Clinical trial NCT01941706: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: University of Washington
name: The University of Texas Health Science Center, Houston
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2013-09-13
Enrollment: 130
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Changes in Depressive Symptoms
timeFrame: Baseline (at 0 week) , Interim (at 8 weeks), Follow-up (at16 weeks)
Secondary outcomes:
measure: Changes in seizure severity
timeFrame: Baseline (0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
measure: Changes in Depression and Mindfulness Knowledge and Skills
timeFrame: Baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
measure: Changes in Depressive Symptoms
timeFrame: baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
measure: Changes in Depressive Symptoms
timeFrame: baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
measure: Changes in Depressive Symptoms
timeFrame: baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
measure: Change in Seizure Activity
timeFrame: Baseline (0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
Other outcomes:
measure: Changes in Satisfaction with Life
timeFrame: Baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
measure: Changes in Sleep Quality
timeFrame: Baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
measure: Changes in Depression Coping Self-Efficacy
timeFrame: Baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
measure: Changes in Self Compassion
timeFrame: Baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
measure: Changes in Physical and Mental Health Quality of Life
timeFrame: Baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks)
Locations:
city: Atlanta
country: United States
facility: Rollins School of Public Health
state: Georgia
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Houston
country: United States
facility: University of Texas Health Science Center
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Emory University
name: Nancy J Thompson, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References: