Recruiting

Tele-PROTECT Therapy

Sponsor:

Weill Medical College of Cornell University

Code:

NCT06039930

Conditions

Depression

Elder Abuse

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Tele PROTECT

Depression Education

Study Details

Brief 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.

Conditions

Depression

Elder Abuse

Study ID

NCT06039930

Start date

Sep 22, 2023

Status verified date

Jul, 2026

Completion date

Jan 1, 2029

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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 Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tele-PROTECT (Effectiveness Aim, Abuse Impact Aim)

This group of participants will receive the Tele-PROTECT intervention, a behavioral intervention for depressed elder abuse (EA) victims designed to work in synergy with EA resolution services that provide safety planning, support services, and links to legal services.

active comparator: Depression Education (DepEd) (Effectiveness Aim, Abuse Impact Aim)

This group of participants will receive the Depression Education intervention, an intervention designed with active therapeutic ingredients (education, support, empathy) and designed to be what a good clinician providing education would do with an individual with depression.

no intervention: Stakeholder Groups (Implementation Aim)

To address the Implementation Aim of the study, investigators will conduct qualitative data via surveys, interviews, and focus groups. Qualitative data from NAPSA surveys, interviews, and focus groups will be analyzed to identify barriers and facilitators to the implementation of Tele-PROTECT in elder abuse agencies nation-wide using a mixed methods design with multiple stakeholder groups (e.g., EA directors, staff) in collaboration with the National Adult Protective Services Association (NAPSA).

Interventions

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.

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 outcome measure

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

Central Contacts and Locations

Central contacts

Jo Anne Sirey, Ph.D

914-997-4333jsirey@med.cornell.edu

Locations

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065

Contacts

Jo Anne Sirey, PhD

914-997-4333jsirey@med.cornell.edu

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Keywords

  • Elder Abuse
  • Depression
  • Mental Health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-07-29.