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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Epilepsy; Depressive Symptoms; Seizure Disorder
• Intervention / Treatment: Behavioral: Project UPLIFT

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 Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Rollins School of Public Health
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Project UPLIFT; 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.
Experimental: 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.	Behavioral: Project UPLIFT; 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.

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Satisfaction with Life	Changes are measured using the Satisfaction with Life Scale (Denier, E., et al., The satisfaction with life scale. Journal of Personality Assessment, 1985)	Baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
Changes in Sleep Quality	The study uses the Pittsburgh Sleep Quality Index to assess changes in sleep quality.	Baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
Changes in Depression Coping Self-Efficacy	The study uses Perraud, S., Development of the Depression Coping Self-Efficacy Scale (DCSES). Archives of Psychiatric Nursing, 2000 to assess changes in depression coping self-efficacy.	Baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
Changes in Self Compassion	The study uses Neff, K.D. and R. Vonk, Self-compassion versus global self-esteem: two different ways of relating to oneself. J Pers, 2009. 77(1): p. 23-50.. to assess changes in self compassion.	Baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
Changes in Physical and Mental Health Quality of Life	The study uses the Centers for Disease Control's Behavioral Risk Factors Surveillance System (BRFSS) questionnaire to assess changes in physical and mental health quality of life.	Baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: The University of Texas Health Science Center, Houston; National Institute on Minority Health and Health Disparities (NIMHD); University of Michigan; University of Washington
• Investigators: Principal Investigator: Nancy J Thompson, MPH, PhD, Emory University

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: September 5, 2013
• First Submitted That Met QC Criteria: September 10, 2013
• First Posted (Estimate): September 13, 2013

Study Record Updates

• Last Update Posted (Estimate): February 12, 2014
• Last Update Submitted That Met QC Criteria: February 11, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Epilepsy; Depression; Quality of life; Mindfulness; prevention; Telehealth; Cognitive Behavioral Therapy; Depressive symptoms; Seizure; Coping skills; Phone intervention; Internet-based intervention
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mood Disorders; Neurologic Manifestations; Epilepsy; Depression; Depressive Disorder; Seizures
• Other Study ID Numbers: IRB00026786; 5RC1MD004563-02 (U.S. NIH Grant/Contract); 09042433 (Other Identifier: Other)