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
390 Victoria Street Darlinghurst NSW 2010
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
This preliminary project examines the efficacy of an education program for people with PTSD. We expect that people in either immediate or delayed treatment groups will report similar benefit following the active component of their program.
Trial website
www.virtualclinic.org.au
Trial related presentations / publications
- Andrews, G. and N. Titov, Alternate models of care. Treating people you never see: Internet-based treatment of the internalizing mental disorders. Australian Health Review, In Press. - Titov, N., et al., The Shyness Program: Longer Term Benefits, Cost-Effectiveness, and Acceptability. Australian & New Zealand Journal of Psychiatry, 2009. 43(1): p. 36-44. - Titov, N., G. Andrews, and P.M. McEvoy, Key components in low intensity interventions for anxiety. Oxford Guide, submitted - Titov, N. and G. Andrews, Email and brief internet based mental health interventions. Oxford Guide, submitted. - Titov, N., et al., Brief Internet Treatment for Social Phobia reduces Comorbidity Australian and New Zealand Journal of Psychiatry in press. - Titov N, Andrews G, Schwencke G: Shyness 2: Treating social phobia online: replication and extension. Australian and New Zealand Journal of Psychiatry 2008 42(7):595-605. - Titov N, Andrews G, Schwencke G, Drobny J, Einstein D: Shyness 1: Distance treatment for social over the Internet. A randomized controlled trial. Australian & New Zealand Journal of Psychiatry 2008; 42(7):585-594. - Titov N, Andrews G, Choi I, Schwencke G, Mahoney A: Shyness 3: An RCT of guided vs unguided internet based CBT for social phobia. Australian & New Zealand Journal of Psychiatry 2008; 42(12):1030-1040. - Titov N: Status of computerized cognitive behavioural therapy for adults. Australian & New Zealand Journal of Psychiatry 2007; 41(2):95-114. - Wims E, Titov N, Andrews G: The Climate Panic program: an open trial of Internet-based treatment for panic disorder. Electronic Journal of Applied Psychology 2008; 4(2)
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
Prof 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
Prof 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


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No Supporting Document Provided



Results publications and other study-related documents

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