ANZCTR - Registration

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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

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]

Nil

Universal Trial Number (UTN)

U1111-1117-3676

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Psychological adjustment

Traumatic Brain Injury

Condition category

Condition code

Mental Health

Other mental health disorders

Injuries and Accidents

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]

Treatment: Other

Intervention code [2]

Behaviour

Intervention code [3]

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]

mean Acceptance and Action Questions for Acquired Brain Injury (AAQ-ABI)

Timepoint [1]

Baseline, weekly during the intervention period at the beginning of each session, immediately post intervention and at one month post intervention.

Primary outcome [2]

mean Motivation for Traumatic Brain Injury Rehabilitation Questionnaire (MOT-Q)

Timepoint [2]

Baseline, immediately post intervention and one month post intervention

Secondary outcome [1]

Acceptance and Action Questionnaire - II (AAQ-II)

Timepoint [1]

Baseline, weekly during the intervention period at the beginning of each session, immediately post intervention and at one month post intervention.

Secondary outcome [2]

Depression Anxiety Stress Scale (DASS)

Timepoint [2]

Baseline, weekly during the intervention period at the beginning of each session, immediately post intervention and at one month post intervention.

Secondary outcome [3]

Hospital Anxiety and Depression Scale

Timepoint [3]

Baseline, immediately post intervention and one month post intervention

Secondary outcome [4]

Positive and Negative Affect Schedule-Short Form (PANAS-SF)

Timepoint [4]

Baseline, weekly during the intervention period at the beginning of each session, immediately post intervention and at one month post intervention.

Secondary outcome [5]

The General Health Questionnaire - 12 (GHQ-12)

Timepoint [5]

Baseline, immediately post intervention and one month post intervention

Secondary outcome [6]

Sydney Psychosocial Reintegration Scale (SPRS)

Timepoint [6]

Baseline, immediately post intervention and one month post intervention

Secondary outcome [7]

SF-12 Health Survey

Timepoint [7]

Baseline, immediately post intervention and one month post intervention

Secondary outcome [8]

Awareness Questionnaire

Timepoint [8]

Baseline, immediately post intervention and one month post intervention

Secondary outcome [9]

The Survey of Life Principles

Timepoint [9]

Baseline, immediately post intervention and one month post intervention

Secondary outcome [10]

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]

Baseline, immediately post intervention and one month post intervention

Secondary outcome [11]

Homework rating scale

Timepoint [11]

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

Sex

Both males and females

Can healthy volunteers participate?

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

15/01/2011

Actual

7/11/2011

Date of last participant enrolment

Anticipated

28/02/2017

Actual

1/10/2014

Date of last data collection

Anticipated

30/06/2017

Actual

18/01/2015

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

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]

Individual

Name [1]

Dr Hamish McLeod

Address [1]

Faculty of Health and Behavioural Sciences
University of Wollongong
Northfields Avenue
Wollongong NSW 2522

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

a/Prof Joseph Ciarrochi

Address [2]

Faculty of Health and Behavioural Sciences
University of Wollongong
Northfields Avenue
Wollongong NSW 2522

Country [2]

Australia

Secondary sponsor category [3]

Individual

Name [3]

Dr Grahame Simpson

Address [3]

Brain Injury Rehabilitation Unit
Liverpool Hospital
PO Box 7103
Liverpool CB NSW 1871

Country [3]

Australia

Secondary sponsor category [4]

Individual

Name [4]

Professor Frank Deane

Address [4]

Faculty of Health and Behavioural Sciences, Univeristy of Wollongong, Northfields Avencue Wollongong NSW 2522

Country [4]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney South West Areah Health Service Human Research Ethics Committee (HREC) (Western Zone)

Ethics committee address [1]

Locked Bag 7017
Liverpool BC NSW 1871

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

11/06/2010

Ethics approval number [1]

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

Ms Diane Whiting

Address

Brain Injury Rehabilitation Unit
Liverpool Hospital
Elizabeth Street, Liverpool NSW 2170

Country

Australia

Phone

61 2 873 85498

Fax

[email protected]

Contact person for public queries

Name

Diane Whiting

Address

Brain Injury Rehabilitation Unit
Locked Bag 7103
Liverpool BC NSW 1871

Country

Australia

Phone

+61 2 98285495

Fax

+ 61 2 98285497

[email protected]

Contact person for scientific queries

Name

Diane Whiting

Address

Brain Injury Rehabilitation Unit
Locked Bag 7103
Liverpool BC NSW 1871

Country

Australia

Phone

+61 2 98285495

Fax

+61 2 98285497

[email protected]

Data sharing statement

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

No/undecided IPD sharing reason/comment

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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically