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

NCT ID: NCT01941706

Last Updated: 2014-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2012-06-30

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.

Conditions

Epilepsy; Depressive Symptoms; Depression; Seizure Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Project UPLIFT

Intervention Type: BEHAVIORAL

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)

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.

Group Type: EXPERIMENTAL

Project UPLIFT

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Nancy J Thompson, PhD

Associate Professor, Behavioral Sciences and Health Education

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nancy J Thompson, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Rollins School of Public Health

Atlanta, Georgia, United States

University of Michigan

Ann Arbor, Michigan, United States

University of Texas Health Science Center

Houston, Texas, United States

University of Washington

Seattle, Washington, United States

Countries

United States

Other Identifiers

5RC1MD004563-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

09042433

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00026786

Identifier Type: -

Identifier Source: org_study_id