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Clinical Trial Summary

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT04990401
Study type Interventional
Source University of Texas Southwestern Medical Center
Contact Elizabeth Dedrick
Phone 214-648-5020
Email Elizabeth.Dedrick@UTSouthwestern.edu
Status Recruiting
Phase N/A
Start date August 31, 2021
Completion date December 2024

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