Skip to main content
OpenTrials
Completed

NCT Number: NCT04990401

Behavioral Activation Teletherapy to Increase Physical Activity

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Depression Behavior Behavioral Symptoms Depressive Disorder Depressive Episode Depressive Symptoms Mental Disorders Mood Disorders Motor Activity

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Southwestern Medical Center

Dallas, Texas, 75235, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral Activation Teletherapy

Behavioral

A total of 10 teletherapy sessions to be delivered over 12-14 weeks, designed to increase physical activity among depressed individuals.

Primary outcomes

  1. Feasibility and acceptability - Screening

    Time frame: 1 week

    Number of participants screened per week (Goal 1-2 per week)

  2. Feasibility and acceptability - Recruitment

    Time frame: 1 week

    Percentage of screened participants enrolled (Goal: 50%)

  3. Intervention Adherence

    Time frame: Up to 14 weeks

    Percentage of intervention sessions attended (goal 75%)

  4. Intervention Validity via Quality of Behavioral Activation Short Form

    Time frame: Up to 14 weeks

    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.

  5. Participant retention

    Time frame: Up to 22 weeks

    Percentage of PHQ-9 assessments completed (Goal: 80%)

  6. Participant outcome completion

    Time frame: Up to 22 weeks

    Percentage of valid Fitbit wear days > 12 hours (Goal: 80%)

Secondary outcomes

  1. Depressive symptoms - 9-item Patient Health Questionnaire

    Time frame: Up to 22 weeks

    Change in self-Reported Depressive Symptoms, analyzed using linear mixed effects modeling controlling for baseline depressive symptoms and additional covariates

  2. Physical activity - self-report days per week

    Time frame: Up to 22 weeks

    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

  3. Physical activity - self-report minutes per day

    Time frame: Up to 22 weeks

    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

  4. Physical activity - Fitbit step counter active minutes

    Time frame: Up to 22 weeks

    Change in objective data from Fitbit of "active minutes", using linear mixed effects modeling controlling for baseline physical activity and additional covariates

  5. Physical activity - Fitbit step counter step count

    Time frame: Up to 22 weeks

    Change in objective data from Fitbit of "step count", using linear mixed effects modeling controlling for baseline physical activity and additional covariates

Other outcomes

  1. Mediation of intervention through a number of pathways

    Time frame: Up to 22 weeks, using mediating timepoints post-session at Weeks 0, 3 and 7

    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).

  2. Minimum number of therapy sessions needed to achieve depression remission

    Time frame: Up to 14 weeks

    The minimum number of completed therapy sessions (1-10) needed to achieve depression remission, analyzed through discrete-time survival analysis.

  3. Depressive symptoms - IDS-SR

    Time frame: Up to 22 weeks

    Change in self-reported Inventory of Depressive Symptoms (IDS-SR), analyzed using linear mixed effects modeling controlling for baseline depressive symptoms and additional covariates

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: BAT

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Aug 4, 2021
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.