Status:
NOT_YET_RECRUITING
Exercise-priming of CBT for Depression: the CBT+ Trial
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This study investigates the effects of intentionally sequencing aerobic exercise immediately prior to cognitive behavioral therapy (CBT) to determine its effects on mechanisms of CBT (i.e., working al...
Detailed Description
The overall goals of this project are to examine the efficacy of exercise priming (i.e., intentional sequencing of aerobic exercise immediately prior to cognitive behavioral therapy \['ActiveCBT'\]) t...
Eligibility Criteria
Inclusion
- a diagnosis of DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5) MDD, confirmed via Structured Clinical Interview for DSM-5 (SCID)
- current depressive symptoms of at least mild severity defined by a Hamilton Rating Scale of Depression (using the GRID-HAMD) score greater than or equal to 8
- EITHER not currently take any mental health medications or use other mental health treatment (e.g., behavioral, psychological) OR be on a stable mental health medication and/or treatment regimen for the past 8 weeks, and encouraged to maintain that regimen for the duration of the 8 week intervention period
- willing and safe to perform exercise based on responses on the Physical Activity Readiness Questionnaire (rules out contraindications to exercise)
- reported being CBT-naïve (as defined by never undergoing structured CBT).
Exclusion
- reporting being currently pregnant, nursing, or planning to become pregnant during the study
- being diagnosed with current Substance Use Disorder, via the SCID
- being diagnosed with lifetime or current Psychosis, Mania, or Bipolar Disorder, via the SCID
- having class III+ obesity (BMI greater than or equal to 40)
- active suicidal ideation with specific plan and intent ('5' score on Suicidal Ideation from Columbia Suicide Severity Rating Scale \[C-SSRS\])
- exhibiting behavioral disturbance (e.g., aggression, mild-moderate cognitive impairment) or relationships with the study team members (e.g., therapists) that would significantly interfere with study participation, as assessed by research personnel.
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2029
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07221929
Start Date
January 1 2026
End Date
November 1 2029
Last Update
October 28 2025
Active Locations (1)
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1
University of Wisconsin
Madison, Wisconsin, United States, 53792