Clinical trial NCT04258579: Trial to Test Effectiveness of Depression Intervention for Mistreated Older Adults
Official title: EM/PROTECT-Hybrid: Improving Depression in Elder Mistreatment Victims
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Depression in Old Age
Elder Abuse
Anxiety
Keywords: Mental Health
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-02-06
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The investigators will be comparing data collected from this project to previously collected data from the first phase of this project, in which PROTECT was delivered only in-person.
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 50 subjects that will participate in the study for approximately 12 weeks.


Eligibility criteria: Inclusion Criteria:

* 55 years of age or older
* Capacity to consent (per Elder Mistreatment staff)
* Significant depression (per Elder Mistreatment 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 Elder Mistreatment (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 (Montgomery Asberg Depression Rating Scale item 10\>4)
* Inability to speak English or Spanish
* Axis 1 Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnoses other than unipolar depression or generalized anxiety disorder (by Structured Clinical Interview for DSM-5)
* Severe or life-threatening medical illness
* EM emergency and or referral out of EM agency (per EM staff)

Primary outcomes:
measure: Change in Clinically Significant Depressive Symptoms as Measured by the MADRS
timeFrame: 6 weeks, 9 weeks, 12 weeks
measure: Change in Assessment of Quality of Life, as Measured by the WHO-QOL
timeFrame: 6 weeks, 9 weeks, 12 weeks
measure: Change in Assessment of Stress, as Measured by the PSS
timeFrame: Baseline, 6 weeks
Secondary outcomes:
measure: Change in Assessment of Exposure to Meaningful Activities, as Measured by the BADS
timeFrame: Baseline, 6 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Jo Anne Sirey, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: