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EM/PROTECT: Improving Depression in Elder Mistreatment Victims

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EM/PROTECT
EM/MH
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Elder abuse, Depression, Mental health

Eligibility Criteria

55 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 55 years of age or older
  • Capacity to consent (per EM staff)
  • Significant depression (per EM staff) as indicated by a score of 10 or above on the Patient Health Questionnaire-9 (PHQ-9), a widely used screening tool routinely administered in EM agency settings (the PHQ-9 has a sensitivity of 88% and a specificity of 88% for major depression)
  • Need for EM services

Exclusion Criteria:

  • Active suicidal ideation (MADRS item 10>4)
  • Inability to speak English
  • Axis 1 DSM-5 diagnoses other than unipolar depression or generalized anxiety disorder (by SCID)
  • Mini-Mental Exam score of 23 or less 5
  • Severe or life-threatening medical illness
  • EM emergency and or referral out of EM agency (per EM staff)

Sites / Locations

  • Elderly Crime Victim Resource Center of the New York City Department for the Aging
  • Weill Cornell Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EM/PROTECT

EM/MH

Arm Description

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.

This group of participants experiencing elder mistreatment will receive support services from staff trained in linking elder mistreatment victims to community mental health services.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
July 31, 2017
Last Updated
February 9, 2022
Sponsor
Weill Medical College of Cornell University
Collaborators
New York City Department for the Aging, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT03241225
Brief Title
EM/PROTECT: Improving Depression in Elder Mistreatment Victims
Official Title
EM/PROTECT: Improving Depression in Elder Mistreatment Victims
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
New York City Department for the Aging, National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Elder abuse, Depression, Mental health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
Standardized assessments will be conducted by trained raters blind to participant assignment.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EM/PROTECT
Arm Type
Experimental
Arm Description
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.
Arm Title
EM/MH
Arm Type
Active Comparator
Arm Description
This group of participants experiencing elder mistreatment will receive support services from staff trained in linking elder mistreatment victims to community mental health services.
Intervention Type
Behavioral
Intervention Name(s)
EM/PROTECT
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
EM/MH
Intervention Description
EM/MH provides individuals experiencing elder mistreatment with support services from staff trained in linking elder mistreatment victims to community mental health services.
Primary Outcome Measure Information:
Title
Clinically Significant Depressive Symptoms (MADRS).
Description
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.
Time Frame
These measures are assessed at baseline, six week, nine week and twelve weeks after study enrollment during the study.
Secondary Outcome Measure Information:
Title
Assessment of Quality of Life (WHO-QOL)
Description
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).
Time Frame
These measures are assessed at baseline, six week, nine week and twelve weeks after study enrollment during the study.
Other Pre-specified Outcome Measures:
Title
Satisfaction With Study Intervention (CSQ)
Description
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.
Time Frame
Assessed after EM/PROTECT sessions completed at six, nine, and twelve weeks after study enrollment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 55 years of age or older Capacity to consent (per EM staff) Significant depression (per EM staff) as indicated by a score of 10 or above on the Patient Health Questionnaire-9 (PHQ-9), a widely used screening tool routinely administered in EM agency settings (the PHQ-9 has a sensitivity of 88% and a specificity of 88% for major depression) Need for EM services Exclusion Criteria: Active suicidal ideation (MADRS item 10>4) Inability to speak English Axis 1 DSM-5 diagnoses other than unipolar depression or generalized anxiety disorder (by SCID) Mini-Mental Exam score of 23 or less 5 Severe or life-threatening medical illness EM emergency and or referral out of EM agency (per EM staff)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Alexopoulos, MD
Organizational Affiliation
Weill Cornell Medicine/New York Presbyterian Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jo Anne Sirey, PhD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Elderly Crime Victim Resource Center of the New York City Department for the Aging
City
New York
State/Province
New York
ZIP/Postal Code
10007
Country
United States
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Per NIMH guidelines
IPD Sharing Access Criteria
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.

Learn more about this trial

EM/PROTECT: Improving Depression in Elder Mistreatment Victims

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