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Tranquil Moments II-CBT vs. Yoga for Worry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02968238
Recruitment Status : Completed
First Posted : November 18, 2016
Last Update Posted : December 19, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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).

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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)




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02968238


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
Last Update Posted: December 19, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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