N/A
N=40
Trial to Test Effectiveness of Depression Intervention for Mistreated Older Adults
Depression · Depression in Old Age · Elder Abuse · Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT04258579 ↗Enrolled (actual)
40
Serious AEs
5.0%
Results posted
Aug 2023
Primary outcome: Primary: Change in Clinically Significant Depressive Symptoms as Measured by the MADRS — 19.13; 16.87; 15.00 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PROTECT with Technology Augmentation (Behavioral)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Clinically Significant Depressive Symptoms as Measured by the MADRS |
19.13; 16.87; 15.00 | — |
| PRIMARY Change in Assessment of Quality of Life, as Measured by the WHO-QOL |
22.10; 19.90; 8.93; 26.63; 22.53; 21.00 | — |
| PRIMARY Change in Assessment of Stress, as Measured by the PSS |
22.45; 20.53 | — |
| SECONDARY Change in Assessment of Exposure to Meaningful Activities, as Measured by the BADS |
19.89; 22.46; 16.00; 17.79; 22.79; 26.70 | — |
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)
Data sourced from ClinicalTrials.gov (NCT04258579). 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.