Tele-PROTECT Therapy: Effectiveness, Empowerment, and Implementation
Recruiting · NCT06039930 · Interventional (participants receive a specific treatment) · Lead sponsor: Weill Medical College of Cornell University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed across 1 US state.
- Weill Cornell Medicine - New York, New York, United States