Recruiting

Tele-Behavioral Activation

Sponsor:

University of Texas at Austin

Code:

NCT05011864

Conditions

Depression, Unipolar

Fall

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Behavioral Activation

Fall Prevention

Telephone support

Study Details

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.

Conditions

Depression, Unipolar

Fall

Study ID

NCT05011864

Start date

Nov 1, 2021

Status verified date

Jan, 2024

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

320 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tele-Behavioral Activation and Fall Prevention

Each subject will participate in five 1-hour, weekly Tele-BA sessions followed by four 1-1.5 hour, weekly in-home FP sessions with the same provider

experimental: Tele-Behavioral Activation

Each subject in this arm will participate in five 1-hour, weekly Tele-BA sessions followed by four weekly check-in (booster) calls of up to 30 minutes each.

experimental: Fall Prevention

Each subject will participate in four 1-1.5 hour, weekly in-home (or tele, if COVID continues) FP sessions followed by four weekly check-in (booster) calls of up to 30 minutes each.

active comparator: Attention Control (Telephone Support Call)

AC participants in this study will receive five weekly telephone calls of up to 45 minutes each and four weekly check-in calls of up to 30 minutes each from a research assistant (RA) who will employ genuine regard and attentive listening and provide nonspecific support.

Interventions

Behavioral Activation

In BA, depressive symptoms are viewed as depressive behaviors. Compared to those without depression, people with depression engage in fewer overt behaviors that provide positive reinforcement and pleasure/enjoyment and in more behaviors that function to escape or avoid aversive stimuli (e.g., staying in bed all day).55-59 Thus, BA is aimed at increasing and reinforcing meaningful, healthy, and enjoyable behaviors while decreasing depressive behaviors and is well-suited to help depressed, disabled older adults increase mood-enhancing activities, self-care management skills, and social connectedness.

Fall Prevention

Following FP psychoeducation based on the Centers for Disease Control and Prevention (CDC)'s STEADI tool kits, lay coaches will assist clients in implementing evidence-based FP strategies that have been adapted for low-income homebound seniors. These include referrals to healthcare providers as needed, home safety checks, practice of safe ambulation/transfer and mobility aid use, medication review, and in-home exercise routines with an innovative, gamified tablet-based exercise app for balance and strength building.

Telephone support

Subjects in this arm will receive 9 weekly support calls last 30 minutes each. These calls are intended to provide an opportunity for social support and check safety.

Primary outcome measure

  • Changes from baseline depressive symptom at 12, 24, and 36 weeks [ Time Frame: at 12, 24, and 36 weeks after baseline ]
  • Changes from baseline fall count and injury at 12, 24, and 36 weeks [ Time Frame: monthly (form 12 weeks to 36 weeks) ]
  • Changes from baseline EuroQol-5D score at 12, 24, and 36 weeks [ Time Frame: at 12, 24, and 36 weeks after baseline ]
  • Changes from baseline physical and mental health service use [ Time Frame: at 12, 24, and 36 weeks after baseline ]
  • Changes from baseline disability score at 12, 24, and 36 weeks [ Time Frame: at 12, 24, and 36 weeks after baseline ]
  • Changes from baseline social engagement and activities score at 12, 24, and 36 weeks [ Time Frame: at 12, 24, and 36 weeks after baseline ]
  • Changes from baseline satisfaction with social roles & activities at 12, 24, and 36 weeks [ Time Frame: at 12, 24, and 36 weeks after baseline ]

Central Contacts and Locations

Central contacts

Namkee G Choi, PhD

5122329590nchoi@austin.utexas.edu

Kelly Vences, BSW

5122320604kelly.vences@utexas.edu

Locations

University of Texas at Austin

Recruiting

Austin, Texas, United States, 78712-0358

Contacts

Namkee G. Choi, PhD

512-232-9590nchoi@mail.utexas.edu

Principal Investigator:

Namkee G. Choi, PhD

More Information

Sponsor

University of Texas at Austin

Last update posted

Jan 9, 2024

Last verified

Jan, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas at Austin on 2024-01-09.