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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.
Scientific title
Evaluation and feasibility of eHealth for individuals with a traumatic brain injury (TBI) experiencing psychological distress: ACT-Adjust via video consulting.
Secondary ID [1] 299508 0
Nil known.
Universal Trial Number (UTN)
U1111-1241-7053
Trial acronym
ACT-Adjust VC-Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 314752 0
Traumatic brain injury (TBI) 314753 0
Anxiety 315086 0
Stress 315087 0
Condition category
Condition code
Mental Health 313080 313080 0 0
Depression
Mental Health 313081 313081 0 0
Anxiety
Neurological 313082 313082 0 0
Other neurological disorders
Injuries and Accidents 313083 313083 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 315761 0
Rehabilitation
Intervention code [2] 315762 0
Behaviour
Intervention code [3] 315763 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 321672 0
Changes in psychological distress, as measured using the validated Depression Anxiety and Stress Scale (DASS-21)
Timepoint [1] 321672 0
Baseline, at completion of therapy and three months following therapy intervention
Primary outcome [2] 321673 0
Changes in psychological flexibility, as measured using the validated Acceptance and Action Questionnaire - Acquired Brain Injury (AAQ-ABI).
Timepoint [2] 321673 0
Baseline, at completion of therapy and three months following therapy intervention,
Secondary outcome [1] 375847 0
Changes in Quality of Life, as measured using the validated Quality of Life after Brain Injury (QOLIBRI)
Timepoint [1] 375847 0
Baseline, at completion of therapy intervention and 3 months post-intervention
Secondary outcome [2] 375848 0
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
Timepoint [2] 375848 0
Baseline, at completion of therapy intervention and 3 months post-intervention
Secondary outcome [3] 375854 0
Changes in committed action (a client's engagement in the therapy process), as measured using the Engaged Living Scale (ELS)
Timepoint [3] 375854 0
Baseline, at completion of therapy intervention and 3 months post-intervention
Secondary outcome [4] 375856 0
Changes to global measures of life satisfaction, as measured using the validated Satisfaction with Life Scale (SWLS)
Timepoint [4] 375856 0
Baseline, at completion of therapy intervention and 3 months post-intervention
Secondary outcome [5] 376921 0
Changes in perceived importance of identified values using the Survey of Life Principles (SLP Version 2.2)
Timepoint [5] 376921 0
Baseline, at completion of therapy intervention and 3 months post-intervention

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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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;

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)
Allocation will be concealed; allocation of participants will be undertaken by a senior research staff member who is otherwise not involved with the study.
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)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2020
Actual
17/03/2020
Date of last participant enrolment
Anticipated
31/01/2024
Actual
Date of last data collection
Anticipated
1/10/2024
Actual
Sample size
Target
56
Accrual to date
46
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 14960 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 14961 0
Port Kembla Hospital - Warrawong
Recruitment hospital [3] 14962 0
Bathurst Base Hospital - Bathurst
Recruitment hospital [4] 22547 0
Wagga Wagga Base Hospital - Wagga Wagga
Recruitment hospital [5] 22548 0
Goulburn Base Hospital - Goulburn
Recruitment hospital [6] 22549 0
John Hunter Hospital - New Lambton
Recruitment hospital [7] 22550 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 28245 0
2170 - Liverpool
Recruitment postcode(s) [2] 28246 0
2502 - Warrawong
Recruitment postcode(s) [3] 28247 0
2795 - Bathurst
Recruitment postcode(s) [4] 37786 0
2650 - Wagga Wagga
Recruitment postcode(s) [5] 37787 0
2580 - Goulburn
Recruitment postcode(s) [6] 37788 0
2305 - New Lambton
Recruitment postcode(s) [7] 37789 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 304002 0
Government body
Name [1] 304002 0
icare NSW
Country [1] 304002 0
Australia
Primary sponsor type
Government body
Name
South Western Sydney Local Health District
Address
Liverpool Hospital Eastern Campus
Corner of Lachlan and Hart Streets
LIVERPOOL NSW 2170
Country
Australia
Secondary sponsor category [1] 304241 0
None
Name [1] 304241 0
Address [1] 304241 0
Country [1] 304241 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304494 0
South Western Sydney Local Health District HREC [EC00136]
Ethics committee address [1] 304494 0
Ethics committee country [1] 304494 0
Australia
Date submitted for ethics approval [1] 304494 0
10/10/2019
Approval date [1] 304494 0
25/11/2019
Ethics approval number [1] 304494 0
2019/ETH13152

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

Contacts
Principal investigator
Name 97146 0
Dr Diane Whiting
Address 97146 0
Ingham Institute
Liverpool Hospital
Locked Bag 7103
Liverpool BC NSW 1871
Country 97146 0
Australia
Phone 97146 0
+61 403 128 447
Fax 97146 0
Email 97146 0
diane.whiting@health.nsw.gov.au
Contact person for public queries
Name 97147 0
Diane Whiting
Address 97147 0
Ingham Institute
Liverpool Hospital
Locked Bag 7103
Liverpool BC NSW 1871
Country 97147 0
Australia
Phone 97147 0
+61 403 128 447
Fax 97147 0
Email 97147 0
diane.whiting@health.nsw.gov.au
Contact person for scientific queries
Name 97148 0
Diane Whiting
Address 97148 0
Ingham Institute
Liverpool Hospital
Locked Bag 7103
Liverpool BC NSW 1871
Country 97148 0
Australia
Phone 97148 0
+61 403 128 447
Fax 97148 0
Email 97148 0
diane.whiting@health.nsw.gov.au

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


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.