DepressionBATNCT04990401
Behavioral Activation Teletherapy to Increase Physical Activity
A study testing Behavioral Activation Teletherapy in people with Depression and Depressive Disorder, run by University of Texas Southwestern Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Depression, Depressive Disorder, Depressive Symptoms
- What is being tested?
- Behavioral Activation Teletherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2021to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75235
About this study
Official title: 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.
Read the 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.
- Being tested
- Behavioral Activation Teletherapy
- Keywords
- Therapy, Teletherapy, Physical Activity, Exercise
- Medical subject headings
- Depression, Depressive Disorder, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Activation TeletherapyBehavioural
A total of 10 teletherapy sessions to be delivered over 12-14 weeks, designed to increase physical activity among depressed individuals.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Activation Teletherapy | Experimental | All eligible participants will be assigned to receive the behavioral activation teletherapy intervention. Receives: Behavioral: Behavioral Activation Teletherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and acceptability - Screening
Number of participants screened per week (Goal 1-2 per week)
Measured: 1 week
Feasibility and acceptability - Recruitment
Percentage of screened participants enrolled (Goal: 50%)
Measured: 1 week
Intervention Adherence
Percentage of intervention sessions attended (goal 75%)
Measured: 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.
Measured: Up to 14 weeks
Participant retention
Percentage of PHQ-9 assessments completed (Goal: 80%)
Measured: Up to 22 weeks
Participant outcome completion
Percentage of valid Fitbit wear days > 12 hours (Goal: 80%)
Measured: Up to 22 weeks
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start31 Aug 2021
- Primary completion30 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All eligible participants will receive the behavioral activation teletherapy intervention in this single-arm study.
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Madhukar H. Trivedi, MD, University of Texas Southwestern Medical Center
- Investigators
- Chad Rethorst, PhD, Principal investigator, University of Texas Southwestern Medical CenterMadhukar Trivedi, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04990401
- Sponsor's protocol ID
- STU-2021-0441
- Other IDs
- 1R34MH122640-01A1
- Acronym
- BAT
- Status last verified
- Dec 2025
- First submitted
- 21 Jul 2021
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: If other investigators are interested in accessing data, they may contact the principal investigator in writing.
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.
PubMed 39522018
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapted Tele-Behavioral Activation Targeted to Increase Physical Activity in Depression
- ClinicalTrials.gov ID
- NCT04990401
- Acronym / sponsor ID
- BAT / STU-2021-0441
- Keywords
- Therapy, Teletherapy, Physical Activity, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 4 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All eligible participants will receive the behavioral activation teletherapy intervention in this single-arm study.
| Arm | Type | Receives |
|---|---|---|
| Behavioral Activation Teletherapy | Experimental | Behavioral: Behavioral Activation TeletherapyAll eligible participants will be assigned to receive the behavioral activation teletherapy intervention. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Activation TeletherapyA total of 10 teletherapy sessions to be delivered over 12-14 weeks, designed to increase physical activity among depressed individuals. | Behavioural | Behavioral Activation Teletherapy |
Primary outcome
Feasibility and acceptability - Screening
Time frame: 1 week
Number of participants screened per week (Goal 1-2 per week)
Feasibility and acceptability - Recruitment
Time frame: 1 week
Percentage of screened participants enrolled (Goal: 50%)
Intervention Adherence
Time frame: Up to 14 weeks
Percentage of intervention sessions attended (goal 75%)
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.
Participant retention
Time frame: Up to 22 weeks
Percentage of PHQ-9 assessments completed (Goal: 80%)
Participant outcome completion
Time frame: Up to 22 weeks
Percentage of valid Fitbit wear days > 12 hours (Goal: 80%)
5 secondary outcomes
Depressive symptoms - 9-item Patient Health Questionnaire
Time frame: Up to 22 weeks
Physical activity - self-report days per week
Time frame: Up to 22 weeks
Physical activity - self-report minutes per day
Time frame: Up to 22 weeks
Physical activity - Fitbit step counter active minutes
Time frame: Up to 22 weeks
Physical activity - Fitbit step counter step count
Time frame: Up to 22 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Derived from this study: PubMed 39522018Rethorst 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.
- Individual participant dataSharing planned: No. If other investigators are interested in accessing data, they may contact the principal investigator in writing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chad Rethorst, PhD principal investigator
University of Texas Southwestern Medical Center
Madhukar Trivedi, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation Teletherapy in people with Depression and Depressive Disorder, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and acceptability - Screening (time frame: 1 week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04990401, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.