None listed
Conditions
Brief summary
New, effective biological interventions for treatment of depressive episodes and recurrent depression are still needed. Whole-body cryotherapy (WBC), which is a treatment using cryogenic temperature, is a novel therapeutic modality in neurology and rheumatology. The objective of this study was to determine the efficacy and safety of WBC as an add-on treatment for depressive episode.
Interventions
The Whole-Body Cryotherapy (WBC). A cryotherapy chamber (CR 2002, Wroclaw type, provided by Creator Sp. z o. o.), cooled by liquid nitrogen consists of two rooms: the vestibule/antechamber (temperature: -60 C-degrees) and the proper chamber (temperature – days: 1st day: -110 C-degrees, 2nd: - 115 C-degrees, 3rd: -120 C-degrees, 4th: -130 C-degrees, 5th and 6th: -135 C-degrees, 7th: -130 C-degrees, 8th: -125 C-degrees, 9th: -120 C-degrees, 10th: -115 C-degrees). There is no direct contact with the liquid nitrogen in this type of device. The usual WBC session lasts for 2 minutes in the main chamber with 30 seconds extra for adaptation in the vestibule before and after the proper session. Each procedure is under control by the personnel - the interevntion was administered by physiotherapist. A group of 5–6 people usually uses the device at the same time. Participants are required to wear shorts and t-shirt, gloves, headband or beanie, a nose and mouth mask, high-knee socks and wooden shoes. This outfit should be woollen or cotton to reduce the risk of injuries caused by cold. Before every WBC session participants had the blood pressure measured. Participants undertake 10 whole-body cryotherapy sessions for two weeks (Monday–Friday without weekend).
Sponsors
Polish Ministry of Science and Higher Education
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Medically stable (based on physical examination, medical history and vital signs at screening) adults with a diagnosis of depressive episode (F.32 or F.33 according to research criteria of International Classification of Diseases, ICD-10).
Exclusion criteria
The exclusion criteria were alcohol and drug abuse, dementia diagnosis, inability to understand questions and written information, psychosis, suicidal thoughts, standard contraindications to use WBC (e.g. acute respiratory diseases, acute cardiovascular disease like coronary disease, circulatory insufficiency, unstable hypertension, cold intolerance, claustrophobia, cryoglobulinemia, cancer, deep vein diseases, hypothyroidism, neuropathies, purulent skin changes, Reynaud disease) and previous exposition to WBC treatment.
Outcome results
None listed