- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06910267
Leveraging Adult Protective Service Interaction to Offer Evidence-Based Treatment for Depression in Elder Neglect/Self Neglect
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Leila Wood, PhD, MSSW
- Phone Number: (713) 486-2700
- Email: Leila.G.Wood@uth.tmc.edu
Study Contact Backup
- Name: Jason Burnett
- Phone Number: (713) 873-4685
- Email: Jason.Burnett@uth.tmc.edu
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- The University of Texas Health Science Center at Houston
-
Contact:
- Leila Wood, PhD, MSSW
- Phone Number: (713) 486-2700
- Email: Leila.G.Wood@uth.tmc.edu
-
Contact:
- Jason Burnett
- Phone Number: (713) 873-4685
- Email: Jason.Burnett@uth.tmc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
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
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
Collaborators
Investigators
- Principal Investigator: Leila Wood, PhD, MSSW, The University of Texas Health Science Center, Houston
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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