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NCT02968238 · ClinicalTrials.gov registry record · NA
Tranquil Moments II-CBT vs. Yoga for Worry
A NA study of Anxiety, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- NA
- Development phase
- 500
- Enrollment target
- 1
- Study location
NCT02968238: Completed NA study of Anxiety, sponsored by Wake Forest University Health Sciences.
NCT02968238 is a NA study of Anxiety that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 500 participants, above the 439-participant average among 364 other Anxiety trials with a reported enrollment target (14% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02968238, a NA study of Anxiety, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- NA
- Development phase
- 500 participants
- Enrollment target
- 1
- Study location
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).
Primary Outcome
worry symptoms
Conditions Studied
Interventions
- BEHAVIORAL Yoga
- BEHAVIORAL Cognitive-behavioral therapy
Study Locations (1)
North Carolina
- Wake Forest University Health Sciences - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2017-05-01 |
| Est. Completion | 2019-08-28 |
| Phase | NA |
What the finished NCT02968238 record still lists
NCT02968238 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, above the 439-participant average among 364 other Anxiety trials with a reported enrollment target (14% higher).
The record links to 1 condition, with Anxiety appearing as the primary indexed condition, and to 2 interventions - of which Yoga is the first listed.
NCT02968238 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT02968238 about?
NCT02968238 is a clinical study titled "Tranquil Moments II-CBT vs. Yoga for Worry". 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 ca...
What is the current status of trial NCT02968238?
This trial is currently completed. It is a NA study. The enrollment target is 500 participants. The study started on 2017-05-01. Estimated completion is 2019-08-28.
What conditions does trial NCT02968238 study?
This clinical trial studies the following conditions: Anxiety.
What interventions are being tested in trial NCT02968238?
The interventions under investigation include: Yoga (BEHAVIORAL), Cognitive-behavioral therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT02968238?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02968238 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02968238's enrollment target sits among peer trials
500 31st of 364 higher than 329 of 364 other Anxiety trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anxiety trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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