Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT07221929

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

Led by University of Wisconsin, Madison · Updated on 2026-03-04

100

Participants Needed

1

Research Sites

203 weeks

Total Duration

On this page

Sponsors

U

University of Wisconsin, Madison

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 65 years
  • Diagnosis of Major Depressive Disorder confirmed by Structured Clinical Interview for DSM-5
  • Current depressive symptoms with GRID-HAMD score of 8 or higher
  • Either not currently using mental health medications or treatments, or on a stable regimen for at least 8 weeks
  • Willing and safe to perform exercise based on Physical Activity Readiness Questionnaire
  • Never undergone structured cognitive behavioral therapy (CBT-naïve)
Not Eligible

You will not qualify if you...

  • Currently pregnant, nursing, or planning pregnancy during the study
  • Diagnosed with current Substance Use Disorder
  • Diagnosed with lifetime or current Psychosis, Mania, or Bipolar Disorder
  • Class III or higher obesity (BMI ≥ 40)
  • Active suicidal ideation with specific plan and intent (score of 5 on Columbia Suicide Severity Rating Scale)
  • Behavioral disturbances or interpersonal issues interfering with study participation as assessed by research staff

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Wisconsin

Madison, Wisconsin, United States, 53792

Actively Recruiting

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Research Team

M

Madeleine Connolly, PhD

CONTACT

J

Jeni Lansing, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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