Depression
Conditions
Keywords
Elder abuse, Depression, Mental health
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.
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.
Interventions
BEHAVIORALEM/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
BEHAVIORALEM/MH
EM/MH provides individuals experiencing elder mistreatment with support services from staff trained in linking elder mistreatment victims to community mental health services.
Sponsors
New York City Department for the Aging
National Institute of Mental Health (NIMH)
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Standardized assessments will be conducted by trained raters blind to participant 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.
Eligibility
Sex/Gender
ALL
Age
55 Years to 100 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 24 |
| 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. | 16 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Protocol Violation | 4 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Total | EM/PROTECT | EM/MH |
|---|---|---|---|
| Age, Continuous | 72.77 years STANDARD_DEVIATION 8.01 | 72.04 years STANDARD_DEVIATION 8.48 | 73.5 years STANDARD_DEVIATION 7.53 |
| Assessment of Quality of Life (WHO-QOL) Domain 1 | 5.58 units on a scale STANDARD_DEVIATION 4.3 | 5.71 units on a scale STANDARD_DEVIATION 2.27 | 5.44 units on a scale STANDARD_DEVIATION 2.03 |
| Assessment of Quality of Life (WHO-QOL) Domain 2 | 19.73 units on a scale STANDARD_DEVIATION 4.26 | 19.33 units on a scale STANDARD_DEVIATION 5.16 | 20.13 units on a scale STANDARD_DEVIATION 3.36 |
| Assessment of Quality of Life (WHO-QOL) Domain 3 | 18.14 units on a scale STANDARD_DEVIATION 4.61 | 18.22 units on a scale STANDARD_DEVIATION 5.18 | 18.06 units on a scale STANDARD_DEVIATION 4.04 |
| Assessment of Quality of Life (WHO-QOL) Domain 4 | 7.58 units on a scale STANDARD_DEVIATION 2.51 | 6.71 units on a scale STANDARD_DEVIATION 3.01 | 8.44 units on a scale STANDARD_DEVIATION 2 |
| Assessment of Quality of Life (WHO-QOL) Domain 5 | 23.73 units on a scale STANDARD_DEVIATION 6.64 | 23.58 units on a scale STANDARD_DEVIATION 7.71 | 23.88 units on a scale STANDARD_DEVIATION 5.57 |
| Clinically Significant Depressive Symptoms (MADRS) | 23.58 units on a scale STANDARD_DEVIATION 4.22 | 24.21 units on a scale STANDARD_DEVIATION 3.09 | 22.94 units on a scale STANDARD_DEVIATION 5.35 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants | 10 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 16 Participants | 13 Participants | 3 Participants |
| Satisfaction With Study Intervention (CSQ) Domain 1 | 2.83 units on a scale STANDARD_DEVIATION 1.36 | 2.95 units on a scale STANDARD_DEVIATION 1.23 | 2.7 units on a scale STANDARD_DEVIATION 1.49 |
| Satisfaction With Study Intervention (CSQ) Domain 2 | 2.98 units on a scale STANDARD_DEVIATION 2.64 | 2.95 units on a scale STANDARD_DEVIATION 1.23 | 3.00 units on a scale STANDARD_DEVIATION 1.41 |
| Satisfaction With Study Intervention (CSQ) Domain 3 | 3.25 units on a scale STANDARD_DEVIATION 1.27 | 3.30 units on a scale STANDARD_DEVIATION 1.22 | 3.20 units on a scale STANDARD_DEVIATION 1.32 |
| Sex: Female, Male Female | 32 Participants | 19 Participants | 13 Participants |
| Sex: Female, Male Male | 8 Participants | 5 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 16 |
| other Total, other adverse events | 0 / 24 | 1 / 16 |
| serious Total, serious adverse events | 3 / 24 | 3 / 16 |
Outcome results
Primary
Clinically Significant Depressive Symptoms (MADRS).
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EM/PROTECT | Clinically Significant Depressive Symptoms (MADRS). | Baseline Outcomes | 24.21 score on a scale | Standard Deviation 5.35 |
| EM/PROTECT | Clinically Significant Depressive Symptoms (MADRS). | Week 6 Outcomes | 12.59 score on a scale | Standard Deviation 7.02 |
| EM/PROTECT | Clinically Significant Depressive Symptoms (MADRS). | Week 9 Outcomes | 15.80 score on a scale | Standard Deviation 5.76 |
| EM/PROTECT | Clinically Significant Depressive Symptoms (MADRS). | Week 12 Outcomes | 16.64 score on a scale | Standard Deviation 7.87 |
| EM/MH | Clinically Significant Depressive Symptoms (MADRS). | Week 12 Outcomes | 13.05 score on a scale | Standard Deviation 7.39 |
| EM/MH | Clinically Significant Depressive Symptoms (MADRS). | Baseline Outcomes | 22.94 score on a scale | Standard Deviation 3.09 |
| EM/MH | Clinically Significant Depressive Symptoms (MADRS). | Week 9 Outcomes | 22.82 score on a scale | Standard Deviation 7.95 |
| EM/MH | Clinically Significant Depressive Symptoms (MADRS). | Week 6 Outcomes | 17.54 score on a scale | Standard Deviation 7.21 |
Comparison: Week 12p-value: 0.1695% CI: [-1.43, 8.61]t-test, 2 sided
Secondary
Assessment of Quality of Life (WHO-QOL)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EM/PROTECT | Assessment of Quality of Life (WHO-QOL) | Domain 3- Baseline | 18.22 score on a scale | Standard Deviation 5.18 |
| EM/PROTECT | Assessment of Quality of Life (WHO-QOL) | Domain 1- Week 9 | 5.93 score on a scale | Standard Deviation 2.64 |
| EM/PROTECT | Assessment of Quality of Life (WHO-QOL) | Domain 1- Week 6 | 6.70 score on a scale | Standard Deviation 1.81 |
| EM/PROTECT | Assessment of Quality of Life (WHO-QOL) | Domain 2- Week 9 | 20.14 score on a scale | Standard Deviation 7.15 |
| EM/PROTECT | Assessment of Quality of Life (WHO-QOL) | Domain 5- Week 12 | 26.59 score on a scale | Standard Deviation 3.02 |
| EM/PROTECT | Assessment of Quality of Life (WHO-QOL) | Domain 3- Week 9 | 18.62 score on a scale | Standard Deviation 4.23 |
| EM/PROTECT | Assessment of Quality of Life (WHO-QOL) | Domain 2- Week 6 | 21.30 score on a scale | Standard Deviation 3.33 |
| EM/PROTECT | Assessment of Quality of Life (WHO-QOL) | Domain 4- Week 9 | 8.64 score on a scale | Standard Deviation 3.37 |
| EM/PROTECT | Assessment of Quality of Life (WHO-QOL) | Domain 4- Baseline | 6.71 score on a scale | Standard Deviation 3.01 |
| EM/PROTECT | Assessment of Quality of Life (WHO-QOL) | Domain 5- Week 9 | 23.79 score on a scale | Standard Deviation 8.32 |
| EM/PROTECT | Assessment of Quality of Life (WHO-QOL) | Domain 3- Week 6 | 19.30 score on a scale | Standard Deviation 4.23 |
| EM/PROTECT | Assessment of Quality of Life (WHO-QOL) | Domain 1- Week 12 | 6.41 score on a scale | Standard Deviation 2 |
| EM/PROTECT | Assessment of Quality of Life (WHO-QOL) | Domain 1- Baseline | 5.71 score on a scale | Standard Deviation 2.27 |
| EM/PROTECT | Assessment of Quality of Life (WHO-QOL) | Domain 2- Week 12 | 21.88 score on a scale | Standard Deviation 3.16 |
| EM/PROTECT | Assessment of Quality of Life (WHO-QOL) | Domain 4- Week 6 | 5.20 score on a scale | Standard Deviation 2.09 |
| EM/PROTECT | Assessment of Quality of Life (WHO-QOL) | Domain 3-Week 12 | 20.47 score on a scale | Standard Deviation 4.29 |
| EM/PROTECT | Assessment of Quality of Life (WHO-QOL) | Domain 5- Baseline | 23.58 score on a scale | Standard Deviation 7.71 |
| EM/PROTECT | Assessment of Quality of Life (WHO-QOL) | Domain 4- Week 12 | 7.76 score on a scale | Standard Deviation 1.99 |
| EM/PROTECT | Assessment of Quality of Life (WHO-QOL) | Domain 5- Week 6 | 26.85 score on a scale | Standard Deviation 5.76 |
| EM/PROTECT | Assessment of Quality of Life (WHO-QOL) | Domain 2- Baseline | 19.33 score on a scale | Standard Deviation 5.16 |
| EM/MH | Assessment of Quality of Life (WHO-QOL) | Domain 5- Week 12 | 27.21 score on a scale | Standard Deviation 5.01 |
| EM/MH | Assessment of Quality of Life (WHO-QOL) | Domain 1- Baseline | 5.44 score on a scale | Standard Deviation 2.03 |
| EM/MH | Assessment of Quality of Life (WHO-QOL) | Domain 2- Baseline | 20.13 score on a scale | Standard Deviation 3.36 |
| EM/MH | Assessment of Quality of Life (WHO-QOL) | Domain 3- Baseline | 18.06 score on a scale | Standard Deviation 4.04 |
| EM/MH | Assessment of Quality of Life (WHO-QOL) | Domain 4- Baseline | 8.44 score on a scale | Standard Deviation 2 |
| EM/MH | Assessment of Quality of Life (WHO-QOL) | Domain 5- Baseline | 23.88 score on a scale | Standard Deviation 5.57 |
| EM/MH | Assessment of Quality of Life (WHO-QOL) | Domain 1- Week 6 | 4.83 score on a scale | Standard Deviation 3.04 |
| EM/MH | Assessment of Quality of Life (WHO-QOL) | Domain 2- Week 6 | 16.17 score on a scale | Standard Deviation 7.99 |
| EM/MH | Assessment of Quality of Life (WHO-QOL) | Domain 3- Week 6 | 16.90 score on a scale | Standard Deviation 3.41 |
| EM/MH | Assessment of Quality of Life (WHO-QOL) | Domain 4- Week 6 | 6.42 score on a scale | Standard Deviation 3.55 |
| EM/MH | Assessment of Quality of Life (WHO-QOL) | Domain 5- Week 6 | 19.92 score on a scale | Standard Deviation 10.56 |
| EM/MH | Assessment of Quality of Life (WHO-QOL) | Domain 1- Week 9 | 6.82 score on a scale | Standard Deviation 1.7 |
| EM/MH | Assessment of Quality of Life (WHO-QOL) | Domain 2- Week 9 | 22.59 score on a scale | Standard Deviation 2.87 |
| EM/MH | Assessment of Quality of Life (WHO-QOL) | Domain 3- Week 9 | 19.53 score on a scale | Standard Deviation 4.9 |
| EM/MH | Assessment of Quality of Life (WHO-QOL) | Domain 4- Week 9 | 7.94 score on a scale | Standard Deviation 2.11 |
| EM/MH | Assessment of Quality of Life (WHO-QOL) | Domain 5- Week 9 | 27.00 score on a scale | Standard Deviation 5.28 |
| EM/MH | Assessment of Quality of Life (WHO-QOL) | Domain 1- Week 12 | 6.57 score on a scale | Standard Deviation 1.74 |
| EM/MH | Assessment of Quality of Life (WHO-QOL) | Domain 2- Week 12 | 20.50 score on a scale | Standard Deviation 3.18 |
| EM/MH | Assessment of Quality of Life (WHO-QOL) | Domain 3-Week 12 | 25.00 score on a scale | Standard Deviation 19.43 |
| EM/MH | Assessment of Quality of Life (WHO-QOL) | Domain 4- Week 12 | 13.00 score on a scale | Standard Deviation 8.36 |
Comparison: Domain #1, Week 12p-value: 0.7995% CI: [-1.37, 1.05]t-test, 2 sided
Comparison: Domain #2, Week 12p-value: 0.1995% CI: [-0.7, 3.46]t-test, 2 sided
Comparison: Domain #3, Week 12p-value: 0.3795% CI: [-14.99, 5.93]t-test, 2 sided
Comparison: Domain #4, Week 12p-value: 0.02695% CI: [-9.75, -0.73]t-test, 2 sided
Comparison: Domain #5, Week 12p-value: 0.6695% CI: [-3.51, 2.27]t-test, 2 sided
Other Pre-specified
Satisfaction With Study Intervention (CSQ)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EM/PROTECT | Satisfaction With Study Intervention (CSQ) | Domain 3- Week 12 | 3.65 score on a scale | Standard Deviation 0.61 |
| EM/PROTECT | Satisfaction With Study Intervention (CSQ) | Domain 1- Week 6 | 2.95 score on a scale | Standard Deviation 1.2 |
| EM/PROTECT | Satisfaction With Study Intervention (CSQ) | Domain 2- Week 6 | 2.95 score on a scale | Standard Deviation 1.23 |
| EM/PROTECT | Satisfaction With Study Intervention (CSQ) | Domain 3- Week 6 | 3.30 score on a scale | Standard Deviation 1.22 |
| EM/PROTECT | Satisfaction With Study Intervention (CSQ) | Domain 1- Week 9 | 3.00 score on a scale | Standard Deviation 1.06 |
| EM/PROTECT | Satisfaction With Study Intervention (CSQ) | Domain 2- Week 9 | 3.29 score on a scale | Standard Deviation 1.05 |
| EM/PROTECT | Satisfaction With Study Intervention (CSQ) | Domain 3- Week 9 | 3.41 score on a scale | Standard Deviation 1 |
| EM/PROTECT | Satisfaction With Study Intervention (CSQ) | Domain 1- Week 12 | 3.12 score on a scale | Standard Deviation 0.93 |
| EM/PROTECT | Satisfaction With Study Intervention (CSQ) | Domain 2- Week 12 | 3.53 score on a scale | Standard Deviation 0.62 |
| EM/MH | Satisfaction With Study Intervention (CSQ) | Domain 1- Week 12 | 2.42 score on a scale | Standard Deviation 1.68 |
| EM/MH | Satisfaction With Study Intervention (CSQ) | Domain 2- Week 9 | 2.69 score on a scale | Standard Deviation 1.89 |
| EM/MH | Satisfaction With Study Intervention (CSQ) | Domain 1- Week 6 | 2.70 score on a scale | Standard Deviation 1.49 |
| EM/MH | Satisfaction With Study Intervention (CSQ) | Domain 3- Week 12 | 3.00 score on a scale | Standard Deviation 1.81 |
| EM/MH | Satisfaction With Study Intervention (CSQ) | Domain 2- Week 6 | 3.00 score on a scale | Standard Deviation 1.41 |
| EM/MH | Satisfaction With Study Intervention (CSQ) | Domain 3- Week 9 | 2.54 score on a scale | Standard Deviation 1.81 |
| EM/MH | Satisfaction With Study Intervention (CSQ) | Domain 3- Week 6 | 3.20 score on a scale | Standard Deviation 1.32 |
| EM/MH | Satisfaction With Study Intervention (CSQ) | Domain 2- Week 12 | 2.75 score on a scale | Standard Deviation 1.71 |
| EM/MH | Satisfaction With Study Intervention (CSQ) | Domain 1- Week 9 | 2.31 score on a scale | Standard Deviation 1.7 |
Comparison: Domain #1, Week 12p-value: 0.1495% CI: [-0.26, 1.66]t-test, 2 sided
Comparison: Domain #2, Week 12p-value: 0.04795% CI: [0.011, 1.55]t-test, 2 sided
Comparison: Domain #3, Week 12p-value: 0.1895% CI: [-0.34, 1.64]t-test, 2 sided