- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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).
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
North Carolina
-
Winston-Salem, North Carolina, États-Unis, 27157
- Wake Forest University Health Sciences
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: 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
Autres noms:
|
Comparateur actif: 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)
|
Comparateur actif: 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
Autres noms:
|
Comparateur actif: 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)
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Penn State Worry Questionnaire-Abbreviated
Délai: Week 11
|
worry symptoms
|
Week 11
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
PROMIS Anxiety
Délai: Week 11, Week 37
|
anxiety symptoms
|
Week 11, Week 37
|
Insomnia Sleep Index
Délai: Week 11, Week 37
|
sleep problems
|
Week 11, Week 37
|
Penn State Worry Questionnaire-Abbreviated
Délai: Week 6, Week 37
|
worry symptoms
|
Week 6, Week 37
|
PROMIS 29
Délai: 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
Délai: Week 11, Week 37
|
depressive symptoms
|
Week 11, Week 37
|
PROMIS Physical Function with Mobility Aid
Délai: Week 11, Week 37
|
Self-report measure of current capability for physical activities
|
Week 11, Week 37
|
GAD-7
Délai: Week 11, Week 37
|
Self-report symptoms of Generalized Anxiety Disorder
|
Week 11, Week 37
|
Cornell Medical Services Index
Délai: Week 11, Week 37
|
measure of medical care utilization
|
Week 11, Week 37
|
Client Satisfaction Questionnaire
Délai: Week 11
|
self-report measure of satisfaction with treatment
|
Week 11
|
Working Alliance Inventory, Client and Therapist
Délai: 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
Délai: 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
Délai: Week 11, Week 37
|
attrition from study
|
Week 11, Week 37
|
FES-I
Délai: Week 11, Week 37
|
falls self-efficacy
|
Week 11, Week 37
|
Falls
Délai: Week 11, Week 37
|
self-report incidence of falls
|
Week 11, Week 37
|
Penn State Worry Questionnaire-Abbreviated
Délai: Week 37
|
worry symptoms
|
Week 37
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Gretchen Brenes, PhD, Wake Forest University Health Sciences
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- IRB00041530
- CER-1511-33007 (Autre subvention/numéro de financement: Patient-Centered Outcomes Research Institute (PCORI))
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Cognitive-behavioral therapy
-
Norwegian Center for Violence and Traumatic Stress...King's College London; University of Oslo; Ministry of Health and Care Services...RecrutementSSPT | Qualité de vie | Troubles du sommeil | Symptômes dépressifsNorvège
-
VA Office of Research and DevelopmentComplétéTroubles de stress, post-traumatiqueÉtats-Unis
-
Weill Medical College of Cornell UniversityRecrutementDépression périnatale | Anxiété périnataleÉtats-Unis
-
University of WashingtonNational Institute on Drug Abuse (NIDA)ComplétéTroubles liés à l'utilisation de substances | Troubles de stress post-traumatique | Sexe à risqueÉtats-Unis
-
Medical University of South CarolinaNational Institute on Deafness and Other Communication Disorders (NIDCD)Actif, ne recrute pasAccident vasculaire cérébral | Aphasie | Aphasie Non FluentÉtats-Unis
-
Columbia UniversityRésilié
-
NeuroTronik Inc.InconnueInsuffisance cardiaque | Insuffisance cardiaque aiguëParaguay
-
Microclinic InternationalRoyal Health Awareness Society (RHAS); Jordanian Ministry of Health (MoH)ComplétéHyperglycémie | Hypertension | Obésité | Diabète sucré, Type 2 | Diabète sucré | Diabète | Poids | Perte de poids | Pression artérielle | Gain de poids | Comportement social | Poids, Corps | Glycémie, hypertension | Mode de vie, Sain | Changement de poids, Corps | Comportement, Santé | Réduction des risques liés au mode... et d'autres conditionsJordan
-
University of Applied Sciences and Arts of Southern...Vrije Universiteit Brussel; Universiteit Antwerpen; THIM - die internationale...ComplétéEn bonne santéSuisse
-
NeuroTronik Inc.InconnueInsuffisance cardiaque aiguëPanama