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Behavioral Activation Teletherapy for Depression (BAT Trial)
N/A
Recruiting
Led By Joseph M Trombello, PhD, ABPP
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be18-64 years old
Able and willing to provide informed consent
Timeline
Screening 2 days
Treatment Varies
Follow Up 60 days
Awards & highlights
BAT Trial Summary
This trial looks at whether a ten-session behavior intervention delivered over teletherapy can help people with depression become more active and improve their symptoms.
Who is the study for?
This trial is for adults aged 18-64 with moderate-to-severe depression who are not very active physically (less than 90 minutes of activity a week) and want to be more active. They must have a smartphone, score ≥10 on the PHQ-9 depression scale, and give informed consent. People in current psychotherapy or at high risk for suicide can't join.Check my eligibility
What is being tested?
The study tests a short program called Behavioral Activation Teletherapy over ten sessions aimed at increasing physical activity through remote therapy to help reduce symptoms of depression.See study design
What are the potential side effects?
Since this intervention involves therapy rather than medication, typical medical side effects aren't expected. Participants may experience emotional discomfort discussing personal issues during sessions.
BAT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 64 years old.
Select...
I have moderate to severe depression, scored 10 or higher on PHQ-9.
Select...
You are not physically active enough and do not engage in at least 90 minutes of moderate-to-vigorous physical activity per week.
Select...
You have shown that you want to exercise more.
Select...
You need to have a smartphone.
BAT Trial Timeline
Screening ~ 2 days2 visits
Treatment ~ Varies
Follow Up ~ 60 days2 visits
Screening ~ 2 days
Treatment ~ Varies
Follow Up ~60 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility and acceptability - Recruitment
Feasibility and acceptability - Screening
Intervention Adherence
+3 moreSecondary outcome measures
Depressive symptoms - 9-item Patient Health Questionnaire
Physical activity - Fitbit step counter active minutes
Physical activity - Fitbit step counter step count
+2 moreOther outcome measures
Depressive symptoms - IDS-SR
Mediation of intervention through a number of pathways
Minimum number of therapy sessions needed to achieve depression remission
BAT Trial Design
1Treatment groups
Experimental Treatment
Group I: Behavioral Activation TeletherapyExperimental Treatment1 Intervention
All eligible participants will be assigned to receive the behavioral activation teletherapy intervention.
Find a Location
Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,048 Previous Clinical Trials
1,053,670 Total Patients Enrolled
45 Trials studying Depression
19,332 Patients Enrolled for Depression
Joseph M Trombello, PhD, ABPPPrincipal InvestigatorUniversity of Texas Southwestern Medical Center
Madhukar Trivedi, MDPrincipal InvestigatorUniversity of Texas Southwestern Medical Center
14 Previous Clinical Trials
11,011 Total Patients Enrolled
8 Trials studying Depression
9,721 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have shown that you want to exercise more.You are not physically active enough and do not engage in at least 90 minutes of moderate-to-vigorous physical activity per week.I am currently seeing a therapist regularly.I am between 18 and 64 years old.I am between 18 and 64 years old.I have moderate to severe depression, with a PHQ-9 score of 10 or higher.You need to have a smartphone.You need to have a smartphone.You don't exercise enough each week (less than 90 minutes of moderate-to-vigorous physical activity).You are interested in becoming more physically active.You are currently having strong thoughts of wanting to hurt or kill yourself, or the study team thinks you may be at high risk for suicide during the study.I have moderate to severe depression, scored 10 or higher on PHQ-9.
Research Study Groups:
This trial has the following groups:- Group 1: Behavioral Activation Teletherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 2 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 90 null
- Follow Ups: You may be asked to continue sharing information regarding the trial for 60 Months after you stop receiving the treatment.
Depression Patient Testimony for trial: Trial Name: NCT04990401 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have been registered for this experiment?
"Indeed, clinicaltrials.gov states that this medical initiative is actively seeking participants. It was first published on August 31st 2021 and the most recent updates were made on September 16th 2022. The study requires 65 individuals at a single location to complete it."
Answered by AI
Are individuals of a more senior age being admitted to the clinical trial?
"All suitable participants must be aged 18 or over but less than 64 to take part in this clinical trial."
Answered by AI
May I volunteer for this clinical experiment?
"This clinical trial is recruiting 65 individuals aged 18-64 afflicted with melancholia. In order to qualify, patients must provide informed consent, present moderate-to-severe depressive symptoms (PHQ-9 score ≥ 10), partake in less than 90 minutes of physical activity per week and demonstrate a desire to increase this amount, as well as possess a smartphone device."
Answered by AI
What is the ultimate aim of this medical investigation?
"The main objective of this week-long clinical trial is to examine participant retention. Secondary goals include examining changes in self-reported physical activity (minutes per day), depressive symptoms, and active minutes taken from Fitbit data using linear mixed effects modelling controlling for baseline values and additional covariates."
Answered by AI
Are there available slots for participants in this experiment?
"Affirmative. According to the information displayed on clinicaltrials.gov, this medicinal trial is currently seeking prospective volunteers. It was first posted on August 31st 2021 and most recently updated on September 16th 2022; 65 patients are required from a single location."
Answered by AI
Who else is applying?
What state do they live in?
Florida
Louisiana
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
University of Texas Southwestern Medical Center
How many prior treatments have patients received?
0
2
3+
Why did patients apply to this trial?
I can’t find motivation to excersice. My energy levels are super slow and I feel sluggish. I really want help to start working exercising again.
PatientReceived 1 prior treatment
I really need motivation to exercise more because it generally helps with my depression and I love the fact that it is remote.
PatientReceived 1 prior treatment
I have tried many medications, types of therapy, being active, vitamins, etc for treatment and I still suffer and I want to see if something else might work. I also would like to be apart of something that could potentially help others.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
I can begin ASAP with an open schedule... When will the study begin and is it a paid study?
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Email
Phone Call
Most responsive sites:
- University of Texas Southwestern Medical Center: < 24 hours
Average response time
- < 2 Days
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