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

Primary Purpose

Epilepsy, Depressive Symptoms, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Project UPLIFT
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Epilepsy focused on measuring Epilepsy, Seizure, Cognitive Behavioral Therapy, Mindfulness, Depression, Depressive symptoms, prevention, Coping skills, Quality of life, Telehealth, Phone intervention, Internet-based intervention

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rollins School of Public Health
  • University of Michigan
  • University of Texas Health Science Center
  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Project UPLIFT (Treatment)

Project UPLIFT (TAU Waitlist Control)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in seizure severity
Changes in seizure severity measured using the Liverpool Seizure Severity.
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.
Changes in Depressive Symptoms
Changes in depressive symptoms are measured using the Beck Depression Inventory (BDI).
Changes in Depressive Symptoms
Changes in depressive symptoms are measured using the Patient Health Questionnaire (PHQ-9).
Changes in Depressive Symptoms
Changes in depressive symptoms are measured using the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E).
Change in Seizure Activity
Change measured using self-reported number of seizures in the past 4 weeks.

Full Information

First Posted
September 5, 2013
Last Updated
February 11, 2014
Sponsor
Emory University
Collaborators
University of Michigan, University of Washington, The University of Texas Health Science Center, Houston, National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT01941706
Brief Title
Preventing Depression in People With Epilepsy: an Extension of Project UPLIFT
Official Title
Preventing Depression in People With Epilepsy: an Extension of Project UPLIFT
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
University of Michigan, University of Washington, The University of Texas Health Science Center, Houston, National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Depressive Symptoms, Depression, Seizure Disorder
Keywords
Epilepsy, Seizure, Cognitive Behavioral Therapy, Mindfulness, Depression, Depressive symptoms, prevention, Coping skills, Quality of life, Telehealth, Phone intervention, Internet-based intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Project UPLIFT (Treatment)
Arm Type
Experimental
Arm Description
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.
Arm Title
Project UPLIFT (TAU Waitlist Control)
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Project UPLIFT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Depressive Symptoms
Description
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 Outcome Measure Information:
Title
Changes in seizure severity
Description
Changes in seizure severity measured using the Liverpool Seizure Severity.
Time Frame
Baseline (0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
Title
Changes in Depression and Mindfulness Knowledge and Skills
Description
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)
Title
Changes in Depressive Symptoms
Description
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)
Title
Changes in Depressive Symptoms
Description
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)
Title
Changes in Depressive Symptoms
Description
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)
Title
Change in Seizure Activity
Description
Change measured using self-reported number of seizures in the past 4 weeks.
Time Frame
Baseline (0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
Other Pre-specified Outcome Measures:
Title
Changes in Satisfaction with Life
Description
Changes are measured using the Satisfaction with Life Scale (Denier, E., et al., The satisfaction with life scale. Journal of Personality Assessment, 1985)
Time Frame
Baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
Title
Changes in Sleep Quality
Description
The study uses the Pittsburgh Sleep Quality Index to assess changes in sleep quality.
Time Frame
Baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
Title
Changes in Depression Coping Self-Efficacy
Description
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.
Time Frame
Baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
Title
Changes in Self Compassion
Description
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.
Time Frame
Baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
Title
Changes in Physical and Mental Health Quality of Life
Description
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.
Time Frame
Baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy J Thompson, MPH, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rollins School of Public Health
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
University of Texas Health Science Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

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

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