Multi-site Feasibility of an Integrated Treatment for the Biology and Experience of Depression: The MULTIBED Study
Assessing Multi-site Feasibility of an Integrated Whole-body Hyperthermia and Behavioral Intervention for Major Depressive Disorder: The MULTIBED Study
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests talk therapy called cognitive behavioral therapy (CBT), whole-body heating in a sauna device, or both for depression. It is for adults age 18 or older with major depression. The treatments include 8 weekly therapy sessions and 4 heating sessions.
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are age 18 or older.
- You can read and speak English.
- You understand the study and can give written consent to join.
- You have had a current episode of major depression for at least 2 weeks, confirmed by an interview, and score at least 10 on the PHQ-8 depression survey.
- If you were assigned female at birth and have not gone through menopause, you are willing to use birth control.
- You can lie on your back in a sauna device for 2 hours.
- You have internet access through a computer, smartphone, or tablet.
Who can't join
- Your BDI-II depression score drops by more than 30% between two screening visits about a week apart; you attempted suicide in the past year; or you score 3 on the survey's question about suicidal thoughts.
- You have heart or blood vessel disease other than controlled high blood pressure; seizures; a past stroke or another serious brain or nerve condition; a current tumor; a trapped infection, such as a dental abscess; a bleeding disorder; or another condition that could make heating unsafe.
- You have a current or past mental health condition that may better explain your depression, such as schizophrenia, schizoaffective disorder, bipolar I disorder, obsessive-compulsive disorder, anorexia, bulimia, or alcohol or drug dependence. You also cannot join if you started new talk therapy in the past 6 weeks.
- You are unusually sensitive to heat or infrared exposure, cannot fit in the sauna device, or have breast implants. You are pregnant, breastfeeding, or plan to become pregnant during the study.
- You take medicines that may affect body temperature control or study safety. These include certain water pills, sedatives, heart medicines, mental health medicines, allergy medicines, and aspirin other than low-dose prevention use. You must have been off depression medicines for at least 4 weeks. Antibiotics, opioid pain medicine for a procedure, or emergency birth control pills in the past 14 days also exclude you.
- You recently took several doses in a row of anti-inflammatory medicines, such as NSAIDs, steroids that act throughout the body, or cytokine blockers.
- You regularly use nicotine. If you use it only sometimes, you must avoid it for 24 hours before and after heating sessions. You must also avoid marijuana and alcohol during those times and heavy exercise on heating days.
- You are unwilling to avoid saunas, hot yoga, cold plunges, cold therapy, and hot tubs outside the study, or you used them within 30 days before your baseline study visit.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * 18 years or older * Able to read and speak in English * Able to understand the nature of the study and able to provide written informed consent * Current major depressive episode of at least 2 weeks duration as assessed by the Structured Clinical Interview for DSM-5 (SCID) and a Patient Health Questionnaire - 8 (PHQ-8) score of 10 or greater at screening * Willing to use a form of pregnancy contraceptive (e.g., barrier methods such as condoms, oral contraception, or other birth control type) if assigned female sex at birth and premenopausal * Able to lie supine for 2 hours in a sauna device * Access to the internet via computer, smartphone, or tablet Exclusion Criteria: * \>30% reduction in BDI-II score between Screen #1 and Screen #2 (conducted \~1 week after Screen #1) * Suicide attempt in the past 12 months defined using the SAMHSA suicidality question during the clinician-administered interview or active suicidal ideation as indexed by a score of 3 on the BDI-II suicidality item during the clinician-administered interview * Any of the following medical conditions: cardiovascular disease (other than controlled hypertension), seizure disorder, history of cerebrovascular accident (CVA) or other serious neurological condition (e.g. Parkinson's disease, multiple sclerosis, or dementia), current neoplasia, any active enclosed infection (e.g. dental abscess, joint infection), hemophilia or other cause for excessive bleeding (e.g. platelet disorder), or other medical condition that in the opinion of investigators may increase the risk of WBH * Comorbid psychiatric conditions or history of comorbid psychiatric conditions that might better explain depressive symptoms, including schizophrenia, schizoaffective disorder, Bipolar Disorder I, Obsessive Compulsive Disorder, Anorexia Nervosa, Bulimia Nervosa, Alcohol Dependence, or Drug Dependence * Known hypersensitivity to hyperthermia and/or infrared exposure * Inability to fit into the sauna device * Breast implants * Pregnancy, active lactation or intention to become pregnant during the study period * Use of any medication that might impact thermoregulatory capacity, including: Diuretics, barbiturates, beta-blockers, antipsychotic agents, anti-cholinergic agents or chronic use of antihistamines, aspirin (other than low-dose ASA for prophylactic purposes), medication prescribed for the treatment of depression (antidepressant medication \[ADM\]) including but not limited to: selective serotonin reuptake inhibitors \[SSRIs\], Serotonin and norepinephrine reuptake inhibitors \[SNRIs\], Monoamine oxidase inhibitors \[MAOIs\], Tricyclics \[TCAs\], and atypical antipsychotic and antidepressant medications (participants must have been free of these medications for at least 4 weeks), antibiotics (past 14 days), pain medication (opioids) due to procedure, e.g., dental procedure (past 14 days), Emergency contraception pill (past 14 days), or any other medication that in the judgment of the PI would increase risk of study participation or introduce excessive variance into physiological or behavioral responses to WBH * Recent use (multiple consecutive doses) of: non-steroidal anti-inflammatory drugs (NSAIDs), systemic corticosteroids, cytokine antagonists * Regular use of any nicotine products, including cigarettes, vapes, chewing tobacco, or other forms of nicotine (if use is not regular, must be willing to refrain for 24 hours before and 24 hours after WBH session) * Unwilling to refrain from using marijuana products and alcohol for the 24 hours before and 24 hours after WBH session * Unwilling to refrain from heavy exercise on the day of WBH sessions * Unwilling to refrain from engaging with sauna, hot yoga, cold plunges, cryotherapy, and hot tub/jacuzzi outside of study (prospective participant must not have engaged with any of these activities for 30 days prior to their baseline study visit). * Has begun new psychotherapy treatment in the prior 6 weeks
Study sites (3)
CA
- University of California, San Francisco, Osher Center for Integrative Health · San Francisco, CA 94115Sarah M Fisher, MA · Study contact · 415-514-8445 · Sarah.Fisher4@ucsf.eduAshley E Mason, PhD · Principal investigatorMore trials in San Francisco
MA
- Massachusetts General Hospital (MGH) · Boston, MA 02114Maren Nyer, PhD · Study contact · mnyer@mgh.harvard.eduMaren Nyer, PhD · Principal investigatorMore trials in Boston
OH
- Cleveland Clinic Foundation · Cleveland, OH 44195Narissa McCarty · Study contact · 216-780-1931 · MCCARTN3@CCF.orgChelsea Siwik, PhD · Principal investigatorMore trials in Cleveland