Tele-Behavioral Activation + Fall Prevention for Depression
(TBF Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of tele-counseling and in-home sessions to help older adults manage depression and prevent falls. It targets low-income seniors who are homebound and receive meal deliveries in Central Texas. Participants will be divided into groups to receive either behavioral counseling (Behavioral Activation Therapy), fall prevention, a combination of both (Integrated Tele-Behavioral Activation and Fall Prevention), or supportive calls. Eligible participants should have experienced depression and be at risk for falls. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative approaches in mental health and fall prevention.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop your current medications. However, if you have recently started or changed your antidepressant medication within the last 4 weeks, you cannot participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
In a previous study, participants in a Tele-Behavioral Activation (Tele-BA) program reported high satisfaction, scoring an average of 70 out of 77 on a satisfaction scale, indicating that most users liked the treatment. Additionally, no major negative effects have been reported from the Tele-BA sessions.
Research has shown that Fall Prevention (FP) programs can help reduce falls among older adults. In one study, only 21% of participants experienced a fall after joining a fall prevention program, which is lower than the national average. This suggests the program is effective and likely safe.
Specific safety data for the combined Tele-Behavioral Activation and Fall Prevention approach is not yet available. However, no negative effects have been reported so far, suggesting it is generally safe. These treatments are designed to help without causing harm, and past evidence supports this.
In summary, existing data suggests these treatments are safe and well-tolerated by participants.12345Why are researchers excited about this trial?
Researchers are excited about these treatments for depression because they integrate behavioral activation (BA) with fall prevention (FP) strategies, offering a comprehensive approach to patient care. Unlike traditional treatments for depression, which often involve medication or therapy alone, this method combines mental health support with physical safety measures, potentially addressing both psychological and physical well-being. The use of telehealth for BA sessions and the flexibility of in-home or tele sessions for FP make these treatments particularly accessible, especially for those who may have mobility issues or prefer remote care. This integrated approach could lead to improved outcomes by targeting multiple aspects of a patient's health simultaneously.
What evidence suggests that this trial's treatments could be effective for depression and fall prevention?
Research has shown that tele-behavioral activation (Tele-BA), one of the treatments in this trial, effectively reduces depression in older adults. Studies have found that participants using Tele-BA experienced noticeable improvements in depression and anxiety. Another treatment arm in this trial focuses on fall prevention programs, which also reduce depression symptoms. By preventing falls, these programs decrease the fear of falling, often linked to depression. While the combination of Tele-BA and fall prevention is still under study in this trial, current evidence supports the potential benefits of each treatment for reducing depression in older adults.678910
Who Is on the Research Team?
Namkee G. Choi, PhD
Principal Investigator
University of Texas at Austin
Are You a Good Fit for This Trial?
This trial is for low-income, homebound seniors over 50 who are struggling with depression and have a risk of falling. They must speak English or Spanish and not be currently receiving psychotherapy or fall prevention programs. Those with substance misuse, high suicide risk, bedbound status, probable dementia, recent changes in antidepressant medication, or bipolar disorder cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive integrated Tele-Behavioral Activation and Fall Prevention sessions
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Behavioral Activation
- Fall Prevention
- Integrated Tele-Behavioral Activation and Fall Prevention
- Telephone support
Trial Overview
The study tests a combined phone-based behavioral activation (BA) therapy and in-home fall prevention (FP) program versus each intervention alone or regular check-in calls as control. Participants will receive sessions through telephone support and at-home visits to see if this improves their mental health and reduces falls.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
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
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.
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.
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.
Behavioral Activation is already approved in United States, China, European Union for the following indications:
- Depression
- Anxiety in older adults undergoing cardiac procedures
- Loneliness in older adults
- Depression
- Depression
- Anxiety
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Texas at Austin
Lead Sponsor
Baylor College of Medicine
Collaborator
Citations
Association between Falls, Fear of Falling and Depressive ...
Results: The mean age was 75.2 (SD = 8.53) years, with 63.2% being female. Depressive symptoms were observed in 18.3% of the participants, while ...
Depression and Outcome of Fear of Falling in a Falls ...
To examine whether depression predicts less improvement in fear of falling and falls efficacy in older adults attending a falls prevention program (FPP).
The Complex Interplay of Depression and Falls in Older Adults
Individuals with moderate to severe depressive symptoms are more likely to be severely afraid of falling than those without depression (OR: 2.74; 95% CI: 1.69– ...
The association between falls and depressive symptoms ...
Conclusions: This cross-sectional study demonstrated a significant association between falls and depressive symptoms in Chinese older adults.
Understanding the High Risk of Depression on Older Adults ...
Among the patients who experienced an initial fall, 450 individuals (16.6%) exhibited symptoms of depression. In contrast, 270 individuals (25.7%) in the ...
Evaluation of a Fall Prevention Program to Reduce ...
Twenty-one percent of respondents reported a fall after participating in the SAH program, which is lower than both the US and the DC average ...
Facts About Falls | Older Adult Fall Prevention
One out of 10 falls results in an injury that causes the older adult to restrict their activities for a day or more or to seek attention from ...
Falls Prevention Programs: Who They Reach and How ...
According to the Healthy Aging Programs Integrated Database (HAPID®), over 183,000 lives have been impacted by falls prevention programs held at ...
Effectiveness and cost-effectiveness of a single home-based ...
This study assessed the fall rate and other health outcomes, as well as the cost-effectiveness of a home-based fall prevention programme for community-dwelling ...
Fall Prevention Practices and Implementation Strategies
In the United States, estimated hospital fall rates vary from 3.3 to 11.5 falls per 1000 patient days. Approximately 25% of hospital falls result in injury, ...
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