- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03000725
Adapting Project UPLIFT for Hispanic Patients With Epilepsy II
Adapting Project UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) is for Hispanic Patients With Epilepsy II
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The goal of this study is to adapt Project UPLIFT for Hispanic adults with epilepsy and depression. A 2-arm randomized control trial will be conducted to evaluate the feasibility, acceptability and effects of Project UPLIFT versus usual care (UC) in Hispanic patients with epilepsy.
The specific aim of this study is: To evaluate the feasibility, acceptability and short- and long-term effects of the adapted intervention on depression and other outcomes in 72 English- and Spanish-speaking Hispanic epilepsy patients.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
New York
-
New York, New York, États-Unis, 10016
- New York University School of Medicine
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- self-identified as Hispanic
- English or Spanish speaking
- diagnosis of epilepsy for at least one year post diagnosis
- willing to participate in 8 one-hour telephone sessions every week for eight weeks.
- willing to be audio-taped
- Elevated depressive symptoms (Center for Epidemiological Studies Depression Scale (CES-D) score >13
Exclusion Criteria:
- Severe depression (CES-D > 37)
- Active suicidal ideation
- Significant cognitive impairment (evident during screening)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: UPLIFT
Project UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) is a home-based intervention that teaches cognitive and mindfulness skills to people with epilepsy by phone to reduce their depression and improve quality of life (QOL).
|
Description of the UPLIFT program: Participants who choose to participate in UPLIFT will complete 8 weekly group sessions via telephone. Session 1: Introduction to UPLIFT/Noticing Thoughts Session 2: Checking and Changing Thoughts Session 3: Coping & Relaxing Session 4: Attention & Mindfulness Session 5: The Present as a Calm Place Session 6: Thoughts as Changeable, Thoughts as Not Fixed Session 7: Focus on Pleasure & the Importance of Reinforcement Session 8: Preventing Lapses and Giving Thanks |
Comparateur actif: USUAL CARE
Participants randomized to the UC group will receive printed educational materials on management of epilepsy in English or Spanish as preferred.
|
Participants randomized to the UC group will receive printed educational materials on management of epilepsy in English or Spanish as preferred.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Patient Health Questionnaire (PHQ-9)
Délai: 12 Months
|
This measure assesses depressive symptoms in the past two weeks based on DSM-IV diagnostic criteria for major depression.
|
12 Months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Quality Of Life in Epilepsy (QOLIE-10)
Délai: 12 Months
|
This measure assesses health-related quality of life for adults with epilepsy.
|
12 Months
|
PROMIS-Global
Délai: 12 Months
|
This 10-item measure was developed by NIH to assess physical, mental and social functioning.
It is a generic rather than disease-specific measure of global health.
|
12 Months
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Work Productivity and Activity Impairment Questionnaire (WPAI)
Délai: 12 Months
|
This self-report measure assesses the impact of disease on productivity and work productivity loss due to general health or a specified health problem.
|
12 Months
|
Self-Compassion Scale (SCS)
Délai: 12 Months
|
This measure assesses trait levels of self-compassion, including the thoughts, emotions and behaviors associated with the various components of self-compassion.
|
12 Months
|
Satisfaction with Life Scale (SWLS)
Délai: 12 Months
|
This 5-item instrument measures global cognitive judgments of satisfaction with one's life.
|
12 Months
|
Interpersonal Support Evaluation List (ISEL)
Délai: 12 Months
|
This measure assesses the perceived availability of appraisal, belonging and tangible social support.
|
12 Months
|
Five Facet Mindfulness Questionnaire Description (FFMQ) Short form
Délai: 12 Months
|
This 24-item measure assesses the construct of mindfulness through five component skills: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience.
|
12 Months
|
Ruminative Responses Scale (RRS)
Délai: 12 Months
|
This 22-item scale assesses cognitive responses to depressed mood.
|
12 Months
|
Perceived Stress Scale (PSS-10)
Délai: 12 Months
|
This 10-item measure assesses the degree to which situations in one's life are appraised as stressful or overwhelming.
|
12 Months
|
Pittsburgh Sleep Quality Index (PSQI)
Délai: 12 Months
|
This 19-item questionnaire assesses sleep quality over the past month.
|
12 Months
|
Epilepsy Stigma Scale
Délai: 12 Months
|
This 10-item measure assesses the degree to which a person believes that epilepsy is perceived as negative and interferes with relationships with others.
|
12 Months
|
Healthcare Utilization
Délai: 12 Months
|
This self-report questionnaire assesses the use of healthcare services (e.g., clinic visits ED visits, etc).
|
12 Months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Tanya Spruill, NYU Langone Health
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 16-01531
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 .