Tele-PROTECT Therapy: Effectiveness, Empowerment, and Implementation
Part of paid clinical trials in New York, New York.
- Sponsor
- Weill Medical College of Cornell University
- Study ID
- NCT06039930
- Status
- Recruiting
Conditions
- Depression
- Elder Abuse
Eligibility Criteria
- Sex
- ALL
- Age
- 60 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Tele PROTECT — BEHAVIORALTele-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 — BEHAVIORALDepEd 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.
Study Details
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.
Key Dates
- Start date
- Sep 22, 2023
- Status verified
- Aug 2025
- Primary completion
- Mar 31, 2028
- Completion
- Jan 1, 2029
Study Design
- Enrollment
- 140 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
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).
Primary Outcome Measure
Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: Assessed at baseline and week three of treatment ]
Central Contacts
- Jo Anne Sirey, Ph.D914-997-4333
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Weill Cornell Medicine | New York | New York | 10065 |
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