Tranquil Moments II-CBT vs. Yoga for Worry
Cognitive-behavioral Therapy Versus Yoga for the Treatment of Worry in Anxious Older Adults: A Randomized Preference Trial
2 other identifiers
interventional
500
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable anxiety
Started May 2017
Typical duration for not_applicable anxiety
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2016
CompletedFirst Posted
Study publicly available on registry
November 18, 2016
CompletedStudy Start
First participant enrolled
May 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 22, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 28, 2019
CompletedMay 12, 2020
December 1, 2019
2 years
November 16, 2016
May 8, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Penn State Worry Questionnaire-Abbreviated
worry symptoms
Week 11
Secondary Outcomes (15)
PROMIS Anxiety
Week 11, Week 37
Insomnia Sleep Index
Week 11, Week 37
Penn State Worry Questionnaire-Abbreviated
Week 6, Week 37
PROMIS 29
Week 11, Week 37
PROMIS Depression
Week 11, Week 37
- +10 more secondary outcomes
Study Arms (4)
CBT preference arm
ACTIVE COMPARATORCBT preference arm consists of participants who are randomized to the preference condition and choose to receive cognitive-behavioral therapy (CBT). CBT consists of 10 weeks of weekly treatment.
Yoga preference arm
ACTIVE COMPARATORYoga preference arm consists of participants who are randomized to the preference condition and choose to receive yoga. Yoga consists of 10 weeks of bi-weekly treatment (total = 20 treatments).
CBT randomized arm
ACTIVE COMPARATORCBT randomized arm consists of participants who are randomized to the random condition and are randomized to receive cognitive-behavioral therapy (CBT). CBT consists of 10 weeks of weekly treatment.
Yoga randomized arm
ACTIVE COMPARATORYoga randomized arm consists of participants who are randomized to the random condition and are randomized to receive yoga. Yoga consists of 10 weeks of bi-weekly treatment (total = 20 treatments).
Interventions
10 weekly sessions of cognitive-behavioral therapy
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Related Publications (3)
Danhauer SC, Miller ME, Divers J, Anderson A, Hargis G, Brenes GA. Long-Term Effects of Cognitive-Behavioral Therapy and Yoga for Worried Older Adults. Am J Geriatr Psychiatry. 2022 Sep;30(9):979-990. doi: 10.1016/j.jagp.2022.02.002. Epub 2022 Feb 6.
PMID: 35260292DERIVEDSohl SJ, Brenes GA, Krucoff C, Hargis G, Anderson A, Miller ME, Danhauer SC. Ensuring Yoga Intervention Fidelity in a Randomized Preference Trial for the Treatment of Worry in Older Adults. J Altern Complement Med. 2021 Jun;27(6):489-495. doi: 10.1089/acm.2020.0476. Epub 2021 Mar 8.
PMID: 33684325DERIVEDBrenes GA, Divers J, Miller ME, Danhauer SC. A randomized preference trial of cognitive-behavioral therapy and yoga for the treatment of worry in anxious older adults. Contemp Clin Trials Commun. 2018 May 4;10:169-176. doi: 10.1016/j.conctc.2018.05.002. eCollection 2018 Jun.
PMID: 30009275DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gretchen Brenes, PhD
Wake Forest University Health Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2016
First Posted
November 18, 2016
Study Start
May 1, 2017
Primary Completion
April 22, 2019
Study Completion
August 28, 2019
Last Updated
May 12, 2020
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share