DepressionNCT04258579

Trial to Test Effectiveness of Depression Intervention for Mistreated Older Adults

A study testing PROTECT with Technology Augmentation in people with Depression and Depression in Old Age, run by Weill Medical College of Cornell University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 55 to 100 years
Conditions the study is for: Depression, Depression in Old Age, Elder Abuse
What is being tested?: PROTECT with Technology Augmentation
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 15 Jul 2020to 11 Aug 2022
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 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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

Weill Cornell Medicine
New York, New York, 10065

Other trials in United States

About this study

Official title: EM/PROTECT-Hybrid: Improving Depression in Elder Mistreatment Victims

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.

Conditions: Depression, Depression in Old Age, Elder Abuse, Anxiety
Being tested: PROTECT with Technology Augmentation
Keywords: Mental Health
Medical subject headings: Depression, Anxiety Disorders, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PROTECT with Technology AugmentationBehavioural
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.

Study groups in NCT04258579
Study group	Role	What they receive
Video PROTECT	Experimental	Participants will receive PROTECT therapy once a week for 9 weeks. Receives: Behavioral: PROTECT with Technology Augmentation

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6 weeks

Secondary outcomes (1)

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).
Measured: Baseline, 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jul 202011 Aug 2022

First posted6 Feb 2020
Study start15 Jul 2020
Primary completion11 Aug 2022
Study completion11 Aug 2022

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.
More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
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: Not applicable
Intervention model: Single group
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.
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04258579
Sponsor's protocol ID: 19-09020854
Other IDs: P50MH113838-03
Status last verified: Aug 2023
First submitted: 4 Feb 2020
Last updated: 28 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: EM/PROTECT-Hybrid: Improving Depression in Elder Mistreatment Victims
ClinicalTrials.gov ID: NCT04258579
Acronym / sponsor ID: 19-09020854
Conditions: Depression, Depression in Old Age, Elder Abuse, Anxiety
Keywords: Mental Health
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Weill Medical College of Cornell UniversityUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 15 Jul 2020 (actual)
Primary completion: 11 Aug 2022 (actual)
Study completion: 11 Aug 2022 (actual)
First posted: 6 Feb 2020 (actual)
Results: Posted 28 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
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.

Arm	Type	Receives
Video PROTECT	Experimental	Behavioral: PROTECT with Technology AugmentationParticipants will receive PROTECT therapy once a week for 9 weeks.

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 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

Key exclusion criteria (5 listed)

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)

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
PROTECT with Technology AugmentationPROTECT 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.	Behavioural	Video PROTECT

Primary outcome

Change in Clinically Significant Depressive Symptoms as Measured by the MADRS
Time frame: 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
Time frame: 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
Time frame: 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.

1 secondary outcome

Change in Assessment of Exposure to Meaningful Activities, as Measured by the BADS
Time frame: Baseline, 6 weeks

Results and safety

Results posted to the registry on 28 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Video PROTECT	40	27

Primary outcome: Change in Clinically Significant Depressive Symptoms as Measured by the MADRS

Time frame: 6 weeks, 9 weeks, 12 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Video PROTECT n = 30
Week 6 Outcomes	19.13 (9.47)
Week 9 Outcomes	16.87 (11.69)
Week 12 Outcomes	15.00 (9.32)

Video PROTECT: Mean value at 6 weeks: 19.13 (95% CI 15.59 to 22.67)
Video PROTECT: Mean value at 9 weeks: 16.87 (95% CI 12.50 to 21.24)
Video PROTECT: Mean value at 12 weeks: 15.00 (95% CI 11.24 to 18.76)

Population analysed: 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.

Primary outcome: Change in Assessment of Quality of Life, as Measured by the WHO-QOL

Time frame: 6 weeks, 9 weeks, 12 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Video PROTECT n = 30
Week 6 Outcomes- Domain 1	22.10 (6.39)
Week 6 Outcomes- Domain 2	19.90 (4.99)
Week 6 Outcomes- Domain 3	8.93 (3.36)
Week 6 Outcomes- Domain 4	26.63 (6.18)
Week 9 Outcomes- Domain 1	22.53 (7.24)
Week 9 Outcomes- Domain 2	21.00 (5.71)
Week 9 Outcomes- Domain 3	8.69 (3.49)
Week 9 Outcomes- Domain 4	27.38 (6.18)

Video PROTECT: Mean value at 6 weeks, Domain 1: 22.10 (95% CI 19.70 to 24.50)
Video PROTECT: Mean value at 6 weeks, Domain 2: 19.90 (95% CI 18.00 to 21.80)
Video PROTECT: Mean value at 6 weeks, Domain 3: 8.93 (95% CI 7.68 to 10.18)

Population analysed: 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.

Primary outcome: Change in Assessment of Stress, as Measured by the PSS

Time frame: Baseline, 6 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Video PROTECT n = 30
Baseline	22.45 (7.74)
Week 6	20.53 (7.71)

Video PROTECT: Mean value at baseline: 22.45 (95% CI 19.56 to 25.34)
Video PROTECT: Mean value at 6 weeks: 20.53 (95% CI 17.65 to 23.41)

Population analysed: Due to participant withdrawal and loss to follow-up, the total number of participants at Week 6 was 30.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Video PROTECT	2 of 40 (5%)	4 of 40 (10%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. 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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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.

Jo Anne Sirey, Ph.D. principal investigator

Weill Medical College of Cornell University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing PROTECT with Technology Augmentation in people with Depression and Depression in Old Age, run by Weill Medical College of Cornell University at 1 site 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 5 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 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 28 Aug 2023). 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?

Change in Clinically Significant Depressive Symptoms as Measured by the MADRS (time frame: 6 weeks, 9 weeks, 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04258579.

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 28 Aug 2023.