Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000685314
Ethics application status
Approved
Date submitted
5/05/2017
Date registered
12/05/2017
Date last updated
12/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving mental health outcomes following mild to moderate traumatic brain injury.
Scientific title
Investigating the efficacy of positive psychology interventions in improving mental health outcomes after mild to moderate traumatic brain injury.
Secondary ID [1] 291732 0
Nil.
Universal Trial Number (UTN)
U1111-1195-7085
Trial acronym
ORBIT-RCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild Traumatic Brain Injury 302923 0
Moderate Traumatic Brain Injury 302924 0
Mental Illness 302925 0
Condition category
Condition code
Injuries and Accidents 302403 302403 0 0
Other injuries and accidents
Mental Health 302650 302650 0 0
Depression
Mental Health 302651 302651 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised into one of three arms. Two arms will consist of a brief positive psychology intervention aimed at reducing mental illness symptoms after brain injury. The third arm represents treatment as usual (TAU). The intervention arms are discussed below.

Arm 1: Positive Psychology Bibliotherapy Intervention

Materials:
The bibliotherapy intervention consists of a booklet containing information relevant to mild or moderate traumatic brain injury. The booklet provides information to the patient and their family on common symptoms that they may experience, and helpful strategies to help them cope. This booklet also provides health relevant information, should the patient experience any adverse symptoms in the weeks after injury. Evidence suggests that the possession of information regarding their illness can have a positive affect on a patients resilience and recovery after injury.

Source:
The bibliotherapy booklet titled, "Information about Mild Head Injury or Concussion" was originally developed by Professor Jennie Ponsford and colleagues in 2004., This booklet is for use with mild traumatic brain injuries, hence the booklet has been adapted for the purposes of this study to include information relevant to mild or moderate traumatic brain injuries. Information used for the adaptation of this booklet to include information for moderate traumatic brain injury was derived from the following sources:

Headway Queensland Inc. 1995, "Changing Paths; The Adult Brain Injury Series" Information Bundle, Brian Injury Association Queensland, Milton, Queensland. Australia.

Maas, Stocchetti & Bullock (2008). Moderate and severe traumatic brain injury in adults, Lancet Neurology, 7, 728-741.

Perel, P., Arango, M., Clayton, T., Edwards, P., Komolafe, E., ... & Yutthakasemsunt, S. (2008). Predicting outcome after traumatic brain injury: practical prognostic models based on large cohort of international patients. Bmj, 336(7641), 425-9.


Procedure:
The booklet containing the bibliotherapy material will be provided to participants in a one-on-one initial assessment conducted by the trial coordinator following recruitment. The Clinical Research Coordinator will provide the hard-copy booklet to participants. After receiving the booklet from the trial coordinator, participants are simply required take to booklet home to read and refer to at least three times for a period of one week. The Clinical Research Coordinator holds a Bachelor of Psychology with Honours and is currently completing a Doctorate of Philosophy in Neuropsychology and Positive Health, with over six years experience and knowledge in the field of psychology. Supervision of the Clinical Research Coordinator is also provided by Dr Maria Hennessy, a clinical psychologist, clinical neuropsychologist and senior lecturer at James Cook University.

Arm 2: Positive Psychology "What Went Well" Intervention Task
Materials:
The second intervention is a positive psychology task, termed "What Went Well". This task asks that as you end your day, you think about three things that went well and how they made you feel. This tasks is aimed at focusing an individuals attention toward the positive experiences of daily life, rather than the negative and evidence suggests that the use of this task significantly reduces the experience of depression and mood disorders.

Source:
The "What Went Well" exercise, is a task derived from an original study conducted by Seligman (2009). Please see reference below. The three questions contained in the task have been formatted to resemble similar font and spacing as seen in the Bibliotherapy intervention to ensure continuity among the materials given to participants and subsequently reduce potential error.

Seligman, Ernst, Gillham, Reivich & Linkins (2009). Positive education: positive psychology classroom interventions, Oxford Review of Education, 35(3), 293-311.

Procedure:
The booklet containing the instructions for the "What Went Well" task will be provided to participants in a one-on-one initial assessment conducted by the trial coordinator. The trial coordinator will provide the hard-copy booklet to participants. After this has been received, participants are required to take the booklet home and begin the task on the first day following the initial assessment. Participants will be required to record three things what went well and how that made them feel. This is to be completed each day for a period of one week. All required materials and worksheet for these entries are provided to participants at the initial assessment.

These are evidence-based interventions identified for their efficacy in reducing mental illlness symptoms in the general population and among mild traumatic brain injury patients. The adherence/fidelity of these interventions will be assessed based on their ability to reduce mental illness in mild to moderate traumatic brain injury patients.
Intervention code [1] 297839 0
Prevention
Intervention code [2] 298030 0
Behaviour
Comparator / control treatment
As part of the randomisation process and to ensure methodological rigor, a treatment arm has been included in this study to depict Treatment As Usual (TAU). This represents a control treatment.
The current practice, or Treatment as Usual, within Queensland Health is governed by the type of brain injury sustained.

For mild traumatic brain injury patients, a Clinical Pathways Guide Sheet is used to triage the patient into necessary care in the period immediately following presentation to the emergency department. If patients are considered at risk of post-concussional symptoms such as persistent abnornmal neurological symptoms, further scans are conducted and patients are commonly referred to the neurosurgical service for management and potential surgery.

If mild traumatic brain injury patients are deemed neurologically intact whilst in the emergency department, they are provided with a brief fact sheet on "Minor Head Injury" and provided with a referral letter to present to their GP within 72 hours after injury for follow-up and reassessment of any residual neurological symptoms. After this point and if patients are deemed neurologically healthy, they are discharged from care. No further care or follow-up care is provided for mental illness symptoms beyond this point. If patients require treatment or management of these symptoms, they would be required to voluntarily seek out a referral from their respective GP.

With regards to Moderate Traumatic Brain Injuries, these patients commonly require neurosurgical intervention and potential surgery. Once surgery has been conducted and patients have been deemed neurologically intact, they are discharged from the hospital to an appropriate social environment with a responsibly person. Follow-up commonly occurs within three to six months post-op with the operating surgeon. At this time, an MRI or CT is commonly performed to assess any potential residual changes and any subjective symptoms experienced by the patient. Patients may receive a follow-up appointment at twelve months depending on their status at the initial follow-up. There is currently no standardised practice in place to manage the potential development of mental health symptoms after moderate traumatic brain injury. Similar to mild traumatic brain injury patients, if patients are experiencing symptoms they would be expected to voluntarily present to their respective GP for referral to neuropsychological/psychological services.
Control group
Active

Outcomes
Primary outcome [1] 301814 0
The primary outcome is represented as the diagnosis of a psychological disorder as measured by clinical interview.

The clinical interview will include the Mini-International Neuropsychiatric Interview (MINI)(Sheehan et al., 1998), the Depression Anxiety Stress Scale (DASS21)(Henry & Crawford, 2005), the Quality of Life After Brain Injury Scale (von Steinbuchel et al., 2010), the Comprehensive Inventory of Thriving (Su, Tay, & Diener, 2014).
Timepoint [1] 301814 0
Measured at the initial assessment, one-week, three months and six months post-initial assessment.
Secondary outcome [1] 334650 0
Residual neurological symptoms occurring after injury. Measured using the Rivermead Post-Concussion Symptoms Questionnaire, (King, Crawford, Wenden, Moss, & Wade, 1995) and current physical pain symptoms associated with the brain injury assessed by rating on a visual analogue scale.
Timepoint [1] 334650 0
Measured at the initial assessment, one-week, three months and six months post-initial assessment.

Eligibility
Key inclusion criteria
Individuals who are consecutive admissions to The Townsville Hospital for mild or moderate traumatic brain injury. These will be defined using standard clinical diagnostic criteria. For mild TBI this will include: individuals with a Glasgow Coma Scale (GCS) on admission of 13-15, a loss of consciousness of <30 minutes, a post-traumatic amnesia (PTA) of <24 hours, and normal neuroimaging. Clinical diagnostic criterial for moderate TBI will include a GCS on admission of 9-12, a loss of consciousness of >30 minutes, a post-traumatic amnesia period of >24 hours, and abnormal neuroimaging.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The clinical assessment protocol used in this project uses tests that were developed and normed on individuals whose primary language is English. Thus, their use on individuals whose primary language is not English would have limited reliability and validity.
The project is specifically assessing adult outcomes following TBI and uses adult assessment tests. Thus it is not valid t recruit children an/or young people <18 years of age into this study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software, specifically www.graphpad.com/quickcalcs.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This study uses a randomised between-groups repeated-measures design. For independent groups with an alpha = .05, and a target effect size of .5, we require a minimum 30 participants in each treatment group. The information collected about participants will then be analysed using a mixed Analysis of Variance (ANOVA), assessing differences between treatment groups and investigating any changes over time.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2017
Actual
Date of last participant enrolment
Anticipated
1/10/2017
Actual
Date of last data collection
Anticipated
1/04/2018
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 7867 0
The Townsville Hospital - Douglas
Recruitment postcode(s) [1] 15813 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 296229 0
Hospital
Name [1] 296229 0
The Townsville Hospital
Country [1] 296229 0
Australia
Primary sponsor type
Hospital
Name
The Townsville Hospital
Address
100 Angus Smitth Drive
Douglas QLD 4814
Country
Australia
Secondary sponsor category [1] 295146 0
University
Name [1] 295146 0
James Cook University
Address [1] 295146 0
1 James Cook Drive
Townsville QLD 4810
Country [1] 295146 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297468 0
Central Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 297468 0
PO Box 871
Rockhampton QLD 4700
Ethics committee country [1] 297468 0
Australia
Date submitted for ethics approval [1] 297468 0
15/12/2016
Approval date [1] 297468 0
01/02/2017
Ethics approval number [1] 297468 0
HREC/16/QCQ/44

Summary
Brief summary
Over 7000 individuals sustain a Traumatic Brain Injury (TBI) each year in Queensland with minimal rehabilitation services available after injury, particularly in regional areas. Individuals with TBI are at increased risk for the development of depression, anxiety, alcohol misuse and suicide. The diagnosis of psychiatric disorders is estimated to occur in approximately 75% of TBI survivors within five years post-injury, with the highest increase of mental illness recorded in the first twelve months. Currently, there are limited resources or services in regional Queensland to address the mental health needs of TBI survivors. This pilot project will use a prospective randomised controlled trial design to compare the efficacy of short psychology treatment interventions after mild to moderate traumatic brain injury. Participants will be recruited at 1-2 weeks post-injury, and complete a short one hour assessment that will consist of a clinical interview and self-report measures of health and wellbeing. They will then be allocated into one of three treatment arms: (1) treatment as usual (TAU): bibliotherapy intervention or (3) brief positive psychology intervention. Follow-up interviews will occur at the end of the one week intervention, and again at 3 months and 6 months post-injury. The findings from this study may assist in the development of short practical interventions that may prevent the onset of novel mental illness in the first 12 months following a TBI.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74138 0
Dr Maria Hennessy
Address 74138 0
Department of Psychology,
College of Healthcare Sciences,
James Cook University,
1 James Cook Drive,
DOUGLAS QLD 4810
Country 74138 0
Australia
Phone 74138 0
+61747228728
Fax 74138 0
Email 74138 0
[email protected]
Contact person for public queries
Name 74139 0
Dr Maria Hennessy
Address 74139 0
Department of Psychology,
College of Healthcare Sciences,
James Cook University
1 James Cook Drive
DOUGLAS QLD 4810
Country 74139 0
Australia
Phone 74139 0
+61747228728
Fax 74139 0
Email 74139 0
[email protected]
Contact person for scientific queries
Name 74140 0
Dr Maria Hennessy
Address 74140 0
Department of Psychology,
College of Healthcare Sciences,
James Cook University
1 James Cook Drive,
DOUGLAS QLD 4810
Country 74140 0
Australia
Phone 74140 0
+61747228728
Fax 74140 0
Email 74140 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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