Exercise before cognitive behavioral therapy for depression (CBT+)
Exercise-priming of CBT for Depression: the CBT+ Trial
NA · University of Wisconsin, Madison · NCT07221929
This study will test whether doing moderate aerobic exercise right before CBT helps adults with major depressive disorder by improving therapy engagement and reducing depressive symptoms.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Wisconsin, Madison (other) |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT07221929 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial will enroll 100 adults with DSM-5 major depressive disorder and randomize them to eight weekly CBT sessions preceded either by moderate aerobic exercise ('ActiveCBT') or by quiet rest watching a nature documentary ('CalmCBT'). Primary outcomes are participant-rated working alliance and change in behavioral activation averaged across the eight sessions, with post-intervention Hamilton Depression Rating Scale scores as a secondary outcome. Suicide risk will be monitored with the Columbia-Suicide Severity Rating Scale for safety, and eligibility requires being CBT‑naïve and medically cleared for exercise. The trial tests whether intentional sequencing of exercise immediately before therapy increases engagement with CBT targets and yields larger symptom reductions than rest before therapy.
Who should consider this trial
Good fit: Adults with DSM‑5 major depressive disorder who have at least mild symptoms (GRID‑HAMD ≥8), are CBT‑naïve, medically able to perform moderate aerobic exercise, and are either not receiving other mental health treatment or are on a stable regimen for at least 8 weeks.
Not a fit: People who are pregnant, nursing, planning pregnancy, have medical contraindications to exercise, or have previously completed structured CBT are excluded and thus would not be expected to benefit from this specific protocol.
Why it matters
Potential benefit: If successful, adding brief aerobic exercise before CBT could strengthen the therapeutic relationship and behavioral activation, making CBT more effective or faster at reducing depressive symptoms.
How similar studies have performed: Exercise alone has established antidepressant effects, but the specific approach of priming CBT with immediate pre-session aerobic exercise is relatively novel and has limited prior randomized trial evidence.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Madison, Wisconsin
- University of Wisconsin — Madison, Wisconsin, United States (RECRUITING)
Study contacts
- Principal investigator: Jacob Meyer, PhD — University of Wisconsin, Madison
- Study coordinator: Madeleine Connolly, PhD
- Email: mconnolly5@wisc.edu
- Phone: (608) 890-0154
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Major Depressive Disorder, cognitive behavioral therapy, CBT