NCT01941706

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2009

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 13, 2013

Completed
Last Updated

February 12, 2014

Status Verified

February 1, 2014

Enrollment Period

2.2 years

First QC Date

September 5, 2013

Last Update Submit

February 11, 2014

Conditions

EpilepsyDepressive SymptomsDepressionSeizure Disorder

Keywords

EpilepsySeizureCognitive Behavioral TherapyMindfulnessDepressionDepressive symptomspreventionCoping skillsQuality of lifeTelehealthPhone interventionInternet-based intervention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Changes in seizure severity

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

  • Changes in Depression and Mindfulness Knowledge and Skills

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

  • Changes in Depressive Symptoms

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

  • Changes in Depressive Symptoms

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

  • Changes in Depressive Symptoms

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

  • +1 more secondary outcomes

Other Outcomes (5)

  • Changes in Satisfaction with Life

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

  • Changes in Sleep Quality

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

  • Changes in Depression Coping Self-Efficacy

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

  • +2 more other outcomes

Study Arms (2)

Project UPLIFT (Treatment)

EXPERIMENTAL

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

Project UPLIFT (TAU Waitlist Control)

EXPERIMENTAL

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

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.

Project UPLIFT (TAU Waitlist Control)Project UPLIFT (Treatment)

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Rollins School of Public Health

Atlanta, Georgia, 30322, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of Texas Health Science Center

Houston, Texas, 77030, United States

Location

University of Washington

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

EpilepsyDepressionSeizures

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesBehavioral SymptomsBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nancy J Thompson, MPH, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Behavioral Sciences and Health Education

Study Record Dates

First Submitted

September 5, 2013

First Posted

September 13, 2013

Study Start

October 1, 2009

Primary Completion

December 1, 2011

Study Completion

June 1, 2012

Last Updated

February 12, 2014

Record last verified: 2014-02

Locations

US(4)