Preventing Depression in People With Epilepsy: an Extension of Project UPLIFT
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Emory University
- Enrollment
- 130
- Locations
- 4
- Primary Endpoint
- Changes in Depressive Symptoms
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Arms & Interventions
Project UPLIFT (Treatment)
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.
Intervention: Project UPLIFT (Behavioral)
Project UPLIFT (TAU Waitlist Control)
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.
Intervention: Project UPLIFT (Behavioral)
Outcomes
Primary Outcomes
Changes in Depressive Symptoms
Time Frame: 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 Outcomes
- Changes in Depressive Symptoms(baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks))
- Changes in seizure severity(Baseline (0 week), Interim (at 8 weeks), Follow-up (at 16 weeks))
- Changes in Depression and Mindfulness Knowledge and Skills(Baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks))
- Change in Seizure Activity(Baseline (0 week), Interim (at 8 weeks), Follow-up (at 16 weeks))
Investigators
Nancy J Thompson, PhD
Associate Professor, Behavioral Sciences and Health Education
Emory University