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

University of Wisconsin (UW)

Status: Enrolling

Conditions: Major Depressive Disorder

Treatments: Behavioral: Rest; Behavioral: Aerobic Activity

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07221929

R33MH129407 (U.S. NIH Grant/Contract)

Protocol Version 12/19/25 (Other Identifier)

EDUC/KINESIOLOGY (Other Identifier)

2025-1128

Details and patient eligibility

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.

Full description

The overall goals of this project are to examine the efficacy of exercise priming (i.e., intentional sequencing of aerobic exercise immediately prior to cognitive behavioral therapy ['ActiveCBT']) to treat depression.

Specific aims are to 1) demonstrate the effects of exercise priming on mechanisms associated with therapy success (i.e., working alliance, behavioral activation) and 2) determine the efficacy of exercise priming for treatment of depression and strength of relationship with engagement of target CBT mechanisms.

The primary outcomes of this trial are participant-rated working alliance and change in behavioral activation each averaged across all eight sessions. Secondary outcomes include post-intervention depressive scores (Hamilton Depression Rating Scale).

For safety, suicide severity will be evaluated using the Columbia-Suicide Severity Rating Scale.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

CalmCBT

Experimental group

Description:

In this arm, participants would complete 30 minutes of rest while watching a nature documentary before cognitive behavioral therapy

Treatment:

Behavioral: Rest

ActiveCBT

Experimental group

Description:

In this arm, participants would complete 30 minutes of aerobic activity before cognitive behavioral therapy, while watching the same nature documentary the CalmCBT group watches.

Treatment:

Behavioral: Aerobic Activity