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Treatment for Depressed Primary Care Patients

Primary Purpose

Depression

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Depression Care Management (DCM)

Enhanced Care

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 Structured Clinical Interview for DSM Disorders(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 Diagnostic and Statistical Manual of Mental Disorders (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.

Sites / Locations

Westchester Medical Group Practices

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Depression Care Management (DCM)

Enhanced Care

Arm Description

Participants will receive Depression Care Management.

Participants will receive the standard of care from their primary care physicians enhanced by a summary of the study's diagnostic interview.

Outcomes

Primary Outcome Measures

Reduction in severity of depression over 16 weeks as measured by the Montgomery Asberg Depression Rating Scale (MADRS).

Secondary Outcome Measures

Reduction in disability over 16 weeks as measured by the World Health Organization Disability Scale (WHODAS).

Full Information

NCT ID

NCT01014312

First Posted

November 3, 2009

Last Updated

February 17, 2017

Sponsor

Weill Medical College of Cornell University

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT01014312

Brief Title

Treatment for Depressed Primary Care Patients

Official Title

Community-Based Depression Care Management for Elderly Primary Care Patients

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

September 1, 2009 (Actual)

Primary Completion Date

April 30, 2015 (Actual)

Study Completion Date

April 30, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Weill Medical College of Cornell University

Collaborators

National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression

Keywords

Depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Depression Care Management (DCM)

Arm Type

Experimental

Arm Description

Participants will receive Depression Care Management.

Arm Title

Enhanced Care

Arm Type

Active Comparator

Arm Description

Participants will receive the standard of care from their primary care physicians enhanced by a summary of the study's diagnostic interview.

Intervention Type

Behavioral

Intervention Name(s)

Depression Care Management (DCM)

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Enhanced Care

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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 Structured Clinical Interview for DSM Disorders(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 Diagnostic and Statistical Manual of Mental Disorders (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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jo Anne Sirey, Ph.D.

Organizational Affiliation

Weill Medical College of Cornell University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

George S. Alexopoulos, M.D.

Organizational Affiliation

Weill Medical College of Cornell University

Official's Role

Study Director

Facility Information:

Facility Name

Westchester Medical Group Practices

City

White Plains

State/Province

New York

ZIP/Postal Code

10605

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Treatment for Depressed Primary Care Patients

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