title: Yoga for generalized anxiety disorder: design of a randomized controlled clinical trial.
abstract: Generalized anxiety disorder (GAD) is a common disorder associated with significant distress and interference. Although cognitive behavioral therapy (CBT) has been shown to be the most effective form of psychotherapy, few patients receive or have access to this intervention. Yoga therapy offers another promising, yet under-researched, intervention that is gaining increasing popularity in the general public, as an anxiety reduction intervention. The purpose of this innovative clinical trial protocol is to investigate the efficacy of a Kundalini Yoga intervention, relative to CBT and a control condition. Kundalini yoga and CBT are compared with each other in a noninferiority test and both treatments are compared to stress education training, an attention control intervention, in superiority tests. The sample will consist of 230 individuals with a primary DSM-5 diagnosis of GAD. This randomized controlled trial will compare yoga (N=95) to both CBT for GAD (N=95) and stress education (N=40), a commonly used control condition. All three treatments will be administered by two instructors in a group format over 12 weekly sessions with four to six patients per group. Groups will be randomized using permuted block randomization, which will be stratified by site. Treatment outcome will be evaluated bi-weekly and at 6month follow-up. Furthermore, potential mediators of treatment outcome will be investigated. Given the individual and economic burden associated with GAD, identifying accessible alternative behavioral treatments will have substantive public health implications.
authors.affiliation: Boston University, United States.
authors.forename: Stefan G
authors.initials: SG
authors.lastname: Hofmann
authors.affiliation: Boston University, United States.
authors.forename: Joshua
authors.initials: J
authors.lastname: Curtiss
authors.affiliation: Brigham and Women's Hospital, Harvard Medical School, United States.
authors.forename: Sat Bir S
authors.initials: SBS
authors.lastname: Khalsa
authors.affiliation: Massachusetts General Hospital, United States.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Hoge
authors.affiliation: Southern Methodist University, United States.
authors.forename: David
authors.initials: D
authors.lastname: Rosenfield
authors.affiliation: Massachusetts General Hospital, United States.
authors.forename: Eric
authors.initials: E
authors.lastname: Bui
authors.affiliation: Massachusetts General Hospital, United States.
authors.forename: Aparna
authors.initials: A
authors.lastname: Keshaviah
authors.affiliation: Massachusetts General Hospital, United States.
authors.forename: Naomi
authors.initials: N
authors.lastname: Simon
keywords: Alternative medicine; Clinical trial; Cognitive behavioral therapy; Generalized anxiety disorder; Kundalini yoga; Mindfulness