Treatment for Depressed Primary Care Patients - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT01014312

Purpose

This research study develop a collaborative depression care management model (C-DCM) that encourages collaboration between primary care physicians (PCPs) and trained social workers employed by community-based, public and nonprofit mental health clinics.

Condition	Intervention
Depression	Behavioral: Depression Care Management (DCM) Behavioral: Enhanced Care

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Community-Based Depression Care Management for Elderly Primary Care Patients

Resource links provided by NLM:

MedlinePlus related topics: Depression Mental Health

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	112
Study Start Date:	September 2009
Estimated Study Completion Date:	March 2014
Estimated Primary Completion Date:	March 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 60 years and older: This study focuses on the clinical complexities of late-life depression and its treatment. Family Services of Westchester (our partner community mental health agency) offers geriatric mental health counseling services to adults age 60 and older.
Diagnosis of unipolar major depression
MADRS score >=18: Depression of such severity in primary care patients requires treatment.
CANE score >0: Reflects the presence of at least one unmet need in the domains of housing, self-care, safety, finances, benefits, legal matters, transportation, etc. and thus need for social services.
Capacity to provide written consent for both research assessment and depression care management: PCPs will be asked to clinically evaluate prospective participants' capacity to consent and document it in their medical record.
Working knowledge of English: Command in English sufficient for comprehending questionnaires of the study and/or for understanding the DCM therapists. English does not have to be the subject's first language.

Exclusion Criteria:

Psychotic depression: This will be determined by the SCID assessment; presence of delusions and or hallucinations. This is a severe disorder typically referred for treatment to mental health specialists.
Active suicidal ideation: This will be determined by the SCID and MADRS assessments. Older patients at these levels of risk for self-harm typically are referred to mental health specialists.
Antisocial personality by DSM-IV: This disorder will possibly interfere with adherence to research procedures and treatment.
Significant Cognitive Impairment (MMSE score <24) or clinical diagnosis of dementia by DSM-IV: These conditions may limit the patient's ability to participate in treatment and require social service interventions exceeding those available through the proposed depression care management models.
Current participation in specialist psychiatric care: Such patients will require the development of collaborative arrangements for depression care management which differ from those being tested in this study.
Acute or severe medical illness: i.e., delirium, metastatic cancer, decompensated cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction during the three months prior to entry; or drugs often causing depression, e.g., steroids, reserpine, alpha-methyl-dopa, tamoxifen, vincristine.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01014312

Locations

United States, New York
Westchester Medical Group Practices
White Plains, New York, United States, 10605

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

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

More Information

No publications provided

Responsible Party:	Jo Anne Sirey, Ph.D., Weill Cornell Medical College
ClinicalTrials.gov Identifier:	NCT01014312 History of Changes
Other Study ID Numbers:	P30 MH085943-02, P30MH085943, DATR A4-GPC
Study First Received:	November 3, 2009
Last Updated:	August 9, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Depression

Additional relevant MeSH terms:

Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on February 09, 2012