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Trial registered on ANZCTR


Registration number
ACTRN12611000989943
Ethics application status
Approved
Date submitted
15/08/2011
Date registered
16/09/2011
Date last updated
3/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison of Internet-based Cognitive Behavioural Therapy for Posttraumatic Stress Disorder with and without exposure: A randomized controlled trial
Scientific title
A randomized controlled trial of the effects of Cognitive Behavioural Therapy (CBT) with and without exposure on symptoms of Posttraumatic Stress Disorder (PTSD) using an Internet-based education program for PTSD.
Secondary ID [1] 262827 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic stress disorder 270551 0
Condition category
Condition code
Mental Health 270712 270712 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be conducted in two phases with 2 parallel groups in each phase (total sample size = 128. Each phase n=64 contains the following groups:
Group 1: Clinician-guided iCBT including exposure (n = 32). Receive access to an internet-based CBT (iCBT) program with clinician-guidance.
Group 2: Clinician-guided iCBT minus exposure (n = 32). Receive access to the above iCBT program with clinician-guidance without the exposure component.
(NB: There is no waiting list control condition in this study)

Evidence from face to face treatment trials suggests that PTSD can be successfully treated without an exposure component To date, there is no research evaluating the benefits of exposure within an Internet-based cognitive behavioural treatment for PTSD. Exposure requires engagement with avoided situations, objects and memories. For example: it is common for people with PTSD to avoid places that remind them of their trauma even though such places are safe. Exposure involves a gradual introduction to such places that is done in a step-wise manner so that participants don’t become overwhelmed. A similar procedure is recommended for memories and objects. However, exposure places burden on participants in terms of time and energy. We propose to compare iCBT for PTSD with and without exposure by testing a group that follows an established iCBT protocol with an exposure component versus the same protocol without the exposure component.

Phase 1 will be conducted over 8 weeks and will involve the treatment of 2 groups (iCBT with exposure & iCBT without exposure). Phase 2 will commence during week 7 of the trial (as the Phase 1 groups are finishing treatment) and will involve the commencement of treatment for 2 new groups who will receive the identical treatments (iCBT with exposure & iCBT without exposure) but will involve new participants.

All participants will report experiencing symptoms of Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) criteria for posttraumatic stress disorder (PTSD). Participants in the iCBT with exposure group will complete 6 lessons of Internet based treatment about management of symptoms of PTSD. One lesson will be completed every 7-10 days over 8 weeks. Participants in the iCBT without exposure group will complete 4 lessons of of Internet based treatment about management of symptoms of PTSD using the same protocol with 2 lessons about exposure removed. One lesson will be completed every 7 to 14 days over 8 weeks. Each lesson will take about 15 minutes to complete. Participants will also have access to summaries of each lesson, and will read anonymous stories about other people with PTSD, taking a further 20 minutes per summary. Participants in both groups will also receive automatic email and weekly reminder phone calls by a clinical psychologist. The duration of the reminder emails/phone calls is expected to be 15-20 minutes per week. The duration of the program is 8 weeks, but participants will be contacted 3 and 12 months post program and asked to complete follow-up questionnaires. Study questionnaires will be administered at application, pre-treatment, post-treatment, and at 3-months post-treatment. These will take about 20-30 minutes to complete.

The treatment materials are based on our previous Internet treatment protocols, which apply cognitive behavioural techniques.
Intervention code [1] 269182 0
Treatment: Other
Comparator / control treatment
There are two treatment conditions being compared in this study (outlined above). There is no waiting list control condition. The iCBT with exposure group is the active control condition.
Control group
Active

Outcomes
Primary outcome [1] 269426 0
PTSD is measured by the Posttraumatic Stress Disorder Symptom Scale (PSS-I)
Timepoint [1] 269426 0
Administered at 1 day pre-treatment, one day post-treatment, 3-months post-treatment, 12-months post-treatment.
Secondary outcome [1] 287607 0
PTSD is measured by the PTSD Checklist - Civilian version (PCL-C)
Timepoint [1] 287607 0
Administered at 1 day pre-treatment, one day post-treatment, 3-months post-treatment, 12-months post-treatment.
Secondary outcome [2] 287608 0
Neuroticism is measured by using the NEO-Five Factor Inventory (NEO-FFI) Neuroticism scale
Timepoint [2] 287608 0
Administered at 1 day pre-treatment, one day post-treatment, 3-months post-treatment, 12-months post-treatment.
Secondary outcome [3] 287609 0
Disability is measured by the Sheehan Disability Scale (SDS)
Timepoint [3] 287609 0
Administered at 1 day pre-treatment, one day post-treatment, 3-months post-treatment, 12-months post-treatment.
Secondary outcome [4] 287610 0
Symptoms and severity of depression is measured by the Patient Health Questionnaire-9 (PHQ-9)
Timepoint [4] 287610 0
Administered at 1 day pre-treatment, one day post-treatment, 3-months post-treatment, 12-months post-treatment.
Secondary outcome [5] 287611 0
Anxiety is measured by the Generalised Anxiety Disorder 7 Item Scale (GAD-7)
Timepoint [5] 287611 0
Administered at 1 day pre-treatment, one day post-treatment, 3-months post-treatment, 12-months post-treatment.
Secondary outcome [6] 287612 0
Service use is measured by the Service Use Questionnaire (SEQ)
Timepoint [6] 287612 0
Administered at 1 day pre-treatment, one day post-treatment, 3-months post-treatment, 12-months post-treatment.
Secondary outcome [7] 287613 0
Health status is measured by the EuroQol-5D (EQ-5D)
Timepoint [7] 287613 0
Administered at 1 day pre-treatment, one day post-treatment, 3-months post-treatment, 12-months post-treatment.

Eligibility
Key inclusion criteria
- PTSD symptoms above a recommended clinical cutoff (A score of 27 or above on the Impact of Events Scale- Revised (Weiss & Marmar, 1996) as recommended by Coffey et al. (2006) - Internet access + printer access - Australian resident - Males and females

Coffey SF, Gudmundsdottir B, Beck JG, Palyo SA, Miller L. Screening for PTSD in motor vehicle
accident survivors using the PSS-SR and IES. Journal of Traumatic Stress 2006;19:119–128.
Weiss, D. S., & Marmar, C. R. (1996). The Impact of Event Scale - Revised. In J. Wilson & T. M. Keane (Eds.), Assessing psychological trauma and PTSD (pp. 399-411). New York: Guilford.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Psychotic disorder - Current or planned psychological treatment during study duration - Change in medications during last 1 month or intended change during study duration - Actively suicidal - Highly dissociative

Study design
Purpose of the study
Educational / counselling / training
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 assess symptoms via structured diagnostic interview using the Mini Neuropsychiatric Interview Schedule (MINI 5.0.0).
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 via a software program (www.random.org), at another site, in another country. The list will then be transcribed and details transferred to sealed envelopes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This trial is to be run in two phases with two parallel groups in each phase.
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/07/2011
Actual
20/07/2011
Date of last participant enrolment
Anticipated
Actual
1/12/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
128
Accrual to date
Final
125
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269656 0
Government body
Name [1] 269656 0
New South Wales Institute of Psychiatry (NSWIOP)
Country [1] 269656 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
eCentreClinic
Centre for Emotional Health
Macquarie University
Balaclava Rd, Ryde, NSW, 2109
Country
Australia
Secondary sponsor category [1] 266690 0
None
Name [1] 266690 0
Address [1] 266690 0
Country [1] 266690 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269602 0
Macquarie University of New South Wales Human Research Committee
Ethics committee address [1] 269602 0
Ethics committee country [1] 269602 0
Australia
Date submitted for ethics approval [1] 269602 0
14/04/2011
Approval date [1] 269602 0
01/06/2011
Ethics approval number [1] 269602 0
5201100413

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

Contacts
Principal investigator
Name 33013 0
Prof Nick Titov
Address 33013 0
Department of Psychology
Macquarie University
NSW 2109
Country 33013 0
Australia
Phone 33013 0
61 2 9850 9901
Fax 33013 0
Email 33013 0
nick.titov@mq.edu.au
Contact person for public queries
Name 16260 0
Jay Spence
Address 16260 0
Centre for Emotional Health,
Balaclava Rd, Macquarie University, Ryde, NSW, 2019
Country 16260 0
Australia
Phone 16260 0
+612 9850 9643
Fax 16260 0
+612 9850 8062
Email 16260 0
jay.spence@students.mq.edu.au
Contact person for scientific queries
Name 7188 0
Jay Spence
Address 7188 0
Centre for Emotional Health, Balaclava Rd, Macquarie University, Ryde, NSW, 2019
Country 7188 0
Australia
Phone 7188 0
+612 9850 9643
Fax 7188 0
+612 9850 8062
Email 7188 0
jay.spence@students.mq.edu.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 and behavioural therapies for post-traumatic stress disorder (PTSD) in adults.2021https://dx.doi.org/10.1002/14651858.CD011710.pub3
N.B. These documents automatically identified may not have been verified by the study sponsor.