PEARL Intervention to Reduce Depression Among Adults With Epilepsy

NCT ID: NCT00459329

Last Updated: 2008-06-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2009-03-31

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.

Conditions

Depression; Epilepsy

Keywords

Depression; Epilepsy; Problem-Solving Therapy; Mental Health; Neurology; Home-based health care; Community-based program; Collaborative care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

University of Washington

Principal Investigators

Paul S Ciechanowski, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Regional Epilepsy Center, Harborview Medical Center

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 21333607 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 20609631 (View on PubMed)

Other Identifiers

NCT00459329

Identifier Type: -

Identifier Source: secondary_id

SIP 07-2006

Identifier Type: -

Identifier Source: secondary_id

06-4237-C 01

Identifier Type: -

Identifier Source: org_study_id