Behavioral Activation Teletherapy for Depression

(BAT Trial)

Overseen By Fannie M Brito

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Manic, Psychosis, Schizophrenia, Suicidal, others

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

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a 10-session teletherapy program can increase physical activity and reduce symptoms of depression. The focus is on Behavioral Activation, a method that encourages engaging in more activities to boost mood and energy. It suits individuals with moderate-to-severe depression who are not very active but wish to become more so. Participants must have a smartphone and be willing to try increasing their activity levels. As an unphased trial, this study provides a unique opportunity for participants to explore innovative ways to enhance their mental and physical well-being.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this Behavioral Activation Teletherapy is safe for treating depression?

Research shows that Behavioral Activation Teletherapy is generally safe for treating depression. Past studies have linked this therapy to better outcomes for depression and anxiety. Some research found only a small improvement in symptoms, but reported no major safety issues. Conducted remotely, the therapy is easy and convenient to access. Overall, patients seem to receive it well, with no significant negative effects noted. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Behavioral Activation Teletherapy for depression because it offers a unique approach compared to traditional treatments like medication and in-person therapy. This treatment delivers therapy remotely, making it more accessible to individuals who may have difficulty attending in-person sessions due to location, mobility, or scheduling constraints. Additionally, it focuses on encouraging patients to engage in meaningful activities that can improve their mood and overall mental health, providing a practical and proactive method to combat depression. Unlike medication, which can have side effects, this teletherapy approach empowers patients to actively participate in their recovery process without pharmacological interventions.

What evidence suggests that Behavioral Activation Teletherapy is effective for treating depression?

Research has shown that Behavioral Activation Teletherapy can help reduce depression symptoms. In one study, patients in primary care who used BA teletherapy felt less depressed and anxious. Another study found that a ten-session online Behavioral Activation program greatly reduced depression symptoms. Additionally, short Behavioral Activation sessions decreased anxiety. These findings suggest that this teletherapy method can improve mood and boost activity levels in people with depression. Participants in this trial will receive the Behavioral Activation Teletherapy intervention to further evaluate its effectiveness. ^{1 2 3 6 7}

Who Is on the Research Team?

Chad Rethorst, PhD

Principal Investigator

University of Texas Southwestern Medical Center

Madhukar Trivedi, MD

Principal Investigator

University of Texas Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for adults aged 18-64 with moderate-to-severe depression who are not very active physically (less than 90 minutes of activity a week) and want to be more active. They must have a smartphone, score ≥10 on the PHQ-9 depression scale, and give informed consent. People in current psychotherapy or at high risk for suicide can't join.

Inclusion Criteria

You have shown that you want to exercise more.

You are not physically active enough and do not engage in at least 90 minutes of moderate-to-vigorous physical activity per week.

Able and willing to provide informed consent;

Exclusion Criteria

I am currently seeing a therapist regularly.

You are currently having strong thoughts of wanting to hurt or kill yourself, or the study team thinks you may be at high risk for suicide during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment Phase 1

Participants complete 8 behavioral activation teletherapy sessions to increase physical activity, followed by two biweekly booster sessions, totaling 10 sessions.

14 weeks

1 visit (in-person), 9 visits (virtual)

Focus Group/Interview

Participants who completed the intervention may join a focus group, and those who partially completed may join a semi-structured interview.

1 week

Treatment Phase 2

Refined intervention delivered to a larger group, with the same session structure as Phase 1.

22 weeks

1 visit (in-person), 9 visits (virtual)

Follow-up

Participants complete a one-month and a two-month follow-up after the intervention sessions.

8 weeks

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral Activation Teletherapy

Trial Overview

The study tests a short program called Behavioral Activation Teletherapy over ten sessions aimed at increasing physical activity through remote therapy to help reduce symptoms of depression.

How Is the Trial Designed?

Group I: Behavioral Activation Teletherapy Experimental Treatment 1 Intervention

All eligible participants will be assigned to receive the behavioral activation teletherapy intervention.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12227033/

Effectiveness of Digital Behavioral Activation Interventions for ...

Digital BA interventions are effective in reducing depressive symptoms and improving QoL in the short- to midterm. However, these effects tend to diminish over ...

2.

psychiatrist.com

psychiatrist.com/pcc/behavioral-activation-teletherapy-for-depression-and-anxiety/

Efficacy of a Behavioral Activation Teletherapy Intervention ...

Conclusions: Primary care patients demonstrated improvements in depressive and anxious symptoms throughout BA-based teletherapy. BA teletherapy ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0005791624000727

An online group behavioral activation therapy for major ...

A ten-session online group BAT program significantly reduced depressive symptoms in this pre-post trial. •Online group BAT increased behavioral activation ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11264713/

Comparing the effectiveness of behavioral activation in ...

The results of a Mixed ANOVA analysis revealed that participants who underwent BAGT showed significant improvement in depression, rumination, ...

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0883941724001493

The effects of a telenursing scheduled intervention of brief ...

Brief Behavioral Activation Teletherapy (BBAT) effectively reduces depression symptoms and significantly lowers anxiety levels.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06273995

NCT06273995 | Telehealth Behavioral Activation for Teens

This project will provide Behavioral Activation for youth (12-17) experiencing depression or suicidal ideation who are currently enrolled in the Youth ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12021889/

Efficacy and safety of behavioural activation on depression ...

Six studies rated as low risk of bias. For short-term follow-ups (up to 6 months), meta-analysis showed behavioural activation had little effect on depression ...