Tranquil Moments II-CBT vs. Yoga for Worry

Anxiety Clinical Trial

Official title:

Cognitive-behavioral Therapy Versus Yoga for the Treatment of Worry in Anxious Older Adults: A Randomized Preference Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02968238
• Other study ID #: IRB00041530
• Secondary ID: CER-1511-33007
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: August 28, 2019

Study information

• Verified date: December 2019
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: August 28, 2019
• Est. primary completion date: April 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety

Intervention

Behavioral:
• Cognitive-behavioral therapy
10 weekly sessions of cognitive-behavioral therapy
• Yoga
10 weeks of biweekly yoga sessions (N = 20)

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Penn State Worry Questionnaire-Abbreviated	worry symptoms	Week 11
Secondary	PROMIS Anxiety	anxiety symptoms	Week 11, Week 37
Secondary	Insomnia Sleep Index	sleep problems	Week 11, Week 37
Secondary	Penn State Worry Questionnaire-Abbreviated	worry symptoms	Week 6, Week 37
Secondary	PROMIS 29	29-item self-report measure with 4 items each for the following: physical function, anxiety, depression, fatigue, sleep, social function, pain interference; 1 item for average pain intensity	Week 11, Week 37
Secondary	PROMIS Depression	depressive symptoms	Week 11, Week 37
Secondary	PROMIS Physical Function with Mobility Aid	Self-report measure of current capability for physical activities	Week 11, Week 37
Secondary	GAD-7	Self-report symptoms of Generalized Anxiety Disorder	Week 11, Week 37
Secondary	Cornell Medical Services Index	measure of medical care utilization	Week 11, Week 37
Secondary	Client Satisfaction Questionnaire	self-report measure of satisfaction with treatment	Week 11
Secondary	Working Alliance Inventory, Client and Therapist	assesses therapist-patient working alliance; measures are completed by the participant and the therapist	Week 11, Week 37
Secondary	Adherence to the intervention as assessed by the number of sessions attended	adherence to treatment	Week 11
Secondary	Attrition from the intervention as assessed by the number of participants who do not complete study assessments at Week 11 and Week 37	attrition from study	Week 11, Week 37
Secondary	FES-I	falls self-efficacy	Week 11, Week 37
Secondary	Falls	self-report incidence of falls	Week 11, Week 37
Secondary	Penn State Worry Questionnaire-Abbreviated	worry symptoms	Week 37