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

February 11, 2014 updated by: Nancy J Thompson, PhD, Emory University
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Baseline (at 0 week) , Interim (at 8 weeks), Follow-up (at16 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in seizure severity
Time Frame: Baseline (0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
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
Time Frame: Baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
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
Time Frame: baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
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
Time Frame: baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
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
Time Frame: baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
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
Time Frame: Baseline (0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Satisfaction with Life
Time Frame: Baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
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
Time Frame: Baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
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
Time Frame: Baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
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
Time Frame: Baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
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
Time Frame: Baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emory University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The University of Texas Health Science Center, Houston
National Institute on Minority Health and Health Disparities (NIMHD)
University of Michigan
University of Washington

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nancy J Thompson, MPH, PhD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00026786
  • 5RC1MD004563-02 (U.S. NIH Grant/Contract)
  • 09042433 (Other Identifier: Other)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings