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

This study is looking at whether doing aerobic exercise right before cognitive behavioral therapy (CBT) can help people with Major Depressive Disorder (MDD). Researchers want to see if this combination, called 'ActiveCBT,' works better than just resting before CBT, called 'CalmCBT.' You would watch a nature documentary while either resting or exercising for 30 minutes before 8 weekly CBT sessions. The study aims to understand if 'ActiveCBT' improves how well you connect with your therapist (working alliance) and your ability to engage in positive activities (behavioral activation), and ultimately, if it helps reduce depression symptoms. To join, you need to be between 18 and 65 years old, have a diagnosis of MDD, and have at least mild depression symptoms. The study plans to enroll 100 adults, but its current status is unclear.

Study design
This is an interventional study with 100 planned participants. It compares two groups: one that rests before CBT ('CalmCBT') and one that exercises before CBT ('ActiveCBT').
What's involved
You would participate in 8 weekly CBT sessions, with either rest or aerobic activity beforehand. You would also have assessments at baseline, during each CBT session, immediately after the intervention (week 9), and at weeks 20 and 52.
Compensation
Not stated in the trial record.
Follow-up
Your depression symptoms and behavioral activation will be measured at week 20 and week 52 after the intervention.

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NCT07221929

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

Recruiting
NAAges 18–65InterventionalTreatment
University of Wisconsin, Madison
~100 participants
Updated 2026-03-04 on ClinicalTrials.gov
What's tested:RestAerobic Activity

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Working Alliance Inventory (WAI) - Bond subscale
Measured over data collected at each CBT session (weeks 1-8)
+3 more outcomes measured
Major Depressive Disorder
1 sites across 1 states
Wisconsin1
  • Jacob Meyer, PhD · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Madison

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Eligibility criteria

Inclusion

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

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.
  • Working Alliance Inventory (WAI) - Bond subscaledata collected at each CBT session (weeks 1-8)

    The WAI-Bond subscale scores 4 items, with scores ranging from 4-28. Higher scores are stronger perceived patient-therapist bond: how the participant experiences feelings of bond (i.e., feelings of mutual trust, acceptance, and connection) with their therapist.. The Bond subscale is a primary outcome measure for this study and the total score will be analyzed as a secondary outcome.

  • 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

    BADS is a 25-item survey, each item scored from 0 (not at all) to 6 (completely), with some items reverse scored. There are 4 sub-scales: Activation, Avoidance / Rumination, Work / School Impairment, Social Impairment. The total possible range of scores is from 0 to 150 where higher scores indicate higher behavioral activation (increased avoidance and impairment).

  • GRID Hamilton Rating Scale for Depression (GRID-HAMD)baseline, post intervention visit (week 9), week 20, week 52

    The GRID-HAM-D is a 17-item clinician-completed questionnaire that will be used to rate depressive symptom severity. The questionnaire is designed for adults and is used to rate the intensity and frequency of depressive symptoms by probing mood, feelings of guilt, suicidal ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. As recommended by the Depression Rating Scale Standardization Team, Clinical Interviewers will follow the Structured Interview Guide and use GRID scoring, in which dimensions of intensity and frequency of a symptom are rated independently for each item. Higher scores reflect greater symptom severity, categorized as Normal (0-7), Mild Depression (8-13), Moderate Depression (14-18), Severe Depression (19-22), and Very Severe Depression (greater than 23).

  • 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

    The PHQ-9 is a 9-item questionnaire that asks the participant to consider the last 2 weeks and score each question from 0-3 for a total possible range of scores from 0-27 where higher scores indicate increase depression.