Clinical trial NCT06039930: Tele-PROTECT Therapy: Effectiveness, Empowerment, and Implementation
Official title: Tele-PROTECT Therapy: Effectiveness, Empowerment, and Implementation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Elder Abuse
Keywords: Elder Abuse
Depression
Mental Health
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: New York City Department for the Aging
name: National Institute of Mental Health (NIMH)
First posted: 2023-09-15
Enrollment: 140
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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:

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.

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.

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.

Primary outcomes:
measure: Montgomery Asberg Depression Rating Scale (MADRS)
timeFrame: Assessed at baseline and week three of treatment
measure: Montgomery Asberg Depression Rating Scale (MADRS)
timeFrame: Assessed baseline and week six of treatment
measure: Montgomery Asberg Depression Rating Scale (MADRS)
timeFrame: Assessed baseline and week nine of treatment
measure: Montgomery Asberg Depression Rating Scale (MADRS)
timeFrame: Assessed baseline and 3 weeks after treatment end, approximately 12 weeks from enrollment
measure: Measure Of Victim Empowerment Related to Safety (MOVERS) Scale
timeFrame: Assessed at baseline and week three of treatment
measure: Measure Of Victim Empowerment Related to Safety (MOVERS) Scale
timeFrame: Assessed at baseline and week six of treatment
measure: Measure Of Victim Empowerment Related to Safety (MOVERS) Scale
timeFrame: Assessed at baseline and week nine of treatment
measure: Measure Of Victim Empowerment Related to Safety (MOVERS) Scale
timeFrame: Assessed baseline and 3 weeks after treatment end, approximately 12 weeks from enrollment
Secondary outcomes:
measure: 2 item survey assessing agency access to mental health services
timeFrame: Year 3 of study duration
measure: Organizational Change Manager (OCM)
timeFrame: Year 3 of study duration
measure: The Organizational Readiness to Change Assessments (ORCA)
timeFrame: Year 3 of study duration
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Jo Anne Sirey, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: