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Behavioral Activation Teletherapy for Depression (BAT Trial)
N/A
Recruiting
Led By Chad Rethorst, PhD
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
No Placebo-Only Group
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.
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.
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility and acceptability - Recruitment
Feasibility and acceptability - Screening
Intervention Adherence
+3 moreSecondary study objectives
Depressive symptoms - 9-item Patient Health Questionnaire
Physical activity - Fitbit step counter active minutes
Physical activity - Fitbit step counter step count
+2 moreOther study objectives
Depressive symptoms - IDS-SR
Mediation of intervention through a number of pathways
Minimum number of therapy sessions needed to achieve depression remission
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
1,088 Previous Clinical Trials
1,059,655 Total Patients Enrolled
46 Trials studying Depression
19,336 Patients Enrolled for Depression
Chad Rethorst, PhDPrincipal InvestigatorUniversity of Texas Southwestern Medical Center
1 Previous Clinical Trials
38 Total Patients Enrolled
1 Trials studying Depression
38 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
10,778 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