NCT02968238

Tranquil Moments II-CBT vs. Yoga for Worry

Completed NA Last updated 12 May 2020

What this trial tests

NA trial testing Cognitive-behavioral therapy in Anxiety in 500 participants. Completed in 28 August 2019.

Timeline

1 May 2017

Primary endpoint
22 April 2019

28 August 2019

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	single
Primary purpose	treatment
Enrollment	500
Start date	1 May 2017
Primary completion	22 April 2019
Estimated completion	28 August 2019
Sites	1 location across United States

Drugs / interventions tested

• Cognitive-behavioral therapy
• Yoga

Conditions studied

• Anxiety — all drugs for Anxiety →

Sponsor

Wake Forest University Health Sciences

Who can join

60 and older, any sex, with Anxiety. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. A randomized preference trial of cognitive-behavioral therapy and yoga for the treatment of worry in anxious older adults.
   Brenes GA, Divers J, Miller ME, Danhauer SC. · · 2018 · cited 16× · PMID 30009275 · DOI 10.1016/j.conctc.2018.05.002
2. Long-Term Effects of Cognitive-Behavioral Therapy and Yoga for Worried Older Adults.
   Danhauer SC, Miller ME, Divers J, Anderson A, et al · · 2022 · cited 8× · PMID 35260292 · DOI 10.1016/j.jagp.2022.02.002
3. Ensuring Yoga Intervention Fidelity in a Randomized Preference Trial for the Treatment of Worry in Older Adults.
   Sohl SJ, Brenes GA, Krucoff C, Hargis G, et al · · 2021 · cited 2× · PMID 33684325 · DOI 10.1089/acm.2020.0476