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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]

Nil

Universal Trial Number (UTN)

Nil

Trial acronym

Nil

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Posttraumatic stress disorder

Condition category

Condition code

Mental Health

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]

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]

PTSD is measured by the Posttraumatic Stress Disorder Symptom Scale (PSS-I)

Timepoint [1]