Tele-Behavioral Activation + Fall Prevention for Depression

(TBF Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Namkee G. Choi, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Texas at Austin

Must not be taking: Antidepressants

Disqualifiers: High suicide risk, Dementia, Bipolar, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the idea that Tele-Behavioral Activation + Fall Prevention for Depression is an effective treatment?

The available research shows that fall prevention programs, which are part of the Tele-Behavioral Activation + Fall Prevention treatment, can reduce falls and improve physical factors like balance and strength in older adults. However, the research does not specifically address the effectiveness of this treatment for depression. It highlights the benefits of fall prevention in reducing fall risk and related injuries, but there is no direct comparison to other depression treatments in the provided data. ^{1 2 3 4 5}

What safety data exists for Tele-Behavioral Activation and Fall Prevention for Depression?

The provided research does not contain relevant safety data for Tele-Behavioral Activation and Fall Prevention for Depression. The studies focus on endovascular treatment for acute basilar artery occlusion and androgen deprivation therapy in prostate cancer, which are unrelated to the treatment in question. ^{6 7 8 9 10}

Is the treatment Behavioral Activation and Fall Prevention effective for depression?

Yes, Behavioral Activation combined with Fall Prevention is a promising treatment for depression. Behavioral Activation helps people engage in activities that bring them joy and a sense of achievement, which can improve mood. It has been shown to work well both in-person and through teletherapy, making it accessible to more people. The addition of Fall Prevention can help older adults stay safe while benefiting from the positive effects of Behavioral Activation. ^{11 12 13 14 15}

Research Team

Namkee G. Choi, PhD

Principal Investigator

University of Texas at Austin

Eligibility Criteria

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 proficient in English or Spanish.

I am 50 years old or older.

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

Exclusion Criteria

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

You might have dementia.

You have bipolar disorder.

Trial Timeline

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

Treatment Details

Interventions

• Behavioral Activation (Behavioural Intervention)
• Fall Prevention (Behavioural Intervention)
• Integrated Tele-Behavioral Activation and Fall Prevention (Behavioural Intervention)
• Telephone support (Behavioural Intervention)

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.

Participant Groups

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 China for the following indications:

Approved in China as Behavioral Activation Therapy for:

• Loneliness in older adults
• Depression

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Texas at Austin Austin, TX

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

Dr. Elly Barry

University of Texas at Austin

Chief Medical Officer

MD from Harvard Medical School

Dr. Brian Windsor

University of Texas at Austin

Chief Executive Officer since 2023

PhD in Molecular Biology from the University of Texas at Austin

Baylor College of Medicine

Collaborator

Trials

1,044

Recruited

6,031,000+

Paul Klotman

Baylor College of Medicine

Chief Executive Officer since 2010

MD, PhD

James Versalovic

Baylor College of Medicine

Chief Medical Officer since 2020

MD from Baylor College of Medicine

Findings from Research

Multifactorial fall prevention programs that include home evaluations, modifications, physical activity, and education significantly reduce falls and improve balance and strength in community-dwelling older adults, based on a review of 33 articles.

While both physical activity and home modification programs show moderate evidence of effectiveness when implemented individually, combining these strategies yields the best outcomes in preventing falls and reducing fear of falling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of the effect of home modification and fall prevention programs on falls and the performance of community-dwelling older adults. Chase, CA., Mann, K., Wasek, S., et al.[2018]

Effective fall risk management for older adults requires early screening, tailored interventions, and active participation from both healthcare professionals and the individuals at risk.

Despite available guidelines and financial incentives to promote evidence-based practices, there is still a significant gap in the implementation of fall prevention strategies in clinical settings, highlighting the need for improved adoption methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complexities of fall prevention in clinical settings: a commentary. Shubert, TE., Smith, ML., Prizer, LP., et al.[2014]

A modified version of the Otago Exercise Program was implemented for 15 adults with intellectual and developmental disorders (IDD) over 7 weeks, showing improvements in balance and mobility without any reported falls during the study.

The results suggest that this exercise program could be a promising fall prevention strategy for adults with IDD, highlighting the need for further research with larger and more diverse participant groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of Evidence-Based Fall Prevention Programs for Adults with Intellectual and/or Developmental Disorders: A Modified Otago Exercise Program. Renfro, M., Bainbridge, DB., Smith, ML.[2020]

A systematic review of 17 trials involving 5034 older adults found that multiple component fall prevention interventions significantly reduced the number of individuals who fell by 15% and the overall fall rate by 20% compared to control groups.

These interventions were effective even without being tailored to individual risk factors, suggesting that implementing such programs could be a practical approach to enhance fall prevention strategies in older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple component interventions for preventing falls and fall-related injuries among older people: systematic review and meta-analysis. Goodwin, VA., Abbott, RA., Whear, R., et al.[2022]

Recanalization therapy for acute basilar artery occlusion (BAO) significantly reduces the risk of death or dependency (DoD) by 1.5-fold and mortality by two-fold, based on a review of 45 studies involving 2056 patients.

The study found that the rate of intracerebral hemorrhage (ICH) was relatively low, at 13%, with no significant increase in risk when treatment was administered within 12 hours compared to after 12 hours.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recanalization of acute basilar artery occlusion improves outcomes: a meta-analysis. Kumar, G., Shahripour, RB., Alexandrov, AV.[2022]

Endovascular therapy (EVT) significantly improves functional outcomes and reduces mortality in patients with acute basilar artery occlusion (ABAO) and severe symptoms, with an adjusted odds ratio of 3.44 for improved outcomes compared to standard medical treatment (SMT).

Factors such as baseline NIHSS score and posterior circulation Acute Stroke Prognosis Early Computed Tomography Score (pc-ASPECTS) are critical in predicting outcomes, where higher NIHSS scores correlate with worse outcomes and higher pc-ASPECTS scores indicate better functional recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Endovascular Therapy in Acute Basilar Artery Occlusion With Severe Symptoms. Kong, W., Yuan, J., Huang, J., et al.[2022]

A nomogram was developed to predict a favorable outcome at 90 days for patients with acute basilar artery occlusion (ABAO) undergoing endovascular treatment (EVT), based on data from 378 patients.

Key predictors of a favorable outcome included a lower baseline NIHSS score, higher pc-ASPECT score, better collateral circulation, and timely recanalization, with the nomogram showing high reliability in both training and validation sets (C-index values of 0.8730 and 0.8857).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nomogram model of functional outcome for endovascular treatment in patients with acute basilar artery occlusion. Li, L., Lv, J., Han, JJ., et al.[2023]

Participation in the STAND Clinic, which provided individualized lifestyle modifications and management for men undergoing androgen deprivation therapy (ADT), was well-received, with a high attendance rate of 91% for clinic visits.

Despite the positive engagement, the study found no significant differences in body fat percentage, metabolic impact, bone health, quality of life, or physical activity between the STAND Clinic participants and those receiving usual care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multidisciplinary team-based approach with lifestyle modification and symptom management to address the impact of androgen deprivation therapy in prostate cancer: A randomized phase II study. Pollock, Y., Zhang, L., Kenfield, SA., et al.[2022]

Endovascular treatment (EVT) for patients with acute basilar artery occlusion (ABAO) shows a favorable functional outcome in 45.6% of cases, with successful reperfusion achieved in 89.7% of patients, indicating its potential efficacy.

The initial severity of the stroke, measured by the National Institutes of Health stroke scale (NIHSS), is the most significant predictor of a good clinical outcome, suggesting that patients with less severe strokes may benefit more from EVT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome of endovascular treatment for acute basilar artery occlusion in the modern era: a single institution experience. Li, C., Zhao, W., Wu, C., et al.[2018]

In a 9-week randomized controlled trial involving 78 patients with major depression, the study found that both expected mastery and pleasure from behavioral activation tasks were strongly correlated with improvements in depression severity.

The results suggest that the anticipation of pleasure from planned activities may be more important for the effectiveness of behavioral activation than the actual pleasure experienced, highlighting the role of meaningful engagement in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral activation: Is it the expectation or achievement, of mastery or pleasure that contributes to improvement in depression? Furukawa, TA., Imai, H., Horikoshi, M., et al.[2019]

Behavioral Activation (BA) is a well-supported psychotherapy for depression that has evolved over the years, incorporating various techniques such as activity monitoring, scheduling, and skills training, which have empirical support as effective components.

While some techniques like activity scheduling and relaxation training have been validated as effective on their own, others are more effective when used as part of a comprehensive treatment package, highlighting the importance of a tailored approach in BA interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is behavioral activation? A review of the empirical literature. Kanter, JW., Manos, RC., Bowe, WM., et al.[2022]

In a study of 130 low-income primary care patients receiving brief behavioral activation teletherapy for depression and anxiety, those who completed 4 or more sessions showed significantly lower depression and anxiety scores compared to those who completed fewer sessions.

The majority of patients achieved and maintained remission from depression, indicating that BA teletherapy is a feasible and effective treatment option for improving mental health outcomes in low-income populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a Behavioral Activation Teletherapy Intervention to Treat Depression and Anxiety in Primary Care VitalSign6 Program. Trombello, JM., South, C., Cecil, A., et al.[2022]

A study involving seven patients with bipolar depression analyzed 2,480 hours of self-reported activities, revealing that movement-related activities were linked to the highest pleasure scores, suggesting that physical activity may enhance mood.

The research demonstrated the feasibility of using a data-driven approach to identify behavioral patterns, which could inform therapists and lead to the development of digital solutions for behavioral activation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Data-Driven Learning in High-Resolution Activity Sampling From Patients With Bipolar Depression: Mixed-Methods Study. Rohani, DA., Tuxen, N., Quemada Lopategui, A., et al.[2020]

A systematic review of nine randomized controlled trials involving 2157 adult participants found that guided Internet-based behavioral activation (BA) is effective in reducing depression and anxiety, showing promising results compared to other treatments like physical activity and psychoeducation.

While Internet-based BA demonstrated non-inferior efficacy to other behavioral therapies and mindfulness, the overall quality of evidence was low to moderate, indicating a need for more rigorous studies to confirm its effectiveness in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis on the efficacy of Internet-delivered behavioral activation. Huguet, A., Miller, A., Kisely, S., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Formative evaluation of the telecare fall prevention project for older veterans. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Systematic review of the effect of home modification and fall prevention programs on falls and the performance of community-dwelling older adults. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Complexities of fall prevention in clinical settings: a commentary. [2014]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Validation of Evidence-Based Fall Prevention Programs for Adults with Intellectual and/or Developmental Disorders: A Modified Otago Exercise Program. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Multiple component interventions for preventing falls and fall-related injuries among older people: systematic review and meta-analysis. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Recanalization of acute basilar artery occlusion improves outcomes: a meta-analysis. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Outcomes of Endovascular Therapy in Acute Basilar Artery Occlusion With Severe Symptoms. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Nomogram model of functional outcome for endovascular treatment in patients with acute basilar artery occlusion. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

A multidisciplinary team-based approach with lifestyle modification and symptom management to address the impact of androgen deprivation therapy in prostate cancer: A randomized phase II study. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Outcome of endovascular treatment for acute basilar artery occlusion in the modern era: a single institution experience. [2018]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Behavioral activation: Is it the expectation or achievement, of mastery or pleasure that contributes to improvement in depression? [2019]

12. United States pubmed.ncbi.nlm.nih.gov

What is behavioral activation? A review of the empirical literature. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Efficacy of a Behavioral Activation Teletherapy Intervention to Treat Depression and Anxiety in Primary Care VitalSign6 Program. [2022]

14. Canada pubmed.ncbi.nlm.nih.gov

Data-Driven Learning in High-Resolution Activity Sampling From Patients With Bipolar Depression: Mixed-Methods Study. [2020]

15. Netherlands pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis on the efficacy of Internet-delivered behavioral activation. [2019]