Recruiting

Tele-PROTECT Therapy: Effectiveness, Empowerment, and Implementation

ClinicalTrials.gov IDNCT06039930

PhaseNA

Enrollment140

SponsorWeill Medical College of Cornell University

Age60 Years

SexALL

I'm interested View official listing

Conditions studied

Depression, Elder Abuse

About this study

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.

Interventions

Behavioral: Tele PROTECT — Tele-PROTECT is a behavioral intervention delivered virtually over nine 30-60-minute sessions for depressed elder abuse (EA) victims. It is designed to work in synergy with EA resolution services that provide safety planning, support services, and links to legal services.
Behavioral: Depression Education — DepEd is designed as an intervention delivered virtually over nine 30-60-minute sessions with active therapeutic ingredients (education, support, empathy). It is designed to be what a good clinician providing education would do with an individual with depression.

Primary outcomes

Montgomery Asberg Depression Rating Scale (MADRS) (Assessed at baseline and week three of treatment)
Montgomery Asberg Depression Rating Scale (MADRS) (Assessed baseline and week six of treatment)
Montgomery Asberg Depression Rating Scale (MADRS) (Assessed baseline and week nine of treatment)
Montgomery Asberg Depression Rating Scale (MADRS) (Assessed baseline and 3 weeks after treatment end, approximately 12 weeks from enrollment)
Measure Of Victim Empowerment Related to Safety (MOVERS) Scale (Assessed at baseline and week three of treatment)
Measure Of Victim Empowerment Related to Safety (MOVERS) Scale (Assessed at baseline and week six of treatment)
Measure Of Victim Empowerment Related to Safety (MOVERS) Scale (Assessed at baseline and week nine of treatment)
Measure Of Victim Empowerment Related to Safety (MOVERS) Scale (Assessed baseline and 3 weeks after treatment end, approximately 12 weeks from enrollment)

Eligibility information

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.

Study locations

Weill Cornell Medicine, New York, New York 10065 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.