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Trial registered on ANZCTR
Registration number
ACTRN12623000368639p
Ethics application status
Submitted, not yet approved
Date submitted
27/03/2023
Date registered
13/04/2023
Date last updated
13/04/2023
Date data sharing statement initially provided
13/04/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
Randomized E-Hypnotherapy for Chronic Pelvic Pain Syndrome Trial (REST)
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Scientific title
A randomised controlled trial comparing the influence of e-Hypnotherapy on pain, quality of life and healthcare costs in people with chronic pelvic pain syndrome
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Secondary ID [1]
309069
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
REST
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic pelvic pain
329140
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Condition category
Condition code
Reproductive Health and Childbirth
326117
326117
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0
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Menstruation and menopause
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Oral and Gastrointestinal
326521
326521
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0
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Inflammatory bowel disease
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Oral and Gastrointestinal
326522
326522
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0
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Crohn's disease
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Renal and Urogenital
326523
326523
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0
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Other renal and urogenital disorders
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Renal and Urogenital
326524
326524
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0
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Pelvic inflammatory disease
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Anaesthesiology
326525
326525
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0
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Pain management
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The study intervention is e-Hypnotherapy: participants randomised to e-Hypnotherapy will first receive one session of Chronic Pelvic Pain Syndrome (CPPS) and hypnosis education. Education will consist of information regarding pathophysiology of the pain process, specifically chronic pelvic pain, along with the impact that complimentary therapies such as hypnotherapy can have on pain. Education will be delivered via the website and will consist of short videos, animations and informative text sections to read. Following week one education, participants will need to listen to e-Hypnotherapy recordings at least once a week for seven weeks. The group will also be instructed to continue listening to recordings from the weeks prior whilst progressing. Each weekly recording will go for approximately one hour, with the total weekly time commitment being no more than three hours.
The active control is relaxation: participants randomised to relaxation will first receive one session of Chronic Pelvic Pain Syndrome (CPPS) similar to the hypnosis. Following week one education, participants will need to listen to relaxation recordings at least once a week for seven weeks. The group will also be instructed to continue listening to recordings from the weeks prior whilst progressing. Each weekly recording will go for approximately one hour, with the total weekly time commitment being no more than three hours.
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Intervention code [1]
325520
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Behaviour
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Intervention code [2]
325521
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Lifestyle
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Intervention code [3]
325522
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Treatment: Other
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Comparator / control treatment
The control treatment in this study will be waitlist: participants randomised to the waitlist arm will receive their usual care (e.g. pelvic pain specialist, pharmaceutical treatment, physiotherapy, complimentary medicines, etc) and will receive e-Hypnotherapy at the end of the testing period (12 months post-randomization).
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Control group
Active
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Outcomes
Primary outcome [1]
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The primary outcome measure will be pain severity at post-treatment (8 weeks) measured by the Brief Pain Inventory (BPI), which has good validity and reliability
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Assessment method [1]
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Timepoint [1]
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8 weeks (primary outcome), 6 months and 12 months post-intervention
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Secondary outcome [1]
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The secondary outcome measures include: Pain Interference as assessed with the Brief Pain Inventory (BPI)
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Assessment method [1]
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Timepoint [1]
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8 weeks, 6 months and 12 months post-intervention
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Secondary outcome [2]
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Quality of Life (QOL) will be measured with the EQ5D5L
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Assessment method [2]
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Timepoint [2]
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8 weeks, 6 months and 12 months post-intervention
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Secondary outcome [3]
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Psychological symptoms will be measured by the Depression Anxiety Stress Scale (DASS-21)
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Assessment method [3]
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Timepoint [3]
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8 weeks, 6 months and 12 months post-intervention
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Secondary outcome [4]
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Fatigue will be measured by the Fatigue Symptom Inventory (FSI)
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Assessment method [4]
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Timepoint [4]
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8 weeks, 6 months and 12 months post-intervention
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Secondary outcome [5]
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Sleep quality will be measured with the Jenkins Sleep Scale
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Assessment method [5]
418953
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Timepoint [5]
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8 weeks, 6 months and 12 months post-intervention
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Secondary outcome [6]
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Pain catastrophizing will be measured with the Pain Catastrophizing Scale (PCS)
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Assessment method [6]
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Timepoint [6]
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8 weeks, 6 months and 12 months post-intervention
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Secondary outcome [7]
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Self-efficacy will be measured with the Pain Self-Efficacy Questionnaire (PSEQ).
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Assessment method [7]
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Timepoint [7]
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8 weeks, 6 months and 12 months post-intervention
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Secondary outcome [8]
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Health utilisation and cost data will be collected via a patient health service utilisation and employment questionnaire administered at all time-points.
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Assessment method [8]
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Timepoint [8]
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8 weeks, 6 months and 12 months post-intervention
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Secondary outcome [9]
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Acceptability of e-Hypnotherapy and Relaxation: will be measured with a treatment satisfaction scale at 8-weeks
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Assessment method [9]
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Timepoint [9]
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8 weeks post-intervention
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Secondary outcome [10]
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Safety of e-Hypnotherapy and Relaxation: will be established with weekly check-ins by the trial manager to understand whether any adverse events (e.g., increased anxiety) have occurred.
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Assessment method [10]
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Timepoint [10]
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Weekly throughout 8-week intervention
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Secondary outcome [11]
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Suggestibility in e-Hypnotherapy participants will be assessed using the Short Suggestibility Scale (SSS) and include in our sensitivity analyses.
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Assessment method [11]
420404
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Timepoint [11]
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Weekly throughout 8-week intervention
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Eligibility
Key inclusion criteria
- Patients diagnosed with CPPS with persistent pain for at least 6 months, supported by a letter from treating physician or other evidence confirming the above.
- At least 18 years of age.
- Capacity to provide informed consent.
- English speaking, or sufficient level of English to understand the trial intervention, answer relevant questionnaires and participate in a group context.
- Access to internet.
- Residing in Australia.
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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
- High risk of harming self or others.
- Severe mental illness (e.g., schizophrenia, severe depression).
- Significant cognitive impairment (the former three criteria confirmed by psychological screening by our psychology team or treating physician).
- Inability to read or write.
- Inability to speak or understand English.
- Currently pregnant.
- Currently or in the past received hypnotherapy.
- Have contraindications for hypnotherapy.
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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)
A block randomisation sequence with variable block size will be embedded in Qualtrics for allocation concealment. The biostatistician will be blinded to allocation.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Consenting participants will be randomly assigned (1:1:1 ratio) to e-Hypnotherapy, relaxation or waitlist control. A block randomisation sequence with variable block size will be embedded in Qualtrics for allocation concealment. The biostatistician will be blinded to allocation.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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
All statistical analyses will be conducted on an intention-to-treat basis. A detailed analysis plan will be developed for the study protocol. The intervention effect over the 12-month period on the primary outcome (pain severity) and other outcomes will be estimated using linear mixed models. The models will include study arm, time (T1, T2, T3, T4) and time by study arm interaction as fixed effects and patient as random effect. Reasons for non-completion will be collected for participants withdrawing from the study. Multiple imputation will be used to handle missing data. Given the untestable assumption of data missing at random from those who do not provide information about reason for drop out, sensitivity analyses involving pattern mixture models will also be conducted to evaluate robustness of findings to different assumptions about participant dropout. The data analyst will be blinded to the group allocation.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/12/2023
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Actual
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Date of last participant enrolment
Anticipated
30/04/2025
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Actual
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Date of last data collection
Anticipated
31/07/2026
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Actual
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Sample size
Target
132
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
313273
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Government body
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Name [1]
313273
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National Health and Medical Research Council
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Address [1]
313273
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National Health and Medical Research Council
GPO Box 1421
Canberra City ACT 2601
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Country [1]
313273
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Australia
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Primary sponsor type
University
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Name
Deakin University
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Address
Deakin University
Geelong Waurn Ponds Campus
Locked Bag 20000
Geelong VIC 3220
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Country
Australia
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Secondary sponsor category [1]
315041
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None
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Name [1]
315041
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Address [1]
315041
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Country [1]
315041
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
312504
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Deakin University Human Research Ethics Committee
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Ethics committee address [1]
312504
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Human Research Ethics Office
Deakin University
221 Burwood Hwy
Burwood, VIC 3125
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Ethics committee country [1]
312504
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Australia
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Date submitted for ethics approval [1]
312504
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31/03/2023
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Approval date [1]
312504
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Ethics approval number [1]
312504
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Summary
Brief summary
Chronic pelvic pain syndrome (CPPS) subsumes several costly, common and challenging conditions including endometriosis and irritable bowel syndrome (IBS). Effective treatment is lacking, and CPPS is associated with poor quality of life (QoL), and psychological and sexual ill health. Hypnotherapy is an effective psychological treatment for mental health and pain. Hypnotherapy modulates neural processes associated with pain intensity and unpleasantness, supporting its use for CPPS where pain and distress become entrenched. Using a pragmatic, parallel-group, single-blind efficacy and implementation RCT, we aim to improve pain, mental health and reduce healthcare costs associated with CPPS.
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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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Prof Antonina Mikocka-Walus
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Address
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Deakin University
School of Psychology
221 Burwood Hwy
Burwood 3125 VIC
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Country
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Australia
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Phone
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+61392468575
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Ms Elesha Parigi
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Address
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Deakin University
1 Gheringhap Street, Geelong, VIC. 3220
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Country
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Australia
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Phone
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+61 3 522 73612
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Prof Antonina Mikocka-Walus
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Address
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Deakin University
School of Psychology
221 Burwood Hwy
Burwood 3125 VIC
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Country
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Australia
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Phone
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+61392468575
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Fax
124900
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Email
124900
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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
We will only be sharing unidentified agregated data to protect privacy of our participants
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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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