NCT07221929 Exercise-priming of CBT for Depression: the CBT+ Trial
| NCT ID | NCT07221929 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Wisconsin, Madison |
| Condition | Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-01-05 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2026-01-05 with a primary completion date of 2029-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Jacob Meyer, PhD
PRINCIPAL INVESTIGATOR
University of Wisconsin, Madison
Frequently Asked Questions
Who can join the NCT07221929 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07221929 currently recruiting?
Yes, NCT07221929 is actively recruiting participants. Contact the research team at mconnolly5@wisc.edu for enrollment information.
Where is the NCT07221929 trial being conducted?
This trial is being conducted at Madison, United States.
Who is sponsoring the NCT07221929 clinical trial?
NCT07221929 is sponsored by University of Wisconsin, Madison. The principal investigator is Jacob Meyer, PhD at University of Wisconsin, Madison. The trial plans to enroll 100 participants.