Clinical trial NCT03241225: EM/PROTECT: Improving Depression in Elder Mistreatment Victims
Official title: EM/PROTECT: Improving Depression in Elder Mistreatment Victims
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Elder abuse
Depression
Mental health
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: New York City Department for the Aging
name: National Institute of Mental Health (NIMH)
First posted: 2017-08-07
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Clinically Significant Depressive Symptoms (MADRS).
timeFrame: These measures are assessed at baseline, six week, nine week and twelve weeks after study enrollment during the study.
Secondary outcomes:
measure: Assessment of Quality of Life (WHO-QOL)
timeFrame: These measures are assessed at baseline, six week, nine week and twelve weeks after study enrollment during the study.
Other outcomes:
measure: Satisfaction With Study Intervention (CSQ)
timeFrame: Assessed after EM/PROTECT sessions completed at six, nine, and twelve weeks after study enrollment.
Locations:
city: New York
country: United States
facility: Elderly Crime Victim Resource Center of the New York City Department for the Aging
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Cornell Medicine/New York Presbyterian Hospital
name: George Alexopoulos, MD
role: STUDY_DIRECTOR
affiliation: Weill Medical College of Cornell University
name: Jo Anne Sirey, PhD
role: PRINCIPAL_INVESTIGATOR
References: