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Improving wellbeing after acquired brain injury with a group program to enhance participation in valued activities

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)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001243101
Acronym
VaLiANT
Enrollment
54
Registered
2019-09-09
Start date
2019-09-10
Completion date
2022-02-03
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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).

Interventions

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

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).

Sponsors

La Trobe University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Apr 23, 2026