Exercise-priming of CBT for Depression: the CBT+ Trial
Recruiting · NCT07221929 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Wisconsin, Madison
View the official record on ClinicalTrials.gov →Interventions studied
Aerobic ActivityRest
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed across 1 US state.
- University of Wisconsin - Madison, Wisconsin, United States