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Trial registered on ANZCTR
Registration number
ACTRN12617000757314
Ethics application status
Approved
Date submitted
6/05/2017
Date registered
23/05/2017
Date last updated
6/05/2019
Date data sharing statement initially provided
6/05/2019
Date results information initially provided
6/05/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Understanding and managing Traumatic Brain Injury (TBI) in a South Auckland prison - trialling a psychological intervention for male sentenced prisoners with a history of TBI.
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Scientific title
Understanding and managing Traumatic Brain Injury (TBI) in a South Auckland Corrections Facility- a pilot randomised control trial to test the efficacy of group cognitive behaviour therapy (CBT).
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Secondary ID [1]
291869
0
Nil known
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Universal Trial Number (UTN)
U1111-1183-3666
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
depression
303156
0
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anxiety
303157
0
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cognitive dysfunction
303158
0
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executive dysfunction
303159
0
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traumatic brain injury (TBI)
303371
0
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Condition category
Condition code
Neurological
302797
302797
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0
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Other neurological disorders
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Mental Health
302798
302798
0
0
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Anxiety
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
A pilot Randomised Control Trial (RCT) of group Cognitive Behavioural Therapy (CBT)to assist prisoners to manage mood and persistent symptoms following TBI.
A manualised programme will be delivered to cohorts of 12 sentenced male prisoners who have a criminal history of violence, burglary or sexual offences. The manualised programme has been adapted from a programme developed for anger management. The programme will be administered by a Registered Psychologist and Intern Psychologist within the health space inside the prison. The programme is manualised and will be delivered in 10 x 1 hour sessions, across 5 weeks. The study will involve 72 men in total. The sessions are summarised as below:
1 Introduction of facilitator and session structure
Housekeeping and group rules – confidentiality and respect
Rationale for this intervention- discuss CBT and Mindfulness for TBI
Homework is to develop personal goals for the programme
2 Psychoeducation on the importance of emotional regulation following TBI
Introduction of CBT 5 part model and the role of emotions in driving behaviour
3 Psychoeducation on relationship between thoughts, emotions and behaviour using 5 part CBT model
4 Introduction of the concept of mindfulness.
Mindfulness exercises in group using Acceptance and Commitment Therapy template
5 Application of mindfulness to thoughts- psychoeducation on thought diffusion strategies
6 Application of mindfulness to emotional regulation –
Exercise in acceptance of emotions
7 Standard session structure
Integration of CBT and Mindfulness to understand relationship between thoughts and emotions and how this drives behavioural patterns
8 Introduction of the importance of life values and how they link to personal goals
9 Every day use of CBT techniques and Mindfulness practice to make alternative choices based on values/goals
10 Overview of programme
Feedback and discussion.
The group members will be encouraged to complete all sessions but are able to withdraw consent to participate at any time. Successful completion will be considered attendance at 80% of the sessions. A register will be maintained noting attendance or absence.
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Intervention code [1]
297987
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Rehabilitation
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Intervention code [2]
298129
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Behaviour
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Intervention code [3]
298130
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Treatment: Other
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Comparator / control treatment
The wait list control group will be offered standard prison healthcare and will be offered the treatment within 6 months.
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Control group
Active
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Outcomes
Primary outcome [1]
302014
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Scores on negative affect repair questionnaire.
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Assessment method [1]
302014
0
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Timepoint [1]
302014
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The negative affect repair questionnaire will be administered at the commencement of the intervention, at completion of the 5 weeks of the intervention and again 12 post-completion of the intervention.
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Primary outcome [2]
302015
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TBI symptoms assessed using the Rivermead post concussion screen.
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Assessment method [2]
302015
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Timepoint [2]
302015
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The Rivermead post concussion screen will be administered at the commencement of the intervention, at completion of the intervention and then 12 weeks after the intervention has been completed.
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Secondary outcome [1]
334519
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Number of violent episodes assessed by review of offender file notes and prison misconducts.
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Assessment method [1]
334519
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Timepoint [1]
334519
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The file notes will be measured at the commencement of the intervention, immediately following completion of the intervention and 12 weeks after the intervention has been completed.
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Eligibility
Key inclusion criteria
Any man who has reported at least one TBI in their lifetime (based on the screening offered to all prisoners on arrival to the prison) who has been imprisoned for a violent, burglary or sexual offence (groups found to experience particularly high rates of TBI in screening data) will be included.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
Men who are unable to speak English and those with active psychosis are excluded as these would both prevent engagement in the intervention and completion of the pre and post intervention measures.
Men who following assessment from a psychologist have barriers to participating in a group format or non-associations with other group members will also be excluded.
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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)
Once all consenting participants were assessed for suitability for inclusion they were assigned a sealed opaque envelope which allocated them to the intervention or wait list control. The administrator of the intervention was not involved in this process
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using paper based allocation
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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 administering the treatment/s
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
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Statistical methods / analysis
The sample size was calculated using G power 3.1.0 to identify the number of group participants required to provide for meaningful analysis. The required sample size was calculated as 62 with a medium effect size of 0.3 (a=0.05, power = 80%, Number of groups = 2, number of measurements = 3). The effect size was estimated from other studies which report an appropriate effect size for a positive psychological intervention as being between 0.23-0.34. It is acknowledged that prison populations are relatively mobile, both from criminal rehabilitation (certain programmes happen in other parts of NZ) and release (both scheduled end dates and paroled releases, which is an unavoidable part of prison life). The sample was consequently increased to 72 to allow for this potential source of attrition.
A combination of repeated measures ANOVA and multi-level modelling will be used to determine the effectiveness of the intervention whilst controlling for demographic factors.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
12/06/2017
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Actual
30/06/2017
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Date of last participant enrolment
Anticipated
8/01/2018
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Actual
15/02/2018
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Date of last data collection
Anticipated
2/04/2018
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Actual
30/06/2018
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Sample size
Target
72
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Accrual to date
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Final
50
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Recruitment outside Australia
Country [1]
8879
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New Zealand
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State/province [1]
8879
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Auckland
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Funding & Sponsors
Funding source category [1]
296371
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University
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Name [1]
296371
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Auckland University of Technology (AUT)
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Address [1]
296371
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Private Bag 92006
Auckland 1142, New Zealand
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Country [1]
296371
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New Zealand
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Primary sponsor type
University
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Name
Auckland University of Technology (AUT)
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Address
Private Bag 92006
Auckland 1142, New Zealand
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Country
New Zealand
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Secondary sponsor category [1]
295314
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None
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Name [1]
295314
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Nil
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Address [1]
295314
0
Nil
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Country [1]
295314
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
297607
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Health and Disability Ethics committee (HDEC)
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Ethics committee address [1]
297607
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Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
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Ethics committee country [1]
297607
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New Zealand
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Date submitted for ethics approval [1]
297607
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27/01/2017
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Approval date [1]
297607
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12/04/2017
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Ethics approval number [1]
297607
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17/NTB/22
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Ethics committee name [2]
297609
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AUT Ethics committe
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Ethics committee address [2]
297609
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Private Bag 92006
Auckland 1142, New Zealand
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Ethics committee country [2]
297609
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New Zealand
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Date submitted for ethics approval [2]
297609
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19/04/2017
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Approval date [2]
297609
0
26/04/2017
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Ethics approval number [2]
297609
0
17/120
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Summary
Brief summary
International literature has indicated that the lifetime prevalence of TBI in prison populations is higher than in the general population. Given that TBI can lead to difficulties with impulse control, irritability and decision making, there is likely to be a link between TBI history and subsequent behaviour. This pilot RCT study aims to trial a targeted psychological intervention utilising cognitive behavioural therapy with consenting prisoners who are experiencing persistent symptoms from TBI, to determine if the intervention is effective in symptom management, preventing re-injury and subsequent offending behaviour.
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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
74570
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Ms Tracey Mitchell
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Address
74570
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Serco, Auckland South Corrections Facility
c/- 21 Kiwi Tamaki Road,
Wiri
Auckland 2104
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Country
74570
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New Zealand
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Phone
74570
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+64 9 250 5932
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Fax
74570
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nil
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Email
74570
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[email protected]
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Contact person for public queries
Name
74571
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A/Prof Alice Theadom
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Address
74571
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AUT
Address: AR320
Level 3
AR Building
90 Akoranga Drive
Northcote
Auckland 0627
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Country
74571
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New Zealand
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Phone
74571
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+64 9 921 9999
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Fax
74571
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+64 9 921 9812
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Email
74571
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[email protected]
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Contact person for scientific queries
Name
74572
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A/Prof Alice Theadom
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Address
74572
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AUT
Address: AR320
Level 3
AR Building
90 Akoranga Drive
Northcote
Auckland 0627
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Country
74572
0
New Zealand
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Phone
74572
0
+64 9 921 9999
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Fax
74572
0
+64 9 921 9812
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Email
74572
0
[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
All information from this trial will aggregated to protect the anonymity of the participants as they are prisoners and as such vulnerable. Some of the quantitative and qualitative results are shared but utilize a unique study identifier.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
1994
Informed consent form
Consent form for study
372878-(Uploaded-05-05-2019-08-18-09)-Study-related document.docx
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Study results article
Yes
Mitchell, T., Theadom, A., & du Preez, E. (2017). ...
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372878-(Uploaded-05-05-2019-08-25-57)-Journal results publication.pdf
Thesis
No
PhD thesis is currently in examination phase
372878-(Uploaded-05-05-2019-08-26-58)-Other results publication.docx
Basic results
No
372878-(Uploaded-05-05-2019-08-45-48)-Basic results summary.docx
Plain language summary
No
A single centre Randomised Control Trial (RCT) pil...
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Documents added automatically
No additional documents have been identified.
Download to PDF