No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 65
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
100 (estimated)
Sponsor
University of Wisconsin, Madison · Other
Who this trial is looking for
This trial is looking for adults with Major Depressive Disorder who want to try a new approach combining exercise with therapy. Participants will either rest or do moderate exercise before starting therapy sessions for 8 weeks.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with Major Depressive Disorder.
I have mild depressive symptoms or worse.
I am either not taking any mental health medications or have been stable on my medications for the past 8 weeks.
I can safely exercise based on a health questionnaire.
I have never undergone structured cognitive behavioral therapy.
You may not be able to join if
I am currently pregnant, nursing, or planning to become pregnant.
I have a current Substance Use Disorder.
I have had a psychotic episode, mania, or bipolar disorder.
I have class III obesity (BMI 40 or more).
I have active suicidal thoughts with a specific plan.
I have behavioral disturbances that would interfere with my participation.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 w…
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.
Trial Locations
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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…
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.
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