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NCT06039930
Tele-PROTECT Therapy: Effectiveness, Empowerment, and Implementation
Conditions: Depression, Elder Abuse
Sex: All
Ages: 60 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 140
Sponsor: Weill Medical College of Cornell University
Location: Weill Cornell Medicine New York New York
Summary
The purpose of this randomized trial is to conduct a fully powered effectiveness trial of video-delivered PROTECT (Tele-PROTECT) compared to a video-delivered depression education (DepEd) control condition to be delivered to 140 English- and Spanish-speaking NYC elder abuse victims. Investigators hypothesize three main aims:
1. Effectiveness Aim: Tele-PROTECT participants will have significantly greater and clinically meaningful reductions in depression when compared to the DepEd control;
2. Abuse Impact Aim: Tele-PROTECT participants will demonstrate greater safety related empowerment compared to DepEd control, which can help participants take steps to reduce risk;
3. Implementation Aim: Stakeholders' views of the factors impacting the implementation of Tele-PROTECT based on characteristics of the intervention, agency setting, and population served will contribute to a national dissemination of Tele-PROTECT
Participants will
* Receive 9 weeks of tele health psychotherapy delivered by a Master's level mental health clinician from the Weill Cornell Medicine research team. Participants will be assigned to "Tele-PROTECT" or "DepEd" psychotherapy randomly.
* Participate in one baseline assessment and four follow-up assessments at weeks 3, 6, 9, and 12 administered by a trained member of the research team.
Eligibility Criteria
Inclusion Criteria:
* ≥60 years of age
* Capacity to consent (per elder abuse staff)
* Depression, i.e., PHQ-9≥10 (by elder abuse staff), represents mild to moderate severity of depression and has a sensitivity of 88% and a specificity of 88% for major depression
* Need for elder abuse services as verified by the elder abuse case worker.
Exclusion Criteria:
* Active suicidal ideation (MADRS item 10 ≥4)
* Inability to speak English or Spanish
* Axis 1 DSM-5 diagnoses other than unipolar depression or comorbid generalized anxiety disorder (by SCID)
* Mini-MOCA less than 11
* Severe or life-threatening medical illness
* Elder abuse emergency and or referral out of elder abuse agency.
Source: ClinicalTrials.gov (NCT06039930). StuddyBuddy aggregates publicly available trial information.