Tranquil Moments II-CBT vs. Yoga for Worry

• ClinicalTrials.gov Identifier: NCT02968238
• Recruitment Status: Completed
• First Posted: November 18, 2016
• Last Update Posted: May 12, 2020
• Sponsor: Wake Forest University Health Sciences
• Collaborator: Patient-Centered Outcomes Research Institute
• Information provided by (Responsible Party): Wake Forest University Health Sciences

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Anxiety	Behavioral: Cognitive-behavioral therapy; Behavioral: Yoga	Not Applicable

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 500 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Care Provider)
• Primary Purpose: Treatment
• Official Title: Cognitive-behavioral Therapy Versus Yoga for the Treatment of Worry in Anxious Older Adults: A Randomized Preference Trial
• Actual Study Start Date: May 1, 2017
• Actual Primary Completion Date: April 22, 2019
• Actual Study Completion Date: August 28, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: CBT preference arm; CBT 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.	Behavioral: Cognitive-behavioral therapy; 10 weekly sessions of cognitive-behavioral therapy; Other Name: CBT
Active Comparator: Yoga preference arm; Yoga 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).	Behavioral: Yoga; 10 weeks of biweekly yoga sessions (N = 20)
Active Comparator: CBT randomized arm; CBT 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.	Behavioral: Cognitive-behavioral therapy; 10 weekly sessions of cognitive-behavioral therapy; Other Name: CBT
Active Comparator: Yoga randomized arm; Yoga 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).	Behavioral: Yoga; 10 weeks of biweekly yoga sessions (N = 20)

Outcome Measures

Primary Outcome Measures :

1. Penn State Worry Questionnaire-Abbreviated [ Time Frame: Week 11 ]
   worry symptoms

Secondary Outcome Measures :

1. PROMIS Anxiety [ Time Frame: Week 11, Week 37 ]
   anxiety symptoms
2. Insomnia Sleep Index [ Time Frame: Week 11, Week 37 ]
   sleep problems
3. Penn State Worry Questionnaire-Abbreviated [ Time Frame: Week 6, Week 37 ]
   worry symptoms
4. PROMIS 29 [ Time Frame: Week 11, Week 37 ]
   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
5. PROMIS Depression [ Time Frame: Week 11, Week 37 ]
   depressive symptoms
6. PROMIS Physical Function with Mobility Aid [ Time Frame: Week 11, Week 37 ]
   Self-report measure of current capability for physical activities
7. GAD-7 [ Time Frame: Week 11, Week 37 ]
   Self-report symptoms of Generalized Anxiety Disorder
8. Cornell Medical Services Index [ Time Frame: Week 11, Week 37 ]
   measure of medical care utilization
9. Client Satisfaction Questionnaire [ Time Frame: Week 11 ]
   self-report measure of satisfaction with treatment
10. Working Alliance Inventory, Client and Therapist [ Time Frame: Week 11, Week 37 ]
    assesses therapist-patient working alliance; measures are completed by the participant and the therapist
11. Adherence to the intervention as assessed by the number of sessions attended [ Time Frame: Week 11 ]
    adherence to treatment
12. Attrition from the intervention as assessed by the number of participants who do not complete study assessments at Week 11 and Week 37 [ Time Frame: Week 11, Week 37 ]
    attrition from study
13. FES-I [ Time Frame: Week 11, Week 37 ]
    falls self-efficacy
14. Falls [ Time Frame: Week 11, Week 37 ]
    self-report incidence of falls
15. Penn State Worry Questionnaire-Abbreviated [ Time Frame: Week 37 ]
    worry symptoms

Eligibility Criteria

• Ages Eligible for Study: 60 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, North Carolina

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States, 27157

Sponsors and Collaborators

Wake Forest University Health Sciences

Patient-Centered Outcomes Research Institute

Investigators

• Principal Investigator: Gretchen Brenes, PhD; Wake Forest University Health Sciences

  Study Documents (Full-Text)

Documents provided by Wake Forest University Health Sciences:

Informed Consent Form  [PDF] February 9, 2018

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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. Erratum In: Contemp Clin Trials Commun. 2020 Jan 03;19:100517. Contemp Clin Trials Commun. 2020 Dec 10;20:100688.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT02968238
• Other Study ID Numbers: IRB00041530; CER-1511-33007 ( Other Grant/Funding Number: Patient-Centered Outcomes Research Institute (PCORI) )
• First Posted: November 18, 2016
• Last Update Posted: May 12, 2020
• Last Verified: December 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No