GATE: Generalized Anxiety - A Treatment Evaluation

Status Not yet recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03445143
Study type	Interventional
Source	New York University School of Medicine
Contact	Rebecca Lubin
Phone	646 754 7035
Email	rebecca.lubin@nyumc.org
Status	Not yet recruiting
Phase	N/A
Start date	June 2018
Completion date	June 2021

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT03420456` - Transcranial Pulse Near-Infrared Light in Generalized Anxiety Disorder: a Placebo-Controlled Study	N/A
Active, not recruiting	`NCT05530642` - An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel	N/A
Withdrawn	`NCT02382224` - Worry Exposure for Generalized Anxiety Disorder	N/A
Completed	`NCT02256566` - Cognitive Training for Mood and Anxiety Disorders	N/A
Completed	`NCT02306356` - Internet-delivered Treatment for Children With Anxiety Disorders in a Rural Area; an Open Trial in a Clinical Setting	N/A
Completed	`NCT01958788` - Testing Beliefs About Uncertainty in the Treatment of Generalized Anxiety Disorder	N/A
Completed	`NCT01681329` - Cognitive-Behavioral Treatment and Interpretation Modification Training for Adults With Generalized Anxiety Disorder	N/A
Completed	`NCT01201967` - A Collaborative Care Program to Improve Treatment of Depression and Anxiety Disorders in Cardiac Patients	Phase 4
Completed	`NCT01342120` - PHARMO Institute Seroquel Safety Study	N/A
Completed	`NCT01337713` - Efficacy of Massage Therapy in the Treatment of Generalized Anxiety Disorder (GAD)	N/A
Completed	`NCT01203293` - Cognitive Behavioral Therapy (CBT) for Latinos With Generalized Anxiety Disorder in the General Medical Sector	Phase 1
Completed	`NCT01971203` - Efficacy of Extended-release Quetiapine (Seroquel XR) as Adjunctive Therapy to Cognitive Behavioral Therapy in the Treat	N/A
Completed	`NCT00961298` - An Open Label Trial of Duloxetine in the Treatment of Irritable Bowel Syndrome and Comorbid Generalized Anxiety Disorder	Phase 4
Completed	`NCT00744627` - Efficacy and Safety of Vortioxetine (Lu AA21004) for Treatment of Generalized Anxiety Disorder in Adults.	Phase 3
Completed	`NCT00711737` - Study of the Changes in Metabolic Parameters in Patients Treated With Escitalopram for Six Months	N/A
Terminated	`NCT01244711` - Open-Label Pilot Study to Examine the Value of Substituting Quetiapine for Benzodiazepines	Phase 4
Completed	`NCT00537615` - An Open-label Study to Investigate the Absorption, Metabolism and Excretion of Radiolabeled PD 0332334 in Six Healthy Male Volunteers	Phase 1
Completed	`NCT00515242` - Therapeutic Massage for Generalized Anxiety Disorder	Phase 1/Phase 2
Completed	`NCT00525226` - Evaluating the Effects of Stress in Pregnancy	N/A
Completed	`NCT00368745` - Efficacy and Safety of Pregabalin vs Placebo for Generalized Anxiety Disorder (GAD) Symptoms in Subjects Discontinuing Benzodiazepine Treatment and Remaining 6 Weeks on Study Medication, Free From Benzodiazepine Use.	Phase 3