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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 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.

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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).

Conditions Studied

Interventions

  • BEHAVIORAL Yoga
  • BEHAVIORAL Cognitive-behavioral therapy

Study Locations (1)

North Carolina

  • Wake Forest University Health Sciences - Winston-Salem

Trial Details

FieldValue
Enrollment Target 500 participants
Start Date 2017-05-01
Est. Completion 2019-08-28
Phase NA

Sponsor

Wake Forest University Health Sciences

1,140 total trials

What the Registry Record Tells You About NCT02968238

The ClinicalTrials.gov registry entry for NCT02968238 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 439-participant average among 364 other Anxiety trials with a reported enrollment target (14% higher). The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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