Treatment for Depressed Primary Care Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01014312|
Recruitment Status : Completed
First Posted : November 16, 2009
Last Update Posted : February 23, 2017
|Condition or disease||Intervention/treatment|
|Depression||Behavioral: Depression Care Management (DCM) Behavioral: Enhanced Care|
Major depression affects 5%-9% of older primary care patients, is often chronic or recurrent and disabling, and leads to frequent use of medical services. Most depressed elders are treated by primary care physicians (PCPs) and prior research has shown that collaboration between primary care physicians and depression care managers is effective in treating depression. The challenge has been in securing third-party reimbursement for such services.
This research study will address this barrier by developing a collaborative depression care management model (C-DCM) that encourages collaboration between PCPs and trained social workers employed by community-based, public and nonprofit mental health clinics. In addition to developing C-DCM, a total of 112 primary care outpatients will participate in this study to test whether C-DCM is more effective than the standard of care in decreasing the severity of depression and disability experienced by older adults. Each subject will be randomized into either Usual Care or C-DCM. All subjects will be assessed at Baseline and at 2 and 4 months while the C-DCM subjects will also meet with social worker depression case managers bi-weekly over four months. If shown effective, C-DCM may bring to bear an available, yet untapped resource in the care of depressed elders.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Community-Based Depression Care Management for Elderly Primary Care Patients|
|Actual Study Start Date :||September 1, 2009|
|Primary Completion Date :||April 30, 2015|
|Study Completion Date :||April 30, 2015|
Experimental: Depression Care Management (DCM)
Participants will receive Depression Care Management.
Behavioral: Depression Care Management (DCM)
Depression Care Management (DCM) includes: 1. Monitoring the course of the depressive disorder; 2. Contacting the referring primary care physician (PCP) and offering information on the patients' current psychiatric status and medical complaints and the treatment recommended by published pharmacotherapy guidelines; 3. Determining the nature and extent of stressors affecting the patients' clinical status and functioning; 4. Psychoeducation concerning depression and depression treatment, working with the patient to select an appropriate treatment based on informed treatment preferences, and emphasizing treatment adherence; and 5. Supportive psychotherapy.
Active Comparator: Enhanced Care
Participants will receive the standard of care from their primary care physicians enhanced by a summary of the study's diagnostic interview.
Behavioral: Enhanced Care
Primary Care Physicians will be informed by letter from a study psychologist of the participants' depression diagnosis and of suicidal ideation when present. They will have no direct assistance regarding depression treatment, but they will be educated on guideline-based antidepressant treatment recommendations. Moreover, research assistants will use a suicide risk protocol at baseline and at all follow-up assessment periods that mandates immediate contact with PCPs by telephone or beeper in cases with significant risk.
- Reduction in severity of depression over 16 weeks as measured by the Montgomery Asberg Depression Rating Scale (MADRS). [ Time Frame: Measured at Baseline, 8 weeks, and 16 weeks ]
- Reduction in disability over 16 weeks as measured by the World Health Organization Disability Scale (WHODAS). [ Time Frame: Measured at Baseline, 8 weeks, and 16 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01014312
|United States, New York|
|Westchester Medical Group Practices|
|White Plains, New York, United States, 10605|
|Principal Investigator:||Jo Anne Sirey, Ph.D.||Weill Medical College of Cornell University|
|Study Director:||George S. Alexopoulos, M.D.||Weill Medical College of Cornell University|