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Engaging Depressed Low-Income Seniors in Mental Health Services (ENGAGE)

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ENGAGE
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other 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.
  • Positive screen for major depression (PHQ-9 greater than 10): We chose standard PHQ-9 screening to correspond to routine procedures within each House that identify seniors in need of evaluation for treatment.
  • Capacity to provide written consent for both research assessment and treatment. This criterion is necessary because subjects must be able to participate meaningfully in the interventions offered by the study and the assessment procedures.
  • Working knowledge of English. Fluency in English sufficient for comprehending questionnaires of the study and/or for understanding the case worker. English does not have to be the subject's first language.

Exclusion Criteria:

  • MMSE score < 24 or clinical diagnosis of dementia. Dementia, or cognitive impairment at this level may limit the senior's ability to participate in the intervention.
  • Psychotic or manic symptoms or alcohol or substance dependence. These symptoms and disorders will be determined by the SCID assessment and require alternative interventions than those offered by the study. We focus in this project on seniors with depressive symptoms given existing Neighborhood House procedures for standard depression screening, and given difficulties in training case worker staff on screening for other psychiatric disorders. If this project is successful, we may then expand our efforts to target other disorders such as psychotic, manic, and alcohol and substance abuse and dependence disorders.
  • Antidepressant medication or psychotherapy in the 4 weeks prior to baseline evaluation. The intervention is focused on linking depressed seniors who are in need of mental health services rather than those currently receiving treatment.
  • 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.
  • Antisocial personality by DSM-IV: This disorder will possibly interfere with adherence to research procedures and treatment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    ENGAGE

    Arm Description

    In stage 1, study investigators will train Neighborhood House caseworkers to screen their clients for depressive symptoms. In stage 2, study investigators will train Neighborhood House caseworkers to use the ENGAGE intervention in referring their clients to mental health services

    Outcomes

    Primary Outcome Measures

    Feasibility of ENGAGE intervention
    Examine the feasibility of training case workers in 3 Neighborhood Houses in ENGAGE - an intervention that identifies and addresses attitudinal and concrete barriers to pursuing evaluation and care; incorporates shared decision making in service and treatment options; and facilitates connection to affordable mental health services.

    Secondary Outcome Measures

    Increase in referrals for mental health evaluation
    Conduct a preliminary study to evaluate whether ENGAGE can increase the number of seniors (with symptoms of depression on a screen) who follow through with a referral for mental health evaluation.

    Full Information

    First Posted
    March 26, 2010
    Last Updated
    November 6, 2017
    Sponsor
    Weill Medical College of Cornell University
    Collaborators
    National Institute of Mental Health (NIMH)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01094951
    Brief Title
    Engaging Depressed Low-Income Seniors in Mental Health Services
    Acronym
    ENGAGE
    Official Title
    Engaging Depressed Low-Income Seniors in Mental Health Services
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2010 (undefined)
    Primary Completion Date
    April 2015 (Actual)
    Study Completion Date
    April 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

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This two-stage research study will train caseworkers in three participating New York City Neighborhood Houses to screen their clients for depression, and examine the usefulness of training these caseworkers in an intervention that targets barriers seniors face in receiving mental health services. In this intervention, called ENGAGE, Case Workers will: 1. identify and address seniors' barriers to receiving mental health services; 2. include the seniors' preferences in deciding which treatment options to choose; and 3. help seniors connect with affordable mental health services of their choice.
    Detailed Description
    In this research study, study investigators are partnering with United Neighborhood Houses of New York, the umbrella membership organization of the 34 New York City Neighborhood Houses. Due to the limited scope of this feasibility study, we have selected three Houses to serve as recruitment sites. These three house approximate the gender and racial characteristics of the larger group. During Stage 1, investigators will work with the three Houses in implementing systematic research assessments to identify level of psychopathology, referral patterns, and connections to mental health evaluation among their depressed senior clients. Investigators will train caseworkers to screen their clients for depression and will also instruct caseworkers to refer any senior scoring endorsing depressive symptoms to their partnering community-based mental health or medical clinic. Data on successful connections to mental health evaluation will serve as the comparison to that achieved by Stage 2, the ENGAGE intervention. During Stage 2 study investigators will train all caseworkers from each Neighborhood House to use the ENGAGE intervention. For eligible depressed seniors, the caseworker will: provide psychoeducation that addresses client-specific barriers to evaluation and care (e.g., stigma, transportation); use shared decision-making strategies to engage seniors and arrive at a decision about where and from whom to receive an evaluation and possible care; and provide connections to preferred mental health services. Mental health service options will include referral to the senior's primary care physician or local community mental health clinic for further evaluation. In two subsequent sessions 2 and 4 weeks later, the caseworker will assess success in receiving a mental health evaluation, and in initiating treatment: If the senior has not yet pursued an evaluation, the caseworker will continue to address his/her individual barriers and will re-engage in shared decision-making if necessary. If the senior did receive an evaluation that confirms a depressive diagnosis, but remains undecided about treatment, the case worker will empower and help the senior to select an appropriate treatment of his/her choice and will encourage ongoing engagement in this treatment. If an evaluation revealed the absence of a depressive disorder and no treatment recommendations, the caseworker will re-assess to ensure that depression did not emerge.

    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
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ENGAGE
    Arm Type
    Other
    Arm Description
    In stage 1, study investigators will train Neighborhood House caseworkers to screen their clients for depressive symptoms. In stage 2, study investigators will train Neighborhood House caseworkers to use the ENGAGE intervention in referring their clients to mental health services
    Intervention Type
    Behavioral
    Intervention Name(s)
    ENGAGE
    Intervention Description
    During Stage 2, investigators will train Neighborhood House caseworkers to 1. provide psychoeducation that addresses client-specific barriers to evaluation and care; 2. use shared decision-making strategies to engage seniors and arrive at a decision about where and from whom to receive an evaluation and possible care; and 3. provide connections to preferred community-based mental health services.
    Primary Outcome Measure Information:
    Title
    Feasibility of ENGAGE intervention
    Description
    Examine the feasibility of training case workers in 3 Neighborhood Houses in ENGAGE - an intervention that identifies and addresses attitudinal and concrete barriers to pursuing evaluation and care; incorporates shared decision making in service and treatment options; and facilitates connection to affordable mental health services.
    Time Frame
    Measured at Baseline, 4, 8, and 12 weeks
    Secondary Outcome Measure Information:
    Title
    Increase in referrals for mental health evaluation
    Description
    Conduct a preliminary study to evaluate whether ENGAGE can increase the number of seniors (with symptoms of depression on a screen) who follow through with a referral for mental health evaluation.
    Time Frame
    Measured at Baseline, 4, 8, and 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 60 years and older. Positive screen for major depression (PHQ-9 greater than 10): We chose standard PHQ-9 screening to correspond to routine procedures within each House that identify seniors in need of evaluation for treatment. Capacity to provide written consent for both research assessment and treatment. This criterion is necessary because subjects must be able to participate meaningfully in the interventions offered by the study and the assessment procedures. Working knowledge of English. Fluency in English sufficient for comprehending questionnaires of the study and/or for understanding the case worker. English does not have to be the subject's first language. Exclusion Criteria: MMSE score < 24 or clinical diagnosis of dementia. Dementia, or cognitive impairment at this level may limit the senior's ability to participate in the intervention. Psychotic or manic symptoms or alcohol or substance dependence. These symptoms and disorders will be determined by the SCID assessment and require alternative interventions than those offered by the study. We focus in this project on seniors with depressive symptoms given existing Neighborhood House procedures for standard depression screening, and given difficulties in training case worker staff on screening for other psychiatric disorders. If this project is successful, we may then expand our efforts to target other disorders such as psychotic, manic, and alcohol and substance abuse and dependence disorders. Antidepressant medication or psychotherapy in the 4 weeks prior to baseline evaluation. The intervention is focused on linking depressed seniors who are in need of mental health services rather than those currently receiving treatment. 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. Antisocial personality by DSM-IV: This disorder will possibly interfere with adherence to research procedures and treatment.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Patrick J. Raue, 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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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