Tranquil Moments II-CBT vs. Yoga for Worry
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Anxiety, Anxiety |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 60 - Any |
| Updated: | 4/6/2019 |
| Start Date: | May 1, 2017 |
| End Date: | November 2019 |
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).
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).
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).
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).
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
We found this trial at
1
site
1 Medical Center Blvd
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
336-716-2011
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