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Trial to Test Effectiveness of Depression Intervention for Mistreated Older Adults

Primary Purpose

Depression, Depression in Old Age, Elder Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PROTECT with Technology Augmentation
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Mental Health

Eligibility Criteria

55 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Weill Cornell Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Video PROTECT

Arm Description

Participants will receive PROTECT therapy once a week for 9 weeks.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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).

Full Information

First Posted
February 4, 2020
Last Updated
August 10, 2023
Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04258579
Brief Title
Trial to Test Effectiveness of Depression Intervention for Mistreated Older Adults
Official Title
EM/PROTECT-Hybrid: Improving Depression in Elder Mistreatment Victims
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
August 11, 2022 (Actual)
Study Completion Date
August 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Depression in Old Age, Elder Abuse, Anxiety
Keywords
Mental Health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Video PROTECT
Arm Type
Experimental
Arm Description
Participants will receive PROTECT therapy once a week for 9 weeks.
Intervention Type
Behavioral
Intervention Name(s)
PROTECT with Technology Augmentation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Clinically Significant Depressive Symptoms as Measured by the MADRS
Description
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
Title
Change in Assessment of Quality of Life, as Measured by the WHO-QOL
Description
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
Title
Change in Assessment of Stress, as Measured by the PSS
Description
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
Secondary Outcome Measure Information:
Title
Change in Assessment of Exposure to Meaningful Activities, as Measured by the BADS
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jo Anne Sirey, Ph.D.
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data will be available as per the National Institute of Mental Health (NIMH) data sharing policy.
IPD Sharing Access Criteria
Access criteria is determined by NIMH and can be requested by applying online.
IPD Sharing URL
https://nda.nih.gov/

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Trial to Test Effectiveness of Depression Intervention for Mistreated Older Adults

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