Behavioral Activation Teletherapy to Increase Physical Activity (BAT)

Adapted Tele-Behavioral Activation Targeted to Increase Physical Activity in Depression

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.

Study Overview

• Status: Completed
• Conditions: Depressive Disorder; Depression; Depressive Symptoms; Depressive Episode
• Intervention / Treatment: Behavioral: Behavioral Activation Teletherapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75235
      • University of Texas Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behavioral Activation Teletherapy; All eligible participants will be assigned to receive the behavioral activation teletherapy intervention.	Behavioral: Behavioral Activation Teletherapy; A total of 10 teletherapy sessions to be delivered over 12-14 weeks, designed to increase physical activity among depressed individuals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility and acceptability - Screening	Number of participants screened per week (Goal 1-2 per week)	1 week
Feasibility and acceptability - Recruitment	Percentage of screened participants enrolled (Goal: 50%)	1 week
Intervention Adherence	Percentage of intervention sessions attended (goal 75%)	Up to 14 weeks
Intervention Validity via Quality of Behavioral Activation Short Form	Fidelity on supervisor's structured feedback form with average item score ≥3. The 14-item scale has each item ranging from 0-6, with higher values indicating higher levels of fidelity.	Up to 14 weeks
Participant retention	Percentage of PHQ-9 assessments completed (Goal: 80%)	Up to 22 weeks
Participant outcome completion	Percentage of valid Fitbit wear days > 12 hours (Goal: 80%)	Up to 22 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive symptoms - 9-item Patient Health Questionnaire	Change in self-Reported Depressive Symptoms, analyzed using linear mixed effects modeling controlling for baseline depressive symptoms and additional covariates	Up to 22 weeks
Physical activity - self-report days per week	Change in self-reported frequency of physical activity (days per week), analyzed using linear mixed effects modeling controlling for baseline physical activity and additional covariates	Up to 22 weeks
Physical activity - self-report minutes per day	Change in self-reported frequency of physical activity (minutes per day), analyzed using linear mixed effects modeling controlling for baseline physical activity and additional covariates	Up to 22 weeks
Physical activity - Fitbit step counter active minutes	Change in objective data from Fitbit of "active minutes", using linear mixed effects modeling controlling for baseline physical activity and additional covariates	Up to 22 weeks
Physical activity - Fitbit step counter step count	Change in objective data from Fitbit of "step count", using linear mixed effects modeling controlling for baseline physical activity and additional covariates	Up to 22 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mediation of intervention through a number of pathways	Testing whether the physical activity to depression reduction pathway is mediated by changes in (a) positive and negative affect; (b) anhedonia, (c), fatigue, (d) self-esteem, (e) overall depressive symptoms and (f) emotion regulation. For each potential mediator, both a direct and indirect pathway will be tested. First, the mediational model should meet the goodness of fit criteria (e.g., a non-significant X2, fit indices greater than .90 and significant path coefficients) and second, when a direct effect path is added to the model this path is either non-significant or adds little improvement in the overall predictive value of the model (i.e., increase in R2).	Up to 22 weeks, using mediating timepoints post-session at Weeks 0, 3 and 7
Minimum number of therapy sessions needed to achieve depression remission	The minimum number of completed therapy sessions (1-10) needed to achieve depression remission, analyzed through discrete-time survival analysis.	Up to 14 weeks
Depressive symptoms - IDS-SR	Change in self-reported Inventory of Depressive Symptoms (IDS-SR), analyzed using linear mixed effects modeling controlling for baseline depressive symptoms and additional covariates	Up to 22 weeks

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Madhukar Trivedi, MD, University of Texas Southwestern Medical Center; Principal Investigator: Chad Rethorst, PhD, University of Texas Southwestern Medical Center

Publications and helpful links

General Publications

• Rethorst CD, Trombello JM, Chen PM, Carmody TJ, Goodman LC, Lazalde A, Trivedi MH. Pilot evaluation on an adapted tele-behavioral activation to increase physical activity in persons with depression: a single-arm pilot study. BMC Psychol. 2024 Nov 9;12(1):643. doi: 10.1186/s40359-024-02053-5.

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2021
• Primary Completion (Actual): May 30, 2025
• Study Completion (Actual): May 31, 2025

Study Registration Dates

• First Submitted: July 21, 2021
• First Submitted That Met QC Criteria: July 26, 2021
• First Posted (Actual): August 4, 2021

Study Record Updates

• Last Update Posted (Estimated): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Physical Activity; Exercise; Therapy; Teletherapy
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Behavior; Depression; Depressive Disorder; Motor Activity
• Other Study ID Numbers: STU-2021-0441; 1R34MH122640-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: If other investigators are interested in accessing data, they may contact the principal investigator in writing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No