CBT+ for Depression

Completed · Not applicable

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT06001346

Run by

University of Wisconsin, Madison

People needed

40

Starts

2023-09-01

Expected to finish

2025-06-01

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with DSM-5 MDD, confirmed via SCID.
• Having current depressive symptoms of at least mild severity defined by HAM-D rating ≥8.
• Being between age 18 and 65.
• Either not engaging in any mental health treatment (e.g., medication, psychological, or behavioral) OR on a stable mental health treatment regimen and willing to maintain it for the length of the intervention.
• Willing and safe to exercise based on the Physical Activity Readiness Questionnaire.
• Being CBT-naïve (as defined by never undergoing structured CBT).

You may not qualify if…

• currently pregnant, nursing, or planning to become pregnant,
• severe obesity (BMI=40)
• diagnosed with lifetime or current Psychosis, Mania, or Bipolar Disorder, via the SCID
• diagnosed with current Substance Use Disorder, via the SCID
• pose an imminent risk of self-harm or harm to others, assessed via the C-SSRS
• exhibit behavioral disturbance (e.g., aggression, mild-moderate cognitive impairment) that would significantly interfere with study participation, assessed by clinical research personnel

Where it is running

• Iowa State University — Ames, Iowa, United States

Full record on ClinicalTrials.gov

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