Depression Clinical Trial
Official title:
Tele-PROTECT Therapy: Effectiveness, Empowerment, and Implementation
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Weill Cornell Medicine | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University | National Institute of Mental Health (NIMH), New York City Department for the Aging |
United States,
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 |
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