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Tele-PROTECT Therapy: Effectiveness, Empowerment, and Implementation

Primary Purpose

Depression, Elder Abuse

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tele PROTECT
Depression Education
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Elder Abuse, Depression, Mental Health

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Weill Cornell MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Tele-PROTECT (Effectiveness Aim, Abuse Impact Aim)

Depression Education (DepEd) (Effectiveness Aim, Abuse Impact Aim)

Stakeholder Groups (Implementation Aim)

Arm Description

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.

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.

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).

Outcomes

Primary Outcome Measures

Montgomery Asberg Depression Rating Scale (MADRS)
The Montgomery Asberg Depression Rating Scale (MADRS) is a 10-item scale that assesses depression severity. Scores range from 0 to 60, with a score of 0 indicating no depressive symptoms present and a score of 60 indicating severe depression. Scores will be used to assess depression severity outcome and evaluate the impact of interventions in line with the Effectiveness Aim.
Montgomery Asberg Depression Rating Scale (MADRS)
The Montgomery Asberg Depression Rating Scale (MADRS) is a 10-item scale that assesses depression severity. Scores range from 0 to 60, with a score of 0 indicating no depressive symptoms present and a score of 60 indicating severe depression. Scores will be used to assess depression severity outcome and evaluate the impact of interventions in line with the Effectiveness Aim.
Montgomery Asberg Depression Rating Scale (MADRS)
The Montgomery Asberg Depression Rating Scale (MADRS) is a 10-item scale that assesses depression severity. Scores range from 0 to 60, with a score of 0 indicating no depressive symptoms present and a score of 60 indicating severe depression. Scores will be used to assess depression severity outcome and evaluate the impact of interventions in line with the Effectiveness Aim.
Montgomery Asberg Depression Rating Scale (MADRS)
The Montgomery Asberg Depression Rating Scale (MADRS) is a 10-item scale that assesses depression severity. Scores range from 0 to 60, with a score of 0 indicating no depressive symptoms present and a score of 60 indicating severe depression. Scores will be used to assess depression severity outcome and evaluate the impact of interventions in line with the Effectiveness Aim.
Measure Of Victim Empowerment Related to Safety (MOVERS) Scale
The MOVERS a 13-item scale assesses the presence of a set of safety-related goals, the ability to accomplish them, and victims' sense that others can and will assist them as needed. Scores range from 13 to 65 with higher scores indicating a greater degree of empowerment related to safety. The MOVERS serves to measure the Abuse Impact Aim.
Measure Of Victim Empowerment Related to Safety (MOVERS) Scale
The MOVERS a 13-item scale assesses the presence of a set of safety-related goals, the ability to accomplish them, and victims' sense that others can and will assist them as needed. Scores range from 13 to 65 with higher scores indicating a greater degree of empowerment related to safety. The MOVERS serves to measure the Abuse Impact Aim.
Measure Of Victim Empowerment Related to Safety (MOVERS) Scale
The MOVERS a 13-item scale assesses the presence of a set of safety-related goals, the ability to accomplish them, and victims' sense that others can and will assist them as needed. Scores range from 13 to 65 with higher scores indicating a greater degree of empowerment related to safety. The MOVERS serves to measure the Abuse Impact Aim.
Measure Of Victim Empowerment Related to Safety (MOVERS) Scale
The MOVERS a 13-item scale assesses the presence of a set of safety-related goals, the ability to accomplish them, and victims' sense that others can and will assist them as needed. Scores range from 13 to 65 with higher scores indicating a greater degree of empowerment related to safety. The MOVERS serves to measure the Abuse Impact Aim.

Secondary Outcome Measures

2 item survey assessing agency access to mental health services
In line with the Implementation Aim, agency access to mental health services will be assessed with a 2 item survey evaluating the method by which agencies access mental health services for clients (response options: the agency provides services, outside agency referral, no access) and mental health service availability (response options: 0=not at all available; 5=very available).
Organizational Change Manager (OCM)
In line with the Implementation Aim, subscales of the Organizational Change Manager (OCM) scale will be used to assess: Relative advantage (3 items), Tension for change (3 items), and Goals and feedback (2 items). Items are rated on a five-point scale with higher scores indicating greater likelihood of implementation. Barriers/facilitators to mental health service provision across the Consolidated Framework for Implementation Research (CFIR) domains will be assessed with this and other measures.
The Organizational Readiness to Change Assessments (ORCA)
In line with the Implementation Aim, the ORCA will be used to assess client needs and resources (3 items). ORCA is a reliable and valid measure of organization readiness to implement change and barriers of that change. Each item is rated on a five-point scale with higher scores indicating greater organizational readiness for change

Full Information

First Posted
September 8, 2023
Last Updated
October 19, 2023
Sponsor
Weill Medical College of Cornell University
Collaborators
New York City Department for the Aging, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT06039930
Brief Title
Tele-PROTECT Therapy: Effectiveness, Empowerment, and Implementation
Official Title
Tele-PROTECT Therapy: Effectiveness, Empowerment, and Implementation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2023 (Actual)
Primary Completion Date
January 2028 (Anticipated)
Study Completion Date
March 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
New York City Department for the Aging, National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: Effectiveness Aim: Tele-PROTECT participants will have significantly greater and clinically meaningful reductions in depression when compared to the DepEd control; 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; 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Elder Abuse
Keywords
Elder Abuse, Depression, Mental Health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The investigators will compare the effectiveness of the Tele- PROTECT Intervention against the Depression Education (DepEd) Intervention. To ensure rigor and reproducibility, Tele-PROTECT or DepEd will be offered to randomly assigned depressed elder abuse victims, and standard assessments will be conducted by trained raters blind to participant assignment and our hypotheses.
Masking
Outcomes Assessor
Masking Description
Standardized assessments will be conducted by trained raters blind to participant assignment.
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tele-PROTECT (Effectiveness Aim, Abuse Impact Aim)
Arm Type
Experimental
Arm Description
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.
Arm Title
Depression Education (DepEd) (Effectiveness Aim, Abuse Impact Aim)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Stakeholder Groups (Implementation Aim)
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Tele PROTECT
Other Intervention Name(s)
PROTECT
Intervention Description
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
Intervention Name(s)
Depression Education
Other Intervention Name(s)
DepEd
Intervention Description
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.
Primary Outcome Measure Information:
Title
Montgomery Asberg Depression Rating Scale (MADRS)
Description
The Montgomery Asberg Depression Rating Scale (MADRS) is a 10-item scale that assesses depression severity. Scores range from 0 to 60, with a score of 0 indicating no depressive symptoms present and a score of 60 indicating severe depression. Scores will be used to assess depression severity outcome and evaluate the impact of interventions in line with the Effectiveness Aim.
Time Frame
Assessed at baseline and week three of treatment
Title
Montgomery Asberg Depression Rating Scale (MADRS)
Description
The Montgomery Asberg Depression Rating Scale (MADRS) is a 10-item scale that assesses depression severity. Scores range from 0 to 60, with a score of 0 indicating no depressive symptoms present and a score of 60 indicating severe depression. Scores will be used to assess depression severity outcome and evaluate the impact of interventions in line with the Effectiveness Aim.
Time Frame
Assessed baseline and week six of treatment
Title
Montgomery Asberg Depression Rating Scale (MADRS)
Description
The Montgomery Asberg Depression Rating Scale (MADRS) is a 10-item scale that assesses depression severity. Scores range from 0 to 60, with a score of 0 indicating no depressive symptoms present and a score of 60 indicating severe depression. Scores will be used to assess depression severity outcome and evaluate the impact of interventions in line with the Effectiveness Aim.
Time Frame
Assessed baseline and week nine of treatment
Title
Montgomery Asberg Depression Rating Scale (MADRS)
Description
The Montgomery Asberg Depression Rating Scale (MADRS) is a 10-item scale that assesses depression severity. Scores range from 0 to 60, with a score of 0 indicating no depressive symptoms present and a score of 60 indicating severe depression. Scores will be used to assess depression severity outcome and evaluate the impact of interventions in line with the Effectiveness Aim.
Time Frame
Assessed baseline and 3 weeks after treatment end, approximately 12 weeks from enrollment
Title
Measure Of Victim Empowerment Related to Safety (MOVERS) Scale
Description
The MOVERS a 13-item scale assesses the presence of a set of safety-related goals, the ability to accomplish them, and victims' sense that others can and will assist them as needed. Scores range from 13 to 65 with higher scores indicating a greater degree of empowerment related to safety. The MOVERS serves to measure the Abuse Impact Aim.
Time Frame
Assessed at baseline and week three of treatment
Title
Measure Of Victim Empowerment Related to Safety (MOVERS) Scale
Description
The MOVERS a 13-item scale assesses the presence of a set of safety-related goals, the ability to accomplish them, and victims' sense that others can and will assist them as needed. Scores range from 13 to 65 with higher scores indicating a greater degree of empowerment related to safety. The MOVERS serves to measure the Abuse Impact Aim.
Time Frame
Assessed at baseline and week six of treatment
Title
Measure Of Victim Empowerment Related to Safety (MOVERS) Scale
Description
The MOVERS a 13-item scale assesses the presence of a set of safety-related goals, the ability to accomplish them, and victims' sense that others can and will assist them as needed. Scores range from 13 to 65 with higher scores indicating a greater degree of empowerment related to safety. The MOVERS serves to measure the Abuse Impact Aim.
Time Frame
Assessed at baseline and week nine of treatment
Title
Measure Of Victim Empowerment Related to Safety (MOVERS) Scale
Description
The MOVERS a 13-item scale assesses the presence of a set of safety-related goals, the ability to accomplish them, and victims' sense that others can and will assist them as needed. Scores range from 13 to 65 with higher scores indicating a greater degree of empowerment related to safety. The MOVERS serves to measure the Abuse Impact Aim.
Time Frame
Assessed baseline and 3 weeks after treatment end, approximately 12 weeks from enrollment
Secondary Outcome Measure Information:
Title
2 item survey assessing agency access to mental health services
Description
In line with the Implementation Aim, agency access to mental health services will be assessed with a 2 item survey evaluating the method by which agencies access mental health services for clients (response options: the agency provides services, outside agency referral, no access) and mental health service availability (response options: 0=not at all available; 5=very available).
Time Frame
Year 3 of study duration
Title
Organizational Change Manager (OCM)
Description
In line with the Implementation Aim, subscales of the Organizational Change Manager (OCM) scale will be used to assess: Relative advantage (3 items), Tension for change (3 items), and Goals and feedback (2 items). Items are rated on a five-point scale with higher scores indicating greater likelihood of implementation. Barriers/facilitators to mental health service provision across the Consolidated Framework for Implementation Research (CFIR) domains will be assessed with this and other measures.
Time Frame
Year 3 of study duration
Title
The Organizational Readiness to Change Assessments (ORCA)
Description
In line with the Implementation Aim, the ORCA will be used to assess client needs and resources (3 items). ORCA is a reliable and valid measure of organization readiness to implement change and barriers of that change. Each item is rated on a five-point scale with higher scores indicating greater organizational readiness for change
Time Frame
Year 3 of study duration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jo Anne Sirey, Ph.D
Phone
914-997-4333
Email
jsirey@med.cornell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jo Anne Sirey, Ph.D
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jo Anne Sirey, PhD
Phone
914-997-4333
Email
jsirey@med.cornell.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The Center will share its data via the NIMH Data Archive (NDA). Our resource sharing plan is formulated in accordance with the NDA Data Sharing Terms and Conditions. Further, the Center will use NDA technologies to submit data in accordance with the NDA Data Sharing Terms and Conditions. This project will share data comparing the effectiveness of the Tele-PROTECT Intervention against the Depression Education (DepEd) Intervention. Investigators will comply with NIMH's procedures for data deposition into NDCT, and will let NDCT policies dictate the timetable upon which and avenues through which others will be allowed to access those data. Investigators will make the dataset available to other researchers after the main results have been published. Investigators will de- identify the data in the final datasets prior to release for sharing.
IPD Sharing Time Frame
Per NIMH guidelines
IPD Sharing Access Criteria
To ensure data and participant security, investigators will make the data available to users only under a data-sharing agreement. All users will make a direct request to the Principal Investigator with a proposal of hypotheses, variables needed to test these hypotheses, and plans for dissemination of findings. All users will indicate in a signed document: (1) a commitment to using the data only for research purposes; (2) a plan for securing the data; (3) an agreement to either destroying or returning the data once analyses are completed; and (4) an agreement to not share data with other users and to direct all such requests to the Principal Investigator.

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Tele-PROTECT Therapy: Effectiveness, Empowerment, and Implementation

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