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EM/PROTECT: Improving Depression in Elder Mistreatment Victims

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ClinicalTrials.gov Identifier: NCT03241225
Recruitment Status : Recruiting
First Posted : August 7, 2017
Last Update Posted : August 26, 2019
Sponsor:
Collaborators:
New York City Department for the Aging
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: EM/PROTECT Behavioral: EM/MH Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (Outcomes Assessor)
Masking Description: Standardized assessments will be conducted by trained raters blind to participant assignment.
Primary Purpose: Treatment
Official Title: EM/PROTECT: Improving Depression in Elder Mistreatment Victims
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
Experimental: 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.
Behavioral: 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

Active Comparator: 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.
Behavioral: 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.




Primary Outcome Measures :
  1. Change in clinically significant depressive symptoms (MADRS). [ Time Frame: These measures are assessed at baseline, six week, nine week and twelve weeks after study enrollment during the study to document change in depressive symptoms. ]
    In both conditions, the reduction of clinically significant depressive symptoms as measured on the Montgomery Asberg Depression Rating Scale (MADRS).


Secondary Outcome Measures :
  1. Change in assessment of quality of life (WHO-QOL) [ Time Frame: These measures are assessed at baseline, six week, nine week and twelve weeks after study enrollment during the study to document change in assessment of quality of life. ]
    IN both conditions, improvement in assessment of quality of life measured by the World Health Organization Quality of Life (WHOQOL) scale.


Other Outcome Measures:
  1. Change in satisfaction with study intervention (CSQ) [ Time Frame: Assessed after EM/PROTECT sessions completed at six, nine, and twelve weeks after study enrollment. ]
    Client satisfaction with study intervention as measured by the Client Satisfaction Questionnaire (CSQ) in both treatments.



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03241225


Contacts
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Contact: Jo Anne Sirey, Ph.D. 914-997-4333 jsirey@med.cornell.edu

Locations
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United States, New York
Elderly Crime Victim Resource Center of the New York City Department for the Aging Recruiting
New York, New York, United States, 10007
Contact    212-602-4180      
Weill Cornell Medicine Not yet recruiting
New York, New York, United States, 10065
Contact: JoAnne Sirey, Ph.D.    914-997-4333    jsirey@med.cornell.edu   
Sponsors and Collaborators
Weill Medical College of Cornell University
New York City Department for the Aging
National Institute of Mental Health (NIMH)
Investigators
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Study Director: George Alexopoulos, MD Weill Cornell Medicine/New York Presbyterian Hospital
Principal Investigator: Jo Anne Sirey, PhD Weill Medical College of Cornell University

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03241225     History of Changes
Other Study ID Numbers: 1703018101
P50MH113838 ( U.S. NIH Grant/Contract )
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Time Frame: Per NIMH guidelines
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weill Medical College of Cornell University:
Elder abuse
Depression
Mental health
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders