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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
- 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.
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:
- 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.
- 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 group | Role | What they receive |
|---|---|---|
| ENGAGE | Other | 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 Receives: Behavioral: ENGAGE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted29 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Patrick J. Raue, Ph.D., Principal investigator, Weill Medical College of Cornell UniversityGeorge S. Alexopoulos, M.D., Study director, Weill Medical College of Cornell University
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Depressed Low-Income Seniors in Mental Health Services
- ClinicalTrials.gov ID
- NCT01094951
- Acronym / sponsor ID
- ENGAGE / P30MH085943-03
- Conditions
- Depression
- Keywords
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Mar 2010
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 29 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ENGAGE | Other | Behavioral: ENGAGEIn 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ENGAGEDuring 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. | Behavioural | ENGAGE |
Primary outcome
Feasibility of ENGAGE intervention
Time frame: Measured at Baseline, 4, 8, and 12 weeks
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.
1 secondary outcome
Increase in referrals for mental health evaluation
Time frame: Measured at Baseline, 4, 8, and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick J. Raue, Ph.D. principal investigator
Weill Medical College of Cornell University
George S. Alexopoulos, M.D. study director
Weill Medical College of Cornell University
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.