GATE: Generalized Anxiety - A Treatment Evaluation

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.

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)