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GATE: Generalized Anxiety - A Treatment Evaluation

GATE: Generalized Anxiety - A Treatment Evaluation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01912287
Enrollment
226
Registered
2013-07-31
Start date
2013-12-31
Completion date
2019-10-25
Last updated
2020-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized Anxiety Disorder

Keywords

Generalized Anxiety Disorder, GAD, Yoga, CBT

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.

Interventions

BEHAVIORALCognitive Behavioral Therapy

CBT focused on Generalized Anxiety Disorder (12 sessions)

Active control group (12 sessions)

BEHAVIORALYoga

12 sessions, mindfulness components

Sponsors

National Center for Complementary and Integrative Health (NCCIH)
CollaboratorNIH
NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Proportion of Participants With Treatment ResponseBiweekly from weeks 0 through 12Treatment 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).

Secondary

MeasureTime frame
Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A)Weeks 0, 6 , 12 and 6 month follow up

Countries

United States

Participant flow

Participants by arm

ArmCount
Yoga
The yoga intervention will apply Kundalini Yoga practices as taught by Yogi Bhajan. This is a well-known, accessible style of practice in the U.S. that incorporates all of the traditional components of yoga including physical postures and exercises, breathing techniques, relaxation exercises and meditation practices. It is a safe style of yoga that is registered with the Yoga Alliance that is readily and routinely adapted for therapeutic purposes. The 12-week yoga intervention will consist of 12 group classes and assigned daily home practice led by qualified and certified yoga instructors. Each group yoga session will include physical postures/exercises, breathing techniques, meditation and deep relaxation practice that are all easy to learn and do not require extensive practice or athletic ability to perform. Yoga: 12 sessions, mindfulness components
93
Cognitive Behavioral Therapy (CBT)
The 12 session CBT treatment will be based on the standardized protocol developed at one of our centers (CARD) and widely available. This protocol is comprised of four primary treatment modules including cognitive restructuring, progressive muscle relaxation, worry exposures, and in vivo exposure exercises. The initial sessions describe the cognitive behavioral model of worry and GAD. Each session consists of a different lesson. These lessons initially cover basic information about the nature of the anxiety and worry, the possible function and negative consequences of worrying, the maladaptive and paradoxical effects of attempting to control and suppress one's thoughts, the basic cognitive errors of probability overestimation and catastrophic thinking, adaptive strategies to deal with worries, such as problem solving, worry exposure, which may involve exploring and exposing the patient to negative images and scenarios that might be behind some of the worrisome thoughts.
90
Stress Education
SE will also include 12 weeks of group and home practice sessions. SE will control for attention from instructors, expectancy effects, and group support effects, Stress Education (SE) will be employed as an active control intervention. SE is currently used in NIH-funded protocols at the Benson-Henry Institute for Mind-Body Medicine at MGH. In this condition, participants will be provided with detailed and extensive information about stress and health, but will not receive any CBT, yoga, or other mind-body training techniques. Stress Education: Active control group (12 sessions)
43
Total226

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyDissatisfaction with assigned treatment421
Overall StudyFelt treatment no longer needed010
Overall StudyIneligible101
Overall StudyLife circumstances420
Overall StudyLost Interest100
Overall StudyMissed Assesment111
Overall StudyNo-show001
Overall StudyScheduling/change in availability17108
Overall StudyUknown reason - subject drop out573

Baseline characteristics

CharacteristicYogaCognitive Behavioral Therapy (CBT)Stress EducationTotal
Age, Continuous32.6 years
STANDARD_DEVIATION 13.3
35.1 years
STANDARD_DEVIATION 13.8
31.6 years
STANDARD_DEVIATION 13.3
33.1 years
STANDARD_DEVIATION 13.45
Race/Ethnicity, Customized
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Asian and Native Hawaiian or Pacific Islander
8 Participants8 Participants5 Participants21 Participants
Race/Ethnicity, Customized
Black or African American
3 Participants5 Participants3 Participants11 Participants
Race/Ethnicity, Customized
Ethnicity: Hispanic or Latino
11 Participants6 Participants1 Participants18 Participants
Race/Ethnicity, Customized
Unknown or not reported
3 Participants8 Participants5 Participants16 Participants
Race/Ethnicity, Customized
White
79 Participants69 Participants30 Participants178 Participants
Region of Enrollment
United States
93 Participants90 Participants43 Participants226 Participants
Sex: Female, Male
Female
67 Participants62 Participants29 Participants158 Participants
Sex: Female, Male
Male
26 Participants28 Participants14 Participants68 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 930 / 900 / 43
other
Total, other adverse events
40 / 9334 / 908 / 43
serious
Total, serious adverse events
0 / 931 / 900 / 43

Outcome results

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).

Time frame: Biweekly from weeks 0 through 12

ArmMeasureValue (NUMBER)
YogaProportion of Participants With Treatment Response0.54 Proportion of participants
Cognitive Behavioral Therapy (CBT)Proportion of Participants With Treatment Response0.71 Proportion of participants
Stress EducationProportion of Participants With Treatment Response0.33 Proportion of participants
Comparison: This comparison is from the Generalized Linear Mixed Models (GLMM) analysis using a quadratic growth curve over time. This comparison is at post-treatment. Note, although all 3 groups are included in the GLMM, this statistical test specifically compares response rates of KY vs. SE at post-treatmentp-value: 0.0395% CI: [1.12, 5.42]Generalized Linear Mixed Models
Comparison: This comparison is from the Generalized Linear Mixed Models (GLMM) analysis using a quadratic growth curve over time. This comparison is at post-treatment. Note, although all 3 groups are included in the GLMM, this statistical test specifically compares response rates of CBT vs. SE at post-treatmentp-value: <0.00195% CI: [2.12, 11.82]Generalized Linear Mixed Models
Comparison: This comparison is from the Generalized Linear Mixed Models (GLMM) analysis using a quadratic growth curve over time. This comparison is at post-treatment. Note, although all 3 groups are included in the GLMM, this statistical test specifically compares response rates of KY vs. CBT at post-treatmentp-value: 0.0795% CI: [0.24, 1.03]Generalized Linear Mixed Models
Secondary

Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A)

Time frame: Weeks 0, 6 , 12 and 6 month follow up

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026