Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001243101
Ethics application status
Approved
Date submitted
19/08/2019
Date registered
9/09/2019
Date last updated
5/05/2022
Date data sharing statement initially provided
9/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving wellbeing after acquired brain injury with a group program to enhance participation in valued activities
Scientific title
Evaluation of a group-based intervention to enhance wellbeing after acquired brain injury: A Phase II randomised controlled trial of VaLiANT (Valued Living After Neurological Trauma)
Secondary ID [1] 298804 0
Nil
Universal Trial Number (UTN)
U1111-1237-3628
Trial acronym
VaLiANT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acquired Brain Injury 313755 0
Epilepsy 314227 0
Multiple sclerosis
 314228 0
Condition category
Condition code
Neurological 312160 312160 0 0
Other neurological disorders
Neurological 312161 312161 0 0
Epilepsy
Neurological 312162 312162 0 0
Multiple sclerosis
Injuries and Accidents 312589 312589 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The overarching aim of this study is to investigate the clinical effectiveness, feasibility and acceptability of the 8-week valued living program (VaLiANT) in acquired brain injury survivors. VaLiANT is a group therapy program that concurrently targets cognition and emotion by integrating cognitive rehabilitation and Acceptance and Commitment Therapy (ACT) techniques to improve engagement in valued and meaningful activities after acquired brain injury.
Each week has a focus on a different value domain (such as relationships, health or work) and includes exploration of what is important to the participants in this domain. Specific valued activities in each domain are identified. This is followed by various exercises and techniques that encourage engagement in those valued activities, while addressing barriers relating to difficulties with cognitive function and coping. Relevant strategies for managing problems with memory, mental fatigue, and planning are discussed and practiced, with the aim of reducing the impact of these difficulties on participation in valued activities. Alongside this, psychological therapy techniques drawn from an Acceptance and Commitment Therapy (ACT) framework are practiced, to enable participants manage the difficult emotions that may arise when engaging in valued activities.
The focus of each session is:
SESSION 1: Introducing the intervention and key principles of valued living
SESSION 2: Sleep/Fatigue
SESSION 3: Exercise and Diet (participants are provided with general information about exercise and diet)
SESSION 4: Work/study/community involvement
SESSION 5: Leisure activities (participants are provided with general information about participating in leisure activities)
SESSION 6: Friends and family I
SESSION 7: Friends and family II
SESSION 8: Moving forwards and maintaining these changes
The group comprises psychoeducation, discussion, provision of information and resources through multiple modalities (verbal discussion, Powerpoint slides and handouts designed specifically for this study), in-session practice of cognitive and coping strategies (e.g., name association techniques, mindfulness exercises), and weekly homework exercises to encourage implementation of strategies and participation in valued activities in everyday life. Weekly homework tasks involve completing valued activities identified by each participant during the session for the relevant life domain, while practicing the strategies taught in the weekly session(e.g. participating in social catch ups for the ‘Family and Friends’ sessions, using communication strategies taught in those sessions).
The lead facilitator of the VaLiANT group program has completed advanced training in ACT workshops and has expertise in cognitive rehabilitation and running groups. VaLiANT is run either in-person at the La Trobe University Psychology Clinic, or via telehealth (depending on safety restrictions), up to 4 times per year. The program is run weekly for a period of 8 weeks. Each session is 2 hours long.
All VaLiANT sessions will be video recorded. A subset of at least 10% of sessions (randomly selected) will be checked by an independent expert psychologist to ensure the facilitators demonstrate i) adherence to the manual (i.e., meet the specified objectives for each session) and ii) competence in delivering the intervention (using the eNACT group facilitation competency checklist).
Intervention code [1] 315072 0
Rehabilitation
Intervention code [2] 315073 0
Treatment: Other
Intervention code [3] 315074 0
Behaviour
Comparator / control treatment
Waitlist control: the control group will be offered the intervention 16 weeks after the intervention period
Control group
Active

Outcomes
Primary outcome [1] 320802 0
Psychological wellbeing (Warwick-Edinburgh Mental Wellbeing Scale)
Timepoint [1] 320802 0
Baseline, 8 weeks (primary timepoint) and 16 weeks after baseline commencement
Secondary outcome [1] 372895 0
Valued living as assessed by the Valued Living Questionnaire (VLQ) and the Valuing Questionnaire (VQ)
Timepoint [1] 372895 0
Baseline, 8 weeks (primary timepoint) and 16 weeks after baseline commencement
Secondary outcome [2] 374433 0
Post-traumatic growth as assessed by the Changes in Outlook Questionnaire-Short Form
Timepoint [2] 374433 0
Baseline, 8 weeks (primary timepoint) and 16 weeks after baseline commencement
Secondary outcome [3] 374434 0
Psychological flexibility as assessed by the Acceptance and Action Questionnaire-ABI
Timepoint [3] 374434 0
Baseline, 8 weeks (primary timepoint) and 16 weeks after baseline commencement
Secondary outcome [4] 374435 0
Cognitive strategy use as assessed by the Strategy Use Checklist
Timepoint [4] 374435 0
Baseline, 8 weeks (primary timepoint) and 16 weeks after baseline commencement
Secondary outcome [5] 374436 0
Self-efficacy as assessed by an adapted version of the TBI Self-efficacy Questionnaire
Timepoint [5] 374436 0
Baseline, 8 weeks (primary timepoint) and 16 weeks after baseline commencement
Secondary outcome [6] 374437 0
Subjective cognitive function as assessed by the Everyday Memory Questionnaire
Timepoint [6] 374437 0
Baseline, 8 weeks (primary timepoint) and 16 weeks after baseline commencement
Secondary outcome [7] 374438 0
Objective cognitive function as assessed by the Rey Auditory Verbal Learning Test (RAVLT), the Trail Making Test (Parts A & B), and the Controlled Oral Word Association Test (COWAT)
Timepoint [7] 374438 0
Baseline
Secondary outcome [8] 374440 0
Community integration/activities/participation as assessed by the Community Integration Questionnaire
Timepoint [8] 374440 0
Baseline, 8 weeks (primary timepoint) and 16 weeks after baseline commencement
Secondary outcome [9] 374441 0
Mood/anxiety as assessed by Hospital Anxiety and Depression Scale (HADS) and Depression Anxiety Stress Scales (DASS)
Timepoint [9] 374441 0
Baseline, 8 weeks (primary timepoint) and 16 weeks after baseline commencement
Secondary outcome [10] 374442 0
Feasibility/Acceptability as assessed by an adapted version of the Credibility and Expectancy Questionnaire and a study-specific semi-structured interview
Timepoint [10] 374442 0
Credibility and Expectancy Questionnaire completed at baseline and 8 weeks
Study-specific semi-structured interview completed at 16 weeks

Eligibility
Key inclusion criteria
Participants need to have experienced an acquired brain injury at least 3 months prior to enrolment in the study, and be 18 years of age or over. They need to be experiencing some reduction in their participation in valued activities, as well as cognitive difficulties and/or emotional distress. Also, participants will need to be able to attend La Trobe Psychology Clinic for the VaLiANT program on the dates specified.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals will be ineligible for participation if they have a pre-existing intellectual disability, severe psychiatric disorder or comorbid neurodegenerative condition, as these comorbidities would act as significant confounding factors. Participants will also be excluded if they do not have sufficient cognitive functioning or English language ability to complete outcome measures or participate in the group.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Participants will be randomized according to an allocation ratio of 2:1 (Intervention: Control)
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Random-effects regression will be used to compare the trajectory of change in outcome measure performance over time between groups. Models will be fitted with assessment time-point and group allocation as fixed effects, while participants will be modelled as a random effect. A 2-sided alpha value of less than 0.05 will be used. Pairwise comparisons and ANOVAs with Bonferroni correction will be computed to explore between-group differences at each time-point.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/09/2019
Actual
10/09/2019
Date of last participant enrolment
Anticipated
8/08/2022
Actual
3/02/2022
Date of last data collection
Anticipated
31/12/2022
Actual
3/05/2022
Sample size
Target
75
Accrual to date
Final
54
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 303361 0
University
Name [1] 303361 0
La Trobe University Research Focus Areas - Grant Ready Scheme
Country [1] 303361 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University
Plenty Rd & Kingsbury Dr
Bundoora, Melbourne, Victoria 3086
Australia
Country
Australia
Secondary sponsor category [1] 303528 0
None
Name [1] 303528 0
Address [1] 303528 0
Country [1] 303528 0
Other collaborator category [1] 280889 0
University
Name [1] 280889 0
University of Edinburgh, United Kingdom
Address [1] 280889 0
South Bridge
Edinburgh
EH8 9YL
Country [1] 280889 0
United Kingdom
Other collaborator category [2] 280890 0
University
Name [2] 280890 0
University Of Nottingham
Address [2] 280890 0
Innovation Park, Triumph Rd, Nottingham NG7 2TU
Country [2] 280890 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303891 0
La Trobe University Human Research Ethics Committee
Ethics committee address [1] 303891 0
Ethics committee country [1] 303891 0
Australia
Date submitted for ethics approval [1] 303891 0
05/08/2019
Approval date [1] 303891 0
12/08/2019
Ethics approval number [1] 303891 0

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

Contacts
Principal investigator
Name 95146 0
Dr Dana Wong
Address 95146 0
George Singer Building
Department of Psychology and Counselling
School of Psychology and Public Health
La Trobe University
Plenty Rd & Kingsbury Dr
Bundoora, Melbourne, Victoria 3086
Australia
Country 95146 0
Australia
Phone 95146 0
+61 3 94795079
Fax 95146 0
Email 95146 0
[email protected]
Contact person for public queries
Name 95147 0
Dana Wong
Address 95147 0
George Singer Building
Department of Psychology and Counselling
School of Psychology and Public Health
La Trobe University
Plenty Rd & Kingsbury Dr
Bundoora, Melbourne, Victoria 3086
Australia
Country 95147 0
Australia
Phone 95147 0
+61 3 94795079
Fax 95147 0
Email 95147 0
[email protected]
Contact person for scientific queries
Name 95148 0
Dana Wong
Address 95148 0
George Singer Building
Department of Psychology and Counselling
School of Psychology and Public Health
La Trobe University
Plenty Rd & Kingsbury Dr
Bundoora, Melbourne, Victoria 3086
Australia
Country 95148 0
Australia
Phone 95148 0
+61 3 94795079
Fax 95148 0
Email 95148 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
To maintain confidentiality of sensitive data obtained from this vulnerable participant group, only grouped data, which does not identify individual participants, will be published.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3773Study protocolSathananthan, N., Morris, E. M. J., Gillanders, D., Knox, L., Dimech-Betancourt, B., Wright, B. J., das Nair, R., & Wong, D. (2022). Does Integrating Cognitive and Psychological Interventions Enhance Wellbeing After Acquired Brain Injury? Study Protocol for a Phase II Randomized Controlled Trial of the VaLiANT (Valued Living After Neurological Trauma) Group Program [Original Research]. Frontiers in Rehabilitation Sciences, 2. https://doi.org/10.3389/fresc.2021.815111 https://doi.org/10.3389/fresc.2021.815111  To be published in future 378022-(Uploaded-04-05-2022-12-25-00)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIResearch Note: Registry-based randomised controlled trials with examples from the Australian Stroke Clinical Registry2024https://doi.org/10.1016/j.jphys.2024.02.015
N.B. These documents automatically identified may not have been verified by the study sponsor.