PEARL Intervention to Reduce Depression Among Adults With Epilepsy (PEARL)

June 2, 2008 updated by: University of Washington

The purpose of this study is to test the effectiveness of a home-based depression treatment intervention called "Program to Encourage Active, Rewarding Lives (PEARL)". We hypothesize that over a 12-month period, compared to usual care, those receiving the PEARL intervention will show more improvement with their depression, have higher quality of life and function, and use fewer medical services.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Behavioral: Program to Encourage Active, Rewarding Lives (PEARL)

Detailed Description

Compared to non-depressed individuals with epilepsy, those with depression have significantly higher rates of suicide, lower social and occupational functioning, decreased quality of life independent of seizure frequency, and higher non-psychiatric health care utilization. Adults with epilepsy are more likely to be homebound as a result of reduced function and restrictions in driving, opportunities to obtain enhanced quality of care for depression may be limited. This study tests the effectiveness of a home-based multi-modal depression treatment intervention called Program to Encourage Active, Rewarding Lives (PEARL). PEARL consists of problem solving treatment, social and physical activation, pleasant events scheduling, support and education regarding antidepressant medication use as well as psychiatric consultation and recommendations regarding initiation or adjustment of antidepressant medications.

In a sample of adults with epilepsy who have minor depression, major depression and/or dysthymia, we hypothesize that over a 12-month period, compared to usual care, those randomized to the PEARL intervention will: achieve higher levels of depression response and remission, achieve higher quality of life and function, and utilize less non-psychiatric health care.

By providing a multi-modal, home-based stepped collaborative care intervention for adults with depression and epilepsy, this program will offer practical alternatives to usual care and will provide a program for improving depression outcomes, quality of life and potentially, epilepsy outcomes.

Study Type

Interventional

Enrollment (Actual)

Phase

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
- Washington
  - Seattle, Washington, United States, 98104
    - Regional Epilepsy Center, Harborview Medical Center

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

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Home address within 30 miles of Seattle
Diagnosis of epilepsy (ICD-9 code 345.XX)
Appointment in the UW REC or Neurology clinic in the past 2 years and currently enrolled in this clinic.
Current age older than 18 years
Diagnosis of major depression, minor depression or dysthymia
Ability to speak/read English

Exclusion Criteria:

Alcohol and/or substance abuse/dependence based on a score greater than 1 on 4-item validated CAGE-AID
Cognitive impairment based on a score less than 3 on a 6-item validated cognitive screen
Diagnosis of bipolar disorder, schizophrenia/schizoaffective disorder or other psychotic disorder
Women who are pregnant or nursing
Terminal medical illness
Those currently seeing or planning to see a psychiatrist
Those with suicidal ideation nearly every day

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: Treatment
Allocation: Randomized
Interventional Model: Single Group Assignment
Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean SCL-20 depression scores Time Frame: 6 & 12 months post-baseline	6 & 12 months post-baseline
Depression treatment response, defined as greater than 50% decrease in SCL-20 score from baseline Time Frame: 6 & 12 months post-baseline	6 & 12 months post-baseline
Complete depression remission defined as SCL-20 score less than 0.5. Time Frame: 6 & 12 months post-baseline	6 & 12 months post-baseline

Secondary Outcome Measures

Outcome Measure	Time Frame
Quality of Life Time Frame: 6 & 12 months post-baseline	6 & 12 months post-baseline
Pharmaceutical and health care utilization and costs Time Frame: 6 & 12 months post-baseline	6 & 12 months post-baseline
Seizure frequency and severity Time Frame: 6 & 12 months post-baseline	6 & 12 months post-baseline
Satisfaction with epilepsy health care Time Frame: 6 & 12 months post-baseline	6 & 12 months post-baseline
Epilepsy Self-Efficacy Time Frame: 6 & 12 months post-baseline	6 & 12 months post-baseline

Collaborators and Investigators

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

Sponsor

University of Washington

Collaborators

Centers for Disease Control and Prevention

Investigators

Principal Investigator: Paul S Ciechanowski, MD, MPH, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2007

Primary Completion (Anticipated)

March 1, 2009

Study Completion (Anticipated)