NCT05011864 Integrated Tele-Behavioral Activation and Fall Prevention for Low-income Homebound Seniors With Depression
| NCT ID | NCT05011864 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Texas at Austin |
| Condition | Depression, Unipolar |
| Study Type | INTERVENTIONAL |
| Enrollment | 320 participants |
| Start Date | 2021-11-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 320 participants in total. It began in 2021-11-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will test clinical and cost effectiveness of an integrated tele- and bachelor's-level counselor/coach delivered behavioral activation (BA) and fall prevention (FP) for low-income homebound older adults. The long-term objective of the proposed study is to improve access to depression treatment and fall prevention for growing numbers of low-income homebound seniors. We plan to recruit 320 low-income, racially diverse homebound seniors who are served by a home-delivered meal (HDM) program and other aging-service agencies in Central Texas. In a 4-arm, pragmatic clinical trial with randomization prior to consent, the participants in the integrated Tele-BA and FP (TBF hereafter) arm will receive 5 Tele-BA sessions and 4 in-home FP sessions. Those in the Tele-BA or FP alone arms will receive the respective intervention and 4 bimonthly telephone check-in (booster) calls, and those in the Attention Control (AC) arm will receive 5 weekly telephone check-in calls followed by 4 bimonthly follow-up calls. Follow-up assessments will be at 12, 24, and 36 weeks after baseline.
Eligibility Criteria
Inclusion Criteria: * Age 50+ * English or Spanish proficiency * 24-item Hamilton Rating Scale for Depression score \> 15 * 12-item Fall Risk Questionnaire score \>4 Exclusion Criteria: * Recently (\< 4 weeks) initiated or modified antidepressant pharmacotherapy * High suicide risk * Probable dementia * Bipolar disorder * Substance use/misuse * Current participation in any psychotherapy or FP program * Bedbound status
Contact & Investigator
Namkee G Choi
PRINCIPAL INVESTIGATOR
University of Texas at Austin
Frequently Asked Questions
Who can join the NCT05011864 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 100 Years, studying Depression, Unipolar. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05011864 currently recruiting?
Yes, NCT05011864 is actively recruiting participants. Contact the research team at nchoi@austin.utexas.edu for enrollment information.
Where is the NCT05011864 trial being conducted?
This trial is being conducted at Austin, United States.
Who is sponsoring the NCT05011864 clinical trial?
NCT05011864 is sponsored by University of Texas at Austin. The principal investigator is Namkee G Choi at University of Texas at Austin. The trial plans to enroll 320 participants.
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