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Trial registered on ANZCTR


Registration number
ACTRN12611000151932
Ethics application status
Approved
Date submitted
11/01/2011
Date registered
9/02/2011
Date last updated
10/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
An open pilot trial of an Internet-based clinician-guided Cognitive Behavioural Therapy (CBT) plus Eye Movement Desensitization and Reprocessing (EMDR) program for Posttraumatic Stress Disorder (PTSD)
Scientific title
An open trial of the effects of Cognitive Behavioural Therapy (CBT) plus Eye Movement Desensitization and Reprocessing (EMDR) on symptoms of Posttraumatic Stress Disorder (PTSD) using an Internet-based education program for PTSD.
Secondary ID [1] 253385 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 260938 0
Condition category
Condition code
Mental Health 259069 259069 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be assigned to a treatment group whereby they will complete 6 lessons of Internet based treatment about management of symptoms of posttraumatic stress disorder (PTSD). One lesson will be completed every 7 days. 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. From week 2 in the program they will receive instructions on using eye movement desensitzation and reprocessing (EMDR) and will be encouraged to use EMDR twice weekly until the end of the program for up to 45 minutes each session of EMDR. All participants will also receive automatic email and weekly reminder phone calls by a clinical psychologist. The duration of the reminder emails/phone calls and contribution to the forum is expected to be 5-10 minutes per week. The duration of the program is 6 weeks, but participants will be contacted 3 months post program and asked to complete follow-up questionnaires. All participants will have symptoms of PTSD but do not need to meet Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) criteria for PTSD. Study questionnaires will be administered at application, pre-education, post-education, and at 3-months post-education. These will take about 20-30 minutes to complete. The treatment materials are based on the Anxiety and PTSD Programs, which apply cognitive behavioural techniques.
Intervention code [1] 257832 0
Treatment: Other
Comparator / control treatment
Not applicable.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259928 0
PTSD is measured by the PTSD Checklist - Civilian version (PCL-C)
Timepoint [1] 259928 0
Administered at 3 days pre-treatment, one day post-treatment, and at 3-months post-treatment
Secondary outcome [1] 268829 0
Neuroticism is measured by using the NEO-Five Factor Inventory (NEO-FFI) Neuroticism scale
Timepoint [1] 268829 0
Administered at 3 days pre-treatment, one day post-treatment, and at 3-months post-treatment
Secondary outcome [2] 268830 0
Disability is measured by the Sheehan Disability Scale (SDS)
Timepoint [2] 268830 0
Administered at 3 days pre-treatment, one day post-treatment, and at 3-months post-treatment
Secondary outcome [3] 268831 0
Psychological distress is measured by the Kessler 10-item scale (K-10)
Timepoint [3] 268831 0
Administered at 3 days pre-treatment, one day post-treatment, and at 3-months post-treatment
Secondary outcome [4] 268832 0
Symptoms and severity of depression is measured by the Patient Health Questionnaire-9 (PHQ-9)
Timepoint [4] 268832 0
Administered at 3 days pre-treatment, one day post-treatment, and at 3-months post-treatment
Secondary outcome [5] 268833 0
Anxiety is measured by the Generalised Anxiety Disorder 7 Item Scale (GAD-7)
Timepoint [5] 268833 0
Administered at 3 days pre-treatment, one day post-treatment, and at 3-months post-treatment

Eligibility
Key inclusion criteria
- PTSD symptoms above a recommended clinical cutoff - Internet access + printer access - Australian resident - Males and females
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
Non-randomised 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 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)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/07/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258302 0
Charities/Societies/Foundations
Name [1] 258302 0
New South Wales Institute for Psychiatry
Country [1] 258302 0
Australia
Primary sponsor type
University
Name
eCentreClinic
Centre for Emotional Health, Macquarie University
Address
Macquarie University, Ryde, NSW, 2019
Country
Australia
Secondary sponsor category [1] 257466 0
None
Name [1] 257466 0
Address [1] 257466 0
Country [1] 257466 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260286 0
Macquarie University of New South Wales Human Research Committee
Ethics committee address [1] 260286 0
Ethics committee country [1] 260286 0
Australia
Date submitted for ethics approval [1] 260286 0
Approval date [1] 260286 0
06/01/2011
Ethics approval number [1] 260286 0
5201100382

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

Contacts
Principal investigator
Name 32079 0
Address 32079 0
Country 32079 0
Phone 32079 0
Fax 32079 0
Email 32079 0
Contact person for public queries
Name 15326 0
Dr Nickolai Titov
Address 15326 0
Centre for Emotional Health, Macquarie University, Ryde, NSW, 2019
Country 15326 0
Australia
Phone 15326 0
+612 9850 9901
Fax 15326 0
+612 9850 8062
Email 15326 0
nick.titov@mq.edu.au
Contact person for scientific queries
Name 6254 0
Dr Nickolai Titov
Address 6254 0
Centre for Emotional Health, Macquarie University, Ryde, NSW, 2019
Country 6254 0
Australia
Phone 6254 0
+612 9850 9901
Fax 6254 0
+612 9850 8062
Email 6254 0
nick.titov@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
Dimensions AIInternet-delivered eye movement desensitization and reprocessing (iEMDR): an open trial2013https://doi.org/10.12688/f1000research.2-79.v2
N.B. These documents automatically identified may not have been verified by the study sponsor.