AnxietyNCT02968238
Tranquil Moments II-CBT vs. Yoga for Worry
A study testing Cognitive-behavioral therapy and Yoga in people with Anxiety, run by Wake Forest University Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Cognitive-behavioral therapy and Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 28 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 60 years and older
- Moderate to severe levels of worry
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Cognitive-behavioral Therapy Versus Yoga for the Treatment of Worry in Anxious Older Adults: A Randomized Preference Trial
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).
Read the 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).
- Conditions
- Anxiety
- Being tested
- Cognitive-behavioral therapy, Yoga
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioral therapyBehavioural
Also called CBT
10 weekly sessions of cognitive-behavioral therapy
YogaBehavioural
10 weeks of biweekly yoga sessions (N = 20)
| Study group | Role | What they receive |
|---|---|---|
| CBT preference arm | Active comparator | 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. Receives: Behavioral: Cognitive-behavioral therapy |
| Yoga preference arm | Active comparator | 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). Receives: Behavioral: Yoga |
| CBT randomized arm | Active comparator | 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. Receives: Behavioral: Cognitive-behavioral therapy |
| Yoga randomized arm | Active comparator | 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). Receives: Behavioral: Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penn State Worry Questionnaire-Abbreviated
worry symptoms
Measured: Week 11
Secondary outcomes (15)
PROMIS Anxiety
anxiety symptoms
Measured: Week 11, Week 37
Insomnia Sleep Index
sleep problems
Measured: Week 11, Week 37
Penn State Worry Questionnaire-Abbreviated
worry symptoms
Measured: Week 6, Week 37
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
Measured: Week 11, Week 37
PROMIS Depression
depressive symptoms
Measured: Week 11, Week 37
PROMIS Physical Function with Mobility Aid
Self-report measure of current capability for physical activities
Measured: Week 11, Week 37
GAD-7
Self-report symptoms of Generalized Anxiety Disorder
Measured: Week 11, Week 37
Cornell Medical Services Index
measure of medical care utilization
Measured: Week 11, Week 37
Client Satisfaction Questionnaire
self-report measure of satisfaction with treatment
Measured: Week 11
Working Alliance Inventory, Client and Therapist
assesses therapist-patient working alliance; measures are completed by the participant and the therapist
Measured: Week 11, Week 37
Adherence to the intervention as assessed by the number of sessions attended
adherence to treatment
Measured: Week 11
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
Measured: Week 11, Week 37
FES-I
falls self-efficacy
Measured: Week 11, Week 37
Falls
self-report incidence of falls
Measured: Week 11, Week 37
Penn State Worry Questionnaire-Abbreviated
worry symptoms
Measured: Week 37
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study start1 May 2017
- Primary completion22 Apr 2019
- Study completion28 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Gretchen Brenes, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02968238
- Sponsor's protocol ID
- IRB00041530
- Other IDs
- CER-1511-33007
- Status last verified
- Dec 2019
- First submitted
- 16 Nov 2016
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35260292Sohl 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.
PubMed 33684325Brenes 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.
PubMed 30009275
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive-behavioral Therapy Versus Yoga for the Treatment of Worry in Anxious Older Adults: A Randomized Preference Trial
- ClinicalTrials.gov ID
- NCT02968238
- Acronym / sponsor ID
- IRB00041530
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 1 May 2017 (actual)
- Primary completion
- 22 Apr 2019 (actual)
- Study completion
- 28 Aug 2019 (actual)
- First posted
- 18 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CBT preference arm | Active comparator | Behavioral: Cognitive-behavioral therapyCBT 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. |
| Yoga preference arm | Active comparator | Behavioral: YogaYoga 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). |
| CBT randomized arm | Active comparator | Behavioral: Cognitive-behavioral therapyCBT 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. |
| Yoga randomized arm | Active comparator | Behavioral: YogaYoga 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). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 60 years and older
- Moderate to severe levels of worry
Key exclusion criteria (7 listed)
- Currently receiving psychotherapy
- Currently practicing yoga
- Active alcohol/substance abuse
- Dementia
- Current psychotic symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-behavioral therapyAlso: CBT10 weekly sessions of cognitive-behavioral therapy | Behavioural | CBT preference arm, CBT randomized arm |
| Yoga10 weeks of biweekly yoga sessions (N = 20) | Behavioural | Yoga preference arm, Yoga randomized arm |
Primary outcome
Penn State Worry Questionnaire-Abbreviated
Time frame: Week 11
worry symptoms
15 secondary outcomes
PROMIS Anxiety
Time frame: Week 11, Week 37
Insomnia Sleep Index
Time frame: Week 11, Week 37
Penn State Worry Questionnaire-Abbreviated
Time frame: Week 6, Week 37
PROMIS 29
Time frame: Week 11, Week 37
PROMIS Depression
Time frame: Week 11, Week 37
PROMIS Physical Function with Mobility Aid
Time frame: Week 11, Week 37
GAD-7
Time frame: Week 11, Week 37
Cornell Medical Services Index
Time frame: Week 11, Week 37
Client Satisfaction Questionnaire
Time frame: Week 11
Working Alliance Inventory, Client and Therapist
Time frame: Week 11, Week 37
Adherence to the intervention as assessed by the number of sessions attended
Time frame: Week 11
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
FES-I
Time frame: Week 11, Week 37
Falls
Time frame: Week 11, Week 37
Penn State Worry Questionnaire-Abbreviated
Time frame: Week 37
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Derived from this study: PubMed 35260292Danhauer 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.
- Derived from this study: PubMed 33684325Sohl 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.
- Derived from this study: PubMed 30009275Brenes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gretchen Brenes, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-behavioral therapy and Yoga in people with Anxiety, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penn State Worry Questionnaire-Abbreviated (time frame: Week 11). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02968238, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.