EM/PROTECT: Improving Depression in Elder Mistreatment Victims
2 other identifiers
interventional
40
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable depression
Started Jan 2018
Typical duration for not_applicable depression
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2017
CompletedFirst Posted
Study publicly available on registry
August 7, 2017
CompletedStudy Start
First participant enrolled
January 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedResults Posted
Study results publicly available
March 3, 2022
CompletedMarch 3, 2022
February 1, 2022
2.5 years
July 31, 2017
January 3, 2022
February 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Secondary Outcomes (1)
Assessment of Quality of Life (WHO-QOL)
These measures are assessed at baseline, six week, nine week and twelve weeks after study enrollment during the study.
Other Outcomes (1)
Satisfaction With Study Intervention (CSQ)
Assessed after EM/PROTECT sessions completed at six, nine, and twelve weeks after study enrollment.
Study Arms (2)
EM/PROTECT
EXPERIMENTALThis 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 COMPARATORThis group of participants experiencing elder mistreatment will receive support services from staff trained in linking elder mistreatment victims to community mental health services.
Interventions
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
EM/MH provides individuals experiencing elder mistreatment with support services from staff trained in linking elder mistreatment victims to community mental health services.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Elderly Crime Victim Resource Center of the New York City Department for the Aging
New York, New York, 10007, United States
Weill Cornell Medicine
New York, New York, 10065, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jo Anne Sirey
- Organization
- Weill Cornell Medicine
Study Officials
- STUDY DIRECTOR
George Alexopoulos, MD
Weill Cornell Medicine/New York Presbyterian Hospital
- PRINCIPAL INVESTIGATOR
Jo Anne Sirey, PhD
Weill Medical College of Cornell University
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Standardized assessments will be conducted by trained raters blind to participant assignment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2017
First Posted
August 7, 2017
Study Start
January 1, 2018
Primary Completion
June 30, 2020
Study Completion
June 30, 2020
Last Updated
March 3, 2022
Results First Posted
March 3, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will share
- 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.
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.