Behavioral Activation Teletherapy to Increase Physical Activity
NCT ID: NCT04990401
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
65 participants
INTERVENTIONAL
2021-08-31
2025-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Behavioral Activation Teletherapy
All eligible participants will be assigned to receive the behavioral activation teletherapy intervention.
Behavioral Activation Teletherapy
A total of 10 teletherapy sessions to be delivered over 12-14 weeks, designed to increase physical activity among depressed individuals.
Interventions
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Behavioral Activation Teletherapy
A total of 10 teletherapy sessions to be delivered over 12-14 weeks, designed to increase physical activity among depressed individuals.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
64 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Madhukar H. Trivedi, MD
Professor of Medicine
Principal Investigators
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Chad Rethorst, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Texas Southwestern Medical Center
Madhukar Trivedi, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas Southwestern Medical Center
Locations
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University of Texas Southwestern Medical Center
Dallas, Texas, United States
Countries
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References
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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.
Provided Documents
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Document Type: Informed Consent Form: English Informed Consent Form
Other Identifiers
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STU-2021-0441
Identifier Type: -
Identifier Source: org_study_id