Leveraging Adult Protective Service Interaction to Offer Evidence-Based Treatment for Depression in Elder Neglect/Self Neglect

June 28, 2025 updated by: Leila Wood, The University of Texas Health Science Center, Houston
The purpose of this study is to test the feasibility and acceptability of an evidence-based treatment for depression delivered over an ipad, computer, or smartphone can help Adult Protective Services (APS) clients with their activities of daily living to evaluate whether reductions on measures of depression and apathy (a) mediate reduced Elder Neglect/Self Neglect (EN/SN) behaviors; and (b) whether secondary posited mediating mechanisms are also active in impacting depression and apathy

Study Overview

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • APS Case in APS Region VI- Must have open case
  • PHQ 9 score- Must have score of nine (9) or more

Exclusion Criteria:

  • Previous mental health diagnosis of bipolar disorder, psychotic disorders, and moderate to severe dementia
  • Assessment of Consent Proxy- Those who need assessment of consent proxy
  • Suicidal Intent (as indexed by PhQ-9 question 9)- Those scoring 2 or 3
  • Current Alcohol and Drug Dependency- As evidenced by Cut down, Annoyed, Guilty, and Eye-opener (CAGE) score of 3 or more

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: APS Treatment as Usual
APS agencies conduct in-home investigations of alleged abuse and neglect against disabled and older adults. Investigations result in short-term stop-gap measures, primarily brief case-management centering on referral linkage to community-based services and provision of resource allocation. No direct psychological services or treatments are provided by APS, however referral to other services is also standard.
Experimental: Intervention-Behavioral Activation (BA)
Participants will be will be guided through 8 one-hour sessions via home telehealth by the study community health worker. Each weekly < 60 minute BA session will include modules focusing on 1) Psychoeducation for depression and techniques for self-management, including pharmacologic and psychosocial treatment options; 2) Introduction of BA and guided problem-solving techniques to enhance self efficacy for managing depression and other chronic illnesses; 3) BA and problem-solving techniques to support medication management and adherence strategies; 4) BA to develop strategies and techniques for communicating with health providers and/or support resources to foster positive mood and self management; and 5) Developing a relapse prevention plan, which includes identifying triggers for lower functioning, support resources, and practice of BA techniques.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in depression as assessed by the Patient Depression Questionnaire (PHQ-9)
Time Frame: baseline, post-treatment ( 8 weeks after baseline), and 3 months
This is 9 item questionnaire and each is scored from 0 (not at all) to 3 (nearly every day), for a maximum score of 27, higher score indicating more depression
baseline, post-treatment ( 8 weeks after baseline), and 3 months
Change in apathy as assessed by the Apathy Motivations Index (AMI)
Time Frame: baseline, post-treatment ( 8 weeks after baseline), and 3 months
This is an 18 item questionnaire and each item is scored on a scale from 0(completely true) to 4(completely untrue), for a maximum score of 72, with higher scores indicating greater apathy
baseline, post-treatment ( 8 weeks after baseline), and 3 months
Change in Elder Neglect/Self Neglect (EN/SN) as evidenced by study developed goal attainment scale
Time Frame: baseline, post-treatment ( 8 weeks after baseline), and 3 months

Participants will be given a list of 19 common daily activities and will be asked to pick one or more activities form the list that they would like to start doing or do more regularly each day or week.Each activity will be then scored based on the following scoring criteria, higher score indicating better outcome :

(Much less than expected)-2 (Somewhat less than expected)-1 (Expected client outcome)0 (Somewhat better than expected)+1 (Much better than expected)+2

baseline, post-treatment ( 8 weeks after baseline), and 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in social connection as assessed by the Lubben Social Network Scale
Time Frame: baseline, post-treatment ( 8 weeks after baseline), and 3 months
This is a 6 item questionnaire and each is scored from 0(none) to 5(none or more contacts) for a total score range of 0-30 higher scores indicating better outcome
baseline, post-treatment ( 8 weeks after baseline), and 3 months
Change in social isolation as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS 8)
Time Frame: baseline, post-treatment ( 8 weeks after baseline), and 3 months
This is an 8 item questionnaire and each is cored from 1(never) -5 (always) for a maximum score of 40, higher score indicating worse outcome
baseline, post-treatment ( 8 weeks after baseline), and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Leila Wood, PhD, MSSW, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 21, 2025

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

March 24, 2025

First Submitted That Met QC Criteria

April 1, 2025

First Posted (Actual)

April 4, 2025

Study Record Updates

Last Update Posted (Actual)

July 2, 2025

Last Update Submitted That Met QC Criteria

June 28, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • HSC-MS-24-1021
  • 1P30AG086563-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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