Tele-PROTECT Therapy: Effectiveness, Empowerment, and Implementation

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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.

Conditions:

Depression Elder Abuse

Study Start (Actual) 2023-09-22

Primary Completion (Estimated) 2028-01

Study Completion (Estimated) 2028-03

Enrollment (Estimated) 140

Study Type INTERVENTIONAL

Phase NA

Locations:

📍 New York, New York, United States

Eligibility Criteria

Description

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.

Ages Eligible for Study: 60 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted2023-09-08
First Submitted that Met QC Criteria2023-09-08
First Posted2023-09-15

Study Record Updates

Last Update Submitted that Met QC Criteria2023-10-19
Last Update Posted2023-10-23
Last Verified2023-10