GATE: Generalized Anxiety - A Treatment Evaluation

Generalized Anxiety Disorder Clinical Trial

Official title:

GATE: Generalized Anxiety - A Treatment Evaluation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03445143
• Other study ID #: 17-00526
• Status: Not yet recruiting
• Phase: N/A
• First received: February 20, 2018
• Last updated: February 20, 2018
• Start date: June 2018
• Est. completion date: June 2021

Study information

• Verified date: February 2018
• Source: New York University School of Medicine
• Contact: Rebecca Lubin
• Phone: 646 754 7035
• Email: rebecca.lubin[@]nyumc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The general purpose of the study is to determine whether yoga is an effective method for treating Generalized Anxiety (GAD), and its relative efficacy compared to a standard psychosocial intervention. This five-year multi-site study will examine the comparative efficacy of yoga, CBT, and stress education, a previously employed control condition, for patients with GAD. Across 2 enrolling centers (BU and MGH) 230 patients will be randomized with GAD to one of three 12 session weekly study treatments: 12-weekly yoga (n=95), CBT (n=95), or stress education (SE: n=40). Independent clinical assessments will occur before the 12-session intervention phase, at mid-treatment, after the intervention, and at 6-month follow-up. All clinician-rated outcomes will be assessed by trained Independent Evaluators (IEs) blind to treatment assignment.

Description:

Investigators hypothesize that Yoga and Cognitive Beahvioral Therapy (CBT) will each be superior to Stress Education (SE) at post-treatment follow up, and Yoga and CBT will not differ based on equivalency analyses. Treatment changes during yoga are mediated via changes in mindfulness and changes in vagal tone, whereas changes in CBT are mediated via changes in maladaptive cognitions.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• Male or female outpatients 18 years of age or older with a primary psychiatric diagnosis of generalized anxiety disorder

• CGI-severity 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.

Exclusion Criteria:

• Patients unable to understand study procedures and participate in the informed consent process.

• For women of childbearing age: Pregnant (based on urine pregnancy test), planning to become pregnant, or lack the use of approved methods of birth control

• 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

• 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 mind-body techniques (e.g., yoga, meditation, Tai-Chi, etc) or CBT

• Concomitant psychotherapy for GAD (any psychotherapy)

• 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
• Generalized Anxiety Disorder

Intervention

Behavioral:
• 12 Week Kundalini Yoga Practices
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.
• Stress Education (SE)
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.
• 12 session CBT treatment
his protocol is comprised of four primary treatment modules including cognitive restructuring, progressive muscle relaxation, worry exposures, and in vivo exposure exercises.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Clinician Global Impression Improvement Scale (CGI-I)	Treatment response is defined as a CGI-I of 1 (very much improved) or 2 (much improved).	60 Months
Secondary	State Trait Anxiety Inventory (STAI)	The STAI-A is a 40-item, multiple-choice questionnaire that differentiates between the temporary condition of "state anxiety" and the more general and long-standing quality of "trait anxiety." As a result, it is useful in both clinical and research contexts. It will be used at assessments.	60 Months
Secondary	Perceived stress Scale (PSS)	This 10-item scale is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. It will be used at assessments.	60 Months
Secondary	Beck Depression Inventory (BDI-II)	This 21-item self-report inventory designed to measure severity of depression symptoms in psychiatric populations has high internal consistency and test-retest reliability.It will be used at assessments	60 Months
Secondary	Beck Anxiety Inventory (BAI)	This 21-item self-report inventory designed to measure severity of anxiety symptoms in psychiatric populations has high internal consistency and test-retest reliability. It will be used at assessments.	60 Months
Secondary	Quality of Life Scale (WHOQOL-BREF)	This instrument assesses quality of life enjoyment and satisfaction. It will be used at assessments.	60 Months
Secondary	Pittsburgh Sleep Quality Index (PSQI)	This is a 19-item, self report measure of sleep quality over a one month duration. The items make up seven different component scores consisting of sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication and daytime dysfunction. This measure also generates a global sleep quality score. It will be used at assessments.	60 Months
Secondary	Insomnia Severity Index (ISI)	This is a 7-item, self-report measure toassess insomnia as defined by the DSM-IV. It will be used at assessments	60 Months
Secondary	Affective Style Questionnaire (ASQ)	This is a 20-item, self report measure to assess individual differences in emotion regulation.	60 Months
Secondary	Penn State Worry Questionnaire-Past Week (PSWQ-PW)	This is a15-item, self-report measure of worry (PSWQ) Items are rated on a five-point Likert scale, and are summed to form a total score ranging from 16 to 80. The PSWQ has excellent psychometric properties in student, community, and clinical samples. It will be used at assessments.	60 Months