Tranquil Moments II-CBT vs. Yoga for Worry

Completed · Not applicable

Conditions studied: Anxiety

In brief

Anxiety disorders are the most prevalent psychiatric disorders. Among older adults, anxiety is more common that depression, yet research on the nature and treatment of anxiety has lagged far behind that of depression. The investigators' work has demonstrated that CBT is superior to enhanced usual care as well as supportive therapy in improving worry, depressive symptoms, and sleep, and these improvements are maintained for up to 1 year upon completing treatment. Research demonstrates that yoga reduces anxiety symptoms and the investigators' own work demonstrates that yoga improves sleep. However, no one has conducted a comparative effectiveness trial of CBT and yoga for treating worry in older adults. In fact, there are very few comparative effectiveness trials for treating late-life anxiety. Thus, clinicians are unable to provide an informed recommendation of one treatment over the other. The investigators propose a two-stage randomized preference trial comparing 1) cognitive-behavioral therapy with 2) yoga for the treatment of worry in a sample of older adults. Participants will be randomized to either the preference group (participants choose the treatment) or to the random group (participants are randomized to 1 of the 2 treatments). This study design allows for the calculation of traditional treatment effects (differences in outcomes between participants randomized to either CBT or yoga), selection effects (differences in outcomes between participants who choose CBT and those who choose yoga), and preference effects (differences in outcomes between participants who choose their treatment and those who are randomized to treatment).

Key facts

Study ID

NCT02968238

Run by

Wake Forest University Health Sciences

People needed

500

Starts

2017-05-01

Expected to finish

2019-08-28

Last updated by the study team

2020-05-12

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 60 years and older
• Moderate to severe levels of worry

You may not qualify if…

• Currently receiving psychotherapy
• Currently practicing yoga
• Active alcohol/substance abuse
• Dementia
• Current psychotic symptoms
• Active suicidal ideation with plan and intent
• Hearing loss that would prevent a person from participating in telephone/class sessions

Where it is running

• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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