NCT03000725

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

May 21, 2020

Status Verified

May 1, 2020

Enrollment Period

2.9 years

First QC Date

December 20, 2016

Last Update Submit

May 19, 2020

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

  • Patient Health Questionnaire (PHQ-9)

    This measure assesses depressive symptoms in the past two weeks based on DSM-IV diagnostic criteria for major depression.

    12 Months

Secondary Outcomes (2)

  • Quality Of Life in Epilepsy (QOLIE-10)

    12 Months

  • PROMIS-Global

    12 Months

Other Outcomes (10)

  • Work Productivity and Activity Impairment Questionnaire (WPAI)

    12 Months

  • Self-Compassion Scale (SCS)

    12 Months

  • Satisfaction with Life Scale (SWLS)

    12 Months

  • +7 more other outcomes

Study Arms (2)

UPLIFT

ACTIVE COMPARATOR

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).

Behavioral: Using Practice and Learning to Increase Favorable Thoughts

USUAL CARE

ACTIVE COMPARATOR

Participants randomized to the UC group will receive printed educational materials on management of epilepsy in English or Spanish as preferred.

Behavioral: Usual Care

Interventions

Using Practice and Learning to Increase Favorable ThoughtsBEHAVIORAL

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

UPLIFT
Usual CareBEHAVIORAL

Participants randomized to the UC group will receive printed educational materials on management of epilepsy in English or Spanish as preferred.

USUAL CARE

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Severe depression (CES-D \> 37)
  • Active suicidal ideation
  • Significant cognitive impairment (evident during screening)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Tanya Spruill

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2016

First Posted

December 22, 2016

Study Start

October 1, 2016

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

May 21, 2020

Record last verified: 2020-05

Locations

US(1)