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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
Date results information initially provided
23/02/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
Relaxation for Anxiety in healthy adults
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Scientific title
Effects of two relaxation techniques on subclinical anxiety and neural processes in healthy Australian adults: a feasibility randomised controlled trial
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Secondary ID [1]
309892
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None
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Universal Trial Number (UTN)
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Trial acronym
ERASE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
subclinical anxiety
330355
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Condition category
Condition code
Mental Health
327198
327198
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0
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Anxiety
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
326316
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Behaviour
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Feasibility via recruitment success assessed using audit of study recruitment records
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Assessment method [1]
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Timepoint [1]
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end of enrolment
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Primary outcome [2]
335075
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Feasibility via attrition rate assessed using audit of study records
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Assessment method [2]
335075
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Timepoint [2]
335075
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end of study
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Primary outcome [3]
335076
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Feasibility via treatment adherence assessed using session attendance records and checklists, as well as online trackers for online components
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Assessment method [3]
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Timepoint [3]
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end of interventions (8 weeks post-baseline)
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Secondary outcome [1]
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Satisfaction with interventions
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Assessment method [1]
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Timepoint [1]
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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
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Secondary outcome [2]
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Anxiety via State Trait Anxiety Inventory (STAI)
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Assessment method [2]
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Timepoint [2]
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baseline (pre-intervention) and end of interventions (8 weeks post-baseline)
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Secondary outcome [3]
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Anxiety via Beck Anxiety Inventory (BAI)
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Assessment method [3]
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Timepoint [3]
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baseline (pre-intervention) and end of interventions (8 weeks post-baseline)
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Secondary outcome [4]
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Anxiety via PROMIS Short Form v1.0 - Anxiety 8
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Assessment method [4]
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Timepoint [4]
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baseline (pre-intervention) and end of interventions (8 weeks post-baseline)
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Secondary outcome [5]
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Worry via Penn State Worry Questionnaire (PSWQ)
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Assessment method [5]
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Timepoint [5]
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baseline (pre-intervention) and end of interventions (8 weeks post-baseline)
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Secondary outcome [6]
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Stress via Perceived Stress Scale (PSS)
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Assessment method [6]
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Timepoint [6]
422933
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baseline (pre-intervention) and end of interventions (8 weeks post-baseline)
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Secondary outcome [7]
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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.
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Assessment method [7]
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Timepoint [7]
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weekly (1-8 weeks post baseline)
end of interventions (8 weeks post-baseline)
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Secondary outcome [8]
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Neural Activity via brain wave patterns assessed using electroencephalogram (EEG)
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Assessment method [8]
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Timepoint [8]
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baseline (pre-intervention) and end of interventions (8 weeks post-baseline)
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Secondary outcome [9]
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Meditation Depth via Meditation Depth Questionnaire (MEDEQ)
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Assessment method [9]
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Timepoint [9]
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end of interventions (8 weeks post-baseline)
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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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.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
19/06/2023
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Date of last participant enrolment
Anticipated
13/07/2023
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Actual
13/07/2023
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Date of last data collection
Anticipated
31/12/2023
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Actual
18/09/2023
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Sample size
Target
40
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Accrual to date
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Final
40
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment postcode(s) [1]
40549
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2450 - Coffs Harbour
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Funding & Sponsors
Funding source category [1]
314076
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University
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Name [1]
314076
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Southern Cross University
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Address [1]
314076
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Military Rd
East Lismore NSW 2480
Australia
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Country [1]
314076
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Australia
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Primary sponsor type
University
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Name
Southern Cross University
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Address
Military Rd
East Lismore NSW 2480
Australia
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Country
Australia
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Secondary sponsor category [1]
315985
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None
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Name [1]
315985
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N/A
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Address [1]
315985
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N/A
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Country [1]
315985
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
313215
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Southern Cross University HREC
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Ethics committee address [1]
313215
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Southern Cross University
PO Box 157, Lismore NSW 2480
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Ethics committee country [1]
313215
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Australia
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Date submitted for ethics approval [1]
313215
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26/05/2023
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Approval date [1]
313215
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30/05/2023
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Ethics approval number [1]
313215
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2023/091
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Summary
Brief summary
The aim of the proposed research is to investigate the feasibility of conducting a clinical trial of relaxation practice for outcomes of subclinical anxiety, stress, and worry in a healthy adult population via a smaller feasibility trial. A secondary aim is to determine the preliminary efficacy of two different relaxation practices when compared to each other practice across these outcomes. Lastly, the aim of the proposed research is to further understand the neurological mechanisms involved in relaxation practice and whether they may be associated with any clinical outcomes found.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Romy Lauche
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Address
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National Centre for Naturopathic Medicine
Military Rd
East Lismore NSW 2480
Australia
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Country
127370
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Australia
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Phone
127370
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+61 266203362
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Fax
127370
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Email
127370
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[email protected]
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Contact person for public queries
Name
127371
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Ms Helen Moors
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Address
127371
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Southern Cross University
Military Rd
East Lismore NSW 2480
Australia
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Country
127371
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Australia
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Phone
127371
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+61 266203362
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Fax
127371
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Email
127371
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[email protected]
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Contact person for scientific queries
Name
127372
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A/Prof Romy Lauche
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Address
127372
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National Centre for Naturopathic Medicine
Military Rd
East Lismore NSW 2480
Australia
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Country
127372
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Australia
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Phone
127372
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+61 266203362
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Fax
127372
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Email
127372
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
This is a PhD project, and no approval has been obtained for data sharing outside the university
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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.
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