Depression Clinical Trial
Official title:
EM/PROTECT: Improving Depression in Elder Mistreatment Victims
Verified date | February 2022 |
Source | Weill Medical College of Cornell University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | June 30, 2020 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years to 100 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Elderly Crime Victim Resource Center of the New York City Department for the Aging | New York | New York |
United States | Weill Cornell Medicine | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University | National Institute of Mental Health (NIMH), New York City Department for the Aging |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Satisfaction With Study Intervention (CSQ) | Client satisfaction with study intervention as measured by the Client Satisfaction Questionnaire (CSQ) in both treatments. Overall scores range from 3-12. Domain 1 measures met needs. Scores range from 1-4 and higher scores indicate more needs met. Domain 2 measures satisfaction with services. Scores range from 1-4 and higher scores indicate more satisfaction with services. Domain 3 measures willingness to return. Scores range from 1-4 and higher scores indicate greater willingness to return. | Assessed after EM/PROTECT sessions completed at six, nine, and twelve weeks after study enrollment. | |
Primary | Clinically Significant Depressive Symptoms (MADRS). | In both conditions, the reduction of clinically significant depressive symptoms as measured on the Montgomery Asberg Depression Rating Scale (MADRS). Scores on this scale range from 0 to 60, with higher scores indicating more severe depression and lower scores indicating milder depression. | These measures are assessed at baseline, six week, nine week and twelve weeks after study enrollment during the study. | |
Secondary | Assessment of Quality of Life (WHO-QOL) | IN both conditions, improvement in assessment of quality of life measured by the World Health Organization Quality of Life (WHOQOL) scale. The overall scores range between 26-130. In all domains, higher scores indicate better health. Domain 1 measures general health (scores range from 2-10). Domain 2 measures physical health (scores range from 7-35). Domain 3 measures psychological health (scores range from 6-30). Domain 4 measures social health (scores range from 3--15). Domain 5 measures environmental health (scores range from 8-40). | These measures are assessed at baseline, six week, nine week and twelve weeks after study enrollment during the study. |
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