Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001213639
Ethics application status
Approved
Date submitted
22/04/2014
Date registered
18/11/2014
Date last updated
25/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Internet treatment for Posttraumatic Stress Disorder (PTSD)
Scientific title
A randomised controlled trial comparing the impact of internet-based cognitive behavioural therapy (iCBT) for posttraumatic stress disorder (PTSD) to waitlist control on PTSD symptoms
Secondary ID [1] 284393 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic stress disorder (PTSD) 291568 0
Condition category
Condition code
Mental Health 291946 291946 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The internet PTSD program comprises 6 lessons completed over 10 weeks. It includes all treatment components
typically seen in face­-to­-face cognitive behavioural therapy (CBT) (the first­-line treatment for PTSD). One lesson will be completed every 7 to 14 days (it will become available after the preceding lesson has been completed, with a minimum of 5 days between lessons and a maximum of 14 days). Each lesson will take approximately 20-30 minutes to complete. Participants will have access to summaries of each lesson, homework exercises, extra resources, email contact from the clinician (registered clinical psychologist) after completion of the first two lessons, then as required. The participant is also able to email or phone the clinician at any point during the trial as required. The participant completes a measure of psychological distress before each lesson and if their scores increase by one or more standard deviations the clinician is automatically alerted and initiates contact with the participant by phone or email.

Strategies used to improved adherence to intervention protocols and procedures for monitoring adherence include: automated email reminders, monitoring the downloading of homework, collection of data on how long participants spent reading lessons and practicing skills.
Intervention code [1] 289124 0
Behaviour
Intervention code [2] 289261 0
Treatment: Other
Comparator / control treatment
Waitlist control group. These participants remain on the waitlist until the immediate treatment group has completed their treatment and post-treatment assessment (11 weeks). At that time (11 weeks) the waitlist control group will be offered the same internet treatment program for PTSD.
Control group
Active

Outcomes
Primary outcome [1] 291853 0
Reductions in the PTSD Checklist - Civilian Version (PCL-C)
Timepoint [1] 291853 0
Baseline, before each lesson, 1 week post-treatment (week 11), 3 months after post-treatment (week 24), and 6 months after treatment (week 36).
Secondary outcome [1] 307665 0
Reductions in the Patient Health Questionnaire – 9-Item (PHQ-9)
Timepoint [1] 307665 0
Baseline, mid-treatment (week 4), 1 week post-treatment (week 11), 3 months after post-treatment (week 24)
Secondary outcome [2] 307666 0
Reductions in psychological distress according to the Kessler-10 (K10).
Timepoint [2] 307666 0
Baseline, before each lesson, 1 week post-treatment (week 11), 3 months after post-treatment (week 24)
Secondary outcome [3] 307667 0
Treatment Credibility/Expectancy Questionnaire (CEQ).
Timepoint [3] 307667 0
Measured at baseline
Secondary outcome [4] 307668 0
Reductions in self-reported patient disability (Sheehan Disability Scale)
Timepoint [4] 307668 0
Baseline, mid-treatment (week 4), 1 week post-treatment (week 11), 3 months after post-treatment (week 24)
Secondary outcome [5] 315926 0
Reductions in Intolerance of Uncertainty Scale Score (IUS-12)
Timepoint [5] 315926 0
Baseline, mid-treatment (week 4), 1 week post-treatment (week 11), 3 months after post-treatment (week 24).
Secondary outcome [6] 315927 0
Reductions in Emotion Regulation Questionnaire Score (ERQ)
Timepoint [6] 315927 0
Baseline, mid-treatment (week 4), 1 week post-treatment (week 11), 3 months after post-treatment (week 24).
Secondary outcome [7] 315928 0
Reduction in WHODAS-II score
Timepoint [7] 315928 0
Baseline, mid-treatment (week 4), 1 week post-treatment (week 11), 3 months after post-treatment (week 24).

Eligibility
Key inclusion criteria
- Self-identified as suffering from PTSD/experienced a major trauma
- Meet criteria for PTSD as determined by the Mini International Neuropsychiatric Interview Version 5.0.0 (MINI; Sheehan et al., 1998)
- Australian residential status
- At least 18 years of age
- Access to a computer, internet and printer
- If taking medication, must have been taking the same dose for at least 1 month and not intend to change that dose during the course of the program
- Prepared to provide name, phone number and address, and to provide the name and address of a local general practitioner
- Willing to provide written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Does not meet PTSD diagnostic criteria
- Trauma occurrence within the past 4 weeks
- Currently participating in CBT or other treatment for trauma or PTSD
- Currently highly dissociative (indicated by score greater than or equal to 40 on the Dissociative Experiences Scale)
- Current or pending medicolegal proceedings associated with the reported trauma
- Applying for or receiving Workers Compensation associated with their trauma or PTSD
- Regularly using illicit drugs or regularly consuming more than three standard drinks per day
- Current regular use of benzodiazepines
- Currently experiencing a psychotic mental illness or bipolar disorder
- Severe symptoms of depression (defined as a total score of at least 22 or responding at least ‘2’ to Question 9 (suicidal ideation) on the Patient Health Questionnaire_9 Item (PHQ-9) will require risk assessment with the responsible clinician before being admitted into the study

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 apply online, followed by a telephone interview to confirm diagnosis via the Mini-International Neuropsychiatric Interview (MINI), a structured clinical interview.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomized using a list generated prior to the study. Allocation concealment will occur in the following way: A staff member not involved in the clinical trial will generate the sequence using computer software and place each choice in a sequentially numbered, opaque sealed and stapled envelope.
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
A pre-to-post-treatment improvement of effect size (ES) 1.0 is expected for the active treatment group on the primary PTSD measure (the PCL-C). This group is also expected to improve more than the waitlist control group by an ES of 0.47. Sample size is powered to have an 80% chance of detecting differences at p<.05. This will require n=72 per group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/03/2014
Actual
14/09/2014
Date of last participant enrolment
Anticipated
2/01/2016
Actual
2/01/2016
Date of last data collection
Anticipated
Actual
16/06/2016
Sample size
Target
144
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 289036 0
Hospital
Name [1] 289036 0
St Vincent's Hospital, Sydney
Country [1] 289036 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital, Sydney
Address
390 Victoria St
Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 287708 0
None
Name [1] 287708 0
Address [1] 287708 0
Country [1] 287708 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290836 0
St Vincent's Hospital HREC
Ethics committee address [1] 290836 0
St Vincent's Hospital
390 Victoria St
Darlinghurst NSW 2010
Ethics committee country [1] 290836 0
Australia
Date submitted for ethics approval [1] 290836 0
03/02/2014
Approval date [1] 290836 0
31/03/2014
Ethics approval number [1] 290836 0
HREC/14/SVH/28

Summary
Brief summary
The project aims to evaluate the acceptability and clinical efficacy of the online PTSD program; and to examine the role of intolerance of uncertainty and emotion regulation in PTSD symptom change following the PTSD Program.

Up to 144 people with PTSD will be randomly assigned to either the active treatment group or a waitlist
control group. The treatment group will commence the PTSD program immediately, whereas the waitlist control group will commence once the treatment group has completed.

PTSD program efficacy will be determined by comparing the PTSD symptom levels of each group at the time the treatment group completes treatment. The role of intolerance of uncertainty and emotion regulation in PTSD symptom change will be examined using mediation analysis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47518 0
Prof Gavin Andrews
Address 47518 0
Clinical Research Unit for Anxiety and Depression
390 Victoria St
Darlinghurst NSW 2010
Country 47518 0
Australia
Phone 47518 0
+61 2 8382 1405
Fax 47518 0
Email 47518 0
gavina@unsw.edu.au
Contact person for public queries
Name 47519 0
Dr Adrian Allen
Address 47519 0
Clinical Research Unit for Anxiety and Depression
390 Victoria St
Darlinghurst NSW 2010
Country 47519 0
Australia
Phone 47519 0
+61 2 8382 1428
Fax 47519 0
Email 47519 0
aallen@stvincents.com.au
Contact person for scientific queries
Name 47520 0
Dr Adrian Allen
Address 47520 0
Clinical Research Unit for Anxiety and Depression
390 Victoria St
Darlinghurst NSW 2010
Country 47520 0
Australia
Phone 47520 0
+61 2 8382 1428
Fax 47520 0
Email 47520 0
aallen@stvincents.com.au

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
SourceTitleYear of PublicationDOI
EmbaseInternet-based cognitive behavioural therapy (iCBT) for posttraumatic stress disorder versus waitlist control: Study protocol for a randomised controlled trial.2015https://dx.doi.org/10.1186/s13063-015-1059-5
N.B. These documents automatically identified may not have been verified by the study sponsor.