Tele-PROTECT Therapy: Effectiveness, Empowerment, and Implementation

NCT ID: NCT06039930

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-22
• Study Completion Date: 2029-01-01

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.

Detailed Description

The WHO estimates that 1 in 6 older adults have experienced elder abuse in the past year with rates in the community increasing by as much as 83.6% during the pandemic. Elder abuse (EA) takes a serious physical and emotional toll on older adults, including premature mortality, physical injuries and financial losses. EA victims in NYC are more likely to be women than men, and more likely to be women of color.

Previous work by the investigators has demonstrated that 1/3 of victims have clinically significant depressive symptoms. Abused older adults with depression have higher rates of mortality and suicidal ideation. Depression is an additional barrier to implementing safety steps to reduce victimization. PRoviding Options To Elderly Clients Together (PROTECT) is a behavioral intervention for depressed elder abuse victims. It is the only manualized therapy for depressed elder abuse victims designed to be integrated with elder abuse services. It is aligned with the NIMH Strategic Plan "to deliver high quality, impactful research and promote translation of such research into clinical practice" and to serve "underrepresented and underserved communities."

The investigators developed PROTECT to work in synergy with abuse resolution services. PROTECT reduces depression by increasing engagement in pleasurable and rewarding activities and taking steps towards goals to reduce threat. PROTECT has been designed in an iterative process with partners at the New York City (NYC) Dept. for the Aging (DFTA). In the investigators' pilot randomized controlled trial, PROTECT showed an increase in behavioral activation (BADS) and significantly decreased depression as compared to a referral control condition. PROTECT has been adopted by DFTA (Community PROTECT) to increase its use.

In collaboration with partners at DFTA and five NYC elder abuse agencies, the investigators propose 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. In partnership with a national elder abuse organization (NAPSA), and using the CFIR, the investigators will examine factors that could affect future implementation of Tele-PROTECT nationally.

Conditions

Depression; Elder Abuse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Tele PROTECT

Intervention Type: BEHAVIORAL

Tele-PROTECT is a behavioral intervention delivered virtually over nine 45-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) (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.

Group Type: ACTIVE_COMPARATOR

Depression Education

Intervention Type: BEHAVIORAL

DepEd is designed as an intervention delivered virtually over nine 45-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.

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Depression Education

DepEd is designed as an intervention delivered virtually over nine 45-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.

Intervention Type: BEHAVIORAL

Tele PROTECT

Tele-PROTECT is a behavioral intervention delivered virtually over nine 45-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.

Intervention Type: BEHAVIORAL

Other Intervention Names

PROTECT; DepEd

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York City Department for the Aging

OTHER

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jo Anne Sirey, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Cornell Medicine

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jo Anne Sirey, Ph.D

Role: CONTACT

jsirey@med.cornell.edu

914-997-4333

Facility Contacts

Jo Anne Sirey, PhD

Role: primary

jsirey@med.cornell.edu

914-997-4333

Other Identifiers

R01MH132757

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22-12025491

Identifier Type: -

Identifier Source: org_study_id