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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]

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

Epilepsy

Multiple sclerosis

Condition category

Condition code

Neurological

Other neurological disorders

Neurological

Epilepsy

Neurological

Multiple sclerosis

Injuries and Accidents

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]

Rehabilitation

Intervention code [2]

Treatment: Other

Intervention code [3]

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]

Psychological wellbeing (Warwick-Edinburgh Mental Wellbeing Scale)

Timepoint [1]

Baseline, 8 weeks (primary timepoint) and 16 weeks after baseline commencement

Secondary outcome [1]

Valued living as assessed by the Valued Living Questionnaire (VLQ) and the Valuing Questionnaire (VQ)

Timepoint [1]

Baseline, 8 weeks (primary timepoint) and 16 weeks after baseline commencement

Secondary outcome [2]

Post-traumatic growth as assessed by the Changes in Outlook Questionnaire-Short Form

Timepoint [2]

Baseline, 8 weeks (primary timepoint) and 16 weeks after baseline commencement

Secondary outcome [3]

Psychological flexibility as assessed by the Acceptance and Action Questionnaire-ABI

Timepoint [3]

Baseline, 8 weeks (primary timepoint) and 16 weeks after baseline commencement

Secondary outcome [4]

Cognitive strategy use as assessed by the Strategy Use Checklist

Timepoint [4]

Baseline, 8 weeks (primary timepoint) and 16 weeks after baseline commencement

Secondary outcome [5]

Self-efficacy as assessed by an adapted version of the TBI Self-efficacy Questionnaire

Timepoint [5]

Baseline, 8 weeks (primary timepoint) and 16 weeks after baseline commencement

Secondary outcome [6]

Subjective cognitive function as assessed by the Everyday Memory Questionnaire

Timepoint [6]

Baseline, 8 weeks (primary timepoint) and 16 weeks after baseline commencement

Secondary outcome [7]

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]

Baseline

Secondary outcome [8]

Community integration/activities/participation as assessed by the Community Integration Questionnaire

Timepoint [8]

Baseline, 8 weeks (primary timepoint) and 16 weeks after baseline commencement

Secondary outcome [9]

Mood/anxiety as assessed by Hospital Anxiety and Depression Scale (HADS) and Depression Anxiety Stress Scales (DASS)

Timepoint [9]

Baseline, 8 weeks (primary timepoint) and 16 weeks after baseline commencement

Secondary outcome [10]

Feasibility/Acceptability as assessed by an adapted version of the Credibility and Expectancy Questionnaire and a study-specific semi-structured interview

Timepoint [10]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

La Trobe University Research Focus Areas - Grant Ready Scheme

Address [1]

La Trobe University
Plenty Rd & Kingsbury Dr
Bundoora, Melbourne, Victoria 3086
Australia

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

University

Name [1]

University of Edinburgh, United Kingdom

Address [1]

South Bridge
Edinburgh
EH8 9YL

Country [1]

United Kingdom

Other collaborator category [2]

University

Name [2]

University Of Nottingham

Address [2]

Innovation Park, Triumph Rd, Nottingham NG7 2TU

Country [2]

United Kingdom

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

La Trobe University Human Research Ethics Committee

Ethics committee address [1]

David Myers East, Level 2, 224
La Trobe University
Plenty Rd & Kingsbury Dr
Bundoora, Melbourne, Victoria 3086
Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

05/08/2019

Approval date [1]

12/08/2019

Ethics approval number [1]

Summary

Brief summary

Acquired brain injuries (ABIs) such as stroke, traumatic brain injury, and multiple sclerosis are commonly associated with cognitive impairment and emotional distress. These changes significantly impact a range of outcomes, including participation in meaningful and valued activities. Valued living (the extent to which a person lives in accordance with their values) has been associated with improved psychological adjustment and functional outcome in ABI survivors (Pais-Hrit, Wong, Gould & Ponsford, 2019). Therefore, interventions increasing valued living within ABI populations may be effective in improving a range of psychological and functional outcomes.
Since 2018 our research team has been evaluating the feasibility and acceptability of a new group program called VaLiANT (Valued Living After Neurological Trauma) that aims to enhance psychological adjustment in acquired brain injury (ABI) populations by combining cognitive rehabilitation and psychological therapy using Acceptance and Commitment Therapy (ACT) principles. The 8-week group program for individuals with ABI-related cognitive impairment and/or emotional distress focusses on helping participants reconnect with what gives their lives meaning while providing strategies for cognitive and emotional barriers. A Phase I study has been completed utilising a single case experimental design (SCED).  Preliminary results show that wellbeing and psychological flexibility improved following participation in the VaLiANT program, and trends were evident suggesting increased mood and self-efficacy and reduced subjective memory complaints.
This Phase II study aims to build on the findings of the SCED through a pilot randomised controlled trial evaluating the efficacy of the program in enhancing psychological adjustment in people with ABI. Up to four groups will run out of the La Trobe University Psychology clinic per year. Participants who would like to increase their participation in valued activities  and are experiencing ABI-related cognitive dysfunction and/or emotional distress (reported by self or other) will be invited to take part. Participation will involve attending eight group sessions (2 hours per week for 8 weeks), as well as attending assessments immediately before, immediately after, and 8-weeks following the group (1.5 hours each).

Trial website

https://www.latrobe.edu.au/psychology-clinic/services/group-programs/valiant-group

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Dana Wong

Address

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

Australia

Phone

+61 3 94795079

Fax

d.wong@latrobe.edu.au

Contact person for public queries

Name

Dana Wong

Address

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

Australia

Phone

+61 3 94795079

Fax

d.wong@latrobe.edu.au

Contact person for scientific queries

Name

Dana Wong

Address

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

Australia

Phone

+61 3 94795079

Fax

d.wong@latrobe.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
3773	Study protocol	Sathananthan, 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

Source	Title	Year of Publication	DOI
Dimensions AI	Research Note: Registry-based randomised controlled trials with examples from the Australian Stroke Clinical Registry	2024	https://doi.org/10.1016/j.jphys.2024.02.015

N.B. These documents automatically identified may not have been verified by the study sponsor.

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