DepressionPEARLNCT00459329
PEARL Intervention to Reduce Depression Among Adults With Epilepsy
A study testing Program to Encourage Active, Rewarding Lives (PEARL) in people with Depression and Epilepsy, run by University of Washington at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Epilepsy
- What is being tested?
- Program to Encourage Active, Rewarding Lives (PEARL)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Mar 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Regional Epilepsy Center, Harborview Medical Center
Seattle, Washington, 98104
About this study
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.
Read the 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
- Being tested
- Program to Encourage Active, Rewarding Lives (PEARL)
- Keywords
- Depression, Epilepsy, Problem-Solving Therapy, Mental Health, Neurology, Home-based health care, Community-based program, Collaborative care
- Medical subject headings
- Depression, Epilepsy, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Program to Encourage Active, Rewarding Lives (PEARL)Behavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean SCL-20 depression scores
Measured: 6 & 12 months post-baseline
Depression treatment response, defined as greater than 50% decrease in SCL-20 score from baseline
Measured: 6 & 12 months post-baseline
Complete depression remission defined as SCL-20 score less than 0.5.
Measured: 6 & 12 months post-baseline
Secondary outcomes (5)
Quality of Life
Measured: 6 & 12 months post-baseline
Pharmaceutical and health care utilization and costs
Measured: 6 & 12 months post-baseline
Seizure frequency and severity
Measured: 6 & 12 months post-baseline
Satisfaction with epilepsy health care
Measured: 6 & 12 months post-baseline
Epilepsy Self-Efficacy
Measured: 6 & 12 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2007 (estimated)
- Study startMar 2007
- Primary completionMar 2009 (estimated)
- Study completionMar 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Investigators
- Paul S Ciechanowski, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00459329
- Sponsor's protocol ID
- 06-4237-C 01
- Other IDs
- NCT00459329, SIP 07-2006
- Acronym
- PEARL
- Status last verified
- Jun 2008
- First submitted
- 9 Apr 2007
- Last updated
- 4 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21333607Ciechanowski 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.
PubMed 20609631
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PEARL Intervention to Reduce Depression Among Adults With Epilepsy
- ClinicalTrials.gov ID
- NCT00459329
- Acronym / sponsor ID
- PEARL / 06-4237-C 01
- Conditions
- Depression, Epilepsy
- Keywords
- Depression, Epilepsy, Problem-Solving Therapy, Mental Health, Neurology, Home-based health care, Community-based program, Collaborative care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Mar 2007
- Primary completion
- Mar 2009 (estimated)
- Study completion
- Mar 2009 (estimated)
- First posted
- 11 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | – |
Primary outcome
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
5 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2008.
- Derived from this study: PubMed 21333607Chaytor 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.
- Derived from this study: PubMed 20609631Ciechanowski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul S Ciechanowski, MD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Program to Encourage Active, Rewarding Lives (PEARL) in people with Depression and Epilepsy, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean SCL-20 depression scores (time frame: 6 & 12 months post-baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00459329, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2008.