Trial to Test Effectiveness of Depression Intervention for Mistreated Older Adults

NCT04258579 | Completed Results DMC

• 2 other identifiers: 19-09020854P50MH113838-03
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Depression in Old Age; Elder Abuse; Anxiety

Keywords

Mental Health

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (1)

• Change in Assessment of Exposure to Meaningful Activities, as Measured by the BADS

  Baseline, 6 weeks

Study Arms (1)

Video PROTECT

EXPERIMENTAL

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

Behavioral: PROTECT with Technology Augmentation

Interventions

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.

Video PROTECT

Eligibility Criteria

• Age: 55 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Personal Satisfaction

Results Point of Contact

• Title: Dr. Jo Anne Sirey
• Organization: Weill Cornell Medical College

jsirey@med.cornell.edu

914-997-4333

Study Officials

• Jo Anne Sirey, Ph.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 6, 2020
• Study Start: July 15, 2020
• Primary Completion: August 11, 2022
• Study Completion: August 11, 2022
• Last Updated: August 28, 2023
• Results First Posted: August 28, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available as per the National Institute of Mental Health (NIMH) data sharing policy.
• Access Criteria: Access criteria is determined by NIMH and can be requested by applying online.

Locations

US (1)