Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000332527
Ethics application status
Not yet submitted
Date submitted
19/03/2015
Date registered
13/04/2015
Date last updated
12/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised Controlled Trial of Cognitive Behaviour Therapy for Journalists to Reduce Posttraumatic
Stress Disorder
Scientific title
Randomised Controlled Trial of Therapist-Provided Cognitive Behaviour Therapy for Journalists to Reduce Posttraumatic
Stress Disorder
Secondary ID [1] 286383 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic stress disorder 294526 0
Condition category
Condition code
Mental Health 294832 294832 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two arms to this trial. Arm 1: Therapist-Administered Cognitive Behaviour Therapy delivered via telemedicine. Arm 2: Self-Administered Cognitive Behaviour Therapy conducted by self-help manual. Therapist-Administered Cognitive Behaviour Therapy is administered once-weekly over 8 weeks on an individual 60 minute basis. Cognitive Behaviour Therapy includes psychoeducation, exposure to trauma memories, and cognitive restructuring of themes related to traumatic experiences. The duration of the study for any participant will
conclude after a 6-month follow-up assessment, resulting in participation duration of 8 months.
Intervention code [1] 291449 0
Treatment: Other
Intervention code [2] 291582 0
Behaviour
Comparator / control treatment
Self-Administered Cognitive Behaviour Therapy is
administered once-weekly over 8 weeks by participants reading through a manual that suggests completion of a module per week. The therapy includes psychoeducation, exposure to trauma memories, and cognitive restructuring of themes related to traumatic experiences. The duration of the study for any participant will conclude after a 6-month follow-up assessment, resulting in participation duration of 8 months.
Control group
Active

Outcomes
Primary outcome [1] 294597 0
Posttraumatic stress disorder, as measured by the Posttraumatic Stress
Scale.
Timepoint [1] 294597 0
Pretreatment, posttreatment, 6-Month Follow-up
Secondary outcome [1] 313691 0
Depression as measured by the Beck Depression Inventory
Timepoint [1] 313691 0
Pretreatment, posttreatment, 6-Month Follow-up

Eligibility
Key inclusion criteria
Journalists who report diagnostic criteria for posttraumatic stress disorder (as measured on the PTSD Clinician Administered Scale)
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) inadequate comprehension of English, (b) imminent suicidal intent, (c) psychosis, or (d) concurrent 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)
Participants will be journalists who respond to internet announcements, and who indicate meeting PTSD criteria. Participants wishing to participate will be randomly allocated according to a random numbers system administered by an individual who independent of the study and who works at a site that is distant from the treatment centre.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be conducted by a process of minmization stratified on gender and severity of PTSD levels.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The thrust of analyses will be using hierarchical linear models (HLM) to investigate the relative effects of the treatments. Analyses will be conducted using Mplus (version 7.11). The benefit of this approach is that it presumes intent-to-treat analyses as HLM allows the number of observations to vary between participants and effectively handles missing data by using the maximum likelihood estimator, which provides
the optimal estimates of model parameter values and standard errors. The Level 1 model will represent within-patient change over time, and the Level 2 model will predict variation in within-patient change over time and encompass between-patient variables (treatment condition, injury
characteristics, gender). Primary measures will comprise the Clinician Administered PTSD Scale and Beck Depression Inventory. We calculated effect size based on previous recommendations for multilevel models. Statistical power for this design is estimated to be 80%, entering the parameters of 60 per group, effect-size at .7. This effect size was based on a previous data set, which evaluated the relative effects of symptom reduction in comparable therapy modality of PTSD patients.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/05/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 6761 0
United States of America
State/province [1] 6761 0
Country [2] 6762 0
United Kingdom
State/province [2] 6762 0
Country [3] 6763 0
Qatar
State/province [3] 6763 0

Funding & Sponsors
Funding source category [1] 290955 0
Government body
Name [1] 290955 0
NHMRC
Country [1] 290955 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] 289637 0
None
Name [1] 289637 0
Address [1] 289637 0
Country [1] 289637 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 292553 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 292553 0
Ethics committee country [1] 292553 0
Australia
Date submitted for ethics approval [1] 292553 0
01/03/2016
Approval date [1] 292553 0
Ethics approval number [1] 292553 0

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

Contacts
Principal investigator
Name 55906 0
Prof Richard Bryant
Address 55906 0
School of Psychology, University of New South Wales, Sydney, NSW, 2052, NSW
Country 55906 0
Australia
Phone 55906 0
+61293853640
Fax 55906 0
+61293853641
Email 55906 0
[email protected]
Contact person for public queries
Name 55907 0
Richard Bryant
Address 55907 0
School of Psychology, University of New South Wales, Sydney, NSW, 2052, NSW
Country 55907 0
Australia
Phone 55907 0
+61293853640
Fax 55907 0
+61293853641
Email 55907 0
[email protected]
Contact person for scientific queries
Name 55908 0
Richard Bryant
Address 55908 0
School of Psychology, University of New South Wales, Sydney, NSW, 2052, NSW
Country 55908 0
Australia
Phone 55908 0
+61293853640
Fax 55908 0
+61293853641
Email 55908 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.