Trial Outcomes & Findings for EM/PROTECT: Improving Depression in Elder Mistreatment Victims (NCT NCT03241225)
NCT ID: NCT03241225
Last Updated: 2022-03-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
These measures are assessed at baseline, six week, nine week and twelve weeks after study enrollment during the study.
Results posted on
2022-03-03
Participant Flow
Participant milestones
| Measure |
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.
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
|
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
16
|
|
Overall Study
COMPLETED
|
17
|
14
|
|
Overall Study
NOT COMPLETED
|
7
|
2
|
Reasons for withdrawal
| Measure |
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.
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
|
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.
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Protocol Violation
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
EM/PROTECT: Improving Depression in Elder Mistreatment Victims
Baseline characteristics by cohort
| Measure |
EM/PROTECT
n=24 Participants
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
|
EM/MH
n=16 Participants
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
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.04 years
STANDARD_DEVIATION 8.48 • n=5 Participants
|
73.5 years
STANDARD_DEVIATION 7.53 • n=7 Participants
|
72.77 years
STANDARD_DEVIATION 8.01 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Clinically Significant Depressive Symptoms (MADRS)
|
24.21 units on a scale
STANDARD_DEVIATION 3.09 • n=5 Participants
|
22.94 units on a scale
STANDARD_DEVIATION 5.35 • n=7 Participants
|
23.58 units on a scale
STANDARD_DEVIATION 4.22 • n=5 Participants
|
|
Assessment of Quality of Life (WHO-QOL)
Domain 1
|
5.71 units on a scale
STANDARD_DEVIATION 2.27 • n=5 Participants
|
5.44 units on a scale
STANDARD_DEVIATION 2.03 • n=7 Participants
|
5.58 units on a scale
STANDARD_DEVIATION 4.3 • n=5 Participants
|
|
Assessment of Quality of Life (WHO-QOL)
Domain 2
|
19.33 units on a scale
STANDARD_DEVIATION 5.16 • n=5 Participants
|
20.13 units on a scale
STANDARD_DEVIATION 3.36 • n=7 Participants
|
19.73 units on a scale
STANDARD_DEVIATION 4.26 • n=5 Participants
|
|
Assessment of Quality of Life (WHO-QOL)
Domain 3
|
18.22 units on a scale
STANDARD_DEVIATION 5.18 • n=5 Participants
|
18.06 units on a scale
STANDARD_DEVIATION 4.04 • n=7 Participants
|
18.14 units on a scale
STANDARD_DEVIATION 4.61 • n=5 Participants
|
|
Assessment of Quality of Life (WHO-QOL)
Domain 4
|
6.71 units on a scale
STANDARD_DEVIATION 3.01 • n=5 Participants
|
8.44 units on a scale
STANDARD_DEVIATION 2.00 • n=7 Participants
|
7.58 units on a scale
STANDARD_DEVIATION 2.51 • n=5 Participants
|
|
Assessment of Quality of Life (WHO-QOL)
Domain 5
|
23.58 units on a scale
STANDARD_DEVIATION 7.71 • n=5 Participants
|
23.88 units on a scale
STANDARD_DEVIATION 5.57 • n=7 Participants
|
23.73 units on a scale
STANDARD_DEVIATION 6.64 • n=5 Participants
|
|
Satisfaction With Study Intervention (CSQ)
Domain 1
|
2.95 units on a scale
STANDARD_DEVIATION 1.23 • n=5 Participants
|
2.7 units on a scale
STANDARD_DEVIATION 1.49 • n=7 Participants
|
2.83 units on a scale
STANDARD_DEVIATION 1.36 • n=5 Participants
|
|
Satisfaction With Study Intervention (CSQ)
Domain 2
|
2.95 units on a scale
STANDARD_DEVIATION 1.23 • n=5 Participants
|
3.00 units on a scale
STANDARD_DEVIATION 1.41 • n=7 Participants
|
2.98 units on a scale
STANDARD_DEVIATION 2.64 • n=5 Participants
|
|
Satisfaction With Study Intervention (CSQ)
Domain 3
|
3.30 units on a scale
STANDARD_DEVIATION 1.22 • n=5 Participants
|
3.20 units on a scale
STANDARD_DEVIATION 1.32 • n=7 Participants
|
3.25 units on a scale
STANDARD_DEVIATION 1.27 • n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
EM/PROTECT
n=24 Participants
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
|
EM/MH
n=16 Participants
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.
|
|---|---|---|
|
Clinically Significant Depressive Symptoms (MADRS).
Baseline Outcomes
|
24.21 score on a scale
Standard Deviation 5.35
|
22.94 score on a scale
Standard Deviation 3.09
|
|
Clinically Significant Depressive Symptoms (MADRS).
Week 6 Outcomes
|
12.59 score on a scale
Standard Deviation 7.02
|
17.54 score on a scale
Standard Deviation 7.21
|
|
Clinically Significant Depressive Symptoms (MADRS).
Week 9 Outcomes
|
15.80 score on a scale
Standard Deviation 5.76
|
22.82 score on a scale
Standard Deviation 7.95
|
|
Clinically Significant Depressive Symptoms (MADRS).
Week 12 Outcomes
|
16.64 score on a scale
Standard Deviation 7.87
|
13.05 score on a scale
Standard Deviation 7.39
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
EM/PROTECT
n=24 Participants
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
|
EM/MH
n=16 Participants
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.
|
|---|---|---|
|
Assessment of Quality of Life (WHO-QOL)
Domain 1- Baseline
|
5.71 score on a scale
Standard Deviation 2.27
|
5.44 score on a scale
Standard Deviation 2.03
|
|
Assessment of Quality of Life (WHO-QOL)
Domain 2- Baseline
|
19.33 score on a scale
Standard Deviation 5.16
|
20.13 score on a scale
Standard Deviation 3.36
|
|
Assessment of Quality of Life (WHO-QOL)
Domain 3- Baseline
|
18.22 score on a scale
Standard Deviation 5.18
|
18.06 score on a scale
Standard Deviation 4.04
|
|
Assessment of Quality of Life (WHO-QOL)
Domain 4- Baseline
|
6.71 score on a scale
Standard Deviation 3.01
|
8.44 score on a scale
Standard Deviation 2.00
|
|
Assessment of Quality of Life (WHO-QOL)
Domain 5- Baseline
|
23.58 score on a scale
Standard Deviation 7.71
|
23.88 score on a scale
Standard Deviation 5.57
|
|
Assessment of Quality of Life (WHO-QOL)
Domain 1- Week 6
|
6.70 score on a scale
Standard Deviation 1.81
|
4.83 score on a scale
Standard Deviation 3.04
|
|
Assessment of Quality of Life (WHO-QOL)
Domain 2- Week 6
|
21.30 score on a scale
Standard Deviation 3.33
|
16.17 score on a scale
Standard Deviation 7.99
|
|
Assessment of Quality of Life (WHO-QOL)
Domain 3- Week 6
|
19.30 score on a scale
Standard Deviation 4.23
|
16.90 score on a scale
Standard Deviation 3.41
|
|
Assessment of Quality of Life (WHO-QOL)
Domain 4- Week 6
|
5.20 score on a scale
Standard Deviation 2.09
|
6.42 score on a scale
Standard Deviation 3.55
|
|
Assessment of Quality of Life (WHO-QOL)
Domain 5- Week 6
|
26.85 score on a scale
Standard Deviation 5.76
|
19.92 score on a scale
Standard Deviation 10.56
|
|
Assessment of Quality of Life (WHO-QOL)
Domain 1- Week 9
|
5.93 score on a scale
Standard Deviation 2.64
|
6.82 score on a scale
Standard Deviation 1.70
|
|
Assessment of Quality of Life (WHO-QOL)
Domain 2- Week 9
|
20.14 score on a scale
Standard Deviation 7.15
|
22.59 score on a scale
Standard Deviation 2.87
|
|
Assessment of Quality of Life (WHO-QOL)
Domain 3- Week 9
|
18.62 score on a scale
Standard Deviation 4.23
|
19.53 score on a scale
Standard Deviation 4.90
|
|
Assessment of Quality of Life (WHO-QOL)
Domain 4- Week 9
|
8.64 score on a scale
Standard Deviation 3.37
|
7.94 score on a scale
Standard Deviation 2.11
|
|
Assessment of Quality of Life (WHO-QOL)
Domain 5- Week 9
|
23.79 score on a scale
Standard Deviation 8.32
|
27.00 score on a scale
Standard Deviation 5.28
|
|
Assessment of Quality of Life (WHO-QOL)
Domain 1- Week 12
|
6.41 score on a scale
Standard Deviation 2.00
|
6.57 score on a scale
Standard Deviation 1.74
|
|
Assessment of Quality of Life (WHO-QOL)
Domain 2- Week 12
|
21.88 score on a scale
Standard Deviation 3.16
|
20.50 score on a scale
Standard Deviation 3.18
|
|
Assessment of Quality of Life (WHO-QOL)
Domain 3-Week 12
|
20.47 score on a scale
Standard Deviation 4.29
|
25.00 score on a scale
Standard Deviation 19.43
|
|
Assessment of Quality of Life (WHO-QOL)
Domain 4- Week 12
|
7.76 score on a scale
Standard Deviation 1.99
|
13.00 score on a scale
Standard Deviation 8.36
|
|
Assessment of Quality of Life (WHO-QOL)
Domain 5- Week 12
|
26.59 score on a scale
Standard Deviation 3.02
|
27.21 score on a scale
Standard Deviation 5.01
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
| Measure |
EM/PROTECT
n=24 Participants
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
|
EM/MH
n=16 Participants
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.
|
|---|---|---|
|
Satisfaction With Study Intervention (CSQ)
Domain 2- Week 6
|
2.95 score on a scale
Standard Deviation 1.23
|
3.00 score on a scale
Standard Deviation 1.41
|
|
Satisfaction With Study Intervention (CSQ)
Domain 1- Week 6
|
2.95 score on a scale
Standard Deviation 1.2
|
2.70 score on a scale
Standard Deviation 1.49
|
|
Satisfaction With Study Intervention (CSQ)
Domain 3- Week 6
|
3.30 score on a scale
Standard Deviation 1.22
|
3.20 score on a scale
Standard Deviation 1.32
|
|
Satisfaction With Study Intervention (CSQ)
Domain 1- Week 9
|
3.00 score on a scale
Standard Deviation 1.06
|
2.31 score on a scale
Standard Deviation 1.70
|
|
Satisfaction With Study Intervention (CSQ)
Domain 2- Week 9
|
3.29 score on a scale
Standard Deviation 1.05
|
2.69 score on a scale
Standard Deviation 1.89
|
|
Satisfaction With Study Intervention (CSQ)
Domain 3- Week 9
|
3.41 score on a scale
Standard Deviation 1.00
|
2.54 score on a scale
Standard Deviation 1.81
|
|
Satisfaction With Study Intervention (CSQ)
Domain 1- Week 12
|
3.12 score on a scale
Standard Deviation 0.93
|
2.42 score on a scale
Standard Deviation 1.68
|
|
Satisfaction With Study Intervention (CSQ)
Domain 2- Week 12
|
3.53 score on a scale
Standard Deviation 0.62
|
2.75 score on a scale
Standard Deviation 1.71
|
|
Satisfaction With Study Intervention (CSQ)
Domain 3- Week 12
|
3.65 score on a scale
Standard Deviation 0.61
|
3.00 score on a scale
Standard Deviation 1.81
|
Adverse Events
EM/PROTECT
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
EM/MH
Serious events: 3 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EM/PROTECT
n=24 participants at risk
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
|
EM/MH
n=16 participants at risk
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.
|
|---|---|---|
|
General disorders
Dehydration
|
4.2%
1/24 • Number of events 1 • Assessed at 6 weeks, 9 weeks, and 12 weeks after study enrollment.
|
0.00%
0/16 • Assessed at 6 weeks, 9 weeks, and 12 weeks after study enrollment.
|
|
Gastrointestinal disorders
Stomach surgery
|
4.2%
1/24 • Number of events 1 • Assessed at 6 weeks, 9 weeks, and 12 weeks after study enrollment.
|
0.00%
0/16 • Assessed at 6 weeks, 9 weeks, and 12 weeks after study enrollment.
|
|
General disorders
Loss of consciousness
|
4.2%
1/24 • Number of events 1 • Assessed at 6 weeks, 9 weeks, and 12 weeks after study enrollment.
|
0.00%
0/16 • Assessed at 6 weeks, 9 weeks, and 12 weeks after study enrollment.
|
|
Cardiac disorders
Heart attack
|
0.00%
0/24 • Assessed at 6 weeks, 9 weeks, and 12 weeks after study enrollment.
|
6.2%
1/16 • Number of events 1 • Assessed at 6 weeks, 9 weeks, and 12 weeks after study enrollment.
|
|
Reproductive system and breast disorders
Pneumonia
|
0.00%
0/24 • Assessed at 6 weeks, 9 weeks, and 12 weeks after study enrollment.
|
12.5%
2/16 • Number of events 2 • Assessed at 6 weeks, 9 weeks, and 12 weeks after study enrollment.
|
Other adverse events
| Measure |
EM/PROTECT
n=24 participants at risk
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
|
EM/MH
n=16 participants at risk
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.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/24 • Assessed at 6 weeks, 9 weeks, and 12 weeks after study enrollment.
|
6.2%
1/16 • Number of events 1 • Assessed at 6 weeks, 9 weeks, and 12 weeks after study enrollment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place