Behavioral Activation Teletherapy to Increase Physical Activity (BAT)

The University of Texas System (UT)

Status

Completed

Conditions

Depressive Symptoms

Depressive Episode

Depression

Depressive Disorder

Treatments

Behavioral: Behavioral Activation Teletherapy

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04990401

1R34MH122640-01A1 (U.S. NIH Grant/Contract)

STU-2021-0441

Details and patient eligibility

About

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.

Full description

This is a one-site, two-phase study that will use an initial group of individuals between the ages of 18 and 64 who have moderate to severe depressive symptoms and exercise less than 90 minutes a week. In both phases, participants will complete a total of 8 behavioral activation teletherapy sessions used to increase physical activity, followed by two biweekly booster sessions, for a total of 10 sessions. Participants will also complete weekly assessments remotely for both phases of the study. The screening visit and final intervention session will be in-person, and all other visits will be via telehealth. Participants will have the option to come to the clinic if they prefer.

In the initial phase (n = 15), participants who completed the intervention will have the option to participate in a focus group, and participants who partially completed the intervention will have the option to participate in a semi-structured interview. The total duration of phase one is 14 weeks. This initial phase will allow the researchers to refine and optimize the intervention to be delivered in the second phase.

In the second/pilot phase (n = 50), participants will complete a one-month and a two-month follow-up after the 10 intervention sessions. The total duration for phase two is 22 weeks.

Participants for both phases of the study will wear a Fitbit during the duration of their study participation, in order to record step count.

Enrollment

65 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Be18-64 years old;
Able and willing to provide informed consent;
Have moderate-to-severe depressive symptoms, with a PHQ-9 score ≥ 10;
Insufficient moderate-to-vigorous physical activity (< 90 minutes a week);
Demonstrated interest in increasing physical activity;
Have a smartphone.

Exclusion criteria

Have any current, past, or lifetime manic or hypomanic episode, psychosis, schizophrenia or schizophreniform disorder;
Be currently experiencing active suicidal ideation (i.e. with suicidal thoughts, plan, and intent) or at a high risk for suicide during the course of the study, as designated by the PI;
Have a medical condition that prohibits physical activity; be medically prohibited to exercise by primary care physician (PCP), OB-GYN (obstetrician-gynecologist) or study MD.
Be in current, active psychotherapy