Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000988055
Ethics application status
Approved
Date submitted
2/08/2010
Date registered
16/11/2010
Date last updated
7/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The PTSD Program: A randomized controlled trial of an internet based education program for post traumatic stress disorder
Scientific title
The Posttraumatic Stress Disorder (PTSD) Program: A randomized controlled trial of an internet based education program for post traumatic stress disorder
Secondary ID [1] 252344 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post traumatic stress disorder 257846 0
Condition category
Condition code
Mental Health 258011 258011 0 0
Anxiety
Mental Health 258027 258027 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly assigned to one of two groups: 1) an immediate treatment group, or; 2) a delayed treatment group also known as a waitlist control group (beginnning the program 9 weeks after the immediate treatment group begin). All participants will meet Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) criteria for posttraumatic stress disorder (PTSD). All participants will complete 7 lessons of Internet based treatment about management of symptoms of depression and anxiety. 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 anxiety, taking a further 20 minutes per summary. 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 8 weeks, but participants will be contacted 3 months post program and asked to complete follow-up questionnaires. 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 Sadness Programs, which apply cognitive behavioural techniques.
Intervention code [1] 256917 0
Treatment: Other
Comparator / control treatment
The delayed treatment group (beginning the program 9 weeks after the immediate treatment group begins). This is a wait-list control group.
Control group
Active

Outcomes
Primary outcome [1] 258878 0
PTSD is measured by the PTSD Checklist - Civilian version (PCL-C)
Timepoint [1] 258878 0
Administered at 3 days pre-treatment, one day post-treatment, and at 3-months post-treatment
Secondary outcome [1] 265023 0
Neuroticism is measured by using the NEO-Five Factor Inventory (NEO-FFI) Neuroticism scale
Timepoint [1] 265023 0
Administered at 3 days pre-treatment, one day post-treatment, and at 3-months post-treatment
Secondary outcome [2] 265024 0
Disability is measured by the Sheehan Disability Scale (SDS)
Timepoint [2] 265024 0
Administered at 3 days pre-treatment, one day post-treatment, and at 3-months post-treatment
Secondary outcome [3] 265025 0
Psychological distress is measured by the Kessler 10-item scale (K-10)
Timepoint [3] 265025 0
Administered at 3 days pre-treatment, one day post-treatment, and at 3-months post-treatment
Secondary outcome [4] 265026 0
Symptoms and severity of depression is measured by the Patient Health Questionnaire-9 (PHQ-9)
Timepoint [4] 265026 0
Administered at 3 days pre-treatment, one day post-treatment, and at 3-months post-treatment
Secondary outcome [5] 265027 0
Anxiety is measured by the Generalised Anxiety Disorder 7 Item Scale (GAD-7)
Timepoint [5] 265027 0
Administered at 3 days pre-treatment, one day post-treatment, and at 3-months post-treatment
Secondary outcome [6] 265028 0
Alcohol use is measured by the Alcohol Use Disorders Identification Test (AUDIT)
Timepoint [6] 265028 0
Administered at 3 days pre-treatment, one day post-treatment, and at 3-months post-treatment

Eligibility
Key inclusion criteria
-Meet DSM-IV criteria for PTSD
- Internet access + printer access
- Australian resident
- Males and females
Minimum age
18 Years
Maximum age
No limit
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 confirm diagnosis via structured diagnostic interview using the Mini Neuropsychiatric Interview Schedule (MINI 5.0.0). Allocation concealment will occur by providing allocation details for each successive participant in a sealed envelope, which recruitment staff are required to open serially.
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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/07/2010
Actual
26/07/2010
Date of last participant enrolment
Anticipated
Actual
26/08/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257368 0
Government body
Name [1] 257368 0
National Health and Medical Research Council (NHMRC)
Country [1] 257368 0
Australia
Primary sponsor type
University
Name
Clinical Research Unit for Anxiety and Depression (CRUfAD), School of Psychiatry, University of New South Wales
Address
CRUfAD. O'Brien Building, Level 4
Corner of Victoria St and Burton St
Darlinghurst, NSW 2010
Country
Australia
Secondary sponsor category [1] 256608 0
Hospital
Name [1] 256608 0
St Vincent's Hospital, Sydney
Address [1] 256608 0
St Vincent's Hospital
Victoria St
Darlinghurst, NSW 2010
Country [1] 256608 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259390 0
St Vincent's Hospital, Human Research Ethics Committee
Ethics committee address [1] 259390 0
Ethics committee country [1] 259390 0
Australia
Date submitted for ethics approval [1] 259390 0
07/06/2010
Approval date [1] 259390 0
09/07/2010
Ethics approval number [1] 259390 0
10154

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

Contacts
Principal investigator
Name 31449 0
Prof Nickolai Titov
Address 31449 0
eCentreClinic, Department of Psychology, Macquarie University, Sydney, Australia

Balaclava Road, North Ryde NSW, 2109
Country 31449 0
Australia
Phone 31449 0
+61 2 98509901
Fax 31449 0
Email 31449 0
[email protected]
Contact person for public queries
Name 14696 0
Dr Nickolai Titov
Address 14696 0
CRUfAD. O'Brien Building, Level 4
Corner of Victoria St and Burton St
Darlinghurst, NSW 2010
Country 14696 0
Australia
Phone 14696 0
+61 2 8382 1406
Fax 14696 0
+61 2 8382 1401
Email 14696 0
[email protected]
Contact person for scientific queries
Name 5624 0
Dr Nickolai Titov
Address 5624 0
CRUfAD. O'Brien Building, Level 4
Corner of Victoria St and Burton St
Darlinghurst, NSW 2010
Country 5624 0
Australia
Phone 5624 0
+61 2 8382 1406
Fax 5624 0
+61 2 8382 1401
Email 5624 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.