Generalized Anxiety Disorder Clinical Trial
Official title:
GATE: Generalized Anxiety - A Treatment Evaluation
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.
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) |
Country | Name | City | State |
---|---|---|---|
United States | New York University School of Medicine | New York | New York |
Lead Sponsor | Collaborator |
---|---|
New York University School of Medicine | National Institutes of Health (NIH) |
United States,
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 |
Status | Clinical Trial | Phase | |
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