Tele-Behavioral Activation + Fall Prevention for Depression

(TBF Trial)

Overseen By Kelly Vences, BSW

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas at Austin

Must not be taking: Antidepressants

Disqualifiers: High suicide risk, Dementia, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 17

Duration: 9 weeks

320 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{6 7 8 9 10}

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

I am 50 years old or older.

You have a high risk of falling based on a questionnaire score above 4.

24-item Hamilton Rating Scale for Depression score > 15

Exclusion Criteria

I started or changed my antidepressant medication less than 4 weeks ago.

You might have dementia.

You have bipolar disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive integrated Tele-Behavioral Activation and Fall Prevention sessions

9 weeks

5 Tele-BA sessions, 4 in-home FP sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Follow-up assessments at 12, 24, and 36 weeks

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?

Group I: Tele-Behavioral Activation and Fall Prevention Experimental Treatment 2 Interventions

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

Group II: Tele-Behavioral Activation Experimental Treatment 1 Intervention

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.

Group III: Fall Prevention Experimental Treatment 1 Intervention

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.

Group IV: Attention Control (Telephone Support Call) Active Control 1 Intervention

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:

Approved in United States as Behavioral Activation Therapy for:

• Depression
• Anxiety in older adults undergoing cardiac procedures

Approved in China as Behavioral Activation Therapy for:

• Loneliness in older adults
• Depression

Approved in European Union as Behavioral Activation Therapy for:

• Depression
• Anxiety

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

Baylor College of Medicine

Collaborator

Trials

1,044

Recruited

6,031,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11353576/

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 ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1064748115000871

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).

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4880473/

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– ...

4. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2023.1248551/full

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.

5. agmr.hapres.com agmr.hapres.com/htmls/AGMR_1682_Detail.html

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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10924894/

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 ...

7. cdc.gov cdc.gov/falls/data-research/facts-stats/?678e0d83_page=2

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 ...

8. ncoa.org ncoa.org/article/the-national-reach-of-falls-prevention-programs-participant-demographics-and-program-outcomes/

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 ...

9. bmcgeriatr.biomedcentral.com bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-024-05586-x

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 ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7854936/

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, ...