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RecruitingMajor Depressive Disorder

Exercise-priming of CBT for Depression: the CBT+ Trial

Eligible age

18–65 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

No

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About this study

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 alliance, behavioral activation). To assess the utility of this treatment augmentation, investigators will conduct a randomized controlled trial involving 100 adults with Major Depressive Disorder who will watch a nature documentary while either resting quietly ( 'CalmCBT') or exercising at a moderate intensity ('ActiveCBT') immediately prior to 8 weekly sessions of CBT.

Sponsor: University of Wisconsin, Madison

You may qualify if…

  • 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).

You may not qualify if…

  • 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.

Where it's recruiting

Wisconsin

Madison

Source: ClinicalTrials.gov · NCT07221929 · last updated 2026-03-04