Tele-PROTECT Therapy: Effectiveness, Empowerment, and Implementation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Montgomery Asberg Depression Rating Scale (MADRS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Standardized assessments will be conducted by trained raters blind to participant assignment.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Tele PROTECT (Behavioral)
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.
干预措施: Depression Education (Behavioral)
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).
结局指标
主要结局
Montgomery Asberg Depression Rating Scale (MADRS)
时间窗: Assessed baseline and 3 weeks after treatment end, approximately 12 weeks from enrollment
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
时间窗: Assessed baseline and 3 weeks after treatment end, approximately 12 weeks from enrollment
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.
Montgomery Asberg Depression Rating Scale (MADRS)
时间窗: Assessed at baseline and week three of treatment
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)
时间窗: Assessed baseline and week six of treatment
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)
时间窗: Assessed baseline and week nine of treatment
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
时间窗: Assessed at baseline and week three of treatment
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
时间窗: Assessed at baseline and week six of treatment
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
时间窗: Assessed at baseline and week nine of treatment
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.
次要结局
- 2 item survey assessing agency access to mental health services(Year 3 of study duration)
- Organizational Change Manager (OCM)(Year 3 of study duration)
- The Organizational Readiness to Change Assessments (ORCA)(Year 3 of study duration)