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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 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.
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).
Secondary ID [1] 291869 0
Nil known
Universal Trial Number (UTN)
U1111-1183-3666
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 303156 0
anxiety 303157 0
cognitive dysfunction 303158 0
executive dysfunction 303159 0
traumatic brain injury (TBI) 303371 0
Condition category
Condition code
Neurological 302797 302797 0 0
Other neurological disorders
Mental Health 302798 302798 0 0
Anxiety

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 297987 0
Rehabilitation
Intervention code [2] 298129 0
Behaviour
Intervention code [3] 298130 0
Treatment: Other
Comparator / control treatment
The wait list control group will be offered standard prison healthcare and will be offered the treatment within 6 months.
Control group
Active

Outcomes
Primary outcome [1] 302014 0
Scores on negative affect repair questionnaire.
Timepoint [1] 302014 0
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.
Primary outcome [2] 302015 0
TBI symptoms assessed using the Rivermead post concussion screen.
Timepoint [2] 302015 0
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.
Secondary outcome [1] 334519 0
Number of violent episodes assessed by review of offender file notes and prison misconducts.
Timepoint [1] 334519 0
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.

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
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.

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)
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
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using paper based allocation
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/06/2017
Actual
30/06/2017
Date of last participant enrolment
Anticipated
8/01/2018
Actual
15/02/2018
Date of last data collection
Anticipated
2/04/2018
Actual
30/06/2018
Sample size
Target
72
Accrual to date
Final
50
Recruitment outside Australia
Country [1] 8879 0
New Zealand
State/province [1] 8879 0
Auckland

Funding & Sponsors
Funding source category [1] 296371 0
University
Name [1] 296371 0
Auckland University of Technology (AUT)
Country [1] 296371 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology (AUT)
Address
Private Bag 92006
Auckland 1142, New Zealand
Country
New Zealand
Secondary sponsor category [1] 295314 0
None
Name [1] 295314 0
Nil
Address [1] 295314 0
Nil
Country [1] 295314 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297607 0
Health and Disability Ethics committee (HDEC)
Ethics committee address [1] 297607 0
Ethics committee country [1] 297607 0
New Zealand
Date submitted for ethics approval [1] 297607 0
27/01/2017
Approval date [1] 297607 0
12/04/2017
Ethics approval number [1] 297607 0
17/NTB/22
Ethics committee name [2] 297609 0
AUT Ethics committe
Ethics committee address [2] 297609 0
Ethics committee country [2] 297609 0
New Zealand
Date submitted for ethics approval [2] 297609 0
19/04/2017
Approval date [2] 297609 0
26/04/2017
Ethics approval number [2] 297609 0
17/120

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

Contacts
Principal investigator
Name 74570 0
Ms Tracey Mitchell
Address 74570 0
Serco, Auckland South Corrections Facility
c/- 21 Kiwi Tamaki Road,
Wiri
Auckland 2104
Country 74570 0
New Zealand
Phone 74570 0
+64 9 250 5932
Fax 74570 0
nil
Email 74570 0
[email protected]
Contact person for public queries
Name 74571 0
Alice Theadom
Address 74571 0
AUT
Address: AR320
Level 3
AR Building
90 Akoranga Drive
Northcote
Auckland 0627
Country 74571 0
New Zealand
Phone 74571 0
+64 9 921 9999
Fax 74571 0
+64 9 921 9812
Email 74571 0
[email protected]
Contact person for scientific queries
Name 74572 0
Alice Theadom
Address 74572 0
AUT
Address: AR320
Level 3
AR Building
90 Akoranga Drive
Northcote
Auckland 0627
Country 74572 0
New Zealand
Phone 74572 0
+64 9 921 9999
Fax 74572 0
+64 9 921 9812
Email 74572 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1994Informed 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.