Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001451796
Ethics application status
Approved
Date submitted
10/10/2022
Date registered
14/11/2022
Date last updated
14/11/2022
Date data sharing statement initially provided
14/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of a Cold-Shower Therapeutic Intervention on Symptoms Associated with Depression.
Scientific title
Effects of a Cold-Shower Therapeutic Intervention on Symptoms Associated with Depression Amongst First-Year University Students.
Secondary ID [1] 308080 0
Nil Known
Universal Trial Number (UTN)
U1111-1283-2753
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 327794 0
Wellbeing 327795 0
Condition category
Condition code
Mental Health 324865 324865 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The experimental group will take part in a series of six cold-shower treatments, over a two-week period utilizing a controlled breathing technique. On Monday, Wednesday and Friday mornings, participants will be asked to take a three-minute cold-shower. Detailed instructions will be provided in an electronic information sheet and through an introductory video that will be embedded within the electronic information sheet.
Participants will be instructed in a breathing technique designed to negate the “cold-shock” response that may accompany cold-water immersion. This technique involves control of the depth of ones’ respiration and respiratory rate. A long slow in-breath through the nostrils, drawing air into the diaphragm, followed by a slow exhalation through the mouth, making a whooshing sound whilst progressively relaxing muscle groups, can assist in controlling respiration, avoid reflex hyperventilation often associated with cold-shock and help to maintain a resting heart rate.
Participants will require a towel, bathmat or towel to place on the floor to help avoid slipping and a timer or stopwatch.
The intervention will require that participants begin practicing the breathing technique before entering the cold shower and that the cold tap is turned on prior to stepping into the shower. Participants will be asked to set their timer or stopwatch for three minutes. It is recommended that the participants immerse a leg first, slowly entering the shower, until they are fully immersed. Focus is to be maintained on the breathing technique and muscle relaxation. Participants will be instructed to ensure that the right lateral side of the neck is exposed to the cold-water, this area is a terminus for the auricular branch of the Vagal Nerve
At the end of the three minutes, participants may exit the shower, being careful not to slip. They may then take a warm shower if needed.
Adherence to the cold-shower treatment intervention will be assessed through self-report within the post-intervention survey. Participants will be asked whether they were able to comply with the intervention requirements over the course of the six hydrotherapeutic sessions. If unable to comply, participants will be asked to outline any reasons why they were unable to comply with the requirements. A text reminder will be sent to each participant the night before each hydrotherapeutic session to serve as a reminder and aid in increasing compliance (see below).

Dear research participant.
A friendly reminder of your upcoming hydrotherapeutic treatment tomorrow morning.
Please remember your participation in this research is voluntary and you may cease participation or withdraw from the study at any time, without comment or penalty.
If you have any questions or concerns, please contact the student researcher at the following email address: [email protected]
If you are experiencing any adverse psychological effects, please contact Beyond Blue: (1300 224636) or Lifeline (131114).
Thank you again for your participation.
Sincerely.
The research team.
Intervention code [1] 324566 0
Treatment: Other
Comparator / control treatment
An active control group will be used to compare the effectiveness of the cold-shower intervention with.
The control group will be instructed on the same breathing technique used by the intervention group. However, the active control group will not be exposed to the cold-shower treatment. Instead, the control group will be instructed to practice the breathing technique during regular showering three days per week for the trial period.
Mode of delivery: An online information sheet and pre-intervention survey will be provided to the control participants prior to commencement of the trial period. Griffith Universities' Lime Survey platform will be utilized to collect participant data. Following conclusion of the trial period, participants will receive an online post-intervention survey. A third online survey will be provided to the participants one month following conclusion of the trial. This third survey will assist in gauging any prolonged effects of the intervention.
When and how much: The shower and breathing exercise will take place in the participants homes on Monday, Wednesday and Friday mornings. Each session will last for three minutes. The trial period will be two weeks, resulting in a total of six treatment sessions.
Following conclusion of the trial and after the third survey has been returned, participants in the control group will receive a deception debrief, explaining the real aim of the trial and the need for deception. The control group will then have the cold-shower intervention made available to them, should they wish to engage in the treatment.
Control group
Active

Outcomes
Primary outcome [1] 332715 0
Severity of depressive symptomology will be assessed utilizing the Depression Anxiety Stress Scale 21 Item (DASS-21) Form.
Timepoint [1] 332715 0
Baseline, two (primary timepoint) and six-weeks post intervention commencement.
Primary outcome [2] 332716 0
Safety will be assessed by the incidence of adverse events including, but not limited to, reflex hyperventilation as assessed by self-report and light headedness, additionally assessed by self-report.
Self-reports will be recorded through Griffith Universities' online survey tool, Limesurvey. Limesurvey questionnaires will be administered online and can be accessed via computer and smartphone.
Timepoint [2] 332716 0
Safety assessment will be ongoing and assessed during each of the six cold-water therapeutic sessions. Monday, Wednesday and Friday mornings over the two-week trial.
Secondary outcome [1] 414480 0
Subjective level of wellbeing will be assessed using The World Health Organization – Five item Well-Being Index .
Timepoint [1] 414480 0
Baseline, two and six-weeks post intervention commencement.
Secondary outcome [2] 414481 0
Anxiety will be assessed using the anxiety subscale of the Depression, Anxiety Stress Scale (DASS-21)
Timepoint [2] 414481 0
Baseline, two and six-weeks post intervention commencement.
Secondary outcome [3] 414482 0
Stress will be assessed using the stress subscale of the Depression Anxiety Stress Scale (DASS-21).
Timepoint [3] 414482 0
Baseline, two and six-weeks post intervention commencement.
Secondary outcome [4] 414484 0
The Distress / Endorsement Validation Scale (DEVS), measures subjective levels of treatment distress and participant endorsement of therapeutic protocols.
Timepoint [4] 414484 0
Administered at conclusion of the trial, two weeks post-intervention commencement.

Eligibility
Key inclusion criteria
Current Griffith University students.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The following criteria will exclude participants from the study:
• If you have any cardiac disease or condition that through participation in the research, may cause risk of harm to you
• If you have changed medication for any mental illness within the past two weeks

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)
Participants will be allocated into experimental and control groups through central randomization by computer through use of research randomizers’ online random sampling calculator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization of participants into control and experimental group will be performed by research randomizers’ online random sampling calculator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
An a priori power analysis utilizing G*Power was conducted to estimate required sample size. Results of the analysis indicated that the required sample size needed in order to achieve 80 percent power, for detecting a medium effect size at significance of alpha = .05 was N = 34 for conducting a repeated measures Analysis of Variance. Previous research examining the effects of cold-water immersion on mood, reported a significant reduction in total mood disturbance with a large effect size. However the current study purports to adopt a more conservative approach, sufficiently powering the study in order to detect a medium effect size, f = .25. Assuming a 22 percent drop-out rate, the total number of participants required for the proposed study will be 42, where 21 participants will be randomly allocated to the experimental group and 21 to the control group.
Data will be screened for normality by checking for skewness and kurtosis. In addition, sphericity will be assessed using Mauchly’s test. If normality is assumed, the primary outcome, depressive symptomology and secondary outcome, current mental wellbeing as measured by the depression subscale of the DASS-21 and the WHO-5 respectively, will be analyzed through Analysis of Variance (ANOVA) for independent measures. Statistical tests will be conducted in SPSS.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2022
Actual
Date of last participant enrolment
Anticipated
3/04/2023
Actual
Date of last data collection
Anticipated
22/05/2023
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 38731 0
4222 - Griffith University

Funding & Sponsors
Funding source category [1] 312329 0
University
Name [1] 312329 0
Griffith University
Country [1] 312329 0
Australia
Primary sponsor type
Individual
Name
Dr. Kairi Kolves
Address
Griffith University
176 Messines Ridge Rd
Mount Gravatt QLD
4122
Country
Australia
Secondary sponsor category [1] 313889 0
Individual
Name [1] 313889 0
Mrs. Jacinta Hawgood
Address [1] 313889 0
Griffith University
176 Messines Ridge Rd
Mount Gravatt QLD
4122
Country [1] 313889 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311696 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 311696 0
Ethics committee country [1] 311696 0
Australia
Date submitted for ethics approval [1] 311696 0
21/06/2022
Approval date [1] 311696 0
27/09/2022
Ethics approval number [1] 311696 0
2022/561

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

Contacts
Principal investigator
Name 122034 0
Dr Kairi Kolves
Address 122034 0
Griffith University
176 Messines Ridge Rd
Mount Gravatt QLD
4122
Country 122034 0
Australia
Phone 122034 0
+61 07 3735 3380
Fax 122034 0
Email 122034 0
[email protected]
Contact person for public queries
Name 122035 0
edward crooke
Address 122035 0
Griffith University
176 Messines Ridge Rd
Mount Gravatt QLD
4122
Country 122035 0
Australia
Phone 122035 0
+1 63149489870
Fax 122035 0
Email 122035 0
[email protected]
Contact person for scientific queries
Name 122036 0
edward crooke
Address 122036 0
Griffith University
176 Messines Ridge Rd
Mount Gravatt QLD
4122
Country 122036 0
Australia
Phone 122036 0
+1 63149489870
Fax 122036 0
Email 122036 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified data collected during the trial
When will data be available (start and end dates)?
Immediately following publication, ending five years following main results publication.
Available to whom?
Only researchers who provide a methodologically sound proposal.
Available for what types of analyses?
To achieve aims in approved proposals and for the purposes of IDP meta-analyses.
How or where can data be obtained?
Access subject to approval by Student Researcher
Mr. Sam Crooke
[email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17307Informed consent form  [email protected] 384744-(Uploaded-10-10-2022-05-28-45)-Study-related document.docx



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.