Recruiting

ActiveCBT & CalmCBT

Sponsor:

University of Wisconsin, Madison

Code:

NCT07221929

Conditions

Major Depressive Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Rest

Aerobic Activity

Study Details

Brief summary:

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.

Conditions

Major Depressive Disorder

Study ID

NCT07221929

Start date

Jan 5, 2026

Status verified date

Mar, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CalmCBT

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

experimental: ActiveCBT

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.

Interventions

Rest

30 minutes of rest while watching a nature documentary before cognitive behavioral therapy

Aerobic Activity

30 minutes of aerobic activity before cognitive behavioral therapy, while watching the same nature documentary the CalmCBT group watches.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Madeleine Connolly, PhD

(608) 890-0154mconnolly5@wisc.edu

Locations

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53792

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Mar 4, 2026

Last verified

Mar, 2026

Keywords

  • cognitive behavioral therapy
  • CBT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-03-04.