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Trial registered on ANZCTR


Registration number
ACTRN12609000910202
Ethics application status
Approved
Date submitted
30/07/2009
Date registered
21/10/2009
Date last updated
18/05/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness of Cognitive Processing Therapy (CPT) for Veterans' and Veterans' Families Counselling Service (VVCS) clients with Posttraumatic Stress Disorder (PTSD)
Scientific title
The effectiveness of Cognitive Processing Therapy (CPT) for Veterans' and Veterans' Families Counselling Service (VVCS) clients with Posttraumatic Stress Disorder (PTSD)
Secondary ID [1] 251790 0
Not applicable
Universal Trial Number (UTN)
Trial acronym
CPT Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic Stress Disorder 4620 0
Condition category
Condition code
Mental Health 4920 4920 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive Processing Therapy.
Total of 12 1hour sessions, delivered twice a week for 6 weeks. One-on-one therapy administered by a trained psychologist or social worker.
Intervention code [1] 4381 0
Behaviour
Intervention code [2] 241435 0
Treatment: Other
Comparator / control treatment
Treatment as Usual; comprising usual treatment. Treatment may involve supportive counselling, relaxation or cognitive behaviour therapy (CBT). Session content is monitored for the same period as the CPT intervention.
Control group
Active

Outcomes
Primary outcome [1] 5768 0
PTSD Severity
Clinician-Administered PTSD Scale and PTSD Checklist (PCL-S)
Timepoint [1] 5768 0
Imediately post treatment, 3 months post treatment
Secondary outcome [1] 241724 0
Depression:
Mini International Neuropsychiatric Interview Version 5.5 (M.I.N.I) Module A
Beck Depression Inventory Second Edition (BDI-II)
Timepoint [1] 241724 0
Imediately post treatment, 3 months post treatment
Secondary outcome [2] 257965 0
Anxiety:
State-Trait Anxiety Inventory (STAI) State-Scale only
Timepoint [2] 257965 0
Imediately post treatment, 3 months post treatment
Secondary outcome [3] 257966 0
Anger:
Dimensions of Anger Reactions (DAR7)
Timepoint [3] 257966 0
Imediately post treatment, 3 months post treatment
Secondary outcome [4] 257967 0
Alcohol use:
Alcohol Use Disorders Identification Test (AUDIT)
Timepoint [4] 257967 0
Imediately post treatment, 3 months post treatment
Secondary outcome [5] 257968 0
Social Functioning/ Relationships
Abbreviated Dyadic Adjustment Scale (ADAS)
Timepoint [5] 257968 0
Imediately post treatment, 3 months post treatment
Secondary outcome [6] 257969 0
Quality of Life:
WHOQOL-Br?f (World Health Organization Quality of Life- short from)
Timepoint [6] 257969 0
Imediately post treatment, 3 months post treatment
Secondary outcome [7] 257970 0
Traumatic Thoughts:
Post Traumatic Cognitions Inventory (PTCI)
Timepoint [7] 257970 0
Imediately post treatment, 3 months post treatment

Eligibility
Key inclusion criteria
Veteran/former Australia Defence Force (ADF) member irrespective of age or theatre of conflict
Diagnosis of PTSD or Subsyndromal PTSD on Clinician Administered PTSD Scale (CAPS) (subsyndromal defined as at least one criterion in each symptom cluster as per (Mylle & Maes, 2004), plus full criterion in two of the three symptom clusters) Stable medications for 4 weeks prior to trial entryi.e. prescribed medication must have been the same for the last 4 weeks with no anticipated changes during the upcoming 12 weeks (if prescription has changed, or is under review, delay study enrolment until medications are stable)
A reasonable comprehension of English (defined by proficiency to read and understand the participant information sheet and consent form).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current uncontrolled psychotic or bipolar disorder
Prominent current suicidal or homicidal ideation
Current Substance dependence at a level likely to impede treatment.
Significant cognitive impairment

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 are assessed by an independent blind assessor. The outcome of the intake/eligibility assessment is reported to the project manager who allocates randomly to a. therapist for experimentalor active control treatment. The relevant therapist contacts the client to begin treament. The assessor is naive to all further treatment activity after assessment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random number sequence. Stratified by site (Brisbane Melbourne Adelaide)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Active, not recruiting
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)

Funding & Sponsors
Funding source category [1] 4803 0
Government body
Name [1] 4803 0
Australian Government Department of Veteran Affairs
Address [1] 4803 0
Department of Veteran Affairs
Po Box 21
Wooden
ACT 2606
Country [1] 4803 0
Australia
Primary sponsor type
Government body
Name
Australian Government Department of Veteran Affairs
Address
Department of Veteran Affairs
Po Box 21
Wooden
ACT 2606
Country
Australia
Secondary sponsor category [1] 251249 0
Government body
Name [1] 251249 0
Australian Government Department of Veteran Affairs
Address [1] 251249 0
Department of Veteran Affairs
Po Box 21
Wooden
ACT 2606
Country [1] 251249 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6849 0
Department of Veteran Affairs Human Research Ethics Committee (DVA HREC)
Ethics committee address [1] 6849 0
HREC Coordinator
Department of Veterans' Affairs
PO Box 21
Woden ACT 2606
Ethics committee country [1] 6849 0
Australia
Date submitted for ethics approval [1] 6849 0
Approval date [1] 6849 0
28/04/2006
Ethics approval number [1] 6849 0

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

Contacts
Principal investigator
Name 29503 0
Address 29503 0
Country 29503 0
Phone 29503 0
Fax 29503 0
Email 29503 0
Contact person for public queries
Name 12750 0
Delyth Lloyd
Address 12750 0
Delyth Lloyd
Project Manager
Australian Centre for Posttraumatic Mental Health
Level 1, 340 Albert Street
East Melbourne
Victoria 3002
Country 12750 0
Australia
Phone 12750 0
+61 3 9936 5162
Fax 12750 0
+61 3 9936 5199
Email 12750 0
d.lloyd@unimelb.edu.au
Contact person for scientific queries
Name 3678 0
David Forbes
Address 3678 0
Australian Centre for Posttraumatic Mental Health
Level 1, 340 Albert Street
East Melbourne
Victoria 3002
Country 3678 0
Australia
Phone 3678 0
+61 3 9936 5159
Fax 3678 0
+61 3 9936 5199
Email 3678 0
d.lloyd@unimelb.edu.au

No information has been provided regarding IPD availability
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