Anxiety, Depression, Depression in Old Age, Elder Abuse
Conditions
Keywords
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 50 subjects that will participate in the study for approximately 12 weeks.
Interventions
BEHAVIORALPROTECT with Technology Augmentation
PROTECT is a therapeutic intervention focused on treating victims of elder abuse who are experiencing depression. PROTECT therapy will be delivered through video. Participants will be provided with a mobile device (iPhone), and a wearable device (smart watch) that will track sleep, mood, steps, and heart rate.
Sponsors
National Institute of Mental Health (NIMH)
Weill Medical College of Cornell University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The investigators will be comparing data collected from this project to previously collected data from the first phase of this project, in which PROTECT was delivered only in-person.
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 Elder Mistreatment staff) * Significant depression (per Elder Mistreatment 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 Elder Mistreatment (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 (Montgomery Asberg Depression Rating Scale item 10\>4) * Inability to speak English or Spanish * Axis 1 Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnoses other than unipolar depression or generalized anxiety disorder (by Structured Clinical Interview for DSM-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 |
|---|---|---|
| Change in Clinically Significant Depressive Symptoms as Measured by the MADRS | 6 weeks, 9 weeks, 12 weeks | In all conditions, the change in clinically significant depressive symptoms as measured on the Montgomery Asberg Depression Rating Scale (MADRS). Scores are categorized as following: 0 to 6 - Normal /symptom absent. 7 to 19 - Mild depression. 20 to 34 - Moderate depression. \>34 - Severe depression. The scores presented for each time point are absolute values. |
| Change in Assessment of Quality of Life, as Measured by the WHO-QOL | 6 weeks, 9 weeks, 12 weeks | In all conditions, changes in assessment of quality of life measured by the World Health Organization Quality of Life (WHO-QOL) scale. World Health Organization-Quality Of Life scale. The overall scores range between 26-130. In all domains, higher scores indicate better health. Domain 1 measures physical health (scores range from 7-35). Domain 2 measures psychological health (scores range from 6-30). Domain 3 measures social health (scores range from 3-15). Domain 4 measures environmental health (scores range from 8-40). The scores presented for each time point are absolute values. |
| Change in Assessment of Stress, as Measured by the PSS | Baseline, 6 weeks | In all conditions, changes in assessment of stress measured by the Perceived Stress Scale (PSS) scale. Scores range from 0-40. Scores ranging from 0-13 are considered low stress, scores ranging from 14-26 are considered moderate stress, and scores ranging from 27-40 are considered high perceived stress. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Assessment of Exposure to Meaningful Activities, as Measured by the BADS | Baseline, 6 weeks | In all conditions, changes in assessment of meaningful activities measured by the Behavioral Activation for Depression Scale (BADS). Scores are divided across 4 domains: Activation subscale scores range from 0-42, Avoidance/Rumination subscale scores range from 0-48, Work/School Impairment subscale scores range from 0-30, Social Impairment subscale scores range from 0-30. For all subscales, high scores are consistent with the subscale title (e.g., high scores on Activation subscale = more activation). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Video PROTECT Participants will receive PROTECT therapy once a week for 9 weeks.
PROTECT with Technology Augmentation: PROTECT is a therapeutic intervention focused on treating victims of elder abuse who are experiencing depression. PROTECT therapy will be delivered through video. Participants will be provided with a mobile device (iPhone), and a wearable device (smart watch) that will track sleep, mood, steps, and heart rate. | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Protocol Violation | 2 |
| Overall Study | Withdrawal by Subject | 7 |
Baseline characteristics
| Characteristic | Video PROTECT |
|---|---|
| Age, Continuous | 70.50 years STANDARD_DEVIATION 6.97 |
| Assessment of Meaningful Activities, as Measured by the BADS Domain 1 | 19.89 units on a scale STANDARD_DEVIATION 8.29 |
| Assessment of Meaningful Activities, as Measured by the BADS Domain 2 | 22.46 units on a scale STANDARD_DEVIATION 8.57 |
| Assessment of Meaningful Activities, as Measured by the BADS Domain 3 | 16.00 units on a scale STANDARD_DEVIATION 7.14 |
| Assessment of Meaningful Activities, as Measured by the BADS Domain 4 | 17.79 units on a scale STANDARD_DEVIATION 7.66 |
| Assessment of Quality of Life, as Measured by the WHO-QOL Domain 1 | 21.38 units on a scale STANDARD_DEVIATION 6.34 |
| Assessment of Quality of Life, as Measured by the WHO-QOL Domain 2 | 18.08 units on a scale STANDARD_DEVIATION 5.04 |
| Assessment of Quality of Life, as Measured by the WHO-QOL Domain 3 | 8.45 units on a scale STANDARD_DEVIATION 3.03 |
| Assessment of Quality of Life, as Measured by the WHO-QOL Domain 4 | 25.30 units on a scale STANDARD_DEVIATION 6.26 |
| Assessment of Stress, as Measured by the PSS | 22.45 units on a scale STANDARD_DEVIATION 7.74 |
| Clinically Significant Depressive Symptoms, as Measured by the MADRS | 23.00 units on a scale STANDARD_DEVIATION 8.22 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 4 / 40 |
| serious Total, serious adverse events | 2 / 40 |
Outcome results
Primary
Change in Assessment of Quality of Life, as Measured by the WHO-QOL
In all conditions, changes in assessment of quality of life measured by the World Health Organization Quality of Life (WHO-QOL) scale. World Health Organization-Quality Of Life scale. The overall scores range between 26-130. In all domains, higher scores indicate better health. Domain 1 measures physical health (scores range from 7-35). Domain 2 measures psychological health (scores range from 6-30). Domain 3 measures social health (scores range from 3-15). Domain 4 measures environmental health (scores range from 8-40). The scores presented for each time point are absolute values.
Time frame: 6 weeks, 9 weeks, 12 weeks
Population: The overall number of participants analyzed was 30 at week 6, 30 at week 9, and 26 at week 12. The decline in participants analyzed at each time point is due to participant withdrawal by the study team or by their request.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Video PROTECT | Change in Assessment of Quality of Life, as Measured by the WHO-QOL | Week 6 Outcomes- Domain 1 | 22.10 units on a scale | Standard Deviation 6.39 |
| Video PROTECT | Change in Assessment of Quality of Life, as Measured by the WHO-QOL | Week 6 Outcomes- Domain 2 | 19.90 units on a scale | Standard Deviation 4.99 |
| Video PROTECT | Change in Assessment of Quality of Life, as Measured by the WHO-QOL | Week 6 Outcomes- Domain 3 | 8.93 units on a scale | Standard Deviation 3.36 |
| Video PROTECT | Change in Assessment of Quality of Life, as Measured by the WHO-QOL | Week 6 Outcomes- Domain 4 | 26.63 units on a scale | Standard Deviation 6.18 |
| Video PROTECT | Change in Assessment of Quality of Life, as Measured by the WHO-QOL | Week 9 Outcomes- Domain 1 | 22.53 units on a scale | Standard Deviation 7.24 |
| Video PROTECT | Change in Assessment of Quality of Life, as Measured by the WHO-QOL | Week 9 Outcomes- Domain 2 | 21.00 units on a scale | Standard Deviation 5.71 |
| Video PROTECT | Change in Assessment of Quality of Life, as Measured by the WHO-QOL | Week 9 Outcomes- Domain 3 | 8.69 units on a scale | Standard Deviation 3.49 |
| Video PROTECT | Change in Assessment of Quality of Life, as Measured by the WHO-QOL | Week 9 Outcomes- Domain 4 | 27.38 units on a scale | Standard Deviation 6.18 |
| Video PROTECT | Change in Assessment of Quality of Life, as Measured by the WHO-QOL | Week 12 Outcomes- Domain 1 | 22.62 units on a scale | Standard Deviation 6.04 |
| Video PROTECT | Change in Assessment of Quality of Life, as Measured by the WHO-QOL | Week 12 Outcomes- Domain 2 | 21.58 units on a scale | Standard Deviation 4.31 |
| Video PROTECT | Change in Assessment of Quality of Life, as Measured by the WHO-QOL | Week 12 Outcomes- Domain 3 | 9.19 units on a scale | Standard Deviation 3.14 |
| Video PROTECT | Change in Assessment of Quality of Life, as Measured by the WHO-QOL | Week 12 Outcomes- Domain 4 | 27.81 units on a scale | Standard Deviation 5.64 |
95% CI: [19.84, 23.32]
95% CI: [7.92, 10.46]
95% CI: [19.7, 24.5]
95% CI: [18, 21.8]
95% CI: [7.68, 10.18]
95% CI: [24.32, 28.94]
95% CI: [19.87, 25.23]
95% CI: [18.87, 23.13]
95% CI: [7.39, 9.99]
95% CI: [25.07, 29.69]
95% CI: [20.18, 25.06]
95% CI: [25.53, 30.09]
Primary
Change in Assessment of Stress, as Measured by the PSS
In all conditions, changes in assessment of stress measured by the Perceived Stress Scale (PSS) scale. Scores range from 0-40. Scores ranging from 0-13 are considered low stress, scores ranging from 14-26 are considered moderate stress, and scores ranging from 27-40 are considered high perceived stress.
Time frame: Baseline, 6 weeks
Population: Due to participant withdrawal and loss to follow-up, the total number of participants at Week 6 was 30.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Video PROTECT | Change in Assessment of Stress, as Measured by the PSS | Baseline | 22.45 units on a scale | Standard Deviation 7.74 |
| Video PROTECT | Change in Assessment of Stress, as Measured by the PSS | Week 6 | 20.53 units on a scale | Standard Deviation 7.71 |
95% CI: [19.56, 25.34]
95% CI: [17.65, 23.41]
Primary
Change in Clinically Significant Depressive Symptoms as Measured by the MADRS
In all conditions, the change in clinically significant depressive symptoms as measured on the Montgomery Asberg Depression Rating Scale (MADRS). Scores are categorized as following: 0 to 6 - Normal /symptom absent. 7 to 19 - Mild depression. 20 to 34 - Moderate depression. \>34 - Severe depression. The scores presented for each time point are absolute values.
Time frame: 6 weeks, 9 weeks, 12 weeks
Population: The overall number of participants analyzed was 40 at baseline, 30 at week 6, 30 at week 9, and 26 at week 12. The decline in participants analyzed at each time point is due to participant withdrawal by the study team or by their request.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Video PROTECT | Change in Clinically Significant Depressive Symptoms as Measured by the MADRS | Week 6 Outcomes | 19.13 units on a scale | Standard Deviation 9.47 |
| Video PROTECT | Change in Clinically Significant Depressive Symptoms as Measured by the MADRS | Week 9 Outcomes | 16.87 units on a scale | Standard Deviation 11.69 |
| Video PROTECT | Change in Clinically Significant Depressive Symptoms as Measured by the MADRS | Week 12 Outcomes | 15.00 units on a scale | Standard Deviation 9.32 |
95% CI: [15.59, 22.67]
95% CI: [12.5, 21.24]
95% CI: [11.24, 18.76]
Secondary
Change in Assessment of Exposure to Meaningful Activities, as Measured by the BADS
In all conditions, changes in assessment of meaningful activities measured by the Behavioral Activation for Depression Scale (BADS). Scores are divided across 4 domains: Activation subscale scores range from 0-42, Avoidance/Rumination subscale scores range from 0-48, Work/School Impairment subscale scores range from 0-30, Social Impairment subscale scores range from 0-30. For all subscales, high scores are consistent with the subscale title (e.g., high scores on Activation subscale = more activation).
Time frame: Baseline, 6 weeks
Population: 40 subjects were analyzed at baseline. Due to participant withdrawal and loss to follow-up, the total number of participants at Week 6 was 30.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Video PROTECT | Change in Assessment of Exposure to Meaningful Activities, as Measured by the BADS | Baseline- Domain 4 | 17.79 units on a scale | Standard Deviation 7.66 |
| Video PROTECT | Change in Assessment of Exposure to Meaningful Activities, as Measured by the BADS | Baseline- Domain 1 | 19.89 units on a scale | Standard Deviation 8.29 |
| Video PROTECT | Change in Assessment of Exposure to Meaningful Activities, as Measured by the BADS | Baseline- Domain 2 | 22.46 units on a scale | Standard Deviation 8.57 |
| Video PROTECT | Change in Assessment of Exposure to Meaningful Activities, as Measured by the BADS | Baseline- Domain 3 | 16.00 units on a scale | Standard Deviation 7.14 |
| Video PROTECT | Change in Assessment of Exposure to Meaningful Activities, as Measured by the BADS | Week 6- Domain 1 | 22.79 units on a scale | Standard Deviation 10.02 |
| Video PROTECT | Change in Assessment of Exposure to Meaningful Activities, as Measured by the BADS | Week 6- Domain 2 | 26.70 units on a scale | Standard Deviation 10.02 |
| Video PROTECT | Change in Assessment of Exposure to Meaningful Activities, as Measured by the BADS | Week 6- Domain 3 | 17.45 units on a scale | Standard Deviation 7.7 |
| Video PROTECT | Change in Assessment of Exposure to Meaningful Activities, as Measured by the BADS | Week 6- Domain 4 | 20.69 units on a scale | Standard Deviation 6.59 |
95% CI: [17.24, 22.54]
95% CI: [19.72, 25.2]
95% CI: [13.72, 18.28]
95% CI: [15.34, 20.24]
95% CI: [19.05, 26.53]
95% CI: [22.96, 30.44]
95% CI: [14.57, 20.33]
95% CI: [18.23, 23.15]