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| ID | Type | Description | Link |
|---|---|---|---|
| P50MH113838-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Video PROTECT | Experimental | Participants will receive PROTECT therapy once a week for 9 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PROTECT with Technology Augmentation | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks, 9 weeks, 12 weeks |
| 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. | 6 weeks, 9 weeks, 12 weeks |
| 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. | Baseline, 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jo Anne Sirey, Ph.D. | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | New York | New York | 10065 | United States |
De-identified data from this study is submitted to the National Database for Clinical Trials related to Mental Illness (NDCT). The NDCT is run by the National Institute of Health (NIH) and allows researchers studying mental health to collect and share information with each other. Researchers must apply to NIH in order to be allowed access to the data for 1 year's time; after which they must re-apply.
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Data will be available as per the National Institute of Mental Health (NIMH) data sharing policy.
Access criteria is determined by NIMH and can be requested by applying online.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks, 9 weeks, 12 weeks |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychiatric Hospitalization | Psychiatric disorders | Non-systematic Assessment | Participant was hospitalized due to a pre-existing condition. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emergency Room Visit | Injury, poisoning and procedural complications | Non-systematic Assessment | Emergency room visit to assess pain from previous car accident. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jo Anne Sirey | Weill Cornell Medical College | 914-997-4333 | jsirey@med.cornell.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 6, 2023 | May 8, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 7, 2022 | Nov 18, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D010549 | Personal Satisfaction |
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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.
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|
| Baseline, 6 weeks |
| Adverse Event |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Clinically Significant Depressive Symptoms, as Measured by the MADRS | Montgomery Asberg Depression Rating Scale. Scores on this scale range from 0 to 60, with higher scores indicating more severe depression and lower scores indicating milder depression. | Mean | Standard Deviation | units on a scale |
|
| Assessment of Quality of Life, as Measured by the WHO-QOL | 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). | Mean | Standard Deviation | units on a scale |
|
| Assessment of Stress, as Measured by the PSS | Perceived Stress Scale: Overall scores range from 0-40 with higher scores indicating a more perceived stress and lower scores indicating less perceived stress. | Mean | Standard Deviation | units on a scale |
|
| Assessment of Meaningful Activities, as Measured by the BADS | Behavioral Activation for Depression Scale: For all domains, high scores indicate an increase of the factor or symptom described in the domain title (e.g. higher activation score means more activation). Domain 1 measures activation (scores range from 0-42). Domain 2 measures avoidance/rumination (scores range from 0-48). Domain 3 measures work and school impairment (scores range from 0-30). Domain 4 measures social impairment (scores range from 0-30). | Mean | Standard Deviation | units on a scale |
|
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| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks, 9 weeks, 12 weeks |
|
|
|
|
| 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. | Due to participant withdrawal and loss to follow-up, the total number of participants at Week 6 was 30. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 weeks |
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| 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). | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 weeks |
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|
| 0 |
| 40 |
| 2 |
| 40 |
| 4 |
| 40 |
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| Hospitalization due to Seizures | Nervous system disorders | Non-systematic Assessment | Participant was hospitalized due to seizures related to a pre-existing condition. |
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| Skin Irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Minor skin irritation due to watch given as part of study participation |
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| Week 6 Outcomes- Domain 3 |
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| Week 6 Outcomes- Domain 4 |
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| Week 9 Outcomes- Domain 1 |
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| Week 9 Outcomes- Domain 2 |
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| Week 9 Outcomes- Domain 3 |
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| Week 9 Outcomes- Domain 4 |
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| Week 12 Outcomes- Domain 1 |
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| Week 12 Outcomes- Domain 2 |
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| Week 12 Outcomes- Domain 3 |
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| Week 12 Outcomes- Domain 4 |
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| Mean value at 6 weeks, Domain 2 |
| 19.90 |
| 2-Sided |
| 95 |
| 18.00 |
| 21.80 |
| Other |
Estimation only. |
| Mean value at 6 weeks, Domain 3 | 8.93 | 2-Sided | 95 | 7.68 | 10.18 | Other | Estimation only. |
| Mean value at 6 weeks, Domain 4 | 26.63 | 2-Sided | 95 | 24.32 | 28.94 | Other | Estimation only. |
| Mean value at 9 weeks, Domain 1 | 22.53 | 2-Sided | 95 | 19.87 | 25.23 | Other | Estimation only. |
| Mean value at 9 weeks, Domain 2 | 21.00 | 2-Sided | 95 | 18.87 | 23.13 | Other | Estimation only. |
| Mean value at 9 weeks, Domain 3 | 8.69 | 2-Sided | 95 | 7.39 | 9.99 | Other | Estimation only. |
| Mean value at 9 weeks, Domain 4 | 27.38 | 2-Sided | 95 | 25.07 | 29.69 | Other | Estimation only. |
| Mean value at 12 weeks, Domain 1 | 22.62 | 2-Sided | 95 | 20.18 | 25.06 | Other | Estimation only. |
| Mean value at 12 weeks, Domain 2 | 21.58 | 2-Sided | 95 | 19.84 | 23.32 | Other | Estimation only. |
| Mean value at 12 weeks, Domain 3 | 9.19 | 2-Sided | 95 | 7.92 | 10.46 | Other | Estimation only. |
| Mean value at 12 weeks, Domain 4 | 27.81 | 2-Sided | 95 | 25.53 | 30.09 | Other | Estimation only. |
| Mean value at 6 weeks |
| 20.53 |
| 2-Sided |
| 95 |
| 17.65 |
| 23.41 |
| Other |
Estimation only. |
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| Baseline- Domain 3 |
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| Baseline- Domain 4 |
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| Week 6- Domain 1 |
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| Week 6- Domain 2 |
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| Week 6- Domain 3 |
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| Week 6- Domain 4 |
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| Mean value at baseline, Domain 2 |
| 22.46 |
| 2-Sided |
| 95 |
| 19.72 |
| 25.20 |
| Other |
Estimation only. |
| Mean value at baseline, Domain 3 | 16.00 | 2-Sided | 95 | 13.72 | 18.28 | Other | Estimation only. |
| Mean value at baseline, Domain 4 | 17.79 | 2-Sided | 95 | 15.34 | 20.24 | Other | Estimation only. |
| Mean value at 6 weeks, Domain 1 | 22.79 | 2-Sided | 95 | 19.05 | 26.53 | Other | Estimation only. |
| Mean value at 6 weeks, Domain 2 | 26.70 | 2-Sided | 95 | 22.96 | 30.44 | Other | Estimation only. |
| Mean value at 6 weeks, Domain 3 | 17.45 | 2-Sided | 95 | 14.57 | 20.33 | Other | Estimation only. |
| Mean value at 6 weeks, Domain 4 | 20.69 | 2-Sided | 95 | 18.23 | 23.15 | Other | Estimation only. |