- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02968238
Tranquil Moments II-CBT vs. Yoga for Worry
Cognitive-behavioral Therapy Versus Yoga for the Treatment of Worry in Anxious Older Adults: A Randomized Preference Trial
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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).
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
North Carolina
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Winston-Salem, North Carolina, Spojené státy, 27157
- Wake Forest University Health Sciences
-
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Faktorové přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Aktivní komparátor: 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.
|
10 weekly sessions of cognitive-behavioral therapy
Ostatní jména:
|
Aktivní komparátor: 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).
|
10 weeks of biweekly yoga sessions (N = 20)
|
Aktivní komparátor: 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.
|
10 weekly sessions of cognitive-behavioral therapy
Ostatní jména:
|
Aktivní komparátor: 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).
|
10 weeks of biweekly yoga sessions (N = 20)
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Penn State Worry Questionnaire-Abbreviated
Časové okno: Week 11
|
worry symptoms
|
Week 11
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
PROMIS Anxiety
Časové okno: Week 11, Week 37
|
anxiety symptoms
|
Week 11, Week 37
|
Insomnia Sleep Index
Časové okno: Week 11, Week 37
|
sleep problems
|
Week 11, Week 37
|
Penn State Worry Questionnaire-Abbreviated
Časové okno: Week 6, Week 37
|
worry symptoms
|
Week 6, Week 37
|
PROMIS 29
Časové okno: 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
|
Week 11, Week 37
|
PROMIS Depression
Časové okno: Week 11, Week 37
|
depressive symptoms
|
Week 11, Week 37
|
PROMIS Physical Function with Mobility Aid
Časové okno: Week 11, Week 37
|
Self-report measure of current capability for physical activities
|
Week 11, Week 37
|
GAD-7
Časové okno: Week 11, Week 37
|
Self-report symptoms of Generalized Anxiety Disorder
|
Week 11, Week 37
|
Cornell Medical Services Index
Časové okno: Week 11, Week 37
|
measure of medical care utilization
|
Week 11, Week 37
|
Client Satisfaction Questionnaire
Časové okno: Week 11
|
self-report measure of satisfaction with treatment
|
Week 11
|
Working Alliance Inventory, Client and Therapist
Časové okno: Week 11, Week 37
|
assesses therapist-patient working alliance; measures are completed by the participant and the therapist
|
Week 11, Week 37
|
Adherence to the intervention as assessed by the number of sessions attended
Časové okno: Week 11
|
adherence to treatment
|
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
Časové okno: Week 11, Week 37
|
attrition from study
|
Week 11, Week 37
|
FES-I
Časové okno: Week 11, Week 37
|
falls self-efficacy
|
Week 11, Week 37
|
Falls
Časové okno: Week 11, Week 37
|
self-report incidence of falls
|
Week 11, Week 37
|
Penn State Worry Questionnaire-Abbreviated
Časové okno: Week 37
|
worry symptoms
|
Week 37
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Gretchen Brenes, PhD, Wake Forest University Health Sciences
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- IRB00041530
- CER-1511-33007 (Jiné číslo grantu/financování: Patient-Centered Outcomes Research Institute (PCORI))
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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