Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Multi-site Feasibility of an Integrated Treatment for the Biology and Experience of Depression: The MULTIBED Study

12 maggio 2026 aggiornato da: University of California, San Francisco

Assessing Multi-site Feasibility of an Integrated Whole-body Hyperthermia and Behavioral Intervention for Major Depressive Disorder: The MULTIBED Study

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).

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Stati Uniti
    • California
      • San Francisco, California, Stati Uniti, 94115
        • University of California, San Francisco, Osher Center for Integrative Health
        • Investigatore principale:
          • Ashley E Mason, PhD
        • Contatto:
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02114
        • Massachusetts General Hospital (MGH)
        • Investigatore principale:
          • Maren Nyer, PhD
        • Contatto:
    • Ohio
      • Cleveland, Ohio, Stati Uniti, 44195
        • Cleveland Clinic Foundation
        • Investigatore principale:
          • Chelsea Siwik, PhD
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione fattoriale
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: 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).
Sperimentale: 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.
Dispositivo: Whole-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.
Sperimentale: CBT Only
Participants receive 8 cognitive behavioral therapy (CBT) sessions. Each CBT session is approximately 50 minutes.
Comportamentale: Terapia cognitivo comportamentale (CBT)
La terapia cognitivo comportamentale (CBT) è un intervento comportamentale (psicoterapeutico) per il disturbo depressivo maggiore (MDD). Un master altamente qualificato o un medico di livello PhD somministrerà 8 sessioni settimanali di CBT (~ 50 minuti ciascuna), seguendo la terapia cognitivo comportamentale standard per il protocollo della depressione.
Sperimentale: 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.
Comportamentale: Terapia cognitivo comportamentale (CBT)
La terapia cognitivo comportamentale (CBT) è un intervento comportamentale (psicoterapeutico) per il disturbo depressivo maggiore (MDD). Un master altamente qualificato o un medico di livello PhD somministrerà 8 sessioni settimanali di CBT (~ 50 minuti ciascuna), seguendo la terapia cognitivo comportamentale standard per il protocollo della depressione.
Dispositivo: Whole-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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Retention
Lasso di tempo: 12 weeks
Proportion of participants completing the final assessment (Target: 80% of participants)
12 weeks
CBT Intervention Fidelity
Lasso di tempo: 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)
12 weeks
WBH Intervention Fidelity
Lasso di tempo: 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)
12 weeks
Study Assessment Completion
Lasso di tempo: 6 months
Proportion of study assessments completed, including weekly surveys and post-intervention and follow-up assessments (Target: 85% of assessments)
6 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of California, San Francisco

Collaboratori

National Center for Complementary and Integrative Health (NCCIH)

Investigatori

  • Investigatore principale: Ashley E Mason, PhD, University of California, San Francisco

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

31 marzo 2029

Completamento dello studio (Stimato)

31 marzo 2029

Date di iscrizione allo studio

Primo inviato

12 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

12 maggio 2026

Primo Inserito (Effettivo)

19 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

19 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • MULTIBED
  • R01AT013214 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

The final IPD dataset will include self-reported demographic data, other self-reported data (e.g., subjective mood measures), and clinician-assessed data (e.g., depression diagnosis status).

Periodo di condivisione IPD

Beginning 3 months after the publication of results and unending.

Criteri di accesso alla condivisione IPD

Data will be accessible via the Vivli platform. To access IPD arising from this project, users must complete the Vivli data request form and sign the Vivli Data Use Agreement, which limits subsequent use to the terms of the approved request and requires that users maintain data security, and refrain from any attempts to reidentify research participants or engage in any unauthorized uses of the data. In order to get access to the data, the user must submit a valid scientific question, include a statistical analysis plan, and complete all required fields on the Vivli data request form. Vivli will review the data request for completeness. Anyone who has submitted an approved data request and signed a data use agreement on Vivli will be given access to the data. Vivli will then make the data available, without cost, to users for a set period of time. Vivli will maintain storage and access of the data for as long as it maintains scientific utility.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sottoscrivi