GATE: Generalized Anxiety - A Treatment Evaluation

Generalized Anxiety Disorder Clinical Trial

Official title:

GATE: Generalized Anxiety - A Treatment Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01912287
• Other study ID #: s17-00526
• Secondary ID: 1R01AT007258-01A
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: October 25, 2019

Study information

• Verified date: June 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT03445143

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: October 25, 2019
• Est. primary completion date: April 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

Behavioral:
• Cognitive Behavioral Therapy
CBT focused on Generalized Anxiety Disorder (12 sessions)
• Stress Education
Active control group (12 sessions)
• Yoga
12 sessions, mindfulness components

Locations

Country	Name	City	State
United States	Boston University	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants With Treatment Response	Treatment response is a dichotomous outcome coded 0=no treatment response, 1= treatment response. This treatment response coding was derived from the Clinical Global Impression-Improvement (CGI-I) measure. The CGI-I is a clinician administered instrument that assesses level of symptom change across the course of treatment. The CGI-I ranges from 1 to 7, with lower scores indicating greater improvement. Our treatment response outcome variable was coded 0 if CGI-I was 3 or more. Treatment response was coded 1 if CGI-I was rated 1 (very much improved) or 2 (much improved).	Biweekly from weeks 0 through 12
Secondary	Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A)		Weeks 0, 6 , 12 and 6 month follow up