PEARL Intervention to Reduce Depression Among Adults With Epilepsy (PEARL)
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|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
|Condition or disease||Intervention/treatment||Phase|
|Depression Epilepsy||Behavioral: Program to Encourage Active, Rewarding Lives (PEARL)||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
- Mean SCL-20 depression scores [ Time Frame: 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 ]
- Complete depression remission defined as SCL-20 score less than 0.5. [ Time Frame: 6 & 12 months post-baseline ]
- Quality of Life [ Time Frame: 6 & 12 months post-baseline ]
- Pharmaceutical and health care utilization and costs [ Time Frame: 6 & 12 months post-baseline ]
- Seizure frequency and severity [ Time Frame: 6 & 12 months post-baseline ]
- Satisfaction with epilepsy health care [ Time Frame: 6 & 12 months post-baseline ]
- Epilepsy Self-Efficacy [ Time Frame: 6 & 12 months post-baseline ]
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
|United States, Washington|
|Regional Epilepsy Center, Harborview Medical Center|
|Seattle, Washington, United States, 98104|
|Principal Investigator:||Paul S Ciechanowski, MD, MPH||University of Washington|