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Trial registered on ANZCTR
Registration number
ACTRN12619001602112
Ethics application status
Approved
Date submitted
15/10/2019
Date registered
21/11/2019
Date last updated
28/01/2024
Date data sharing statement initially provided
21/11/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Treating psychological distress after traumatic brain injury (TBI) either by face to face or video consulting.
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Scientific title
Evaluation and feasibility of eHealth for individuals with a traumatic brain injury (TBI) experiencing psychological distress: ACT-Adjust via video consulting.
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Secondary ID [1]
299508
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Nil known.
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Universal Trial Number (UTN)
U1111-1241-7053
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Trial acronym
ACT-Adjust VC-Trial
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Depression
314752
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Traumatic brain injury (TBI)
314753
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Anxiety
315086
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Stress
315087
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Condition category
Condition code
Mental Health
313080
313080
0
0
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Depression
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Mental Health
313081
313081
0
0
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Anxiety
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Neurological
313082
313082
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0
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Other neurological disorders
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Injuries and Accidents
313083
313083
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0
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Other injuries and accidents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
A phase one three-armed non-inferiority randomised controlled trial comparing the efficacy of delivering an evidence-based psychological treatment (ACT-Adjust) to treat psychological distress in individuals with a severe traumatic brain injury (TBI) via video consulting (VC; Arm 1), with face-to-face delivery (FtF; Arm 2) and a wait list control group (Arm 3).
ACT-Adjust is a manualised nine-session treatment program that is specifically tailored to individuals who have sustained a TBI and will be provided on an individual basis to participants. This treatment intervention consists of 7 x 1 hour weekly sessions. In addition to the intervention, an initial assessment session will take place approximately one week prior to the commencement of the intervention, and two follow-up sessions will be held; Session 8 two weeks after session 7; and session 9 which will occur 4 weeks after session 8. Overall the program encompasses 10 sessions which includes one assessment session to complete measures and a total of 9 sessions of treatment.
The treatment is based on Acceptance and Commitment Therapy (ACT) which is a third wave cognitive behavioural therapy. ACT has an strong evidence base across a number of psychological conditions and has been previously delivered to individuals with a TBI and mixed psychological distress (depression, anxiety, stress). The current project is based on this previously trialled intervention (ACT-Adjust) which was only 7 sessions and delivered in a group modality. The current intervention has been modified for individual delivery and the exercises considered by a review panel for their appropriateness to be delivered by video consulting. An additional two sessions have been included to strengthen relapse prevention.The modified therapist manual and a separate client workbook will be available once the clinical trial commences through both the researchers and the funder, icare.
The content of the sessions involves didactic education, interactive exercises including mindfulness activities, completion of worksheets and other activities that support ACT. This includes defusion, values identification and goal setting for committed action. Each session of the intervention focuses on a component on the ACT model with values work and mindfulness activities included in each session. Participants will be asked to complete activities at home and sent reminders by SMS (text messaging by mobile phone) to complete these tasks. Home tasks will include brief mindfulness exercises (from 2 mins to 6 mins by 3 times per week) which were taught in the preceding week and an activity relating to the previous weeks content e.g. a defusion activity which will take 5-10 minutes. Sessions 8 and 9 will set activities unique to each client identified as a committed action in service of identified values. This will be different for each client and set as a structure goal. The first session incorporates education about the intervention and assists the participant in identification of their current issues and coping strategies. A suicide risk assessment is undertaken as a component of the intervention when the normalacy of suffering is covered as part of the ACT treatment. Coping mechanisms include a better understanding of human suffering, allowing space to accept uncontrollable situations and mindfulness to bring the participant into the present moment. Behavioural activation will occur as goal setting will be established in conjunction with participants' values.
The interventions will be delivered by registered psychologists who are trained to provide the ACT-Adjust intervention. Psychologists will use the ACT-Adjust therapist manual to deliver the treatment and participants in the treatment groups will each be provided with the ACT-Adjust client workbook.
Participants allocated to Arm 1 (therapy via video consulting) of the trial will use either an electronic tablet or personal computer to access treatment via video consulting, either from home or a preferred location. Participants allocated to Arm 2 of the trial will attend therapy sessions at a local health clinic.
Delivery of the ACT-Adjust intervention will be recorded and assessed by a blind external assessor for treatment fidelity.
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Intervention code [1]
315761
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Rehabilitation
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Intervention code [2]
315762
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Behaviour
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Intervention code [3]
315763
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Treatment: Other
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Comparator / control treatment
1) active control (participants will receive the ACT-Adjust therapy intervention face-to-face).
2) waitlist control (participants will not receive treatment whilst placed on a waitlist, and will later be randomly assigned to one of the treatment groups (face-to-face intervention or video consulting intervention). The randomisation to either active treatment (face to face or video consulting) will occur after the time 3 assessment period, which will be three months after time 2 assessment and approximately 6 months after allocation to the initial groups.
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Control group
Active
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Outcomes
Primary outcome [1]
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Changes in psychological distress, as measured using the validated Depression Anxiety and Stress Scale (DASS-21)
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Assessment method [1]
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Timepoint [1]
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Baseline, at completion of therapy and three months following therapy intervention
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Primary outcome [2]
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Changes in psychological flexibility, as measured using the validated Acceptance and Action Questionnaire - Acquired Brain Injury (AAQ-ABI).
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Assessment method [2]
321673
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Timepoint [2]
321673
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Baseline, at completion of therapy and three months following therapy intervention,
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Secondary outcome [1]
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Changes in Quality of Life, as measured using the validated Quality of Life after Brain Injury (QOLIBRI)
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Assessment method [1]
375847
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Timepoint [1]
375847
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Baseline, at completion of therapy intervention and 3 months post-intervention
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Secondary outcome [2]
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Changes in identified values, how consistently a person acts in accordance with these values. As measured using the Survey of Life Principles (SLP) Version 2.2
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Assessment method [2]
375848
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Timepoint [2]
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Baseline, at completion of therapy intervention and 3 months post-intervention
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Secondary outcome [3]
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Changes in committed action (a client's engagement in the therapy process), as measured using the Engaged Living Scale (ELS)
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Assessment method [3]
375854
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Timepoint [3]
375854
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Baseline, at completion of therapy intervention and 3 months post-intervention
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Secondary outcome [4]
375856
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Changes to global measures of life satisfaction, as measured using the validated Satisfaction with Life Scale (SWLS)
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Assessment method [4]
375856
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Timepoint [4]
375856
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Baseline, at completion of therapy intervention and 3 months post-intervention
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Secondary outcome [5]
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Changes in perceived importance of identified values using the Survey of Life Principles (SLP Version 2.2)
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Assessment method [5]
376921
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Timepoint [5]
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Baseline, at completion of therapy intervention and 3 months post-intervention
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Eligibility
Key inclusion criteria
(i) having sustained a severe TBI (post-traumatic amnesia =>7 days) after 18 years of age; (ii) being between 18 and 65 years old and less than five years post-injury; (iii) having sufficient cognitive and linguistic capacity to complete self-report measures and participate in the program; and (iv) reporting a clinically significant level of psychological distress (Depression>13, Anxiety>9 and Stress>18; Depression Anxiety Stress Scales 21-item; DASS) (Lovibond & Lovibond, 1995).
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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
(i) having a severe psychiatric illness, including psychotic disorder or substance addiction as determined by the medical file, self-report or consultation with the rehabilitation team; (ii) currently undergoing psychological intervention;
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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)
Allocation will be concealed; allocation of participants will be undertaken by a senior research staff member who is otherwise not involved with the study.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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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
Efficacy
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Statistical methods / analysis
The required sample size of 56 adults with a moderate to severe TBI has been identified based on results of a previous pilot RCT of the ACT-Adjust program (Whiting et al., 2019; which involved a total sample size of 56 [ES Partial chi squared = .17, Power = .80], to establish a significant interaction effect from pre to post intervention.
Prior to the main analysis, between groups comparisons will be undertaken to tests for equivalency of the groups using chi-square and t-tests. Primary analysis will be implemented on an Intention-to-Treat basis using hierarchical linear mixed models to study the differential effects of each treatment condition. For the post-treatment analyses between the three treatment conditions, analysis will focus on linear time effects, treatment conditions and interactions. Cohen’s effect size will be calculated for all analyses. Analyses will focus on the estimated mean differences relative to pre-treatment levels on primary and secondary outcome measures. For the longer-term treatment effects, the non-inferiority of the face to face and video consulting will be assessed at the 3-month follow-up.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/01/2020
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Actual
17/03/2020
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Date of last participant enrolment
Anticipated
31/01/2024
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Actual
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Date of last data collection
Anticipated
1/10/2024
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Actual
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Sample size
Target
56
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Accrual to date
46
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
14960
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Liverpool Hospital - Liverpool
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Recruitment hospital [2]
14961
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Port Kembla Hospital - Warrawong
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Recruitment hospital [3]
14962
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Bathurst Base Hospital - Bathurst
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Recruitment hospital [4]
22547
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Wagga Wagga Base Hospital - Wagga Wagga
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Recruitment hospital [5]
22548
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Goulburn Base Hospital - Goulburn
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Recruitment hospital [6]
22549
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John Hunter Hospital - New Lambton
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Recruitment hospital [7]
22550
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Westmead Hospital - Westmead
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Recruitment postcode(s) [1]
28245
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2170 - Liverpool
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Recruitment postcode(s) [2]
28246
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2502 - Warrawong
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Recruitment postcode(s) [3]
28247
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2795 - Bathurst
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Recruitment postcode(s) [4]
37786
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2650 - Wagga Wagga
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Recruitment postcode(s) [5]
37787
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2580 - Goulburn
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Recruitment postcode(s) [6]
37788
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2305 - New Lambton
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Recruitment postcode(s) [7]
37789
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2145 - Westmead
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Funding & Sponsors
Funding source category [1]
304002
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Government body
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Name [1]
304002
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icare NSW
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Address [1]
304002
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321 Kent St, Sydney NSW 2000
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Country [1]
304002
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Australia
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Primary sponsor type
Government body
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Name
South Western Sydney Local Health District
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Address
Liverpool Hospital Eastern Campus
Corner of Lachlan and Hart Streets
LIVERPOOL NSW 2170
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Country
Australia
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Secondary sponsor category [1]
304241
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None
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Name [1]
304241
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Address [1]
304241
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Country [1]
304241
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
304494
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South Western Sydney Local Health District HREC [EC00136]
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Ethics committee address [1]
304494
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Research Directorate
Locked Bag 7103
LIVERPOOL BC NSW 1871
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Ethics committee country [1]
304494
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Australia
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Date submitted for ethics approval [1]
304494
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10/10/2019
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Approval date [1]
304494
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25/11/2019
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Ethics approval number [1]
304494
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2019/ETH13152
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Summary
Brief summary
Psychological distress after TBI is high and Acceptance and Commitment Therapy (ACT) has been used effectively to treat this distress using the ACT-Adjust program. Access problems to psychologists in Australia in rural and regional areas are limited and this is exacerbated for individuals with a TBI accessing appropriately trained and skilled psychologists. Video consulting is one solution to improve access and though ACT has been delivered by this media, there is currently no evidence base to support the delivery of psychological therapy by video consulting to individuals with a TBI. This study will examine the effectiveness of ACT-Adjust delivered by video consulting to individuals with a TBI, promoting improved access for those living in regional and remote areas of Australia and having a TBI.
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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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Dr Diane Whiting
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Address
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Ingham Institute
Liverpool Hospital
Locked Bag 7103
Liverpool BC NSW 1871
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Country
97146
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Australia
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Phone
97146
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+61 403 128 447
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Fax
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Email
97146
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[email protected]
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Contact person for public queries
Name
97147
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Dr Diane Whiting
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Address
97147
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Ingham Institute
Liverpool Hospital
Locked Bag 7103
Liverpool BC NSW 1871
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Country
97147
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Australia
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Phone
97147
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+61 403 128 447
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Fax
97147
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Email
97147
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[email protected]
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Contact person for scientific queries
Name
97148
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Dr Diane Whiting
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Address
97148
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Ingham Institute
Liverpool Hospital
Locked Bag 7103
Liverpool BC NSW 1871
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Country
97148
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Australia
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Phone
97148
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+61 403 128 447
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Fax
97148
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Email
97148
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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
All participant data will be deidentified and only reported at group level for the purposes of confidentiality for 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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