Adapting Project UPLIFT for Hispanic Patients With Epilepsy II
19 maj 2020 uppdaterad av: NYU Langone Health
Adapting Project UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) is for Hispanic Patients With Epilepsy II
The purpose of this study is to adapt Project UPLIFT for Hispanic adults with epilepsy and depression.
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); it was developed at Emory University with CDC funding.
The purpose of this study is to adapt Project UPLIFT for Hispanic adults with epilepsy and depression.
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); it was developed at Emory University with CDC funding.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
72
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
New York
-
New York, New York, Förenta staterna, 10016
- New York University School of Medicine
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
21 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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 |
|
Aktiv komparator: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Patient Health Questionnaire (PHQ-9)
Tidsram: 12 Months
|
This measure assesses depressive symptoms in the past two weeks based on DSM-IV diagnostic criteria for major depression.
|
12 Months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Quality Of Life in Epilepsy (QOLIE-10)
Tidsram: 12 Months
|
This measure assesses health-related quality of life for adults with epilepsy.
|
12 Months
|
|
PROMIS-Global
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Work Productivity and Activity Impairment Questionnaire (WPAI)
Tidsram: 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)
Tidsram: 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)
Tidsram: 12 Months
|
This 5-item instrument measures global cognitive judgments of satisfaction with one's life.
|
12 Months
|
|
Interpersonal Support Evaluation List (ISEL)
Tidsram: 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
Tidsram: 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)
Tidsram: 12 Months
|
This 22-item scale assesses cognitive responses to depressed mood.
|
12 Months
|
|
Perceived Stress Scale (PSS-10)
Tidsram: 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)
Tidsram: 12 Months
|
This 19-item questionnaire assesses sleep quality over the past month.
|
12 Months
|
|
Epilepsy Stigma Scale
Tidsram: 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
Tidsram: 12 Months
|
This self-report questionnaire assesses the use of healthcare services (e.g., clinic visits ED visits, etc).
|
12 Months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Tanya Spruill, NYU Langone Health
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 oktober 2016
Primärt slutförande (Faktisk)
1 september 2019
Avslutad studie (Faktisk)
1 september 2019
Studieregistreringsdatum
Först inskickad
20 december 2016
Först inskickad som uppfyllde QC-kriterierna
20 december 2016
Första postat (Uppskatta)
22 december 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
21 maj 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
19 maj 2020
Senast verifierad
1 maj 2020
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 16-01531
Läkemedels- och apparatinformation, studiedokument
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Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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