Behavioral Activation for Fall

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Texas at Austin, Austin, TX
Fall+3 More
Behavioral Activation - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

See full description

Eligible Conditions

  • Fall
  • Unipolar Depression

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Behavioral Activation will improve 7 primary outcomes and 2 secondary outcomes in patients with Fall. Measurement will happen over the course of at 12, 24, and 36 weeks after baseline.

Week 36
Changes from baseline EuroQol-5D score at 12, 24, and 36 weeks
Changes from baseline depressive symptom at 12, 24, and 36 weeks
Changes from baseline disability score at 12, 24, and 36 weeks
Changes from baseline exercise frequency at 12, 24, and 36 weeks
Changes from baseline fear of falling at 12, 24, and 36 weeks
Changes from baseline physical and mental health service use
Changes from baseline satisfaction with social roles & activities at 12, 24, and 36 weeks
Changes from baseline social engagement and activities score at 12, 24, and 36 weeks
Week 36
Changes from baseline fall count and injury at 12, 24, and 36 weeks

Trial Safety

Trial Design

4 Treatment Groups

Attention Control (Telephone Support Call)
1 of 4
Tele-Behavioral Activation and Fall Prevention
1 of 4
Fall Prevention
1 of 4
Tele-Behavioral Activation
1 of 4
Active Control
Experimental Treatment

This trial requires 320 total participants across 4 different treatment groups

This trial involves 4 different treatments. Behavioral Activation is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Tele-Behavioral Activation and Fall PreventionEach 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
Fall Prevention
Behavioral
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.
Tele-Behavioral Activation
Behavioral
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.
Attention Control (Telephone Support Call)
Other
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Behavioral Activation
2013
Completed Phase 3
~2840

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: monthly (form 12 weeks to 36 weeks)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly monthly (form 12 weeks to 36 weeks) for reporting.

Who is running the study

Principal Investigator
N. C.
Prof. Namkee Choi, Professor and Louis and Ann Wolens Centennial Chair in Gerontology
University of Texas at Austin

Closest Location

University of Texas at Austin - Austin, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age 50+
English or Spanish proficiency
24-item Hamilton Rating Scale for Depression score > 15
12-item Fall Risk Questionnaire score >4

Patient Q&A Section

What are common treatments for fall?

"Fall prevention is critical when addressing the multiple health and safety concerns resulting from falls. Treatment may be directed toward preventing recurrent falls, assisting with loss of function due to fall injury and maximizing patient participation in fall prevention strategies." - Anonymous Online Contributor

Unverified Answer

Can fall be cured?

"This survey of patients with a history of falls suggests that fall history is not predictive of future falls. In a recent study, findings also confirms that patients who are at high risk of falls do not experience a more severe fall course." - Anonymous Online Contributor

Unverified Answer

How many people get fall a year in the United States?

"More than 80,000 people die from falls in the United States each year, and the risk of falls among older people may increase significantly as they age." - Anonymous Online Contributor

Unverified Answer

What are the signs of fall?

"Many fallers will experience symptoms, but there is a low probability that these will be specific to a fall. Symptoms that may indicate a possible fall include: loss of balance, light headedness, unsteadiness but not a sense of 'floating. In cases where there is a significant history of falling there is a greater chance that a symptom such as these are attributable to a fall. Many fall risks have been identified, but only some are associated with a greater degree of reliability. Although an individual has a variety of fall risk factors, a few are generally found in multiple studies to play a crucial role in falls, e.g." - Anonymous Online Contributor

Unverified Answer

What is fall?

"The term 'fall' is often used to refer to the loss of control over your balance, confidence, or the ability to walk that is characteristic of falls. A fall is an accident, which is an unexpected unplanned event that causes one to lose balance, stability, or the ability to hold or hold onto something.\n" - Anonymous Online Contributor

Unverified Answer

What causes fall?

"There is debate as to whether biomechanical or neurosensory factors are important in falls. It appears that fall propensity is influenced by extrinsic factors which lead to falls rather than intrinsic factors, such as balance or muscle fatigue. Thus, factors on the environment, such as a poor lighting environment for example, should be considered whilst attempting to understand falls." - Anonymous Online Contributor

Unverified Answer

Does fall run in families?

"Overall, familial aggregation of falls was low in this population. Moreover, age and gender did not influence the occurrence of falls in family members. Because of the low prevalence of falls observed, the familial aggregation of falls is thought to be low in most populations." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of fall prevention?

"There were three times more fallers in this trial than non-fallers. A small but significant proportion of people who fell were admitted to the hospital. Although there were no deaths, this is not a good result because many of the fallers were admitted to the hospital for serious injuries that may have been prevented or prevented by better fall prevention and interventions." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating fall?

"There were no new treatments that significantly improves balance recovery and function in patients with fall compared to current treatments. However, there were few clinical trials concerning treatment of falls and there is no consensus on optimal treatment strategy and duration per falls in the elderly and those with disabilities. Currently, there is no evidence to support a recommendation regarding the use of the medications in the prevention or treatment of falls in the elderly and those with disabilities." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for fall?

"Fallers who report a history of falling are highly likely to be interested in receiving help with either physical, psychological, or other type of interventions. Clinicians should encourage fallers to consider clinical trials for falls, even if their main motivation for participating in a clinical trial would not relate to falls in particular." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in fall prevention for therapeutic use?

"There are many fall risk factors that have been identified during rehabilitation, especially for elderly persons with Alzheimer's disease (AD). This condition accounts for half the cases of falls among persons who are at the end of rehabilitation or in the later stages. For these patients, it is important to incorporate into prevention programs fall risk assessment, interventions, and a multifactorial approach for fall risk reduction. In addition, in order to avoid the occurrence of falls, the following interventions should be carried out as a preventive approach. These interventions are effective in reducing fall risk and preventing fall-related injuries." - Anonymous Online Contributor

Unverified Answer

Is fall prevention typically used in combination with any other treatments?

"The use of either an exercise program alone or with an intervention involving the use of footwear is most common. Use of an intervention program or exercise program is more common for women than for men." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Fall by sharing your contact details with the study coordinator.