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Cognitive behavioral therapy versus yoga for the treatment of worry in anxious older adults: a randomized preference trial
Investigator (PI): Brenes, Gretchen
Performing Organization (PO): (Current): Wake Forest University Baptist Health, Department of Psychiatry and Behavioral Medicine / (336) 716-4551
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2016
Final Year: 2020
Record Source/Award ID: PCORI/CER-1511-33007
Funding: Total Award Amount: $2,668,664
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Background and significance: Among older adults, anxiety is more common than depression, yet research on the nature and treatment of anxiety has lagged far behind that of depression. Cognitive-behavioral therapy (CBT) and yoga have been found to reduce anxiety, but no studies have compared these two treatments. Study aims: The study aim is to compare the effects of CBT and yoga on worry, anxiety, and sleep in older (>=60 years) adults. The study also aims to determine participant preference for CBT versus yoga and to determine if preference and selection effects influence outcomes. The results of this study will help providers and older adults consider additional, solid treatment options for anxiety. Study design: We propose a two-stage randomized preference trial comparing CBT with yoga for the treatment of worry in older adults. Five hundred participants will be randomized either to the preference group (participants choose the treatment; n=250) or to the random group (participants are randomized to one of the two treatments; n=250). Intervention and comparator: CBT will consist of 10 individual weekly sessions focused on techniques for managing worry and anxiety. Yoga will consist of 20 biweekly gentle yoga classes that will include meditation/focused attention, breathing exercises, gentle postures, and relaxation. Study population: Participants will be recruited through medical clinics, local YMCAs, a local senior center, low-income housing for older adults, a research database, and newspaper advertisements. Inclusion criteria include age 60 years and older and moderate to severe worry. Exclusion criteria include currently receiving psychotherapy, currently practicing yoga, current active alcohol/substance abuse, dementia, global cognitive impairment, current psychotic symptoms, active suicidal ideation with plan and intent, change in psychotropic medications within the past month, and significant hearing loss. To assist with recruitment and retention, the interventions will be conducted in participants' homes (CBT) or in the community (yoga) rather than at an academic site. Participants will be paid $20 for each of three interviews. Primary and secondary outcomes: The primary outcome is self-reported worry, as assessed by the Penn State Worry Questionnaire-Abbreviated. The secondary outcomes are self-reported anxiety symptoms, as assessed by the PROMIS Anxiety Scale, and self-reported sleep, as assessed by the Insomnia Severity Index. Analytic methods: The analyses will determine if there are differences between the two interventions, taking into consideration possible differences due to recruitment sites, psychotropic medication use, gender, and race. We will also compute preference and selection effects, because half of the participants will choose their treatment group and the other half will be randomized to receive one or the other. All participants who enroll in the study will be included in the analyses, even if they do not complete the study.
MeSH Terms:
  • Aged
  • Anxiety /*therapy
  • Cognitive Behavioral Therapy /*methods
  • Geriatrics /methods
  • Humans
  • Meditation
  • Middle Aged
  • Outcome Assessment, Health Care
  • * Patient Preference
  • Randomized Controlled Trials as Topic
  • Relaxation
  • Respiration
  • Surveys and Questionnaires
  • * Yoga
Country: United States
State: North Carolina
Zip Code: 27103
UI: 20164058
Project Status: Ongoing
Record History: ('2017: Project extended to 2020',)