Depression in Old AgeNCT06910267
Leveraging Adult Protective Service Interaction to Offer Evidence-Based Treatment for Depression in Elder Neglect/Self Neglect
A study testing APS Treatment as Usual and Intervention-Behavioral Activation (BA) in people with Depression in Old Age, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Depression in Old Age
- What is being tested?
- APS Treatment as Usual and Intervention-Behavioral Activation (BA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2026to 24 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- APS Case in APS Region VI- Must have open case
- PHQ 9 score- Must have score of nine (9) or more
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Leila Wood, PhD, MSSW, (713) 486-2700, Leila.G.Wood@uth.tmc.edu
Jason Burnett, (713) 873-4685, Jason.Burnett@uth.tmc.edu
About this study
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
- Conditions
- Depression in Old Age
- Being tested
- APS Treatment as Usual, Intervention-Behavioral Activation (BA)
- Keywords
- Elder neglect, Self neglect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APS Treatment as UsualBehavioural
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.
Intervention-Behavioral Activation (BA)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| APS Treatment as Usual | Active comparator | Not described Receives: Behavioral: APS Treatment as Usual |
| Intervention-Behavioral Activation (BA) | Experimental | Not described Receives: Behavioral: Intervention-Behavioral Activation (BA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
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
Measured: 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)
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
Measured: baseline, post-treatment ( 8 weeks after baseline), and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start15 May 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion24 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression in Old AgeStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Leila Wood, The University of Texas Health Science Center, Houston
- Investigators
- Leila Wood, PhD, MSSW, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910267
- Sponsor's protocol ID
- HSC-MS-24-1021
- Other IDs
- 1P30AG086563-01
- Status last verified
- Jun 2026
- First submitted
- 24 Mar 2025
- Last updated
- 30 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Adult Protective Service Interaction to Offer Evidence-Based Treatment for Depression in Elder Neglect/Self Neglect
- ClinicalTrials.gov ID
- NCT06910267
- Acronym / sponsor ID
- HSC-MS-24-1021
- Conditions
- Depression in Old Age
- Keywords
- Elder neglect, Self neglect
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 15 May 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 24 Jan 2027 (estimated)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APS Treatment as Usual | Active comparator | Behavioral: APS Treatment as Usual |
| Intervention-Behavioral Activation (BA) | Experimental | Behavioral: Intervention-Behavioral Activation (BA) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- APS Case in APS Region VI- Must have open case
- PHQ 9 score- Must have score of nine (9) or more
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APS Treatment as UsualAPS 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. | Behavioural | APS Treatment as Usual |
| 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. | Behavioural | Intervention-Behavioral Activation (BA) |
Primary outcome
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
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
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
2 secondary outcomes
Change in social connection as assessed by the Lubben Social Network Scale
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leila Wood, PhD, MSSW principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APS Treatment as Usual and Intervention-Behavioral Activation (BA) in people with Depression in Old Age, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leila Wood, PhD, MSSW ((713) 486-2700, Leila.G.Wood@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression as assessed by the Patient Depression Questionnaire (PHQ-9) (time frame: baseline, post-treatment ( 8 weeks after baseline), and 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.