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Tele-Behavioral Activation + Fall Prevention for Depression (TBF Trial)
N/A
Recruiting
Led By Namkee G Choi
Research Sponsored by University of Texas at Austin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 50+
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up monthly (form 12 weeks to 36 weeks)
Awards & highlights
TBF Trial Summary
This trial will test the effectiveness of an integrated behavioral activation and fall prevention program delivered by tele-counselors and coaches to low-income homebound seniors. The program will be compared to similar programs delivered by telephone or in person, with the goal of improving access to depression treatment and fall prevention for growing numbers of low-income homebound seniors.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since the interventions involve counseling and coaching rather than medications, side effects may include discomfort from discussing personal issues during BA therapy or potential minor injuries from FP exercises.
TBF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 50 years old or older.
TBF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ monthly (form 12 weeks to 36 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~monthly (form 12 weeks to 36 weeks)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
+4 moreSecondary outcome measures
Changes from baseline exercise frequency at 12, 24, and 36 weeks
Changes from baseline fear of falling at 12, 24, and 36 weeks
TBF Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Tele-Behavioral Activation and Fall PreventionExperimental Treatment2 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 ActivationExperimental Treatment1 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 PreventionExperimental Treatment1 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 Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Behavioral Activation
2013
Completed Phase 3
~2980
Find a Location
Who is running the clinical trial?
University of Texas at AustinLead Sponsor
353 Previous Clinical Trials
80,924 Total Patients Enrolled
Baylor College of MedicineOTHER
1,001 Previous Clinical Trials
6,001,932 Total Patients Enrolled
Namkee G ChoiPrincipal InvestigatorUniversity of Texas at Austin
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I started or changed my antidepressant medication less than 4 weeks ago.You might have dementia.I am proficient in English or Spanish.You have bipolar disorder.I am 50 years old or older.I am currently in a psychotherapy or FP program.You have a high risk of falling based on a questionnaire score above 4.I am confined to bed.You have a history of drug or alcohol abuse.You are at risk of attempting suicide.
Research Study Groups:
This trial has the following groups:- Group 1: Tele-Behavioral Activation and Fall Prevention
- Group 2: Fall Prevention
- Group 3: Tele-Behavioral Activation
- Group 4: Attention Control (Telephone Support Call)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities for enrolment in this clinical trial?
"Clinicaltrials.gov reports this clinical trial is actively recruiting participants, having first been published on November 1st 2021 and most recently revised on May 16th 2022."
Answered by AI
What is the current participant count for this clinical research?
"Affirmative. Per information hosted on clinicaltrials.gov, the medical study is actively recruiting participants and was initially posted in November 2021 before being revised in May 2022. 320 patients are needed from a single centre to fulfil their recruitment goals."
Answered by AI
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