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
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: EM/PROTECT Behavioral: EM/MH||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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.|
|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|
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 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.
EM/MH provides individuals experiencing elder mistreatment with support services from staff trained in linking elder mistreatment victims to community mental health services.
- 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).
- 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.
- 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.
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
|Contact: Jo Anne Sirey, Ph.D.||firstname.lastname@example.org|
|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|
|Weill Cornell Medicine||Not yet recruiting|
|New York, New York, United States, 10065|
|Contact: JoAnne Sirey, Ph.D. 914-997-4333 email@example.com|
|Study Director:||George Alexopoulos, MD||Weill Cornell Medicine/New York Presbyterian Hospital|
|Principal Investigator:||Jo Anne Sirey, PhD||Weill Medical College of Cornell University|