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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00459329
Recruitment Status : Unknown
Verified June 2008 by University of Washington.
Recruitment status was:  Active, not recruiting
First Posted : April 11, 2007
Last Update Posted : June 4, 2008
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by:
University of Washington

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Depression Epilepsy Behavioral: Program to Encourage Active, Rewarding Lives (PEARL) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PEARL Intervention to Reduce Depression Among Adults With Epilepsy
Study Start Date : March 2007
Estimated Primary Completion Date : March 2009
Estimated Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arms and Interventions
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Intervention Details:
  • Behavioral: Program to Encourage Active, Rewarding Lives (PEARL)

    Eight 50-minute in-home sessions over 19 weeks with a masters-level social work counselor using Problem Solving Therapy (PST).

    PST is a skills-enhancing behavioral depression treatment based on the assumption that an accumulation of problems in living cause and maintain depressive symptoms, and through systematically identifying and addressing these problems, patients achieve decreased depressive symptoms. Counselors also help participants to increase social and physical activities and to incorporate pleasant activities into patients' lives.

    Counselors provide education and monitoring for antidepressant use, and work with the participant's physician and PEARL psychiatrist to recommend initiating or adjusting antidepressant medications. The PHQ-9 is administered at each session to track depression change.

    After 19 weeks, counselors will maintain monthly telephone calls with participants, administering the PHQ-9 and assessing PST success.


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

Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: 6 & 12 months post-baseline ]
  2. Pharmaceutical and health care utilization and costs [ Time Frame: 6 & 12 months post-baseline ]
  3. Seizure frequency and severity [ Time Frame: 6 & 12 months post-baseline ]
  4. Satisfaction with epilepsy health care [ Time Frame: 6 & 12 months post-baseline ]
  5. Epilepsy Self-Efficacy [ Time Frame: 6 & 12 months post-baseline ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00459329


Locations
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United States, Washington
Regional Epilepsy Center, Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
Centers for Disease Control and Prevention
Investigators
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Principal Investigator: Paul S Ciechanowski, MD, MPH University of Washington
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Paul Ciechanowski, MD, MPH, University of Washington
ClinicalTrials.gov Identifier: NCT00459329    
Other Study ID Numbers: 06-4237-C 01
SIP 07-2006
First Posted: April 11, 2007    Key Record Dates
Last Update Posted: June 4, 2008
Last Verified: June 2008
Keywords provided by University of Washington:
Depression
Epilepsy
Problem-Solving Therapy
Mental Health
 Neurology
Home-based health care
Community-based program
Collaborative care
Additional relevant MeSH terms:
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Epilepsy
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
 Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases