Treatment for Depressed Primary Care Patients

NCT01014312 | Completed DMC

• 3 other identifiers: P30MH085943-02P30MH085943DATR A4-GPC
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Depression

Outcome Measures

Primary Outcomes (1)

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

  Measured at Baseline, 8 weeks, and 16 weeks

Secondary Outcomes (1)

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

  Measured at Baseline, 8 weeks, and 16 weeks

Study Arms (2)

Depression Care Management (DCM)

EXPERIMENTAL

Participants will receive Depression Care Management.

Behavioral: Depression Care Management (DCM)

Enhanced Care

ACTIVE COMPARATOR

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

Interventions

Depression Care Management (DCM) BEHAVIORAL

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.

Depression Care Management (DCM)

Enhanced Care BEHAVIORAL

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.

Enhanced Care

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Westchester Medical Group Practices

White Plains, New York, 10605, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Jo Anne Sirey, Ph.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

• George S. Alexopoulos, M.D.

  Weill Medical College of Cornell University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2009
• First Posted: November 16, 2009
• Study Start: September 1, 2009
• Primary Completion: April 30, 2015
• Study Completion: April 30, 2015
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)