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Trial registered on ANZCTR


Registration number
ACTRN12610000851066
Ethics application status
Approved
Date submitted
5/10/2010
Date registered
12/10/2010
Date last updated
18/10/2019
Date data sharing statement initially provided
20/02/2019
Date results information initially provided
20/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A trial of Acceptance Commitment Therapy to facilitate psychological adjustment following a traumatic brain injury
Scientific title
An intervention trialling Acceptance and Commitment Therapy to facilitate the adjustment process in adults experiencing psychological distress after a traumatic brain injury
Secondary ID [1] 252821 0
Nil
Universal Trial Number (UTN)
U1111-1117-3676
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological adjustment 258330 0
Traumatic Brain Injury 258347 0
Condition category
Condition code
Mental Health 258515 258515 0 0
Other mental health disorders
Injuries and Accidents 258531 258531 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Psychological intervention based on Acceptance and Commitment Therapy (ACT).
a) ACT is a behavour therapy that involves 6 core process: Defusion, acceptance, contact with present moment, self as context, values identification and committed action. Act focuses on helping clients to accept unpleasant thoughts and feelings when doing so promotes valued living. It incorporates visual metaphors and experiential role plays suggesting it maybe modifiable for use with a cognitively impaired population.
b) Sessions will be undertaken weekly for 2 hours for a period of 6 weeks with a 7th session after a month (7 sessions in total)
c) Duration of the intervention will therefore be 10 weeks
d) Treatment will be administered by a clinical psychologist experienced in both ACT and traumatic brain injury (TBI) to groups of 2 clients.

e) Summary of Treatment Protocol
Session 1
Introduction to the group
- Introductions & name tags
- Administer measures
- Icebreaker activity
- Group guidelines including confidentiality
- Reason for attending
- Group aims
- Program outline
- Confronting the agenda
- Identifying individual issues
- Workability
- Breathing mindfulness activity
- Homework
- Introduce concept of homework
- Homework contract

Session 2
Administer measures
Review homework
Review previous session
Control is the problem
Normalcy of control
Human suffering
Exercise – Let suffering get close
Exercise – Passengers on the Bus
Homework
Valued activity
Homework contract

Session 3
Administer measures
Review homework
Review previous session
Acceptance and Defusion
Defusion exercise – milk milk milk
Physicalise the thought
Don’t get eaten machine
Homework
Physicalising thoughts
Homework contract

Session 4
Administer measures
Review homework
Review previous session
The observing self
Separating self from thoughts/feelings/actions
Exercise: Observer
The Observing Self
Chessboard Metaphor
Mindfulness – eating a sultana
Homework
Listing to mindfulness CD
Homework contract
Weekly diary

Session 5
Administer measures
Review homework
Review previous session
Introduction of values
Difference between goals and values
Exercise - Survey of Life Principles
Exercise - Funeral
Homework
Principles and action
Homework contract

Session 6
Review homework
Values and committed action
Setting goals
Committed action and goals
Recap and review of each session
Homework
Weekly diary
Homework contract

Session 7 (one month later)
Administer measures
Review of homework and progress
Review course content
Exercise – Leaves on a Stream
Certificates
Contacts for further assistance

f) Homework will be given every week and vary depending on the content of the session
Intervention code [1] 257343 0
Treatment: Other
Intervention code [2] 257344 0
Behaviour
Intervention code [3] 257345 0
Rehabilitation
Comparator / control treatment
Befriending protocol
a) Befriending provides a non therapeutic active control that provides social support and combats isolation. It has been developed to provide the clients with approximately teh same amount of therapist contact as the active treatment. The therapist is empathic and non directive and sessions focus on neutral topics such as hobbies, sports and current affairs. Befriending aims to control for the following empirically supported factors: Time, client expectancy, therapeutic or working alliance and therapist factors (such as warmth, understanding) without employing any techniques specific to major models of psychotherapy.
b) Duration will be the same as teh active treatment that is 2 hours per week for 6 sessions with a 2 hour follow up after one month for session 7.
c) Overall duration will be 10 weeks
d) Undertaken by a clinical psychologist (the same as the active treatment) in groups of 2 clients
e) Content of the sessions will be directed by the participants interests and will include learning a card game, discussing a movie or sport or current affairs, going to a coffee shop for example. The content of the sessions will be generated in the first session from a list of suggestions and by brainstorming with the participants.
f) no additional homework tasks will be given
After the befriending protocol has completed, participants will be offered individual treatment by the clinical psychologist at the brain injury unit.
Control group
Active

Outcomes
Primary outcome [1] 259351 0
mean Acceptance and Action Questions for Acquired Brain Injury (AAQ-ABI)
Timepoint [1] 259351 0
Baseline, weekly during the intervention period at the beginning of each session, immediately post intervention and at one month post intervention.
Primary outcome [2] 259352 0
mean Motivation for Traumatic Brain Injury Rehabilitation Questionnaire (MOT-Q)
Timepoint [2] 259352 0
Baseline, immediately post intervention and one month post intervention
Secondary outcome [1] 265822 0
Acceptance and Action Questionnaire - II (AAQ-II)
Timepoint [1] 265822 0
Baseline, weekly during the intervention period at the beginning of each session, immediately post intervention and at one month post intervention.
Secondary outcome [2] 265823 0
Depression Anxiety Stress Scale (DASS)
Timepoint [2] 265823 0
Baseline, weekly during the intervention period at the beginning of each session, immediately post intervention and at one month post intervention.
Secondary outcome [3] 265824 0
Hospital Anxiety and Depression Scale
Timepoint [3] 265824 0
Baseline, immediately post intervention and one month post intervention
Secondary outcome [4] 265825 0
Positive and Negative Affect Schedule-Short Form (PANAS-SF)
Timepoint [4] 265825 0
Baseline, weekly during the intervention period at the beginning of each session, immediately post intervention and at one month post intervention.
Secondary outcome [5] 265826 0
The General Health Questionnaire - 12 (GHQ-12)
Timepoint [5] 265826 0
Baseline, immediately post intervention and one month post intervention
Secondary outcome [6] 265827 0
Sydney Psychosocial Reintegration Scale (SPRS)
Timepoint [6] 265827 0
Baseline, immediately post intervention and one month post intervention
Secondary outcome [7] 265828 0
SF-12 Health Survey
Timepoint [7] 265828 0
Baseline, immediately post intervention and one month post intervention
Secondary outcome [8] 265829 0
Awareness Questionnaire
Timepoint [8] 265829 0
Baseline, immediately post intervention and one month post intervention
Secondary outcome [9] 265830 0
The Survey of Life Principles
Timepoint [9] 265830 0
Baseline, immediately post intervention and one month post intervention
Secondary outcome [10] 265831 0
Record of attendance at other therapy sessions including speech therapy, occupational therapy, physiotherapy, social work, medical appointments, rehabilitation psychology. These will be obtained by reviewing the occasions of service entered into the Brain Injury Rehabilitation Unit (BIRU) database and by looking at file notes.
Timepoint [10] 265831 0
Baseline, immediately post intervention and one month post intervention
Secondary outcome [11] 265832 0
Homework rating scale
Timepoint [11] 265832 0
Weekly during treatment

Eligibility
Key inclusion criteria
Severe Traumatic brain injury
Experiencing at least a moderate level of psychological distress (as measured by any subscale of the Depression Anxiety Stress Scale - DASS)
Sufficient cognitive capacity and English language skills ot complete questionnaires
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pre morbid history of severe psychiatric illness (e.g. psychotic illness)

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)
Subjects will be recruited from the active community case load of the unit who have been referred to clinical psychology for treatment. Allocation to the groups will be undertaken by senior research staff member not involved with the study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple radomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Needed to submit PhD and changed jobs so no longer able to access participants
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 257798 0
Self funded/Unfunded
Name [1] 257798 0
Address [1] 257798 0
Country [1] 257798 0
Primary sponsor type
Individual
Name
Diane Whiting
Address
Brain Injury Rehabilitation Unit
Liverpool Hospital
PO Box 7103
Liverpool CB NSW 1871
Country
Australia
Secondary sponsor category [1] 257000 0
Individual
Name [1] 257000 0
Dr Hamish McLeod
Address [1] 257000 0
Faculty of Health and Behavioural Sciences
University of Wollongong
Northfields Avenue
Wollongong NSW 2522
Country [1] 257000 0
Australia
Secondary sponsor category [2] 257001 0
Individual
Name [2] 257001 0
a/Prof Joseph Ciarrochi
Address [2] 257001 0
Faculty of Health and Behavioural Sciences
University of Wollongong
Northfields Avenue
Wollongong NSW 2522
Country [2] 257001 0
Australia
Secondary sponsor category [3] 257002 0
Individual
Name [3] 257002 0
Dr Grahame Simpson
Address [3] 257002 0
Brain Injury Rehabilitation Unit
Liverpool Hospital
PO Box 7103
Liverpool CB NSW 1871
Country [3] 257002 0
Australia
Secondary sponsor category [4] 287596 0
Individual
Name [4] 287596 0
Professor Frank Deane
Address [4] 287596 0
Faculty of Health and Behavioural Sciences, Univeristy of Wollongong, Northfields Avencue Wollongong NSW 2522
Country [4] 287596 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259821 0
Sydney South West Areah Health Service Human Research Ethics Committee (HREC) (Western Zone)
Ethics committee address [1] 259821 0
Locked Bag 7017
Liverpool BC NSW 1871
Ethics committee country [1] 259821 0
Australia
Date submitted for ethics approval [1] 259821 0
Approval date [1] 259821 0
11/06/2010
Ethics approval number [1] 259821 0
HREC/09/LPOOL/233

Summary
Brief summary
Clinically significant levels of emotional distress and behavioural avoidance are quite frequent after a traumatic brain injury. Interventions with a traumatic brain injured (TBI) population have demonstrated general benefits of group programmes in addressing some of these issues but to date, programs have utilised cognitive behavioural therapy (CBT) as a treatment protocol. At this time, there appears to be no published studies using acceptance and commitment therapy (ACT) with a TBI population. Acceptance and Commitment Therapy (ACT) is one of the ‘third wave’ of behavioural therapies. It aims to change our relationship with internal experiences (thoughts, feelings, memories and physical sensations) so they no longer act as barriers to valued behaviour. The aim of the study is to implement a psychological treatment program to improve psychologically functioning following a traumatic brain injury utilising Acceptance and Commitment Therapy (ACT). With improved psychological functioning it is anticipated that participants will increase their participation in rehabilitation and movement towards a more valued life.

The study will be a randomised controlled group treatment programme. Clients of the brain injury rehabilitation unit demonstrating clinically significantly levels of psychological distress will be randomly allocated to either the treatment group or the control group (consisting of an active control based on Befriending protocol). It is anticipated that the treatment will be offered over a two year period. The intervention will consist of six by two hour group treatment sessions offered weekly at the brain injury unit with a one month follow up session. Content of the sessions will be based on ACT theory including identification of values, defusing techniques, self as context and mindfulness. Testing will be undertaken prior to the commencement of treatment and after the one month follow up with brief measures being undertaken weekly at the beginning and conclusion of each treatment sessions relating to motivation and capacity to complete homework tasks. Demographic information will be collected and elicited from the existing brain injury unit database. Participants on the wait list control will be given the opportunity to participate in the intervention after the second outcome measures are undertaken.

De-identified data form the outcome measures will be analysed statistically for changes pre and post intervention. De-identified demographic and medical information will provide descriptive data about the participants. Attendance at other therapy appointments in the brain injury unit will be reviewed to measure level of participation.
Trial website
Trial related presentations / publications
Whiting DL, Simpson GK, McLeod HJ, Deane FP, Ciarrochi J (2012). Acceptance and Commitment Therapy (ACT) for psychological adjustment after traumatic brain injury: Reporting the protocol for a Randomised Controlled Trial. Brain Impairment, 13(3), 360-376.

Whiting D, Simpson G, Ciarrochi J, McLeod H. (2012). Assessing the feasibility of Acceptance and Commitment Therapy in promoting psychological adjustment after severe traumatic brain injury. Brain Injury, 26(4-5), 588-89.

Presentations:
Whiting DL, McLeod H, Ciarrochi J, Simpson GK. Using Acceptance and Commitment Therapy (ACT) to treat psychological adjustment after severe traumatic brain injury (TBI): Two Case studies. South Western Sydney Local Health District & Inghams Institute Inaugural Allied Health Research Forum, Bankstown-Lidcombe Hospital, 16 September 2011.
Public notes

Contacts
Principal investigator
Name 31736 0
Ms Diane Whiting
Address 31736 0
Brain Injury Rehabilitation Unit
Liverpool Hospital
Elizabeth Street, Liverpool NSW 2170
Country 31736 0
Australia
Phone 31736 0
61 2 873 85498
Fax 31736 0
Email 31736 0
diane.whiting@sswahs.nsw.gov.au
Contact person for public queries
Name 14983 0
Ms Diane Whiting
Address 14983 0
Brain Injury Rehabilitation Unit
Locked Bag 7103
Liverpool BC NSW 1871
Country 14983 0
Australia
Phone 14983 0
+61 2 98285495
Fax 14983 0
+ 61 2 98285497
Email 14983 0
diane.whiting@sswahs.nsw.gov.au
Contact person for scientific queries
Name 5911 0
Ms Diane Whiting
Address 5911 0
Brain Injury Rehabilitation Unit
Locked Bag 7103
Liverpool BC NSW 1871
Country 5911 0
Australia
Phone 5911 0
+61 2 98285495
Fax 5911 0
+61 2 98285497
Email 5911 0
diane.whiting@sswahs.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
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary