This trial is active, not recruiting.

Conditions depression, epilepsy
Treatment program to encourage active, rewarding lives (pearl)
Sponsor University of Washington
Collaborator Centers for Disease Control and Prevention
Start date March 2007
End date March 2009
Trial size 80 participants
Trial identifier NCT00459329, 06-4237-C 01, SIP 07-2006


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model single group assignment
Masking single blind (outcomes assessor)
Primary purpose treatment

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title PEARL Intervention to Reduce Depression Among Adults With Epilepsy
Principal investigator Paul S Ciechanowski, MD, MPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2008.
Information provided to ClinicalTrials.gov by University of Washington.