Our treatment response outcome variable was coded 0 if CGI-I was 3 or more. Treatment response was coded 1 if CGI-I was rated 1 (very much improved) or 2 (much improved).
1 secondary outcome
Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A)
Time frame: Weeks 0, 6 , 12 and 6 month follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41252645Keltz S, Quintana L, Szuhany KL, Adhikari S, Twi-Yeboah A, Baker AW, Khalsa SBS, Hoge E, Bui E, Hoeppner SS, Rosenfield D, Hofmann SG, Simon NM. Impact of homework engagement on treatment response to group cognitive-behavioral therapy, yoga, and stress education for generalized anxiety disorder. Cogn Behav Ther. 2025 Nov 18:1-12. doi: 10.1080/16506073.2025.2589392. Online ahead of print.
- Derived from this study: PubMed 37598625Hoge EA, Simon NM, Szuhany K, Feldman B, Rosenfield D, Hoeppner S, Jennings E, Khalsa SB, Hofmann SG. Comparing Kundalini Yoga, cognitive behavioral therapy, and stress education for generalized anxiety disorder: Anxiety and depression symptom outcomes. Psychiatry Res. 2023 Sep;327:115362. doi: 10.1016/j.psychres.2023.115362. Epub 2023 Aug 6.
- Derived from this study: PubMed 35810600Szuhany KL, Adhikari S, Chen A, Lubin RE, Jennings E, Rassaby M, Eakley R, Brown ML, Suzuki R, Barthel AL, Rosenfield D, Hoeppner SS, Khalsa SB, Bui E, Hofmann SG, Simon NM. Impact of preference for yoga or cognitive behavioral therapy in patients with generalized anxiety disorder on treatment outcomes and engagement. J Psychiatr Res. 2022 Sep;153:109-115. doi: 10.1016/j.jpsychires.2022.07.008. Epub 2022 Jul 5.
- Derived from this study: PubMed 32805013Simon NM, Hofmann SG, Rosenfield D, Hoeppner SS, Hoge EA, Bui E, Khalsa SBS. Efficacy of Yoga vs Cognitive Behavioral Therapy vs Stress Education for the Treatment of Generalized Anxiety Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Jan 1;78(1):13-20. doi: 10.1001/jamapsychiatry.2020.2496.
- Individual participant dataSharing planned: No
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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.
Naomi M Simon, MD, MSc principal investigator
NYU Langone Health
Stefan G Hofmann, PhD principal investigator
Boston University
Eric Bui, MD, PhD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy, Stress Education and Yoga in people with Generalized Anxiety Disorder, run by NYU Langone Health at 2 sites 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 5 inclusion and 13 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 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 22 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Participants With Treatment Response (time frame: Biweekly from weeks 0 through 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01912287, which also lists 4 linked publications.
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 22 Jun 2020.