Assessing Multi-site Feasibility of an Integrated Whole-body Hyperthermia and Behavioral Intervention for Major Depressive Disorder: The MULTIBED Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Retention
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
Study clinician-assessors will perform clinical interviews and provide CBT, but will be masked to the participants' WBH condition (yes/no).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •>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
研究组 & 干预措施
No Interventions
No study-provided interventions. In this design, participants randomized to receive neither intervention can receive any treatment recommended by their healthcare provider (except for engagement with new WBH practices).
WBH Only
Participants receive 4 bi-weekly whole-body hyperthermia (WBH) sessions that raise core body temperature to 38.5 C. Each WBH session (including preparation and post-session activities) is up to approximately 3.5 hours.
干预措施: Whole-Body Hyperthermia (Device)
CBT Only
Participants receive 8 cognitive behavioral therapy (CBT) sessions. Each CBT session is approximately 50 minutes.
干预措施: Cognitive Behavioral Therapy (CBT) (Behavioral)
WBH and CBT
Participants receive 8 cognitive behavioral therapy (CBT) sessions and 4 bi-weekly whole-body hyperthermia (WBH) sessions that raise core body temperature to 38.5 C. Each WBH session (including preparation and post-session activities) is up to approximately 3.5 hours, and each CBT session is approximately 50 minutes.
干预措施: Cognitive Behavioral Therapy (CBT) (Behavioral)
WBH and CBT
Participants receive 8 cognitive behavioral therapy (CBT) sessions and 4 bi-weekly whole-body hyperthermia (WBH) sessions that raise core body temperature to 38.5 C. Each WBH session (including preparation and post-session activities) is up to approximately 3.5 hours, and each CBT session is approximately 50 minutes.
干预措施: Whole-Body Hyperthermia (Device)
结局指标
主要结局
Retention
时间窗: 12 weeks
Proportion of participants completing the final assessment (Target: 80% of participants)
CBT Intervention Fidelity
时间窗: 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
时间窗: 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
时间窗: 6 months
Proportion of study assessments completed, including weekly surveys and post-intervention and follow-up assessments (Target: 85% of assessments)
次要结局
未报告次要终点