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DepressionENGAGENCT01094951

Engaging Depressed Low-Income Seniors in Mental Health Services

A study testing ENGAGE in people with Depression, run by Weill Medical College of Cornell University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This two-stage research study will 1. train caseworkers in three participating New York City Neighborhood Houses to screen their clients for depression, and 2. examine the usefulness of training these caseworkers in an intervention that targets barriers seniors face in receiving mental health services. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Depression
What is being tested?
ENGAGE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
No sites listed yet
Study dates
Mar 2010to Apr 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

This two-stage research study will

  1. train caseworkers in three participating New York City Neighborhood Houses to screen their clients for depression, and
  2. 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.
Read the 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:

  1. provide psychoeducation that addresses client-specific barriers to evaluation and care (e.g., stigma, transportation);
  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 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.
Conditions
Depression
Being tested
ENGAGE
Keywords
Depression
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ENGAGEBehavioural

    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.

Study groups in NCT01094951
Study groupRoleWhat they receive
ENGAGEOtherIn 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
Receives: Behavioral: ENGAGE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Measured at Baseline, 4, 8, and 12 weeks

Secondary outcomes (1)
  1. 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.

    Measured: Measured at Baseline, 4, 8, and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionApr 2015
  4. Study completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01094951
Sponsor's protocol ID
P30MH085943-03
Other IDs
P30MH085943-03, P30MH085943
Acronym
ENGAGE
Status last verified
Nov 2017
First submitted
26 Mar 2010
Last updated
8 Nov 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing ENGAGE in people with Depression, run by Weill Medical College of Cornell University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of ENGAGE intervention (time frame: Measured at Baseline, 4, 8, and 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2017.

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