Status:
COMPLETED
CBT+ for Depression
Lead Sponsor:
Iowa State University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 de...
Detailed Description
Frontline treatments for major depressive disorder (MDD), including cognitive behavioral therapy (CBT), have limited effectiveness, with half of patients not responding to CBT and half relapsing withi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06001346
Start Date
September 1 2023
End Date
June 1 2025
Last Update
August 7 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Iowa State University
Ames, Iowa, United States, 50010