GATE: Generalized Anxiety - A Treatment Evaluation



Status:Recruiting
Conditions:Anxiety, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:2/17/2019
Start Date:December 2013
End Date:March 31, 2019

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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.

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)
We found this trial at
2
sites
One Silber Way
Boston, Massachusetts 02215
(617) 353-2000
Principal Investigator: Stefan G Hofmann, PhD
Phone: 617-353-9610
Boston University Boston University is no small operation . With over 33,000 undergraduate and graduate...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Naomi M Simon, MD, MSc
Phone: 617-726-1579
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