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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Epilepsy, Depressive Symptoms, Depression, Seizure Disorder

Intervention / Treatment
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* Behavioral: Project UPLIFT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Project UPLIFT (Treatment)<br>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. | Behavioral: Project UPLIFT<br>* 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.<br>|
| Experimental: Project UPLIFT (TAU Waitlist Control)<br>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. | Behavioral: Project UPLIFT<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Depressive Symptoms | Changes in depressive symptoms are measured using the modified Beck Depression Inventory (mBDI). | Baseline (at 0 week) , Interim (at 8 weeks), Follow-up (at16 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in seizure severity | Changes in seizure severity measured using the Liverpool Seizure Severity. | 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. | 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). | 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). | 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). | baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks) | 
| Change in Seizure Activity | Change measured using self-reported number of seizures in the past 4 weeks. | Baseline (0 week), Interim (at 8 weeks), Follow-up (at 16 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epilepsy, Seizure, Cognitive Behavioral Therapy, Mindfulness, Depression, Depressive symptoms, prevention, Coping skills, Quality of life, Telehealth, Phone intervention, Internet-based intervention