Trial Review

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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 4361 0
anxiety 4362 0
depression 4363 0
Condition category
Condition code
Neurological 4606 4606 0 0
Other neurological disorders
Mental Health 4607 4607 0 0
Depression
Mental Health 4608 4608 0 0
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] 4094 0
Treatment: Other
Intervention code [2] 4095 0
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] 5482 0
reduction in scores on the Hospital Anxiety and Depression Scale (HADS)
Timepoint [1] 5482 0
at baseline and at 3, 12, and 21 weeks after entry to study/intervention commencement
Secondary outcome [1] 9235 0
Level of self-awareness as measured by the Self-Awareness of Deficits Interview (SADI)
Timepoint [1] 9235 0
at baseline and at 12 and 21 weeks after entry to study/intervention
Secondary outcome [2] 9236 0
Use of productive and unproductive coping strateges as measured by the Coping Scale for Adults Short Form (CSA-S):
Timepoint [2] 9236 0
at baseline and at 12 and 21 weeks after entry to study/intervention
Secondary outcome [3] 9237 0
Level of psychosocial functioning as measured by the Sydney Psychosocial Reintegration Scale (SPRS) Form B Client version
Timepoint [3] 9237 0
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?
No
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
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4544 0
University
Name [1] 4544 0
School of Psychology, Psychiatry and Psychological Medicine, Monash University
Country [1] 4544 0
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] 4099 0
Individual
Name [1] 4099 0
Ming-Yun Hsieh
Address [1] 4099 0
School of Psychology, Psychiatry and Psychological Medicine
Building 17
Clayton Campus
Monash University
Victoria 3800
Country [1] 4099 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6592 0
Monash Standing Committee on Ethics in Research
Ethics committee address [1] 6592 0
Monash University Clayton Campus
Victoria 3800
Ethics committee country [1] 6592 0
Australia
Date submitted for ethics approval [1] 6592 0
Approval date [1] 6592 0
11/02/2008
Ethics approval number [1] 6592 0
2008000130
Ethics committee name [2] 6593 0
Epworth HealthCare Human Research and Ethics Committee
Ethics committee address [2] 6593 0
Administration, Medical Services
Epworth HealthCare, Corporate
89 Bridge Rd. 5LP
RICHMOND VIC 3121
Ethics committee country [2] 6593 0
Australia
Date submitted for ethics approval [2] 6593 0
Approval date [2] 6593 0
14/01/2008
Ethics approval number [2] 6593 0
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 29311 0
Address 29311 0
Country 29311 0
Phone 29311 0
Fax 29311 0
Email 29311 0
Contact person for public queries
Name 12558 0
Professor Jennie Ponsford
Address 12558 0
School of Psychology, Psychiatry and
Psychological Medicine,
Building 17,
Clayton Campus
Monash University
Victoria 3800
Country 12558 0
Australia
Phone 12558 0
+61 (03) 9905 3058
Fax 12558 0
Email 12558 0
[email protected]
Contact person for scientific queries
Name 3486 0
Professor Jennie Ponsford
Address 3486 0
School of Psychology, Psychiatry and Psychological Medicine,
Building 17,
Clayton Campus
Monash University
Victoria 3800
Country 3486 0
Australia
Phone 3486 0
+61 (03) 9905 3058
Fax 3486 0
Email 3486 0
[email protected]

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

Documents added manually
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