Major Depressive Disorder
Conditions
Keywords
Whole-Body Hyperthermia, Heat Therapy, Passive Heating, Cognitive Behavioral Therapy
Brief summary
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).
Detailed description
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.
Interventions
BEHAVIORALCognitive Behavioral Therapy (CBT)
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.
DEVICEWhole-Body Hyperthermia
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.
Sponsors
University of California, San Francisco
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
Study clinician-assessors will perform clinical interviews and provide CBT, but will be masked to the participants' WBH condition (yes/no).
Intervention model description
Participants are randomized to whole-body hyperthermia (yes/no) and cognitive behavioral therapy (yes/no). This is a 2x2 factorial design.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention | 12 weeks | Proportion of participants completing the final assessment (Target: 80% of participants) |
| CBT Intervention Fidelity | 12 weeks | Proportion of CBT sessions coded in the proficient range (score of 48 or greater) on the Cognitive Therapy Scale - Revised (Target: 85% of sessions) |
| WBH Intervention Fidelity | 12 weeks | 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) |
| Study Assessment Completion | 6 months | Proportion of study assessments completed, including weekly surveys and post-intervention and follow-up assessments (Target: 85% of assessments) |
Countries
United States
Contacts
CONTACTAshley E Mason, PhD
CONTACTSarah M Fisher, MS
PRINCIPAL_INVESTIGATORAshley E Mason, PhD
University of California, San Francisco
Outcome results
None listed