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Recruiting NCT07221929

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

No phase Interventional Major Depressive Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rest, Aerobic Activity.
Who it may be relevant to
Registry conditions: Major Depressive Disorder. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed 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.

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 outcome measures

  • Working Alliance Inventory (WAI) - Bond subscale [Time frame: data collected at each CBT session (weeks 1-8)]
  • Behavioral Activation for Depression Scale (BADS) [Time frame: 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) [Time frame: baseline, post intervention visit (week 9), week 20, week 52]
  • Patient Health Questionnaire-9 (PHQ-9) [Time frame: data collected at baseline, each CBT session (weeks 1-8), post intervention visit (week 9), week 20, week 52]
Secondary outcome measures (12)
  • Structured Clinical Interviews for DSM-5 Disorders (SCID) [Time frame: baseline, post intervention visit (week 9), week 20, week 52]
  • Columbia Severity Suicide Rating (CSSRS) [Time frame: data collected at baseline, each CBT session (weeks 1-8), post intervention visit (week 9), week 20, week 52]
  • Dimensional Anhedonia Rating Scale (DARS) [Time frame: Weeks 1-8 CBT sessions (repeated 3 times [before exercise/calm condition, immediately after exercise/calm condition, and after therapy]), final visit (week 9), 20-week follow up, 1-year follow up]
  • Visual Analogue Scale (VAS) [Time frame: Weeks 1-8 CBT sessions (repeated 3 times [before exercise/calm condition, immediately after exercise/calm condition, and after therapy]), final visit (week 9), 20-week follow up, 1-year follow up]
  • Serum Brain Derived Neurotrophic Factor (BDNF) [Time frame: Weeks 1, 4, and 8 CBT sessions (before exercise/calm condition, immediately after exercise/calm condition, and after therapy)]
  • Objective physical activity data (activPAL accelerometer) reported in minutes [Time frame: Baseline, weeks 3 & 8 CBT sessions (monitors worn 1 week following each time point)]
  • Objective physical activity data (activPAL accelerometer) reported in number of steps per day [Time frame: Baseline, weeks 3 & 8 CBT sessions (monitors worn 1 week following each time point)]
  • Self-reported physical activity measured by the International Physical Activity Questionnaire - Short Form (IPAQ-SF) reported in minutes [Time frame: baseline, week 4, post intervention visit (week 9), week 20, week 52]
  • 36-item Short Form health survey (SF-36) [Time frame: baseline, week 4, post intervention visit (week 9), week 20, week 52]
  • Generalized Anxiety Disorder 7 questionnaire (GAD-7) [Time frame: baseline, week 4, post intervention visit (week 9), week 20, week 52]
  • Automatic Thoughts Questionnaire [Time frame: baseline, weeks 1-8, post intervention visit (week 9), week 20, week 52]
  • Session Evaluation Questionnaire (SEQ) [Time frame: Weeks 1-8 CBT sessions]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Wisconsin — Madison

Publications

  • Meyer JD, Kelly SJE, Gidley JM, Lansing JE, Smith SL, Churchill SL, Thomas EBK, Goldberg SB, Abercrombie HC, Murray TA, Wade NG. Protocol for a randomized controlled trial: exercise-priming of CBT for depression (the CBT+ trial). Trials. 2024 Oct 7;25(1):663. doi: 10.1186/s13063-024-08495-x. PMID 39375728

Identifiers

NCT: NCT07221929 · 2025-1128 · R33MH129407 · EDUC/KINESIOLOGY · Protocol Version 12/19/25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗