Recruitment

Recruitment Status
Completed

Inclusion Criterias

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
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
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
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 Criterias

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)
Significant current suicidal ideation or suicidal behaviors within the past 6 months (assessed with the Beck Depression Inventory-II [BDI-II])
...
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)
Significant current suicidal ideation or suicidal behaviors within the past 6 months (assessed with the Beck Depression Inventory-II [BDI-II])
Pregnancy as assessed by pregnancy test at screen or lack of use approved methods birth control for women of childbearing age
Patients unable to understand study procedures and participate in the informed consent process.
Serious medical illness or instability for which hospitalization may be likely within the next year
Posttraumatic stress disorder, substance use disorder, eating disorder, or organic mental disorder within the past 6 months
Cognitive impairment (MOCA<21)
Women who are planning to become pregnant
History of head trauma causing loss of consciousness, or seizure disorder resulting in ongoing cognitive impairment
Significant personality dysfunction likely to interfere with study participation (assessed during the clinical interview)
Physical conditions that might cause injury from yoga (pregnancy, physical injuries and musculoskeletal problems)
Lifetime history of psychotic disorder, bipolar disorder, or developmental disorder

Summary

Conditions
Generalized Anxiety Disorder
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 fo...

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 Criterias

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
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
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
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 Criterias

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)
Significant current suicidal ideation or suicidal behaviors within the past 6 months (assessed with the Beck Depression Inventory-II [BDI-II])
...
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)
Significant current suicidal ideation or suicidal behaviors within the past 6 months (assessed with the Beck Depression Inventory-II [BDI-II])
Pregnancy as assessed by pregnancy test at screen or lack of use approved methods birth control for women of childbearing age
Patients unable to understand study procedures and participate in the informed consent process.
Serious medical illness or instability for which hospitalization may be likely within the next year
Posttraumatic stress disorder, substance use disorder, eating disorder, or organic mental disorder within the past 6 months
Cognitive impairment (MOCA<21)
Women who are planning to become pregnant
History of head trauma causing loss of consciousness, or seizure disorder resulting in ongoing cognitive impairment
Significant personality dysfunction likely to interfere with study participation (assessed during the clinical interview)
Physical conditions that might cause injury from yoga (pregnancy, physical injuries and musculoskeletal problems)
Lifetime history of psychotic disorder, bipolar disorder, or developmental disorder

Locations

Boston, Massachusetts, 02215
Boston, Massachusetts, 02114
Boston, Massachusetts, 02215
Boston, Massachusetts, 02114

Tracking Information

NCT #
NCT01912287
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Investigators
  • Principal Investigator: Naomi M Simon, MD, MSc NYU Langone Health Principal Investigator: Stefan G Hofmann, PhD Boston University Principal Investigator: Eric Bui, MD, PhD Massachusetts General Hospital
  • Naomi M Simon, MD, MSc NYU Langone Health Principal Investigator: Stefan G Hofmann, PhD Boston University Principal Investigator: Eric Bui, MD, PhD Massachusetts General Hospital