NCT06001346Completed
CBT+ for Depression
ActiveCBT for Depression: Transforming Treatment Through Exercise Priming
Source: ClinicalTrials.gov · Last updated 26 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 14 Aug 2023
- Start date
- 1 Sept 2023
- Primary completion date
- 1 Jun 2025
- Lead sponsor
- University of Wisconsin, Madison
- Diseases
- Depression
- NCT number
- NCT06001346
What you commit to
- Study type: Interventional
- Participants enrolled: 40
- From 1 Sept 2023 to the primary completion date, 1 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- diagnosed with lifetime or current Psychosis, Mania, or Bipolar Disorder, via the SCID
- diagnosed with current Substance Use Disorder, via the SCID
- exhibit behavioral disturbance (e.g., aggression, mild-moderate cognitive impairment) that would significantly interfere with study participation, assessed by clinical research personnel
Other
- currently pregnant, nursing, or planning to become pregnant,
- severe obesity (BMI=40)
- pose an imminent risk of self-harm or harm to others, assessed via the C-SSRS
Who the study is looking for
- 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).
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Iowa State University Coordinator of this site? Confirm its status | Ames | United States | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.