Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000969066
Ethics application status
Not yet submitted
Date submitted
1/11/2010
Date registered
10/11/2010
Date last updated
10/11/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised Controlled Trial of Cognitive Behavior Therapy and Education for Reduction in Postconcussive Syndrome Symptoms In Mild Traumatic Brain Injury Patients
Scientific title
Randomised Controlled Trial of Cognitive Behavior Therapy and Education for Reduction in Postconcussive Syndrome Symptoms In Mild Traumatic Brain Injury Patients
Secondary ID [1] 252993 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postconcussive syndrome 258543 0
Condition category
Condition code
Mental Health 258690 258690 0 0
Other mental health disorders
Injuries and Accidents 258771 258771 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive Behavior Therapy: Therapy is administered in once-weekly 60-minute telephone calls with a clinical psychologist over 5 weeks. Cognitive Behavior Therapy includes education about postconcussive syndrome, imaginal reliving of the trauma memories, in vivo exposure that includes gradual exposure to feared situations, and cognitive restructuring of the trauma experience and the postconcussive syndrome symptoms. The duration of the study for any participant will conclude after the 3-month follow-up assessment, resulting in participation duration of a maximum of 5 months.
Intervention code [1] 257515 0
Behaviour
Intervention code [2] 257525 0
Treatment: Other
Comparator / control treatment
The Education condition involves once-weekly 60-minute telephone calls with a clinical psychologist over 5 weeks. Therapy includes education about postconcussive syndrome, and nondirective counselling that does not include any Cognitive Behavior Therapy components. The duration of the study for any participant will conclude after the 3-month follow-up assessment, resulting in participation duration of a maximum of 5 months.
Control group
Active

Outcomes
Primary outcome [1] 259548 0
Postconcussive syndrome symptoms as measured by the Post Concussion Syndrome Checklist
Timepoint [1] 259548 0
1 week pretreatment, 1 week posttreatment, 3-month following treatment completion
Secondary outcome [1] 266167 0
Posttraumatic stress disorder as measured by the Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale
Timepoint [1] 266167 0
1 week pretreatment, 1 week posttreatment, 3-month following treatment completion

Eligibility
Key inclusion criteria
(1) Experience a mild traumatic brain injury, (2) Displays postconcusssive syndrome
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Suicidal intent, psychotic, substance dependent

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)
Participants will be treatment seeking patients attending a neuropsychology clinic at Westmead Hospital. Participants will be randomly allocated according to a random numbers system administered by an individual who is independent of the study and who works at a site that is distant from Westmead Hospital.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be conducted by a process of minimization stratified on gender, trauma type, postconcussive syndrome severity, and posttraumatic stress disorder severity.
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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257975 0
Government body
Name [1] 257975 0
National Health & Medical Research Council
Country [1] 257975 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
School of Psychology, University of New South Wales, Anzac Parade, Kensington, Sydney, NSW, 2052
Country
Australia
Secondary sponsor category [1] 257170 0
Hospital
Name [1] 257170 0
Westmead Hospital
Address [1] 257170 0
Westmead Hospital, O'Brian's Road, Westmead, NSW, 2145
Country [1] 257170 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 259978 0
Ethics committee address [1] 259978 0
Ethics committee country [1] 259978 0
Date submitted for ethics approval [1] 259978 0
17/11/2010
Approval date [1] 259978 0
Ethics approval number [1] 259978 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31852 0
Address 31852 0
Country 31852 0
Phone 31852 0
Fax 31852 0
Email 31852 0
Contact person for public queries
Name 15099 0
Professor Richard Bryant
Address 15099 0
School of Psychology, University of New South Wales, Anzac Parade, Kensington, NSW, 2052
Country 15099 0
Australia
Phone 15099 0
61-2-93853640
Fax 15099 0
61-2-93853641
Email 15099 0
[email protected]
Contact person for scientific queries
Name 6027 0
Professor Richard Bryant
Address 6027 0
School of Psychology, University of New South Wales, Anzac Parade, Kensington, NSW, 2052
Country 6027 0
Australia
Phone 6027 0
61-2-93853640
Fax 6027 0
61-2-93853641
Email 6027 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.