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Tranquil Moments II-CBT vs. Yoga for Worry

NCT02968238 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2020-05-12

No results posted yet for this study

Summary

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).

Conditions

Interventions

BEHAVIORAL

Cognitive-behavioral therapy

10 weekly sessions of cognitive-behavioral therapy

BEHAVIORAL

Yoga

10 weeks of biweekly yoga sessions (N = 20)

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Gretchen Brenes, PhD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2019-04-22
Completion
2019-08-28

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02968238 on ClinicalTrials.gov