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| ID | Type | Description | Link |
|---|---|---|---|
| P50MH113838 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| New York City Department for the Aging | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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The investigators developed EM/PROTECT, a behavioral intervention for depressed EM (elderly mistreatment) victims, to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services. PROTECT is built on a model which postulates that chronic stress promotes dysfunction of the cognitive control (CCN) and reward networks, impairing the victims' ability to flexibly respond to the environment and limits their reward activities. PROTECT therapists work with victims to develop action plans to reduce stress, and to increase rewarding experiences. EM/PROTECT has been designed in an iterative process with community EM providers of the New York City (NYC) Department for the Aging (DFTA) to use agencies' routine PHQ-9 depression screening and referral for service. In the current study, the investigators will compare the effectiveness of EM/PROTECT with EM enriched with staff training in linking EM victims to community mental health services (EM/MH). The investigators intend to enroll 80 subjects that will participate in the study for approximately 12 weeks.
One in ten older adults is a victim of mistreatment, and one third of victims have clinically significant depressive symptoms. Depression increases mortality and decreases motivation to take self-protective steps. Yet, no elder mistreatment (EM) agencies have embedded identification and treatment of depressed EM victims in their programs. The investigators developed EM/PROTECT, a behavioral intervention for depressed EM victims, to work in synergy with EM agencies that provide safety planning and links to legal services. EM/PROTECT has been designed in an iterative process with community EM providers of the NYC Department for the Aging (DFTA), to utilize agencies' routine depression screening and service referrals. The investigators propose to collect data on the feasibility and acceptability of EM/PROTECT as one of three developmental projects under the ALACRITY Center NIMH grant (1 P50 MH113838-01,PI: Alexopoulos) (IRB 1704018108). We will compare the effectiveness of EM/PROTECT with EM enriched with staff training in linking EM victims to community mental health services (EM/MH). To ensure rigor and reproducibility, EM/PROTECT or EM/MH will be offered to randomly assigned depressed EM victims. All EM victims will receive standard EM resolution services from DFTA. EM staff will screen and refer depressed victims to Cornell staff, who will describe the study and obtain consent. Standardized assessments will be conducted by trained raters blind to participant assignment.
In addition, the investigators will use both active and passive sensing technology through smartphone data collection to supplement in-person data collection with an objective measure of socialization and behavioral activation. Smartphone data will be used to explore whether adherence to active recordings and time spent carrying the phone is associated with greater effectiveness of EM/PROTECT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EM/PROTECT | Experimental | This group of participants will receive the EM/PROTECT intervention, a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services. |
|
| EM/MH | Active Comparator | This group of participants experiencing elder mistreatment will receive support services from staff trained in linking elder mistreatment victims to community mental health services. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EM/PROTECT | Behavioral | EM/PROTECT is a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services |
| Measure | Description | Time Frame |
|---|---|---|
| Clinically Significant Depressive Symptoms (MADRS). | In both conditions, the reduction of clinically significant depressive symptoms as measured on the Montgomery Asberg Depression Rating Scale (MADRS). Scores on this scale range from 0 to 60, with higher scores indicating more severe depression and lower scores indicating milder depression. | These measures are assessed at baseline, six week, nine week and twelve weeks after study enrollment during the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Quality of Life (WHO-QOL) | IN both conditions, improvement in assessment of quality of life measured by the World Health Organization Quality of Life (WHOQOL) scale. The overall scores range between 26-130. In all domains, higher scores indicate better health. Domain 1 measures general health (scores range from 2-10). Domain 2 measures physical health (scores range from 7-35). Domain 3 measures psychological health (scores range from 6-30). Domain 4 measures social health (scores range from 3--15). Domain 5 measures environmental health (scores range from 8-40). |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction With Study Intervention (CSQ) | Client satisfaction with study intervention as measured by the Client Satisfaction Questionnaire (CSQ) in both treatments. Overall scores range from 3-12. Domain 1 measures met needs. Scores range from 1-4 and higher scores indicate more needs met. Domain 2 measures satisfaction with services. Scores range from 1-4 and higher scores indicate more satisfaction with services. Domain 3 measures willingness to return. Scores range from 1-4 and higher scores indicate greater willingness to return. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George Alexopoulos, MD | Weill Cornell Medicine/New York Presbyterian Hospital | Study Director |
| Jo Anne Sirey, PhD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elderly Crime Victim Resource Center of the New York City Department for the Aging | New York | New York | 10007 | United States | ||
The Center will share its data via the NIMH Data Archive (NDA). Our resource sharing plan is formulated in accordance with the NDA Data Sharing Terms and Conditions. Further, the Center will use NDA technologies to submit data in accordance with the NDA Data Sharing Terms and Conditions. This project will share feasibility, acceptability, and preliminary effectiveness data of the developmental study of the behavioral intervention EM/PROTECT. Investigators will comply with NIMH's procedures for data deposition into NDCT, and will let NDCT policies dictate the timetable upon which and avenues through which others will be allowed to access those data. Investigators will make the dataset available to other researchers after the main results have been published. Investigators will de-identify the data in the final datasets prior to release for sharing.
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Per NIMH guidelines
To ensure data and participant security, investigators will make the data available to users only under a data-sharing agreement. All users will first provide to the ALACRITY Center and the co-Investigators with a proposal of hypotheses, variables needed to test these hypotheses, and plans for dissemination of findings. All users will indicate in a signed document: (1) a commitment to using the data only for research purposes; (2) a plan for securing the data; (3) an agreement to either destroying or returning the data once analyses are completed; and (4) an agreement to not share data with other users and to direct all such requests to The ALACRITY Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | EM/PROTECT | This group of participants will receive the EM/PROTECT intervention, a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services. EM/PROTECT: EM/PROTECT is a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services |
| FG001 | EM/MH | This group of participants experiencing elder mistreatment will receive support services from staff trained in linking elder mistreatment victims to community mental health services. EM/MH: EM/MH provides individuals experiencing elder mistreatment with support services from staff trained in linking elder mistreatment victims to community mental health services. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | EM/PROTECT | This group of participants will receive the EM/PROTECT intervention, a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services. EM/PROTECT: EM/PROTECT is a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinically Significant Depressive Symptoms (MADRS). | In both conditions, the reduction of clinically significant depressive symptoms as measured on the Montgomery Asberg Depression Rating Scale (MADRS). Scores on this scale range from 0 to 60, with higher scores indicating more severe depression and lower scores indicating milder depression. | Posted | Mean | Standard Deviation | score on a scale | These measures are assessed at baseline, six week, nine week and twelve weeks after study enrollment during the study. |
|
Assessed at 6 weeks, 9 weeks, and 12 weeks after study enrollment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EM/PROTECT | This group of participants will receive the EM/PROTECT intervention, a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services. EM/PROTECT: EM/PROTECT is a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dehydration | General disorders | Non-systematic Assessment | Participant visited the emergency room due to dehydration. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment | Participant fell in their home |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jo Anne Sirey | Weill Cornell Medicine | 914-997-4333 | jsirey@med.cornell.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 24, 2021 | Dec 9, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 24, 2021 | Feb 9, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D010549 | Personal Satisfaction |
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The investigators will compare the effectiveness and target engagement of EM/PROTECT with EM enriched with training of EM staff in linking EM victims to mental health services (EM/MH) in order to position us for a fully powered R01. To ensure rigor and reproducibility, EM/PROTECT or EM/MH will be offered to randomly assigned depressed EM victims, and standard assessments will be conducted by trained raters blind to participant assignment and our hypotheses.
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Standardized assessments will be conducted by trained raters blind to participant assignment.
| EM/MH | Behavioral | EM/MH provides individuals experiencing elder mistreatment with support services from staff trained in linking elder mistreatment victims to community mental health services. |
|
| These measures are assessed at baseline, six week, nine week and twelve weeks after study enrollment during the study. |
| Assessed after EM/PROTECT sessions completed at six, nine, and twelve weeks after study enrollment. |
| Weill Cornell Medicine |
| New York |
| New York |
| 10065 |
| United States |
| Withdrawal by Subject |
|
| BG001 | EM/MH | This group of participants experiencing elder mistreatment will receive support services from staff trained in linking elder mistreatment victims to community mental health services. EM/MH: EM/MH provides individuals experiencing elder mistreatment with support services from staff trained in linking elder mistreatment victims to community mental health services. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Clinically Significant Depressive Symptoms (MADRS) | Montgomery Asberg Depression Rating Scale. Scores on this scale range from 0 to 60, with higher scores indicating more severe depression and lower scores indicating milder depression. | Mean | Standard Deviation | units on a scale |
|
| Assessment of Quality of Life (WHO-QOL) | World Health Organization-Quality Of Life scale. The overall scores range between 26-130. In all domains, higher scores indicate better health. Domain 1 measures general health (scores range from 2-10). Domain 2 measures physical health (scores range from 7-35). Domain 3 measures psychological health (scores range from 6-30). Domain 4 measures social health (scores range from 3--15). Domain 5 measures environmental health (scores range from 8-40). | Mean | Standard Deviation | units on a scale |
|
| Satisfaction With Study Intervention (CSQ) | Client Satisfaction Questionnaire. Overall scores range from 3-12. Domain 1 measures met needs. Scores range from 1-4 and higher scores indicate more needs met. Domain 2 measures satisfaction with services. Scores range from 1-4 and higher scores indicate more satisfaction with services. Domain 3 measures willingness to return. Scores range from 1-4 and higher scores indicate greater willingness to return. | Mean | Standard Deviation | units on a scale |
|
| OG001 | EM/MH | This group of participants experiencing elder mistreatment will receive support services from staff trained in linking elder mistreatment victims to community mental health services. EM/MH: EM/MH provides individuals experiencing elder mistreatment with support services from staff trained in linking elder mistreatment victims to community mental health services. |
|
|
|
| Secondary | Assessment of Quality of Life (WHO-QOL) | IN both conditions, improvement in assessment of quality of life measured by the World Health Organization Quality of Life (WHOQOL) scale. The overall scores range between 26-130. In all domains, higher scores indicate better health. Domain 1 measures general health (scores range from 2-10). Domain 2 measures physical health (scores range from 7-35). Domain 3 measures psychological health (scores range from 6-30). Domain 4 measures social health (scores range from 3--15). Domain 5 measures environmental health (scores range from 8-40). | Posted | Mean | Standard Deviation | score on a scale | These measures are assessed at baseline, six week, nine week and twelve weeks after study enrollment during the study. |
|
|
|
|
| Other Pre-specified | Satisfaction With Study Intervention (CSQ) | Client satisfaction with study intervention as measured by the Client Satisfaction Questionnaire (CSQ) in both treatments. Overall scores range from 3-12. Domain 1 measures met needs. Scores range from 1-4 and higher scores indicate more needs met. Domain 2 measures satisfaction with services. Scores range from 1-4 and higher scores indicate more satisfaction with services. Domain 3 measures willingness to return. Scores range from 1-4 and higher scores indicate greater willingness to return. | Posted | Mean | Standard Deviation | score on a scale | Assessed after EM/PROTECT sessions completed at six, nine, and twelve weeks after study enrollment. |
|
|
|
|
| 0 |
| 24 |
| 3 |
| 24 |
| 0 |
| 24 |
| EG001 | EM/MH | This group of participants experiencing elder mistreatment will receive support services from staff trained in linking elder mistreatment victims to community mental health services. EM/MH: EM/MH provides individuals experiencing elder mistreatment with support services from staff trained in linking elder mistreatment victims to community mental health services. | 0 | 16 | 3 | 16 | 1 | 16 |
|
| Stomach surgery | Gastrointestinal disorders | Non-systematic Assessment | Participant had a planned surgery to remove a stomach mass |
|
| Loss of consciousness | General disorders | Non-systematic Assessment | Participant lost consciousness during a planned doctor's visit |
|
| Heart attack | Cardiac disorders | Non-systematic Assessment | Participant suffered a heart attack |
|
| Pneumonia | Reproductive system and breast disorders | Non-systematic Assessment | Participant diagnosed with pneumonia |
|
|
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| Domain 3- Baseline |
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| Domain 4- Baseline |
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| Domain 5- Baseline |
|
| Domain 1- Week 6 |
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| Domain 2- Week 6 |
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| Domain 3- Week 6 |
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| Domain 4- Week 6 |
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| Domain 5- Week 6 |
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| Domain 1- Week 9 |
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| Domain 2- Week 9 |
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| Domain 3- Week 9 |
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| Domain 4- Week 9 |
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| Domain 5- Week 9 |
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| Domain 1- Week 12 |
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| Domain 2- Week 12 |
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| Domain 3-Week 12 |
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| Domain 4- Week 12 |
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| Domain 5- Week 12 |
|
| 0.19 |
| Mean Difference (Final Values) |
| 1.38 |
| 2-Sided |
| 95 |
| -0.70 |
| 3.46 |
| Superiority |
| Domain #3, Week 12 | t-test, 2 sided | 0.37 | Mean Difference (Final Values) | -4.53 | 2-Sided | 95 | -14.99 | 5.93 | Superiority |
| Domain #4, Week 12 | t-test, 2 sided | 0.026 | Mean Difference (Final Values) | -5.24 | 2-Sided | 95 | -9.75 | -0.73 | Superiority |
| Domain #5, Week 12 | t-test, 2 sided | 0.66 | Mean Difference (Final Values) | -0.62 | 2-Sided | 95 | -3.51 | 2.27 | Superiority |
| Domain 3- Week 6 |
|
| Domain 1- Week 9 |
|
| Domain 2- Week 9 |
|
| Domain 3- Week 9 |
|
| Domain 1- Week 12 |
|
| Domain 2- Week 12 |
|
| Domain 3- Week 12 |
|
| 0.047 |
Domain #2 |
| Mean Difference (Final Values) |
| 0.78 |
| 2-Sided |
| 95 |
| 0.011 |
| 1.55 |
| Superiority |
| Domain #3, Week 12 | t-test, 2 sided | 0.18 | Mean Difference (Final Values) | 0.65 | 2-Sided | 95 | -0.34 | 1.64 | Superiority |