Clinical trial NCT00459329: PEARL Intervention to Reduce Depression Among Adults With Epilepsy
Official title: PEARL Intervention to Reduce Depression Among Adults With Epilepsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Epilepsy
Keywords: Depression
Epilepsy
Problem-Solving Therapy
Mental Health
Neurology
Home-based health care
Community-based program
Collaborative care
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2007-04-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean SCL-20 depression scores
timeFrame: 6 & 12 months post-baseline
measure: Depression treatment response, defined as greater than 50% decrease in SCL-20 score from baseline
timeFrame: 6 & 12 months post-baseline
measure: Complete depression remission defined as SCL-20 score less than 0.5.
timeFrame: 6 & 12 months post-baseline
Secondary outcomes:
measure: Quality of Life
timeFrame: 6 & 12 months post-baseline
measure: Pharmaceutical and health care utilization and costs
timeFrame: 6 & 12 months post-baseline
measure: Seizure frequency and severity
timeFrame: 6 & 12 months post-baseline
measure: Satisfaction with epilepsy health care
timeFrame: 6 & 12 months post-baseline
measure: Epilepsy Self-Efficacy
timeFrame: 6 & 12 months post-baseline
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Regional Epilepsy Center, Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Paul S Ciechanowski, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.