Assessing multi-site feasibility of an integrated whole-body hyperthermia and behavioral intervention for major depressive disorder - PROJECT SUMMARY/ABSTRACT Major Depressive Disorder (MDD) afflicts more than 280 million 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. Body heating practices, such as saunas, sweat lodges, and hot yoga, have rich traditions across cultures as healing practices. Additionally, recent basic and clinical research, as well as the investigative team’s pilot data, suggest that whole-body hyperthermia (WBH) holds promise for depression treatment. The investigative team therefore hypothesizes that WBH, a body-based heat treatment, may decrease depression symptoms. Additionally, pilot data suggest benefit from combining WBH and cognitive behavioral therapy (CBT), an established mind-based treatment for depression. The UCSF investigative team led an NCCIH- funded project testing WBH and CBT in adults with major depressive disorder and have found the combined treatment to be feasible and acceptable. Additionally, preliminary data from this project suggest a clinically meaningful and statistically significant reduction in depression symptoms. Despite promising initial data from such pilot studies, rigorous and well-designed clinical trials are required to evaluate the efficacy of depression treatments that include WBH. Before the investigative team can conduct a definitive efficacy trial, they must assess the feasibility of key study design components. This proposal will test the feasibility of a multi-site 2 x 2 factorial trial design that randomizes adults (N=60) with MDD to two treatment factors: WBH (yes/no) and CBT (yes/no). The three-site investigative team (University of California San Francisco, Cleveland Clinic Foundation, Massachusetts General Hospital) will capitalize on their established collaborative relationships to assess the feasibility of recruitment, enrollment, randomization, and retention (Aim 1), intervention fidelity and acceptability (Aim 2), and consistency of data collection (Aim 3). The study will include a 2-week screening period, a 10-week intervention period, and a 12-week follow-up period. During the intervention period, participants randomized to WBH will receive four biweekly sessions, and participants randomized to CBT will receive eight weekly sessions. If successful, the proposed multi-site feasibility R01 trial will lay key groundwork for a future multi-site 2 x 2 factorial efficacy trial that will test the effects of WBH, CBT, and their combination on depression symptoms. If successful, this program of research may yield novel non-drug treatment options for millions of individuals struggling with depression.
