Preventing Depression in People With Epilepsy: an Extension of Project UPLIFT
- Conditions
- EpilepsyDepressive SymptomsDepressionSeizure 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
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Project UPLIFT (Treatment) Project UPLIFT Participants 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 UPLIFT Participants 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
Name Time Method Changes in Depressive Symptoms Baseline (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
Name Time Method Changes in seizure severity Baseline (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 Skills Baseline (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 Symptoms baseline (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 Activity Baseline (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