BENITIONSClinical Trial Intelligence

CBT+ for Depression

N/A Completed NCT06001346

ConditionMajor Depressive Disorder
PhaseN/A
SponsorUniversity of Wisconsin, Madison
StatusCompleted
Enrollment40 participants
InterventionsActiveCBT, CalmCBT
Start dateSep 1, 2023
Completion dateJun 1, 2025
Results postedJul 30, 2026

Summary

This study investigates the effects of a novel intervention approach, intentionally sequencing aerobic exercise immediately prior to therapy sessions (i.e., cognitive behavioral therapy \[CBT\]) to determine its effects on both specific and common factors underlying the antidepressant effect of CBT (i.e., mechanisms of CBT). To assess the utility of this treatment augmentation, investigators plan to conduct a randomized controlled trial involving 40 adults with Major Depressive Disorder who will watch a nature documentary while either resting quietly (termed 'CalmCBT') or exercising at a moderate intensity ('ActiveCBT') immediately prior to 8 weekly sessions of CBT. It is hypothesized that target CBT mechanisms of antidepressant action (i.e., self-reported working alliance and behavioral activation) will be more effectively engaged by ActiveCBT vs. CalmCBT.

Average Self-reported Working Alliance Measured by Working Alliance Inventory (WAI)

Weeks 1-8 CBT+ visits · score on a scale

ActiveCBT42.2 ± 6.43 score on a scale
CalmCBT42.8 ± 8.89 score on a scale
ActiveCBT47.8 ± 5.99 score on a scale
CalmCBT45.8 ± 9.02 score on a scale
ActiveCBT49.9 ± 6.05 score on a scale
CalmCBT48.1 ± 9.24 score on a scale

Self-reported Behavioral Activation Measured by Behavioral Activation for Depression Scale (BADS)

Intake, Weeks 1-8 CBT+ visits, Week 9 (Post-therapy), 12-week follow up, 1-year follow-up · score on a scale

ActiveCBT72.7 ± 17.2 score on a scale
CalmCBT69.1 ± 24.2 score on a scale
ActiveCBT72.7 ± 19.3 score on a scale
CalmCBT70.3 ± 22.9 score on a scale
ActiveCBT79.1 ± 19.2 score on a scale
CalmCBT69.6 ± 22.7 score on a scale

Open in BENITIONS View on ClinicalTrials.gov

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