EM/PROTECT: Improving Depression in Elder Mistreatment Victims

• Sponsor: Weill Medical College of Cornell University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03241225
• Collaborator: New York City Department for the Aging (Other), National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 40
• Locations: 2
• Arms: 2
• Actual Duration (Months): 29.9
• Patients Per Site: 20
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

The investigators developed EM/PROTECT, a behavioral intervention for depressed EM (elderly mistreatment) victims, to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services. PROTECT is built on a model which postulates that chronic stress promotes dysfunction of the cognitive control (CCN) and reward networks, impairing the victims' ability to flexibly respond to the environment and limits their reward activities. PROTECT therapists work with victims to develop action plans to reduce stress, and to increase rewarding experiences. EM/PROTECT has been designed in an iterative process with community EM providers of the New York City (NYC) Department for the Aging (DFTA) to use agencies' routine PHQ-9 depression screening and referral for service. In the current study, the investigators will compare the effectiveness of EM/PROTECT with EM enriched with staff training in linking EM victims to community mental health services (EM/MH). The investigators intend to enroll 80 subjects that will participate in the study for approximately 12 weeks.

Condition or Disease	Intervention/Treatment	Phase
Depression	Behavioral: EM/PROTECT; Behavioral: EM/MH	N/A

Detailed Description

One in ten older adults is a victim of mistreatment, and one third of victims have clinically significant depressive symptoms. Depression increases mortality and decreases motivation to take self-protective steps. Yet, no elder mistreatment (EM) agencies have embedded identification and treatment of depressed EM victims in their programs. The investigators developed EM/PROTECT, a behavioral intervention for depressed EM victims, to work in synergy with EM agencies that provide safety planning and links to legal services. EM/PROTECT has been designed in an iterative process with community EM providers of the NYC Department for the Aging (DFTA), to utilize agencies' routine depression screening and service referrals. The investigators propose to collect data on the feasibility and acceptability of EM/PROTECT as one of three developmental projects under the ALACRITY Center NIMH grant (1 P50 MH113838-01,PI: Alexopoulos) (IRB 1704018108). We will compare the effectiveness of EM/PROTECT with EM enriched with staff training in linking EM victims to community mental health services (EM/MH). To ensure rigor and reproducibility, EM/PROTECT or EM/MH will be offered to randomly assigned depressed EM victims. All EM victims will receive standard EM resolution services from DFTA. EM staff will screen and refer depressed victims to Cornell staff, who will describe the study and obtain consent. Standardized assessments will be conducted by trained raters blind to participant assignment.

In addition, the investigators will use both active and passive sensing technology through smartphone data collection to supplement in-person data collection with an objective measure of socialization and behavioral activation. Smartphone data will be used to explore whether adherence to active recordings and time spent carrying the phone is associated with greater effectiveness of EM/PROTECT.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: The investigators will compare the effectiveness and target engagement of EM/PROTECT with EM enriched with training of EM staff in linking EM victims to mental health services (EM/MH) in order to position us for a fully powered R01. To ensure rigor and reproducibility, EM/PROTECT or EM/MH will be offered to randomly assigned depressed EM victims, and standard assessments will be conducted by trained raters blind to participant assignment and our hypotheses.The investigators will compare the effectiveness and target engagement of EM/PROTECT with EM enriched with training of EM staff in linking EM victims to mental health services (EM/MH) in order to position us for a fully powered R01. To ensure rigor and reproducibility, EM/PROTECT or EM/MH will be offered to randomly assigned depressed EM victims, and standard assessments will be conducted by trained raters blind to participant assignment and our hypotheses.
• Masking: Single (Outcomes Assessor)
• Masking Description: Standardized assessments will be conducted by trained raters blind to participant assignment.
• Primary Purpose: Treatment
• Official Title: EM/PROTECT: Improving Depression in Elder Mistreatment Victims
• Actual Study Start Date: Jan 1, 2018
• Actual Primary Completion Date: Jun 30, 2020
• Actual Study Completion Date: Jun 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EM/PROTECT This group of participants will receive the EM/PROTECT intervention, a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services.	Behavioral: EM/PROTECT; EM/PROTECT is a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services
Active Comparator: EM/MH This group of participants experiencing elder mistreatment will receive support services from staff trained in linking elder mistreatment victims to community mental health services.	Behavioral: EM/MH; EM/MH provides individuals experiencing elder mistreatment with support services from staff trained in linking elder mistreatment victims to community mental health services.

Outcome Measures

Primary Outcome Measures

1. Clinically Significant Depressive Symptoms (MADRS). [These measures are assessed at baseline, six week, nine week and twelve weeks after study enrollment during the study.]

   In both conditions, the reduction of clinically significant depressive symptoms as measured on the Montgomery Asberg Depression Rating Scale (MADRS). Scores on this scale range from 0 to 60, with higher scores indicating more severe depression and lower scores indicating milder depression.

Secondary Outcome Measures

1. Assessment of Quality of Life (WHO-QOL) [These measures are assessed at baseline, six week, nine week and twelve weeks after study enrollment during the study.]

   IN both conditions, improvement in assessment of quality of life measured by the World Health Organization Quality of Life (WHOQOL) scale. The overall scores range between 26-130. In all domains, higher scores indicate better health. Domain 1 measures general health (scores range from 2-10). Domain 2 measures physical health (scores range from 7-35). Domain 3 measures psychological health (scores range from 6-30). Domain 4 measures social health (scores range from 3--15). Domain 5 measures environmental health (scores range from 8-40).

Other Outcome Measures

1. Satisfaction With Study Intervention (CSQ) [Assessed after EM/PROTECT sessions completed at six, nine, and twelve weeks after study enrollment.]

   Client satisfaction with study intervention as measured by the Client Satisfaction Questionnaire (CSQ) in both treatments. Overall scores range from 3-12. Domain 1 measures met needs. Scores range from 1-4 and higher scores indicate more needs met. Domain 2 measures satisfaction with services. Scores range from 1-4 and higher scores indicate more satisfaction with services. Domain 3 measures willingness to return. Scores range from 1-4 and higher scores indicate greater willingness to return.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 55 years of age or older

• Capacity to consent (per EM staff)

• Significant depression (per EM staff) as indicated by a score of 10 or above on the Patient Health Questionnaire-9 (PHQ-9), a widely used screening tool routinely administered in EM agency settings (the PHQ-9 has a sensitivity of 88% and a specificity of 88% for major depression)

• Need for EM services

Exclusion Criteria:

• Active suicidal ideation (MADRS item 10>4)

• Inability to speak English

• Axis 1 DSM-5 diagnoses other than unipolar depression or generalized anxiety disorder (by SCID)

• Mini-Mental Exam score of 23 or less 5

• Severe or life-threatening medical illness

• EM emergency and or referral out of EM agency (per EM staff)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Elderly Crime Victim Resource Center of the New York City Department for the Aging	New York	New York	United States	10007
2	Weill Cornell Medicine	New York	New York	United States	10065

Sponsors and Collaborators

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

Investigators

• Study Director: George Alexopoulos, MD, Weill Cornell Medicine/New York Presbyterian Hospital
• Principal Investigator: Jo Anne Sirey, PhD, Weill Medical College of Cornell University

Study Documents (Full-Text)

• Study Protocol - Nov 24, 2021
• Statistical Analysis Plan - Nov 24, 2021

More Information

Publications

None provided.

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT03241225
• Other Study ID Numbers: 1703018101; P50MH113838
• First Posted: Aug 7, 2017
• Last Update Posted: Mar 3, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Weill Medical College of Cornell University: Elder abuse; Depression; Mental health
• Additional relevant MeSH terms: Depression; Depressive Disorder

Study Results

Participant Flow

Arm/Group Title	EM/PROTECT	EM/MH
Arm/Group Description	This group of participants will receive the EM/PROTECT intervention, a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services. EM/PROTECT: EM/PROTECT is a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services	This group of participants experiencing elder mistreatment will receive support services from staff trained in linking elder mistreatment victims to community mental health services. EM/MH: EM/MH provides individuals experiencing elder mistreatment with support services from staff trained in linking elder mistreatment victims to community mental health services.
Period Title: Overall Study
STARTED	24	16
COMPLETED	17	14
NOT COMPLETED	7	2

Baseline Characteristics

Arm/Group Title	EM/PROTECT	EM/MH	Total
Arm/Group Description	This group of participants will receive the EM/PROTECT intervention, a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services. EM/PROTECT: EM/PROTECT is a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services	This group of participants experiencing elder mistreatment will receive support services from staff trained in linking elder mistreatment victims to community mental health services. EM/MH: EM/MH provides individuals experiencing elder mistreatment with support services from staff trained in linking elder mistreatment victims to community mental health services.	Total of all reporting groups
Overall Participants	24	16	40
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	72.04 (8.48)	73.5 (7.53)	72.77 (8.01)
Sex: Female, Male (Count of Participants)
Female	19 79.2%	13 81.3%	32 80%
Male	5 20.8%	3 18.8%	8 20%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	10 41.7%	11 68.8%	21 52.5%
White	13 54.2%	3 18.8%	16 40%
More than one race	0 0%	1 6.3%	1 2.5%
Unknown or Not Reported	1 4.2%	1 6.3%	2 5%
Clinically Significant Depressive Symptoms (MADRS) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	24.21 (3.09)	22.94 (5.35)	23.58 (4.22)
Assessment of Quality of Life (WHO-QOL) (units on a scale) [Mean (Standard Deviation) ]
Domain 1	5.71 (2.27)	5.44 (2.03)	5.58 (4.3)
Domain 2	19.33 (5.16)	20.13 (3.36)	19.73 (4.26)
Domain 3	18.22 (5.18)	18.06 (4.04)	18.14 (4.61)
Domain 4	6.71 (3.01)	8.44 (2.00)	7.58 (2.51)
Domain 5	23.58 (7.71)	23.88 (5.57)	23.73 (6.64)
Satisfaction With Study Intervention (CSQ) (units on a scale) [Mean (Standard Deviation) ]
Domain 1	2.95 (1.23)	2.7 (1.49)	2.83 (1.36)
Domain 2	2.95 (1.23)	3.00 (1.41)	2.98 (2.64)
Domain 3	3.30 (1.22)	3.20 (1.32)	3.25 (1.27)

Outcome Measures

1. Primary Outcome

Title	Clinically Significant Depressive Symptoms (MADRS).
Description	In both conditions, the reduction of clinically significant depressive symptoms as measured on the Montgomery Asberg Depression Rating Scale (MADRS). Scores on this scale range from 0 to 60, with higher scores indicating more severe depression and lower scores indicating milder depression.
Time Frame	These measures are assessed at baseline, six week, nine week and twelve weeks after study enrollment during the study.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EM/PROTECT	EM/MH
Arm/Group Description	This group of participants will receive the EM/PROTECT intervention, a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services. EM/PROTECT: EM/PROTECT is a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services	This group of participants experiencing elder mistreatment will receive support services from staff trained in linking elder mistreatment victims to community mental health services. EM/MH: EM/MH provides individuals experiencing elder mistreatment with support services from staff trained in linking elder mistreatment victims to community mental health services.
Measure Participants	24	16
Baseline Outcomes	24.21 (5.35)	22.94 (3.09)
Week 6 Outcomes	12.59 (7.02)	17.54 (7.21)
Week 9 Outcomes	15.80 (5.76)	22.82 (7.95)
Week 12 Outcomes	16.64 (7.87)	13.05 (7.39)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EM/PROTECT, EM/MH
	Comments	Week 12
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.16
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.59
	Confidence Interval	(2-Sided) 95%; -1.43 to 8.61
	Parameter Dispersion	Type: Value:
	Estimation Comments	Mean change in EM/PROTECT group not significantly different from mean change in EM/MH group, at week 12.

2. Secondary Outcome

Title	Assessment of Quality of Life (WHO-QOL)
Description	IN both conditions, improvement in assessment of quality of life measured by the World Health Organization Quality of Life (WHOQOL) scale. The overall scores range between 26-130. In all domains, higher scores indicate better health. Domain 1 measures general health (scores range from 2-10). Domain 2 measures physical health (scores range from 7-35). Domain 3 measures psychological health (scores range from 6-30). Domain 4 measures social health (scores range from 3--15). Domain 5 measures environmental health (scores range from 8-40).
Time Frame	These measures are assessed at baseline, six week, nine week and twelve weeks after study enrollment during the study.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EM/PROTECT	EM/MH
Arm/Group Description	This group of participants will receive the EM/PROTECT intervention, a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services. EM/PROTECT: EM/PROTECT is a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services	This group of participants experiencing elder mistreatment will receive support services from staff trained in linking elder mistreatment victims to community mental health services. EM/MH: EM/MH provides individuals experiencing elder mistreatment with support services from staff trained in linking elder mistreatment victims to community mental health services.
Measure Participants	24	16
Domain 1- Baseline	5.71 (2.27)	5.44 (2.03)
Domain 2- Baseline	19.33 (5.16)	20.13 (3.36)
Domain 3- Baseline	18.22 (5.18)	18.06 (4.04)
Domain 4- Baseline	6.71 (3.01)	8.44 (2.00)
Domain 5- Baseline	23.58 (7.71)	23.88 (5.57)
Domain 1- Week 6	6.70 (1.81)	4.83 (3.04)
Domain 2- Week 6	21.30 (3.33)	16.17 (7.99)
Domain 3- Week 6	19.30 (4.23)	16.90 (3.41)
Domain 4- Week 6	5.20 (2.09)	6.42 (3.55)
Domain 5- Week 6	26.85 (5.76)	19.92 (10.56)
Domain 1- Week 9	5.93 (2.64)	6.82 (1.70)
Domain 2- Week 9	20.14 (7.15)	22.59 (2.87)
Domain 3- Week 9	18.62 (4.23)	19.53 (4.90)
Domain 4- Week 9	8.64 (3.37)	7.94 (2.11)
Domain 5- Week 9	23.79 (8.32)	27.00 (5.28)
Domain 1- Week 12	6.41 (2.00)	6.57 (1.74)
Domain 2- Week 12	21.88 (3.16)	20.50 (3.18)
Domain 3-Week 12	20.47 (4.29)	25.00 (19.43)
Domain 4- Week 12	7.76 (1.99)	13.00 (8.36)
Domain 5- Week 12	26.59 (3.02)	27.21 (5.01)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EM/PROTECT, EM/MH
	Comments	Domain #1, Week 12
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.79
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.16
	Confidence Interval	(2-Sided) 95%; -1.37 to 1.05
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	EM/PROTECT, EM/MH
	Comments	Domain #2, Week 12
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.19
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.38
	Confidence Interval	(2-Sided) 95%; -0.70 to 3.46
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	EM/PROTECT, EM/MH
	Comments	Domain #3, Week 12
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.37
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-4.53
	Confidence Interval	(2-Sided) 95%; -14.99 to 5.93
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	EM/PROTECT, EM/MH
	Comments	Domain #4, Week 12
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.026
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-5.24
	Confidence Interval	(2-Sided) 95%; -9.75 to -0.73
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	EM/PROTECT, EM/MH
	Comments	Domain #5, Week 12
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.66
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.62
	Confidence Interval	(2-Sided) 95%; -3.51 to 2.27
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Other Pre-specified Outcome

Title	Satisfaction With Study Intervention (CSQ)
Description	Client satisfaction with study intervention as measured by the Client Satisfaction Questionnaire (CSQ) in both treatments. Overall scores range from 3-12. Domain 1 measures met needs. Scores range from 1-4 and higher scores indicate more needs met. Domain 2 measures satisfaction with services. Scores range from 1-4 and higher scores indicate more satisfaction with services. Domain 3 measures willingness to return. Scores range from 1-4 and higher scores indicate greater willingness to return.
Time Frame	Assessed after EM/PROTECT sessions completed at six, nine, and twelve weeks after study enrollment.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EM/PROTECT	EM/MH
Arm/Group Description	This group of participants will receive the EM/PROTECT intervention, a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services. EM/PROTECT: EM/PROTECT is a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services	This group of participants experiencing elder mistreatment will receive support services from staff trained in linking elder mistreatment victims to community mental health services. EM/MH: EM/MH provides individuals experiencing elder mistreatment with support services from staff trained in linking elder mistreatment victims to community mental health services.
Measure Participants	24	16
Domain 1- Week 6	2.95 (1.2)	2.70 (1.49)
Domain 2- Week 6	2.95 (1.23)	3.00 (1.41)
Domain 3- Week 6	3.30 (1.22)	3.20 (1.32)
Domain 1- Week 9	3.00 (1.06)	2.31 (1.70)
Domain 2- Week 9	3.29 (1.05)	2.69 (1.89)
Domain 3- Week 9	3.41 (1.00)	2.54 (1.81)
Domain 1- Week 12	3.12 (0.93)	2.42 (1.68)
Domain 2- Week 12	3.53 (0.62)	2.75 (1.71)
Domain 3- Week 12	3.65 (0.61)	3.00 (1.81)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EM/PROTECT, EM/MH
	Comments	Domain #1, Week 12
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.14
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.70
	Confidence Interval	(2-Sided) 95%; -0.26 to 1.66
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	EM/PROTECT, EM/MH
	Comments	Domain #2, Week 12
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.047
	Comments	Domain #2
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.78
	Confidence Interval	(2-Sided) 95%; 0.011 to 1.55
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	EM/PROTECT, EM/MH
	Comments	Domain #3, Week 12
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.18
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.65
	Confidence Interval	(2-Sided) 95%; -0.34 to 1.64
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Assessed at 6 weeks, 9 weeks, and 12 weeks after study enrollment.
Arm/Group Title	EM/PROTECT		EM/MH
Arm/Group Description	This group of participants will receive the EM/PROTECT intervention, a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services. EM/PROTECT: EM/PROTECT is a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services		This group of participants experiencing elder mistreatment will receive support services from staff trained in linking elder mistreatment victims to community mental health services. EM/MH: EM/MH provides individuals experiencing elder mistreatment with support services from staff trained in linking elder mistreatment victims to community mental health services.
All Cause Mortality
	EM/PROTECT		EM/MH
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/16 (0%)
Serious Adverse Events
	EM/PROTECT		EM/MH
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/24 (12.5%)		3/16 (18.8%)
Cardiac disorders
Heart attack	0/24 (0%)	0	1/16 (6.3%)	1
Gastrointestinal disorders
Stomach surgery	1/24 (4.2%)	1	0/16 (0%)	0
General disorders
Dehydration	1/24 (4.2%)	1	0/16 (0%)	0
Loss of consciousness	1/24 (4.2%)	1	0/16 (0%)	0
Reproductive system and breast disorders
Pneumonia	0/24 (0%)	0	2/16 (12.5%)	2
Other (Not Including Serious) Adverse Events
	EM/PROTECT		EM/MH
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		1/16 (6.3%)
Injury, poisoning and procedural complications
Fall	0/24 (0%)	0	1/16 (6.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.