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

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…

ClinicalTrials.gov IDNCT07221929

PhaseNA

Enrollment100

SponsorUniversity of Wisconsin, Madison

Age18 Years – 65 Years

SexALL

I'm interested View official listing

Conditions studied

Major Depressive Disorder

About this study

Interventions

Behavioral: Rest — 30 minutes of rest while watching a nature documentary before cognitive behavioral therapy
Behavioral: Aerobic Activity — 30 minutes of aerobic activity before cognitive behavioral therapy, while watching the same nature documentary the CalmCBT group watches.

Primary outcomes

Working Alliance Inventory (WAI) - Bond subscale (data collected at each CBT session (weeks 1-8))
Behavioral Activation for Depression Scale (BADS) (data collected at baseline, each CBT session (weeks 1-8), post intervention visit (week 9), week 20, week 52)
GRID Hamilton Rating Scale for Depression (GRID-HAMD) (baseline, post intervention visit (week 9), week 20, week 52)
Patient Health Questionnaire-9 (PHQ-9) (data collected at baseline, each CBT session (weeks 1-8), post intervention visit (week 9), week 20, week 52)

Eligibility information

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.

Study locations

University of Wisconsin, Madison, Wisconsin 53792 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-13.