N/A
N=226
GATE: Generalized Anxiety - A Treatment Evaluation
Generalized Anxiety Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01912287 ↗Enrolled (actual)
226
Serious AEs
0.4%
Results posted
Jun 2020
Primary outcome: Primary: Proportion of Participants With Treatment Response — 0.54; 0.71; 0.33 Proportion of participants — p=.03
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cognitive Behavioral Therapy (Behavioral); Stress Education (Behavioral); Yoga (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants With Treatment Response |
0.54; 0.71; 0.33 | .03 sig |
| SECONDARY Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- 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)
Data sourced from ClinicalTrials.gov (NCT01912287). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.