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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

Must not have

Bedbound status

Timeline

Screening 3 weeks

Treatment Varies

Follow Up monthly (form 12 weeks to 36 weeks)

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 50 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am confined to bed.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and monthly (form 12 weeks to 36 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 more

Secondary study objectives

Changes from baseline exercise frequency at 12, 24, and 36 weeks

Changes from baseline fear of falling at 12, 24, and 36 weeks

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2900

0 / 2Eligibility criteria met