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NCT05011864Recruiting

Integrated Tele-Behavioral Activation and Fall Prevention for Low-income Homebound Seniors With Depression

Integrated Tele-Behavioral Activation and Fall Prevention for Low-income Homebound Older Adults With Depression

Source: ClinicalTrials.gov · Last updated 9 Jan 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
320 (estimated)
First submitted
6 Aug 2021
Start date
1 Nov 2021
Primary completion date
31 Dec 2026
Lead sponsor
University of Texas at Austin
Diseases
Depression
NCT number
NCT05011864

What you commit to

  • Study type: Interventional
  • Planned participants: 320
  • From 1 Nov 2021 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Probable dementia
  • Bipolar disorder

Other

  • Recently (\< 4 weeks) initiated or modified antidepressant pharmacotherapy
  • High suicide risk
  • Substance use/misuse
  • Current participation in any psychotherapy or FP program
  • Bedbound status

Who the study is looking for

  • Age 50+
  • English or Spanish proficiency
  • 24-item Hamilton Rating Scale for Depression score \> 15
  • 12-item Fall Risk Questionnaire score \>4

Age in the registry: 50 years to 100 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Texas at Austin
Coordinator of this site? Confirm its status
AustinUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.