Clinical trial NCT01912287: GATE: Generalized Anxiety - A Treatment Evaluation
Official title: GATE: Generalized Anxiety - A Treatment Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Generalized Anxiety Disorder
Keywords: Generalized Anxiety Disorder
GAD
Yoga
CBT
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2013-07-31
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

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)

Primary outcomes:
measure: Proportion of Participants With Treatment Response
timeFrame: Biweekly from weeks 0 through 12
Secondary outcomes:
measure: Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A)
timeFrame: Weeks 0, 6 , 12 and 6 month follow up
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston University
state: Massachusetts
Study officials:
affiliation: NYU Langone Health
name: Naomi M Simon, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston University
name: Stefan G Hofmann, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Eric Bui, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Szuhany 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.
citation: Simon 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.