Tele-PROTECT Therapy: Effectiveness, Empowerment, and Implementation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorWeill Medical College of Cornell University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Tele PROTECT
BehavioralTele-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
BehavioralDepEd 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.
Treatment groups
140 Participants
are divided into 3 treatment groupsGroup A: Tele-PROTECT (Effectiveness Aim, Abuse Impact Aim)Experimental treatment 1 intervention
Group B: Depression Education (DepEd) (Effectiveness Aim, Abuse Impact Aim)Active comparator 1 intervention
Group C: Stakeholder Groups (Implementation Aim)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Assessed at baseline and week three of treatment2
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.
Time frame
Assessed baseline and week six of treatment3
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.
Time frame
Assessed baseline and week nine of treatment4
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.
Time frame
Assessed baseline and 3 weeks after treatment end, approximately 12 weeks from enrollmentSecondary outcomes
1
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).
Time frame
Year 3 of study duration2
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.
Time frame
Year 3 of study duration3
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
Time frame
Year 3 of study durationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Weill Medical College of Cornell University
Lead sponsor
New York City Department for the Aging
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
Memorial Sloan Kettering Cancer Center
Collaborator
Source ClinicalTrials.gov