N/A
N=40
EM/PROTECT: Improving Depression in Elder Mistreatment Victims
Depression
Bottom Line
View on ClinicalTrials.gov: NCT03241225 ↗Enrolled (actual)
40
Serious AEs
15.0%
Results posted
Mar 2022
Primary outcome: Primary: Clinically Significant Depressive Symptoms (MADRS). — 24.21; 22.94; 12.59; 17.54 score on a scale — p=0.16
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EM/PROTECT (Behavioral); EM/MH (Behavioral)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinically Significant Depressive Symptoms (MADRS). |
24.21; 22.94; 12.59; 17.54; 15.80; 22.82 | 0.16 |
| SECONDARY Assessment of Quality of Life (WHO-QOL) |
5.71; 5.44; 19.33; 20.13; 18.22; 18.06 | 0.79 |
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.
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)
Data sourced from ClinicalTrials.gov (NCT03241225). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.