Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial to Test Effectiveness of Depression Intervention for Mistreated Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04258579
Recruitment Status : Recruiting
First Posted : February 6, 2020
Last Update Posted : July 29, 2020
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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.

Condition or disease Intervention/treatment Phase
Depression Depression in Old Age Elder Abuse Anxiety Behavioral: PROTECT with Technology Augmentation Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: EM/PROTECT-Hybrid: Improving Depression in Elder Mistreatment Victims
Actual Study Start Date : July 15, 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Video PROTECT
Participants will receive PROTECT therapy once a week for 9 weeks.
Behavioral: 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.




Primary Outcome Measures :
  1. Change in clinically significant depressive symptoms as measured by the MADRS [ Time Frame: Baseline, 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.

  2. Change in assessment of Quality of Life, as measured by the WHO-QOL [ Time Frame: Baseline, 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. Scores across 4 domains (Physical Health, Psychological, Social Relationships, and Environment) range from 0-100, with higher scores indicating a higher quality of life.

  3. 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.


Secondary Outcome Measures :
  1. Change in assessment of exposure to meaningful activities, as measured by the BADS [ Time Frame: Baseline, 6 weeks ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   55 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04258579


Contacts
Layout table for location contacts
Contact: Jo Anne Sirey, Ph.D. 914-997-4333 jsirey@med.cornell.edu

Locations
Layout table for location information
United States, New York
Weill Cornell Medicine Recruiting
New York, New York, United States, 10065
Contact: Jo Anne Sirey, Ph.D.    914-997-4333    jsirey@med.cornell.edu   
Principal Investigator: Jo Anne Sirey, Ph.D.         
Sponsors and Collaborators
Weill Medical College of Cornell University
National Institute of Mental Health (NIMH)
Investigators
Layout table for investigator information
Principal Investigator: Jo Anne Sirey, Ph.D. Weill Medical College of Cornell University
Layout table for additonal information
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT04258579    
Other Study ID Numbers: 19-09020854
P50MH113838-03 ( U.S. NIH Grant/Contract )
First Posted: February 6, 2020    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
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.
URL: https://nda.nih.gov/

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weill Medical College of Cornell University:
Mental Health
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders