This randomized 2x2 factorial intervention trial administers 8 weekly cognitive behavioral therapy (CBT) sessions (yes/no) and 4 bi-weekly active whole-body hyperthermia (WBH) sessions (yes/no) to adults aged 18 years or older with major depressive disorder (MDD).
Major Depressive Disorder afflicts more than hundreds of millions of people worldwide and is the leading cause of life years lost to disability. Current treatments have important limitations in efficacy and, in the case of medication, substantial side effects. There is thus a compelling need for additional effective, well-tolerated treatments. One such potential treatment is whole-body hyperthermia (WBH). The investigators hypothesize that WBH may be particularly effective in combination with cognitive behavioral therapy (CBT), an established treatment for depression. This randomized 2x2 factorial intervention trial administers 8 weekly cognitive behavioral therapy (CBT) sessions (yes/no) and 4 bi-weekly active whole-body hyperthermia (WBH) sessions (yes/no) to adults aged 18 years or older with major depressive disorder (MDD). This work holds important promise to improve the treatment of depression and to advance understanding of the role of integrated mind-body therapies for mood disorders.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Cognitive Behavioral Therapy (CBT) is a behavioral (psychotherapeutic) intervention for major depressive disorder (MDD). A highly trained masters' or PhD-level clinician will administer 8 weekly CBT sessions (\~50 minutes each), following the standard cognitive behavioral therapy for depression protocol.
Active whole-body hyperthermia (active WBH) will be administered by trained research assistants. Preparation for the active WBH session, the active WBH session, and cool down will last 3.5 hours, with heating lasting approximately 90-100 minutes (and no longer than 140 minutes). The treatment will take place in an infrared sauna dome, and the active heating phase will last until the participants has achieved a core (rectal) temperature of 38.5 C.
University of California, San Francisco, Osher Center for Integrative Health
San Francisco, California, United States
Massachusetts General Hospital (MGH)
Boston, Massachusetts, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Retention
Proportion of participants completing the final assessment (Target: 80% of participants)
Time frame: 12 weeks
CBT Intervention Fidelity
Proportion of CBT sessions coded in the proficient range (score of 48 or greater) on the Cognitive Therapy Scale - Revised (Target: 85% of sessions)
Time frame: 12 weeks
WBH Intervention Fidelity
Proportion of participants randomized to receive WBH who achieve a core body temperature of 38.5 C at one or more WBH sessions (Target: 80% of participants)
Time frame: 12 weeks
Study Assessment Completion
Proportion of study assessments completed, including weekly surveys and post-intervention and follow-up assessments (Target: 85% of assessments)
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.