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Trial registered on ANZCTR


Registration number
ACTRN12619001600134
Ethics application status
Approved
Date submitted
18/09/2019
Date registered
20/11/2019
Date last updated
20/11/2019
Date data sharing statement initially provided
20/11/2019
Date results provided
20/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The whole-body cryotherapy in depression
Scientific title
The whole-body cryotherapy as an augumentation non-pharmacological treatment of depression in adults
Secondary ID [1] 299327 0
Pbmn 167
Universal Trial Number (UTN)
U1111-1240-5400
Trial acronym
KrioDe
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 314470 0
Condition category
Condition code
Alternative and Complementary Medicine 312805 312805 0 0
Other alternative and complementary medicine
Mental Health 312806 312806 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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).
Intervention code [1] 315597 0
Treatment: Other
Comparator / control treatment
The participants from the control (sham) group undertake 10 sessions for two weeks (Monday – Friday without weekend) in the low temperatures -50 ºC but not cryogenic ones in the proper chamber.
Control group
Placebo

Outcomes
Primary outcome [1] 321425 0
Beck Depression Inventory II total score
Timepoint [1] 321425 0
Baseline before 1st session (T1), after the 6th (T2), 10th WBC (T3) sessions and at follow-up after two weeks from the ending of sessions (T4) with primary timepoint T1 and T3
Primary outcome [2] 321426 0
Beck Depression Inventory II two subscales scores and response rates (defined as a 50% decrease in BDI-II total score as well as subscales from baseline). Two dimensions within BDI-II of self-reported depression for psychiatric outpatients in general will be assessed: Cognitive-Affective (BDI-II D1; first 13 items) and Somatic dimensions (BDI-II D2; items 14-21).
Timepoint [2] 321426 0
Baseline before 1st session (T1), after the 6th (T2), 10th WBC (T3) sessions and at follow-up after two weeks from the ending of sessions (T4) with primary timepoint T1 and T3
Secondary outcome [1] 374922 0
Self-report on “well-being” issues including: mood, vitality and sleep quality using Visual Analogue Scales (VAS) - a composite secondary outcome
Timepoint [1] 374922 0
Baseline before 1st session (T1) after the 6th (T2), 10th WBC (T3) sessions and at follow-up after two weeks from the ending of sessions (T4)
Secondary outcome [2] 374923 0
Level of acceptance of the disease (depression) using Acceptance of Illness Scale (AIS)
Timepoint [2] 374923 0
Baseline before 1st session (T1) and at follow-up after two weeks from the ending of sessions (T4)
Secondary outcome [3] 374924 0
Level of sexual satisfaction using The Sexual Life Satisfaction Questionnaire (SLSQ)
Timepoint [3] 374924 0
Baseline before 1st session (T1) after the 6th (T2), 10th WBC (T3) sessions and at follow-up after two weeks from the ending of sessions (T4)
Secondary outcome [4] 375981 0
Quality of life assesed using The World Health Organization Quality of Life – BREF (WHOQOL – BREF)
Timepoint [4] 375981 0
Baseline before 1st session (T1) and at follow-up after two weeks from the ending of sessions (T4)
Secondary outcome [5] 375982 0
Quality of life assesed using EQ-5D
Timepoint [5] 375982 0
Baseline before 1st session (T1) and at follow-up after two weeks from the ending of sessions (T4)
Secondary outcome [6] 375983 0
The levels of cytokines (Il-6 and IL-10) measured in plasma by ELISA.
Timepoint [6] 375983 0
Baseline before 1st session (T1) and after 10th WBC (T3) sessions
Secondary outcome [7] 375984 0
The levels of NO measured in plasma by Griess reaction.
Timepoint [7] 375984 0
Baseline before 1st session (T1) and after 10th WBC (T3) sessions
Secondary outcome [8] 375985 0
The levels of hsCRP in serum determined by CRP High Sensitivity kit (DiaSys, Germany)
Timepoint [8] 375985 0
Baseline before 1st session (T1) and after 10th WBC (T3) sessions
Secondary outcome [9] 375986 0
The levels hsCRP in serum determined by TAS Randox kit (United Kingdom) using Konelab 20i (ThermoScientific, USA) autoanalyzer.
Timepoint [9] 375986 0
Baseline before 1st session (T1) and after 10th WBC (T3) sessions

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/08/2014
Date of last participant enrolment
Anticipated
Actual
9/11/2018
Date of last data collection
Anticipated
Actual
30/11/2018
Sample size
Target
60
Accrual to date
Final
56
Recruitment outside Australia
Country [1] 21869 0
Poland
State/province [1] 21869 0

Funding & Sponsors
Funding source category [1] 303844 0
Government body
Name [1] 303844 0
Polish Ministry of Science and Higher Education
Country [1] 303844 0
Poland
Primary sponsor type
Government body
Name
Polish Ministry of Science and Higher Education
Address
20 Hoza Street,
00-529 Warszawa,
Country
Poland
Secondary sponsor category [1] 303979 0
None
Name [1] 303979 0
Address [1] 303979 0
Country [1] 303979 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304357 0
Bioethical Committee, Wroclaw Medical Univeristy
Ethics committee address [1] 304357 0
Ethics committee country [1] 304357 0
Poland
Date submitted for ethics approval [1] 304357 0
Approval date [1] 304357 0
03/07/2014
Ethics approval number [1] 304357 0
KB-406/2014, KB-252/2015

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96670 0
Dr Bartlomiej Stanczykiewicz
Address 96670 0
Department of Nervous System Diseases
Faculty of Health Science
Wroclaw Medical University
Bartla 5 Str., 51-618 Wroclaw, Poland
Country 96670 0
Poland
Phone 96670 0
+48717841600
Fax 96670 0
+48717841602
Email 96670 0
bartlomiej.stanczykiewicz@umed.wroc.pl
Contact person for public queries
Name 96671 0
Bartlomiej Stanczykiewicz
Address 96671 0
Department of Nervous System Diseases
Faculty of Health Science
Wroclaw Medical University
Bartla 5 Str., 51-618 Wroclaw, Poland
Country 96671 0
Poland
Phone 96671 0
+48717841600
Fax 96671 0
+48717841602
Email 96671 0
bartlomiej.stanczykiewicz@umed.wroc.pl
Contact person for scientific queries
Name 96672 0
Bartlomiej Stanczykiewicz
Address 96672 0
Department of Nervous System Diseases
Faculty of Health Science
Wroclaw Medical University
Bartla 5 Str., 51-618 Wroclaw, Poland
Country 96672 0
Poland
Phone 96672 0
+48717841600
Fax 96672 0
+48717841602
Email 96672 0
bartlomiej.stanczykiewicz@umed.wroc.pl

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No patient permission to share data outside this study.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEfficacy of the Whole-Body Cryotherapy as Add-on Therapy to Pharmacological Treatment of Depression-A Randomized Controlled Trial.2020https://dx.doi.org/10.3389/fpsyt.2020.00522
N.B. These documents automatically identified may not have been verified by the study sponsor.