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Идёт набор NCT06263738

Cold and Heat Investigation to Lower Levels of Depression

Без фазы С лечением Depression Mood Disorders Healthy (Controls)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Whole Body Hyperthermia, Cold Water Plunge.
Кому может быть актуально
Состояния в реестре: Depression, Mood Disorders, Healthy (Controls). Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This study will recruit 112 medically healthy adults (aged 18-65) currently experiencing depressive symptoms to be randomized to receive either a single Whole Body Hyperthermia (heat therapy) treatment or a Whole Body Hyperthermia treatment followed by a cold water plunge. Participants will complete a baseline assessment of their depressive symptoms as well as 1-week and 2-week post-treatment followup assessments.

Подробное описание

The CHILL'D Study aims to figure out how using heat exposure as a treatment for major depressive disorder (MDD) can work better. The researchers want to see if being exposed to heat followed by cold plunge can help people feel better emotionally compared to just being exposed to heat alone.

To answer study questions, 112 adults, ages 18 to 65 experiencing depression for at least 60 days and who meet study eligibility criteria, will be randomized with 1-to-1 allocation to receive either 1) a single session of heat exposure or 2) a single session of heat exposure followed immediately by cold plunge.

A second cohort of up to 50 adults, ages 18 to 65 not experiencing MDD will be randomized with 1-to-1 allocation to the same interventions.

Participants in the heat exposure alone group will receive a single heat session using the Clearlight Sauna Dome lasting up to 140 minutes. Participants in the heat exposure and cold plunge group will receive a single heat session using the Clearlight Sauna Dome lasting up to 140 minutes followed by a cold plunge session lasting up to 10 minutes.

Вмешательства

  • Процедура Whole Body Hyperthermia
    Participants in the heat exposure alone group will receive a single heat session using the Clearlight Sauna Dome lasting up to 140 minutes
  • Процедура Cold Water Plunge
    Participants in the heat exposure and cold plunge group will receive a single heat session using the Clearlight Sauna Dome lasting up to 140 minutes followed by a cold plunge session in 55 degree (Fahrenheit) water, lasting up to 10 minutes.

Первичные конечные точки

  • Montgomery-Åsberg Depression Rating Scale (MADRS) [Срок оценки: Baseline/Treatment (Visit 1), 1 Week Post-Treatment (Visit 2), 2 Weeks Post-Treatment (Visit 3)]
Вторичные конечные точки (4)
  • Warwick Edinburgh Mental Well-Being Scale (WEMWBS) [Срок оценки: Baseline/Treatment (Visit 1), 1 Week Post-Treatment (Visit 2), 2 Weeks Post-Treatment (Visit 3)]
  • Patient Reported Outcome Measure Information System (PROMIS) 8A - Anxiety [Срок оценки: Baseline/Treatment (Visit 1), 1 Week Post-Treatment (Visit 2), 2 Weeks Post-Treatment (Visit 3)]
  • Sheehan Disability Scale (SDS) [Срок оценки: Baseline/Treatment (Visit 1), 1 Week Post-Treatment (Visit 2), 2 Weeks Post-Treatment (Visit 3)]
  • Quality of Life Enjoyment & Satisfaction Questionnaire Short Form (Q-LES-Q SF) [Срок оценки: Baseline/Treatment (Visit 1), 1 Week Post-Treatment (Visit 2), 2 Weeks Post-Treatment (Visit 3)]

Критерии участия

Критерии включения

  • Individuals who currently meet study criteria for depression or individuals who do not currently meet criteria for depression
  • English or Spanish speaking (able to provide informed consent and complete questionnaires in one of these languages)
  • Able and willing to adhere to trial requirements, including attending all trial visits, preparatory and follow-up sessions, and completing all trial evaluations.

Критерии исключения

  • Previous adverse reaction to hypothermia, hyperthermia and/or infrared exposure
  • Use of any medication that may impact thermoregulatory capacity.
  • Pregnancy, active lactation, or intention to become pregnant during the study period.
  • Endorses current active suicidal ideation with a plan or made a suicide attempt in the prior 6 months.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Vail Health Behavioral Health Innovation Center — Edwards

Идентификаторы

NCT: NCT06263738 · 20244106

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗