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

N/ACompletedNCT01941706

Emory University130 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

130

Conditions

Epilepsy Depressive Symptoms Depression Seizure Disorder

Interventions

Project UPLIFTBEHAVIORAL

Developed for home-based treatment of depression in people with epilepsy, Project UPLIFT is based upon Mindfulness-based Cognitive Therapy for depression. It includes 8 modules, group-delivered by either telephone or Web. Trainees and people with epilepsy co-facilitate the groups, supervised by a licensed mental health professional.The co-facilitators are trained and supervised by the Principal Investigator, a Georgia-licensed clinical psychologist and Associate Professor of Behavioral Science and of Epidemiology in public health. Activities are designed to increase knowledge about depression; monitoring, challenging, and changing thoughts; coping and relaxing; attention and mindfulness; focusing on pleasure; the importance of reinforcement, and preventing relapse.

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (4)

Rollins School of Public Health

Atlanta, Georgia, United States

University of Michigan

Ann Arbor, Michigan, United States

University of Texas Health Science Center

Houston, Texas, United States

University of Washington

Seattle, Washington, United States

Outcomes

Primary Outcomes

Changes in Depressive Symptoms

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

Time frame: Baseline (at 0 week) , Interim (at 8 weeks), Follow-up (at16 weeks)

Secondary Outcomes

Changes in seizure severity

Changes in seizure severity measured using the Liverpool Seizure Severity.

Time frame: Baseline (0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)

Changes in Depression and Mindfulness Knowledge and Skills

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.

Time frame: Baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)

Changes in Depressive Symptoms

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

Time frame: baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)

Changes in Depressive Symptoms

Changes in depressive symptoms are measured using the Patient Health Questionnaire (PHQ-9).

Time frame: baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)

Changes in Depressive Symptoms

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

Time frame: baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.