NCT07221929

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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 \['ActiveCBT'\]) to treat depression. Specific aims are to 1) demonstrate the effects of exercise priming on mechanisms associated with therapy success (i.e., working alliance, behavioral activation) and 2) determine the efficacy of exercise priming for treatment of depression and strength of relationship with engagement of target CBT mechanisms. The primary outcomes of this trial are participant-rated working alliance and change in behavioral activation each averaged across all eight sessions. Secondary outcomes include post-intervention depressive scores (Hamilton Depression Rating Scale). For safety, suicide severity will be evaluated using the Columbia-Suicide Severity Rating Scale.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Rest	30 minutes of rest while watching a nature documentary before cognitive behavioral therapy
BEHAVIORAL	Aerobic Activity	30 minutes of aerobic activity before cognitive behavioral therapy, while watching the same nature documentary the CalmCBT group watches.

Timeline

• Start date: 2026-01-05
• Primary completion: 2029-12-01
• Completion: 2029-12-01
• First posted: 2025-10-28
• Last updated: 2026-03-04

Locations

1 site across 1 country: United States