NCT00459329

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 9, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 11, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

June 4, 2008

Status Verified

June 1, 2008

Enrollment Period

2 years

First QC Date

April 9, 2007

Last Update Submit

June 2, 2008

Conditions

DepressionEpilepsy

Keywords

DepressionEpilepsyProblem-Solving TherapyMental HealthNeurologyHome-based health careCommunity-based programCollaborative care

Outcome Measures

Primary Outcomes (3)

  • Mean SCL-20 depression scores

    6 & 12 months post-baseline

  • Depression treatment response, defined as greater than 50% decrease in SCL-20 score from baseline

    6 & 12 months post-baseline

  • Complete depression remission defined as SCL-20 score less than 0.5.

    6 & 12 months post-baseline

Secondary Outcomes (5)

  • Quality of Life

    6 & 12 months post-baseline

  • Pharmaceutical and health care utilization and costs

    6 & 12 months post-baseline

  • Seizure frequency and severity

    6 & 12 months post-baseline

  • Satisfaction with epilepsy health care

    6 & 12 months post-baseline

  • Epilepsy Self-Efficacy

    6 & 12 months post-baseline

Interventions

Program to Encourage Active, Rewarding Lives (PEARL)BEHAVIORAL

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regional Epilepsy Center, Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Related Publications (2)

  • 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.

    PMID: 21333607DERIVED

  • 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.

    PMID: 20609631DERIVED

MeSH Terms

Conditions

DepressionEpilepsyPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPersonal Satisfaction

Study Officials

  • Paul S Ciechanowski, MD, MPH

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 9, 2007

First Posted

April 11, 2007

Study Start

March 1, 2007

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

June 4, 2008

Record last verified: 2008-06

Locations

US(1)