DepressionNCT03241225
EM/PROTECT: Improving Depression in Elder Mistreatment Victims
A study testing EM/PROTECT and EM/MH in people with Depression, run by Weill Medical College of Cornell University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 100 years
- Conditions the study is for
- Depression
- What is being tested?
- EM/PROTECT and EM/MH
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2018to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Elderly Crime Victim Resource Center of the New York City Department for the Aging
New York, New York, 10007
Weill Cornell Medicine
New York, New York, 10065
About this study
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.
Read the 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.
- Conditions
- Depression
- Being tested
- EM/PROTECT, EM/MH
- Keywords
- Elder abuse, Depression, Mental health
- Medical subject headings
- Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EM/PROTECTBehavioural
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/MHBehavioural
EM/MH provides individuals experiencing elder mistreatment with support services from staff trained in linking elder mistreatment victims to community mental health services.
| Study group | Role | What they receive |
|---|---|---|
| EM/PROTECT | Experimental | 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. Receives: Behavioral: EM/PROTECT |
| EM/MH | Active comparator | This group of participants experiencing elder mistreatment will receive support services from staff trained in linking elder mistreatment victims to community mental health services. Receives: Behavioral: EM/MH |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: These measures are assessed at baseline, six week, nine week and twelve weeks after study enrollment during the study.
Secondary outcomes (1)
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).
Measured: These measures are assessed at baseline, six week, nine week and twelve weeks after study enrollment during the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start1 Jan 2018
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- New York City Department for the Aging, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- George Alexopoulos, MD, Study director, Weill Cornell Medicine/New York Presbyterian HospitalJo Anne Sirey, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03241225
- Sponsor's protocol ID
- 1703018101
- Other IDs
- P50MH113838
- Status last verified
- Feb 2022
- First submitted
- 31 Jul 2017
- Last updated
- 3 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Center will share its data via the NIMH Data Archive (NDA). Our resource sharing plan is formulated in accordance with the NDA Data Sharing Terms and Conditions. Further, the Center will use NDA technologies to submit data in accordance with the NDA Data Sharing Terms and Conditions. This project will share feasibility, acceptability, and preliminary effectiveness data of the developmental study of the behavioral intervention EM/PROTECT. Investigators will comply with NIMH's procedures for data deposition into NDCT, and will let NDCT policies dictate the timetable upon which and avenues through which others will be allowed to access those data. Investigators will make the dataset available to other researchers after the main results have been published. Investigators will de-identify the data in the final datasets prior to release for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EM/PROTECT: Improving Depression in Elder Mistreatment Victims
- ClinicalTrials.gov ID
- NCT03241225
- Acronym / sponsor ID
- 1703018101
- Conditions
- Depression
- Keywords
- Elder abuse, Depression, Mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- New York City Department for the Aging, National Institute of Mental Health (NIMH)
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 7 Aug 2017 (actual)
- Results
- Posted 3 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| EM/PROTECT | Experimental | Behavioral: EM/PROTECTThis 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/MH | Active comparator | Behavioral: EM/MHThis group of participants experiencing elder mistreatment will receive support services from staff trained in linking elder mistreatment victims to community mental health services. |
Who may qualify
- Ages
- 55 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EM/PROTECTEM/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 | Behavioural | EM/PROTECT |
| EM/MHEM/MH provides individuals experiencing elder mistreatment with support services from staff trained in linking elder mistreatment victims to community mental health services. | Behavioural | EM/MH |
Primary outcome
Clinically Significant Depressive Symptoms (MADRS).
Time frame: 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.
1 secondary outcome
Assessment of Quality of Life (WHO-QOL)
Time frame: These measures are assessed at baseline, six week, nine week and twelve weeks after study enrollment during the study.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The Center will share its data via the NIMH Data Archive (NDA). Our resource sharing plan is formulated in accordance with the NDA Data Sharing Terms and Conditions. Further, the Center will use NDA technologies to submit data in accordance with the NDA Data Sharing Terms and Conditions. This project will share feasibility, acceptability, and preliminary effectiveness data of the developmental study of the behavioral intervention EM/PROTECT. Investigators will comply with NIMH's procedures for data deposition into NDCT, and will let NDCT policies dictate the timetable upon which and avenues through which others will be allowed to access those data. Investigators will make the dataset available to other researchers after the main results have been published. Investigators will de-identify the data in the final datasets prior to release for sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Alexopoulos, MD study director
Weill Cornell Medicine/New York Presbyterian Hospital
Jo Anne Sirey, PhD principal investigator
Weill Medical College of Cornell University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EM/PROTECT and EM/MH in people with Depression, run by Weill Medical College of Cornell University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically Significant Depressive Symptoms (MADRS). (time frame: These measures are assessed at baseline, six week, nine week and twelve weeks after study enrollment during the study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2022.