Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000948897
Ethics application status
Approved
Date submitted
4/09/2012
Date registered
5/09/2012
Date last updated
5/09/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparing cognitive therapies for earthquake-related post-traumatic stress disorder
Scientific title
The effect of metacognitive therapy versus cognitive behaviour therapy on post traumatic stress disorder (PTSD) symptoms, physiological hyperarousal and behaviour avoidance in people with earthquake-related PTSD
Secondary ID [1] 280838 0
Nil
Universal Trial Number (UTN)
Trial acronym
EQ-PTSD study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post traumatic stress disorder (PTSD) 286905 0
Condition category
Condition code
Mental Health 287225 287225 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to receive up to 12 weeks of weekly individual therapy for earthquake-related PTSD, either metacognitive therapy(MCT) or cognitive behaviour therapy (CBT). Therapy sessions last up to 1 hour. Clinical psychologists deliver both therapies and follow the work of Hamblen & Gibson (2005) and of Wells (2009).
Intervention code [1] 285259 0
Treatment: Other
Intervention code [2] 285260 0
Behaviour
Comparator / control treatment
Cognitive behaviour therapy
Control group
Active

Outcomes
Primary outcome [1] 287507 0
Reduction in PTSD symptoms measured by change in the PTSD-Checklist- Specific (PCL-S)
Timepoint [1] 287507 0
Weeks 0, week 12 (or end treatment if earlier than 12 weeks), 6 month follow-up
Primary outcome [2] 287508 0
Speed of early change measured by reduction in symptoms on the PCL-S.
Timepoint [2] 287508 0
Weeks 0 and 4
Primary outcome [3] 287509 0
Reduction in hyperarousal measured by changes in heart rate variability and the hyperarousal scale of the Impact of Events Scale.
Timepoint [3] 287509 0
Weeks 0 and 12 (or end treatment if earlier than 12 weeks)
Secondary outcome [1] 298298 0
Change over treatment in participants' descriptions of their earthquake experience, measured by change in counts of occurrences of perceptual versus conceptual processing statements in transcribed earthquake-narrative interviews. These data will be analysed in relation to high or low levels of state and trait dissociation, measured by the State Dissociation Questionnaire and the Dissociative Experiences Scale.
Timepoint [1] 298298 0
Weeks 0 and 12 (or end treatment if earlier than 12 weeks)
Secondary outcome [2] 298325 0
Reduction in behavioural avoidance, measured by the Fear and Avoidance Questionnaire
Timepoint [2] 298325 0
Weeks 0, week 12 (or end treatment if earlier than 12 weeks)
Secondary outcome [3] 298326 0
Level of distress (measured by the Depression, Anxiety, Stress Scale, administered weekly) in weeks when a detectable aftershock (e.g. over 3.0 magnitude occurring locally) has occurred, compared to weeks when no detectable aftershocks have occurred.
Timepoint [3] 298326 0
Weekly until week 12 (or end treatment if earlier than 12 weeks)

Eligibility
Key inclusion criteria
Post Traumatic Stress Disorder (past month) or PTSD in partial remission (current post traumatic stress symptoms including hyperarousal symptoms causing clinically significant distress and impacting on life functioning) related to the Christchurch earthquakes.
Any ethnicity
Able to provide written informed consent and to complete questionnaires and therapy in English
Free of regular psychotropic medication, or will remain on a constant dose during the active treatment phase of the study
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Primary severe depressive disorder, active suicidality, current severe alcohol or drug dependence, psychotic symptoms, current mania, cognitive impairment, concurrently attending other psychotherapy.

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 is concealed. The holder of the therapy allocation is outside the research team and holds the allocation in numbered sealed opaque envelopes, only releasing the envelope once the baseline assessments have been completed. Thus therapists recruiting and assessing participants are not given therapy allocation until the baseline assessment are complete, immediately prior to commencing therapy. The study co-ordinator will remain blind to therapy allocation throughout the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised permuted block randomisation
Masking / blinding
Open (masking not 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
Recruiting
Date of first participant enrolment
Anticipated
5/07/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 4402 0
New Zealand
State/province [1] 4402 0
Canterbury

Funding & Sponsors
Funding source category [1] 285635 0
Hospital
Name [1] 285635 0
Canterbury District Health Board
Country [1] 285635 0
New Zealand
Funding source category [2] 285928 0
University
Name [2] 285928 0
University of Otago, Christchurch
Country [2] 285928 0
New Zealand
Primary sponsor type
Individual
Name
Dr Jennifer Jordan
Address
Clinical Research Unit
Department of Psychological Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 284469 0
Hospital
Name [1] 284469 0
Canterbury District Health Board
Address [1] 284469 0
Clinical Research Unit
Canterbury District Health Board
c/- Department of Psychological Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country [1] 284469 0
New Zealand
Other collaborator category [1] 276931 0
Individual
Name [1] 276931 0
Dr Janet D Carter
Address [1] 276931 0
Psychology Department
University of Canterbury
Private Bag 4800
Christchurch 8140
Country [1] 276931 0
New Zealand
Other collaborator category [2] 276932 0
Individual
Name [2] 276932 0
Dr Helen Colhoun
Address [2] 276932 0
c/-Clinical Research Unit
Department of Psychological Medicine
University of Otago, Christchurch
4 Oxford Terrace, PO Box 4345
Christchurch 8140
Anxiety Disorders Unit, The Princess Margaret Hospital
Country [2] 276932 0
New Zealand
Other collaborator category [3] 276933 0
Individual
Name [3] 276933 0
Dr Virginia McIntosh
Address [3] 276933 0
Department of Psychological Medicine
University of Otago, Christchurch
4 Oxford Terrace, PO Box 4345
Christchurch 8140
Country [3] 276933 0
New Zealand
Other collaborator category [4] 276934 0
Individual
Name [4] 276934 0
Dr Cameron Lacey
Address [4] 276934 0
Department of Psychological Medicine
University of Otago, Christchurch
4 Oxford Terrace, PO Box 4345
Christchurch 8140

Maori Indigenous Health Institute
University of Otago, Christchurch
Country [4] 276934 0
New Zealand
Other collaborator category [5] 276935 0
Individual
Name [5] 276935 0
Prof. Peter Joyce
Address [5] 276935 0
Department of Psychological Medicine
University of Otago, Christchurch
4 Oxford Terrace, PO Box 4345
Christchurch 8140
Country [5] 276935 0
New Zealand
Other collaborator category [6] 276936 0
Individual
Name [6] 276936 0
Assoc Prof. Christopher Frampton
Address [6] 276936 0
Department of Psychological Medicine
University of Otago, Christchurch
4 Oxford Terrace, PO Box 4345
Christchurch 8140
Country [6] 276936 0
New Zealand
Other collaborator category [7] 276937 0
Individual
Name [7] 276937 0
Dr Martin Dorahy
Address [7] 276937 0
Psychology Department
University of Canterbury
Private Bag 4800
Christchurch 8140
Country [7] 276937 0
New Zealand
Other collaborator category [8] 276938 0
Individual
Name [8] 276938 0
Ashleigh Hooper
Address [8] 276938 0
Psychology Department
University of Canterbury
Private Bag 4800
Christchurch 8140
Country [8] 276938 0
New Zealand
Other collaborator category [9] 276939 0
Individual
Name [9] 276939 0
Prof. Richard Porter
Address [9] 276939 0
Department of Psychological Medicine
University of Otago, Christchurch
4 Oxford Terrace, PO Box 4345
Christchurch 8140
Country [9] 276939 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287634 0
Central Regional Ethics Committee
Ethics committee address [1] 287634 0
Ethics committee country [1] 287634 0
New Zealand
Date submitted for ethics approval [1] 287634 0
Approval date [1] 287634 0
12/04/2012
Ethics approval number [1] 287634 0
CEN/12/03/003

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

Contacts
Principal investigator
Name 34430 0
Address 34430 0
Country 34430 0
Phone 34430 0
Fax 34430 0
Email 34430 0
Contact person for public queries
Name 17677 0
Dr Jennifer Jordan
Address 17677 0
Department of Psychological Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country 17677 0
New Zealand
Phone 17677 0
+6433720400
Fax 17677 0
+6433720407
Email 17677 0
[email protected]
Contact person for scientific queries
Name 8605 0
Dr Jennifer Jordan
Address 8605 0
Department of Psychological Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country 8605 0
New Zealand
Phone 8605 0
+6433720400
Fax 8605 0
+6433720407
Email 8605 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.