ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12609000456257

Ethics application status

Approved

Date submitted

14/03/2009

Date registered

15/06/2009

Date last updated

6/07/2012

Type of registration

Retrospectively registered

Titles & IDs

Public title

The use of Motivational Interviewing and cognitive behavioural therapy to treat anxiety and/or depression following traumatic brain injury

Scientific title

The use of Motivational Interviewing (MI)and cognitive behavioural therapy (CBT) to treat anxiety and/or depression following traumatic brain injury (TBI)

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

traumatic brain injury

anxiety

depression

Condition category

Condition code

Neurological

Other neurological disorders

Mental Health

Depression

Mental Health

Anxiety

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

(1) Cognitive Behavioural Threapy (CBT)only: 3 weeks of baseline (no intervention), followed by approximately 9 weekly sessions of cognitive behavioural therapy (CBT) and then a 9-week follow-up period, (2) Motivational Interviewing (MI) + Cognitive Behavioural Therapy (CBT): Up to 3 weekly sessions of motivational interviewing (MI) plus approximately 9 weekly sessions of cognitive behavioural therapy, followed by 9 weeks of follow-up period; and (3) treatment as usual. All treatment sessions will be held on a weekly basis wherever possible, and each session will be about 45-60 minutes.

Intervention code [1]

Treatment: Other

Intervention code [2]

Rehabilitation

Comparator / control treatment

Treatment as usual - standard care/non-directive counselling: A form of counselling in which the therapist uses non-strategic reflective listening, i.e., the client is invited to talk about any subject they wish, not necessarily issues related to anxiety, depression or any aspect of their mental health. The direction of content is intentionally left for the client to
determine. In other words, the therapist takes on a more passive role. The control group may receive weekly or fortnightly non-directive counselling sessions as part of their standard care (up to 12 weeks). Each session may be up to 60 minutes long.
In other words, there is a waiting period of 12 weeks before the control group receive Cognitive Behavioural Therapy.

Control group

Active

Outcomes

Primary outcome [1]

reduction in scores on the Hospital Anxiety and Depression Scale (HADS)

Timepoint [1]

at baseline and at 3, 12, and 21 weeks after entry to study/intervention commencement

Secondary outcome [1]

Level of self-awareness as measured by the Self-Awareness of Deficits Interview (SADI)

Timepoint [1]

at baseline and at 12 and 21 weeks after entry to study/intervention

Secondary outcome [2]

Use of productive and unproductive coping strateges as measured by the Coping Scale for Adults Short Form (CSA-S):

Timepoint [2]

at baseline and at 12 and 21 weeks after entry to study/intervention

Secondary outcome [3]

Level of psychosocial functioning as measured by the Sydney Psychosocial Reintegration Scale (SPRS) Form B Client version

Timepoint [3]

at baseline and at 12 and 21 weeks after entry to study/intervention

Eligibility

Key inclusion criteria

Individuals with moderate to severe traumatic brain injury (TBI), aged 17 and over and living in the community.

Minimum age

18 Years

Maximum age

75 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Participants experiencing an acute episode of psychosis or substance abuse will be excluded

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)

Allocation concealment (usng sealed envelopes)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Participants will be randomised on completion of the initial assessment. A stratified block randomisation procedure will be used to ensure that the three treatment groups are as similar as possible in terms of gender and treating psychologist. The randomisation will be computer generated. A researcher not connected with the intervention or assessment will undertake the randomisation sequence. To assist in portability of the randomisation schedule, a series of cards will be made with the randomised group, sealed in envelopes and marked in order including stratification.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Factorial

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

26/05/2008

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)

Funding & Sponsors

Funding source category [1]

University

Name [1]

School of Psychology, Psychiatry and Psychological Medicine, Monash University

Address [1]

Building 17
Clayton Campus
Monash University
Victoria 3800

Country [1]

Australia

Primary sponsor type

Individual

Name

Professor Jennie Ponsford

Address

School of Psychology, Psychiatry and Psychological Medicine
Building 17
Clayton Campus
Monash University
Victoria 3800

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Ming-Yun Hsieh

Address [1]

School of Psychology, Psychiatry and Psychological Medicine
Building 17
Clayton Campus
Monash University
Victoria 3800

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash Standing Committee on Ethics in Research

Ethics committee address [1]

Monash University Clayton Campus
Victoria 3800

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

11/02/2008

Ethics approval number [1]

2008000130

Ethics committee name [2]

Epworth HealthCare Human Research and Ethics Committee

Ethics committee address [2]

Administration, Medical Services
Epworth HealthCare, Corporate
89 Bridge Rd. 5LP 
RICHMOND VIC 3121

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

14/01/2008

Ethics approval number [2]

39407

Summary

Brief summary

Individuals with traumatic brain injury (TBI) are prone to experiencing psychological distress, especially anxiety and depression.  Cognitive-behavioural therapy (CBT) is a promising treatment for anxiety disorders in people with TBI of the mild-moderate spectrum.  However, the effectiveness of CBT to treat anxiety disorders in those with moderate-severe TBI is still not well-understood, and this subgroup tends to have longer-lasting cognitive problems such as poor memory and problem solving.  Furthermore, there has been very limited research investigating ways of enhancing treatment response in those with moderate-severe TBI.  This presents significant challenges to treatment providers, as effective management of anxiety disorders inevitably involves a person to confront some entrenched patterns of fears and worries.  

The proposed study aims to examine the efficacy of an evidence-based CBT programme as a treatment of anxiety disorders for individuals with moderate-severe TBI.  The study will also examine the effects of a brief preparatory intervention on treatment engagement and response rate.  In addition, factors which influence participants’ treatment response and experience with therapy will be explored.  A number of questionnaires, designed to measure levels of anxiety, psychosocial and community reintegration, self-awareness, and beliefs about one’s ability to control anxiety will be given to participants.  Participant’s level of cognitive functioning will also be assessed in order to examine the impact of cognitive problems on their potential to benefit from CBT.  The project is designed such that a control component is embedded in the form of treatment-as-usual wait list protocols.  This enables all participants to have access to the intervention while also ensuring high quality empirical evidence.  

Effective interventions are urgently required in order to prevent prolonged psychological distress and to improve the quality of life for individuals who have had sustained TBI.  This project is expected to contribute to our understanding of ways of assisting individuals to manage anxiety, hence improving their psychosocial functioning.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Professor Jennie Ponsford

Address

School of Psychology, Psychiatry and
Psychological Medicine,
Building 17,
Clayton Campus
Monash University
Victoria 3800

Country

Australia

Phone

+61 (03) 9905 3058

Fax

Jennie.Ponsford@med.monash.edu.au

Contact person for scientific queries

Name

Professor Jennie Ponsford

Address

School of Psychology, Psychiatry and Psychological Medicine,
Building 17,
Clayton Campus
Monash University
Victoria 3800

Country

Australia

Phone

+61 (03) 9905 3058

Fax

Jennie.Ponsford@med.monash.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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Documents added automatically

No additional documents have been identified.

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