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Trial registered on ANZCTR


Registration number
ACTRN12623000712606
Ethics application status
Approved
Date submitted
13/06/2023
Date registered
5/07/2023
Date last updated
23/02/2024
Date data sharing statement initially provided
5/07/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Relaxation for Anxiety in healthy adults
Scientific title
Effects of two relaxation techniques on subclinical anxiety and neural processes in healthy Australian adults: a feasibility randomised controlled trial
Secondary ID [1] 309892 0
None
Universal Trial Number (UTN)
Trial acronym
ERASE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
subclinical anxiety 330355 0
Condition category
Condition code
Mental Health 327198 327198 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Relaxation training (yoga nidra), 8 week training, 2x30 min per week
Of the two sessions, one session is face-to-face, and at least one session is received online via audio recording that can be accessed via an online link
Participants will be instructed verbally by the teacher (psychologist) during the session, with no additional tools or props used
The yoga nidra training uses different components, including imagery, breathing, body scan and awareness, as well as light movements
Participants remain in a supine position for the relaxation intervention, using a mat, and blankets as needed to be comfortable
The adherence will be monitored by attendance lists (face-to-face), and an online log (online sessions)
The same intervention will be during the EEG (electroencephalography) sub-study, only that it will be carried out in the EEG lab, and in a comfortable chair, where the brain activity will be measured during yoga nidra. A total of 20 participants across both groups (ideally 10 each) will participate in the EEG study.
Intervention code [1] 326316 0
Behaviour
Comparator / control treatment
Conventional relaxation training (guided imagery), 8 week training, 2x30 min per week
Of the two sessions, one session is face-to-face, and at least one session is received online via audio recording that can be accessed via an online link
Participants will be instructed verbally by the teacher (psychologist) during the session to visualise different scenarios, with no additional tools or props used
The training uses imagery, combined with breathing and body awareness
Participants remain in a supine position for the relaxation intervention, using a mat, and blankets as needed to be comfortable
The adherence will be monitored by attendance lists (face-to-face), and an online log (online sessions)
The same intervention will be during the EEG (electroencephalography) sub-study, only that it will be carried out in the EEG lab, and in a comfortable chair, where the brain activity will be measured during guided imagery. A total of 20 participants across both groups (ideally 10 each) will participate in the EEG study.
Control group
Active

Outcomes
Primary outcome [1] 335074 0
Feasibility via recruitment success assessed using audit of study recruitment records
Timepoint [1] 335074 0
end of enrolment
Primary outcome [2] 335075 0
Feasibility via attrition rate assessed using audit of study records
Timepoint [2] 335075 0
end of study
Primary outcome [3] 335076 0
Feasibility via treatment adherence assessed using session attendance records and checklists, as well as online trackers for online components
Timepoint [3] 335076 0
end of interventions (8 weeks post-baseline)
Secondary outcome [1] 422928 0
Satisfaction with interventions
Timepoint [1] 422928 0
end of interventions (8 weeks post-baseline) via semi-structured qualitative interviews one-on-one, and face to face with a member of the research team
Secondary outcome [2] 422929 0
Anxiety via State Trait Anxiety Inventory (STAI)
Timepoint [2] 422929 0
baseline (pre-intervention) and end of interventions (8 weeks post-baseline)
Secondary outcome [3] 422930 0
Anxiety via Beck Anxiety Inventory (BAI)
Timepoint [3] 422930 0
baseline (pre-intervention) and end of interventions (8 weeks post-baseline)
Secondary outcome [4] 422931 0
Anxiety via PROMIS Short Form v1.0 - Anxiety 8
Timepoint [4] 422931 0
baseline (pre-intervention) and end of interventions (8 weeks post-baseline)
Secondary outcome [5] 422932 0
Worry via Penn State Worry Questionnaire (PSWQ)
Timepoint [5] 422932 0
baseline (pre-intervention) and end of interventions (8 weeks post-baseline)
Secondary outcome [6] 422933 0
Stress via Perceived Stress Scale (PSS)
Timepoint [6] 422933 0
baseline (pre-intervention) and end of interventions (8 weeks post-baseline)
Secondary outcome [7] 422934 0
Safety via adverse events in accordance with the Common Terminology Criteria for Adverse Events (CTCAE5.0), measured via self-report at each contact with the investigators
Common self-reported adverse effects of relaxation can be emotional reactions, or drowsiness/fatigue after the training.
Timepoint [7] 422934 0
weekly (1-8 weeks post baseline)
end of interventions (8 weeks post-baseline)
Secondary outcome [8] 422935 0
Neural Activity via brain wave patterns assessed using electroencephalogram (EEG)
Timepoint [8] 422935 0
baseline (pre-intervention) and end of interventions (8 weeks post-baseline)
Secondary outcome [9] 422936 0
Meditation Depth via Meditation Depth Questionnaire (MEDEQ)
Timepoint [9] 422936 0
end of interventions (8 weeks post-baseline)

Eligibility
Key inclusion criteria
- Healthy
- Aged 18 or older
- Mild anxiety (5-15 points on the Generalised Anxiety Disorder Scale (GAD-7)
- Access to computer or smartphone for access to online session material
- Availability for the duration of the eight week in-person intervention as well as availability one week before and after for pre-screening, filling out before and after questionnaires, and completion of documents
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Clinical diagnosis of anxiety, depression, or other mental health disorder
- Use of psychotropic medication (e.g., tranquillizers, sedatives or hypnotics)
- Risky alcohol consumption, or illicit drug use (specifically hallucinogenic substances)
- Adults with conditions interfering with the exercises (light stretching, relaxation in supine position)
- Pregnancy
- Regular meditation or relaxation practice in the past 6 months

Those participating in the EEG sub-study also have the following criteria:
- History of claustrophobia, i.e. intense fear of enclosed spaces
- medical, psychiatric, or drug usage that might alter brain functioning

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)
Randomisation will occur via REDCap.
The person randomising the participants has no access to the random number table.
After entering the participants details into REDCap, they will then randomise via REDCap, and receive the participant allocation.
The random number list will be uploaded into REDCap by a researcher not involved in recruitment, treatment or measurements.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random number table will be established via sealedenvelope.com, using a stratified block randomisation (strata: gender), block sizes between 4 and 8 in random order. The randomisation sequence generation will be done by a researcher not involved in recruitment, treatment or measurements.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
19/06/2023
Date of last participant enrolment
Anticipated
13/07/2023
Actual
13/07/2023
Date of last data collection
Anticipated
31/12/2023
Actual
18/09/2023
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 40549 0
2450 - Coffs Harbour

Funding & Sponsors
Funding source category [1] 314076 0
University
Name [1] 314076 0
Southern Cross University
Country [1] 314076 0
Australia
Primary sponsor type
University
Name
Southern Cross University
Address
Military Rd
East Lismore NSW 2480
Australia
Country
Australia
Secondary sponsor category [1] 315985 0
None
Name [1] 315985 0
N/A
Address [1] 315985 0
N/A
Country [1] 315985 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313215 0
Southern Cross University HREC
Ethics committee address [1] 313215 0
Ethics committee country [1] 313215 0
Australia
Date submitted for ethics approval [1] 313215 0
26/05/2023
Approval date [1] 313215 0
30/05/2023
Ethics approval number [1] 313215 0
2023/091

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

Contacts
Principal investigator
Name 127370 0
A/Prof Romy Lauche
Address 127370 0
National Centre for Naturopathic Medicine
Military Rd
East Lismore NSW 2480
Australia
Country 127370 0
Australia
Phone 127370 0
+61 266203362
Fax 127370 0
Email 127370 0
romy.lauche@scu.edu.au
Contact person for public queries
Name 127371 0
Helen Moors
Address 127371 0
Southern Cross University
Military Rd
East Lismore NSW 2480
Australia
Country 127371 0
Australia
Phone 127371 0
+61 266203362
Fax 127371 0
Email 127371 0
h.moors.10@student.scu.edu.au
Contact person for scientific queries
Name 127372 0
Romy Lauche
Address 127372 0
National Centre for Naturopathic Medicine
Military Rd
East Lismore NSW 2480
Australia
Country 127372 0
Australia
Phone 127372 0
+61 266203362
Fax 127372 0
Email 127372 0
romy.lauche@scu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a PhD project, and no approval has been obtained for data sharing outside the university


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
No additional documents have been identified.