Clinical trial NCT02968238: Tranquil Moments II-CBT vs. Yoga for Worry
Official title: Cognitive-behavioral Therapy Versus Yoga for the Treatment of Worry in Anxious Older Adults: A Randomized Preference Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2016-11-18
Enrollment: 500
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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).

Detailed description: The primary aim of this study is to compare the effects of CBT and yoga on worry in older adults (as assessed by the PSWQ-A measured at post-intervention, Week 11). Secondary aims are to compare the effects of these treatments on anxiety and sleep (as assessed by the PROMIS anxiety scale and the ISI, respectively, measured at post-intervention, Week 11). Exploratory aims are to determine participant preference for CBT vs. yoga; examine participant preference effects on worry, anxiety, sleep, adherence to treatment, and attrition rates; and examine selection effects on worry, anxiety, sleep, adherence to treatment, and attrition rates. All analyses will be repeated for measures assessed at Week 37.

The treatment effect for the primary aim will be estimated by comparing mean PSWQ-A scores between CBT and yoga groups in the random group (N=250, 125 per group) using constrained mixed-model repeated measures analysis of covariance with an unstructured covariance matrix to account for the fact that the multiple measurements (at baseline-Week 0, mid-intervention-Week 6, post-intervention-Week 11) from participants are not independent. The model will contain terms for baseline psychotropic medication use, gender and race (both related to depression), and intervention effects that are specific to each follow-up time. Because this arm of the trial has been randomized, we will constrain the pre-randomization intervention-specific outcome means to be the same. A contrast will be used to test the primary hypothesis at the post-intervention (Week 11) time point using a two-sided 0.05 significance level. In the primary analysis, all randomized participants will be included in their original study group for analysis regardless of the final mode of intervention or the extent of compliance with the study protocol; that is, the primary analysis will follow an "intent to treat" philosophy.

As part of the secondary aims, the estimation of selection and preference effects will be performed with mixed models based on the complete sample using data collected in both preference and randomized arms of the trial. Therefore, these analyses will be based on a sample size of 500 individuals. The adjusted means and variance-covariance matrix needed to compute these effects and their standard error will be estimated from the fitted model. The standard error associated with the preference and selection effects will be derived using the delta-method and/or a bootstrapping approach, as needed.

Consistency of intervention effects will be explored within the following baseline subgroups: 1) depressive symptoms from PROMIS measure (none or mild vs. moderate or severe), 2) use of psychotropic meds (any vs none), 3) age (60-79 vs 80+), 4) gender (female/male), and 5) race (White vs. other races).

Eligibility criteria: Inclusion Criteria:

* Age 60 years and older
* Moderate to severe levels of worry

Exclusion Criteria:

* 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

Primary outcomes:
measure: Penn State Worry Questionnaire-Abbreviated
timeFrame: Week 11
Secondary outcomes:
measure: PROMIS Anxiety
timeFrame: Week 11, Week 37
measure: Insomnia Sleep Index
timeFrame: Week 11, Week 37
measure: Penn State Worry Questionnaire-Abbreviated
timeFrame: Week 6, Week 37
measure: PROMIS 29
timeFrame: Week 11, Week 37
measure: PROMIS Depression
timeFrame: Week 11, Week 37
measure: PROMIS Physical Function with Mobility Aid
timeFrame: Week 11, Week 37
measure: GAD-7
timeFrame: Week 11, Week 37
measure: Cornell Medical Services Index
timeFrame: Week 11, Week 37
measure: Client Satisfaction Questionnaire
timeFrame: Week 11
measure: Working Alliance Inventory, Client and Therapist
timeFrame: Week 11, Week 37
measure: Adherence to the intervention as assessed by the number of sessions attended
timeFrame: Week 11
measure: Attrition from the intervention as assessed by the number of participants who do not complete study assessments at Week 11 and Week 37
timeFrame: Week 11, Week 37
measure: FES-I
timeFrame: Week 11, Week 37
measure: Falls
timeFrame: Week 11, Week 37
measure: Penn State Worry Questionnaire-Abbreviated
timeFrame: Week 37
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Gretchen Brenes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Sohl 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.
citation: Brenes 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.