NCT06910267

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 4, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

July 21, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

July 2, 2025

Status Verified

June 1, 2025

Enrollment Period

8 months

First QC Date

March 24, 2025

Last Update Submit

June 28, 2025

Conditions

Keywords

Elder neglectSelf neglect

Outcome Measures

Primary Outcomes (3)

  • Change in depression as assessed by the Patient Depression Questionnaire (PHQ-9)

    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)

    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

    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 Outcomes (2)

  • Change in social connection as assessed by the Lubben Social Network Scale

    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)

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

Study Arms (2)

APS Treatment as Usual

ACTIVE COMPARATOR
Behavioral: APS Treatment as Usual

Intervention-Behavioral Activation (BA)

EXPERIMENTAL
Behavioral: Intervention-Behavioral Activation (BA)

Interventions

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.

APS Treatment as Usual

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.

Intervention-Behavioral Activation (BA)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Study Officials

  • Leila Wood, PhD, MSSW

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

March 24, 2025

First Posted

April 4, 2025

Study Start

July 21, 2025

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

July 2, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations