PEARL Intervention to Reduce Depression Among Adults With Epilepsy (PEARL)
Primary Purpose
Depression, Epilepsy
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Program to Encourage Active, Rewarding Lives (PEARL)
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Depression, Epilepsy, Problem-Solving Therapy, Mental Health, Neurology, Home-based health care, Community-based program, Collaborative care
Eligibility 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
Sites / Locations
- Regional Epilepsy Center, Harborview Medical Center
Outcomes
Primary Outcome Measures
Mean SCL-20 depression scores
Depression treatment response, defined as greater than 50% decrease in SCL-20 score from baseline
Complete depression remission defined as SCL-20 score less than 0.5.
Secondary Outcome Measures
Quality of Life
Pharmaceutical and health care utilization and costs
Seizure frequency and severity
Satisfaction with epilepsy health care
Epilepsy Self-Efficacy
Full Information
NCT ID
NCT00459329
First Posted
April 9, 2007
Last Updated
June 2, 2008
Sponsor
University of Washington
Collaborators
Centers for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT00459329
Brief Title
PEARL Intervention to Reduce Depression Among Adults With Epilepsy
Acronym
PEARL
Official Title
PEARL Intervention to Reduce Depression Among Adults With Epilepsy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Unknown status
Study Start Date
March 2007 (undefined)
Primary Completion Date
March 2009 (Anticipated)
Study Completion Date
March 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Washington
Collaborators
Centers for Disease Control and Prevention
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Epilepsy
Keywords
Depression, Epilepsy, Problem-Solving Therapy, Mental Health, Neurology, Home-based health care, Community-based program, Collaborative care
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Program to Encourage Active, Rewarding Lives (PEARL)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean SCL-20 depression scores
Time Frame
6 & 12 months post-baseline
Title
Depression treatment response, defined as greater than 50% decrease in SCL-20 score from baseline
Time Frame
6 & 12 months post-baseline
Title
Complete depression remission defined as SCL-20 score less than 0.5.
Time Frame
6 & 12 months post-baseline
Secondary Outcome Measure Information:
Title
Quality of Life
Time Frame
6 & 12 months post-baseline
Title
Pharmaceutical and health care utilization and costs
Time Frame
6 & 12 months post-baseline
Title
Seizure frequency and severity
Time Frame
6 & 12 months post-baseline
Title
Satisfaction with epilepsy health care
Time Frame
6 & 12 months post-baseline
Title
Epilepsy Self-Efficacy
Time Frame
6 & 12 months post-baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul S Ciechanowski, MD, MPH
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regional Epilepsy Center, Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21333607
Citation
Chaytor N, Ciechanowski P, Miller JW, Fraser R, Russo J, Unutzer J, Gilliam F. Long-term outcomes from the PEARLS randomized trial for the treatment of depression in patients with epilepsy. Epilepsy Behav. 2011 Mar;20(3):545-9. doi: 10.1016/j.yebeh.2011.01.017. Epub 2011 Feb 18.
Results Reference
derived
PubMed Identifier
20609631
Citation
Ciechanowski P, Chaytor N, Miller J, Fraser R, Russo J, Unutzer J, Gilliam F. PEARLS depression treatment for individuals with epilepsy: a randomized controlled trial. Epilepsy Behav. 2010 Nov;19(3):225-31. doi: 10.1016/j.yebeh.2010.06.003. Epub 2010 Jul 6.
Results Reference
derived
Learn more about this trial
PEARL Intervention to Reduce Depression Among Adults With Epilepsy
We'll reach out to this number within 24 hrs