MedPath

Preventing Depression in People With Epilepsy: an Extension of Project UPLIFT

Not Applicable
Completed
Conditions
Epilepsy
Depressive Symptoms
Depression
Seizure Disorder
Interventions
Behavioral: Project UPLIFT
Registration Number
NCT01941706
Lead Sponsor
Emory University
Brief Summary

Project UPLIFT, a home-based treatment for depression in people with epilepsy, was designed to be delivered to groups by telephone or Web. The Project UPLIFT intervention materials were demonstrated to be effective in treating depression among people with epilepsy in Georgia. This project will assess whether the materials are also effective for preventing depression among people with epilepsy, and will extend the project beyond Georgia to Michigan, Texas, and Washington.

Detailed Description

The study is a pilot test of Project UPLIFT for depression prevention during which the acceptability and estimates of effectiveness of the intervention, presented in the Web and telephone modes, are assessed.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
130
Inclusion Criteria
  • diagnosis of epilepsy
  • at least three months post initial diagnosis of epilepsy and either on medication or permission of the physician
  • symptoms of depression, but absence of moderate-to-severe depression, (8 < CES-D < 27)
  • 21 years of age and older
  • English speaking
  • had access to a telephone
  • mentally stable, as determined by a score of > 26 on the Telephone Mini-Mental Status Exam (T-MMSE)
  • willing to participate
  • willing to complete assessments three times
Read More
Exclusion Criteria
  • no diagnosis of epilepsy
  • less than 3 months since diagnosis of epilepsy
  • no depressive symptom (CES-D <8)
  • severe depression (CES-D > 27)
  • suicidal ideation
  • previous participation in Project UPLIFT
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Project UPLIFT (Treatment)Project UPLIFTParticipants randomly assigned to the Treatment group receive the UPLIFT Intervention immediately after completing the Baseline Assessment. Participants can chose to participate in the Web- or phone-delivery of UPLIFT.
Project UPLIFT (TAU Waitlist Control)Project UPLIFTParticipants randomly assigned to the Treatment-as Usual (TAU) Waitlist Control group will also receive the UPLIFT intervention. However, TAU Waitlist Control participants will begin the Intervention 8 weeks after completing the Baseline Assessment. During the initial 8 weeks, participants in this group will continue whatever treatment they are currently undergoing to prevent or treat mild depressive symptoms. Participants can chose to participate in the Web- or phone-delivery of UPLIFT.
Primary Outcome Measures
NameTimeMethod
Changes in Depressive SymptomsBaseline (at 0 week) , Interim (at 8 weeks), Follow-up (at16 weeks)

Changes in depressive symptoms are measured using the modified Beck Depression Inventory (mBDI).

Secondary Outcome Measures
NameTimeMethod
Changes in seizure severityBaseline (0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)

Changes in seizure severity measured using the Liverpool Seizure Severity.

Changes in Depression and Mindfulness Knowledge and SkillsBaseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)

The changes are measured using an internally consistent scale assessing knowledge and skills associated with depression and mindfulness. The scale includes 18 true-false items assessing knowledge of depression based on the content of the UPLIFT modules. The scale also includes 13 Likert-scale assessing mindfulness skills based on the content of the UPLIFT modules.

Changes in Depressive Symptomsbaseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)

Changes in depressive symptoms are measured using the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E).

Change in Seizure ActivityBaseline (0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)

Change measured using self-reported number of seizures in the past 4 weeks.

Trial Locations

Locations (4)

University of Texas Health Science Center

🇺🇸

Houston, Texas, United States

Rollins School of Public Health

🇺🇸

Atlanta, Georgia, United States

University of Washington

🇺🇸

Seattle, Washington, United States

University of Michigan

🇺🇸

Ann Arbor, Michigan, United States

© Copyright 2025. All Rights Reserved by MedPath