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

65 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a pilot study of acceptability, feasibility, and preliminary efficacy of a brief, 10-session Behavioral Activation intervention delivered via teletherapy to increase physical activity and treat depressive symptoms.

Research Team

Madhukar Trivedi, MD

Principal Investigator

University of Texas Southwestern Medical Center

Chad Rethorst, PhD

Principal Investigator

University of Texas Southwestern Medical Center

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+