Tele-PROTECT Therapy: Effectiveness, Empowerment, and Implementation

Depression Clinical Trial

Official title:

Tele-PROTECT Therapy: Effectiveness, Empowerment, and Implementation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06039930
• Other study ID #: 22-12025491
• Secondary ID: R01MH132757
• Status: Recruiting
• Phase: N/A
• Start date: September 22, 2023
• Est. completion date: March 2028

Study information

• Verified date: October 2023
• Source: Weill Medical College of Cornell University
• Contact: Jo Anne Sirey, Ph.D
• Phone: 914-997-4333
• Email: jsirey[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: March 2028
• Est. primary completion date: January 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Elder Abuse

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	National Institute of Mental Health (NIMH), New York City Department for the Aging

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Assessed at baseline and week three of treatment
Primary	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.	Assessed baseline and week six of treatment
Primary	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.	Assessed baseline and week nine of treatment
Primary	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.	Assessed baseline and 3 weeks after treatment end, approximately 12 weeks from enrollment
Primary	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.	Assessed at baseline and week three of treatment
Primary	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.	Assessed at baseline and week six of treatment
Primary	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.	Assessed at baseline and week nine of treatment
Primary	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.	Assessed baseline and 3 weeks after treatment end, approximately 12 weeks from enrollment
Secondary	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).	Year 3 of study duration
Secondary	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.	Year 3 of study duration
Secondary	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	Year 3 of study duration