PEARL Intervention to Reduce Depression Among Adults With Epilepsy

Depression Clinical Trial

— PEARL  

Official title:

PEARL Intervention to Reduce Depression Among Adults With Epilepsy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00459329
• Other study ID #: 06-4237-C 01
• Secondary ID: SIP 07-2006
• Status: Active, not recruiting
• Phase: N/A
• First received: April 9, 2007
• Last updated: June 2, 2008
• Start date: March 2007
• Est. completion date: March 2009

Study information

• Verified date: June 2008
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Epilepsy

Intervention

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.

Locations

Country	Name	City	State
United States	Regional Epilepsy Center, Harborview Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean SCL-20 depression scores		6 & 12 months post-baseline	No
Primary	Depression treatment response, defined as greater than 50% decrease in SCL-20 score from baseline		6 & 12 months post-baseline	No
Primary	Complete depression remission defined as SCL-20 score less than 0.5.		6 & 12 months post-baseline	No
Secondary	Quality of Life		6 & 12 months post-baseline	No
Secondary	Pharmaceutical and health care utilization and costs		6 & 12 months post-baseline	No
Secondary	Seizure frequency and severity		6 & 12 months post-baseline	No
Secondary	Satisfaction with epilepsy health care		6 & 12 months post-baseline	No
Secondary	Epilepsy Self-Efficacy		6 & 12 months post-baseline	No