NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

CBT+ for Depression

CompletedNA

Sponsor: University of Wisconsin, Madison

Conditions: Major Depressive Disorder

Interventions: ActiveCBT, CalmCBT

Countries: United States

This study investigates the effects of a novel intervention approach, intentionally sequencing aerobic exercise immediately prior to therapy sessions (i.e., cognitive behavioral therapy \[CBT\]) to determine its effects on both specific and common factors underlying the antidepressant effect of CBT (i.e., mechanisms of CBT). To assess the utility of this treatment augmentation, investigators plan to conduct a randomized controlled trial involving 40 adults with Major Depressive Disorder who will watch a nature documentary while either resting quietly (termed 'CalmCBT') or exercising at a moderate intensity ('ActiveCBT') immediately prior to 8 weekly sessions of CBT. It is hypothesized that target CBT mechanisms of antidepressant action (i.e., self-reported working alliance and behavioral activation) will be more effectively engaged by ActiveCBT vs. CalmCBT.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Diagnosed with DSM-5 MDD, confirmed via SCID.
* Having current depressive symptoms of at least mild severity defined by HAM-D rating ≥8.
* Being between age 18 and 65.
* Either not engaging in any mental health treatment (e.g., medication, psychological, or behavioral) OR on a stable mental health treatment regimen and willing to maintain it for the length of the intervention.
* Willing and safe to exercise based on the Physical Activity Readiness Questionnaire.
* Being CBT-naïve (as defined by never undergoing structured CBT).

Exclusion Criteria:

* currently pregnant, nursing, or planning to become pregnant,
* severe obesity (BMI=40)
* diagnosed with lifetime or current Psychosis, Mania, or Bipolar Disorder, via the SCID
* diagnosed with current Substance Use Disorder, via the SCID
* pose an imminent risk of self-harm or harm to others, assessed via the C-SSRS
* exhibit behavioral disturbance (e.g., aggression, mild-moderate cognitive impairment) that would significantly interfere with study participation, assessed by clinical research personnel

Locations (1)

Ames, Iowa, United States