Research reportInternet-based trauma-focused cognitive behavioural therapy for PTSD with and without exposure components: A randomised controlled trial
Introduction
Posttraumatic stress disorder (PTSD) is a common, severe and disabling condition (Kessler et al., 2005) that can be effectively treated by exposure or non-exposure trauma-focused cognitive behavioural therapy (TF-CBT) protocols (Forbes et al., 2007). Dismantling studies examining the relative efficacy of non-exposure-based CBT components (such as cognitive restructuring and stress management) in contrast to exposure-based components (such as in vivo exposure and imaginal exposure), have generally failed to establish a clear superiority of cognitive restructuring, in vivo or imaginal exposure in isolation or combination to ameliorate PTSD symptoms (Marks et al., 1998, Foa et al., 2005, Paunovic and Öst, 2001, Resick et al., 2002, Resick et al., 2008). However, a study that carefully controlled for the effects of time dosages between conditions reported a statistically significant advantage for the combination of exposure components and cognitive restructuring compared with exposure components alone (Bryant et al., 2008).
Results of face-to-face studies indicate that exposure-based protocols are often associated with low rates of treatment deterioration and attrition that are equivocal to non-exposure-based treatments (Hembree et al., 2003). While this may be the case for face-to-face treatment, important questions remain about the relative benefits and risks of exposure during online PTSD treatment, particularly given that safety may be more difficult to assess due to the lack of face-to-face contact. Preliminary evidence indicates that internet-delivered treatment for PTSD results in statistical and clinically significant changes for PTSD symptoms due to a range of traumatic events (Lange et al., 2003, Hirai and Clum, 2005, Knaevelsrud and Maercker, 2007, Knaevelsrud and Maercker, 2010, Klein et al., 2009, Klein et al., 2010, Wagner et al., 2012, Litz et al., 2007, Kersting et al., 2011); however, sufficiently powered randomised controlled trials (RCTs) conducted to date have relied on the combination of exposure and non-exposure components. In a previous study (Spence et al., 2011) we examined the relative benefits of a treatment protocol that comprised internet-delivered psychoeducation for stress management, cognitive restructuring, in vivo and imaginal exposure compared with a waitlist control group. The treatment group obtained large and statistically significant improvements on measures of PTSD, depression and anxiety compared with the controls. The present study aimed to evaluate the benefits and risks of exposure in online treatments by comparing the efficacy and safety of a similar internet-delivered CBT (iCBT) protocol for PTSD with the equivalent protocol without the exposure components. By adopting more relaxed exclusion criteria than those often used in clinical trials, this study aimed to increase the generalisability of results to patients more typically seen in outpatient settings.
Based on findings by Bryant et al. (2008), it was expected that the combination of exposure and CR would be superior to CR alone. It was also expected there would be no differences between rates of adverse events, attrition or treatment satisfaction between groups. We defined an adverse event using Tarrier et al. (1999)׳s definition of treatment deterioration, as any increase in symptom scores greater than zero from pre- to post-treatment or follow up. Serious adverse events were defined as self-reported hospitalisations, suicide attempts and self-harm that required medical attention or the onset of substance abuse due to treatment.
Section snippets
Methods
The study was approved by the Macquarie University Human Research Ethics Committee (HREC♯: 5201100413), was registered with the Australian and New Zealand Clinical Trials registry (ACTRN12611000989943) and complies with updated CONSORT recommendations (Schulz et al., 2010).
Baseline data
Demographic details are included in Table 2. Chi-squared tests failed to identify between-group differences across any demographic characteristics. However, an independent-samples t-test indicated that the non-exposure group (NoEXP) were significantly older (M=43; SD=10.9) than the exposure (EXP) group (M=39; SD=11.7) (t123=2.01, p=0.047). Thus, age was used as a covariate in subsequent relevant group comparisons. There were no pre-treatment differences in any other demographic characteristics
Discussion
The present study aimed to compare the efficacy, acceptability, and safety of an iCBT protocol composed of psychoeducation, stress management, cognitive restructuring, in vivo exposure, imaginal exposure, assertiveness and relapse prevention with the same protocol without the exposure components. It was expected that the combined protocol would be superior to the non-exposure-based protocol but that there would be no differences between rates of adverse events, attrition or treatment
Role of funding source
The funders, the New South Wales Institute of Psychiatry and the National Health and Medical Research Council, had no part in the design, execution or reporting of the study.
Conflict of interest
No conflict declared.
Acknowledgements
JS would like to thank the New South Wales Institute of Psychiatry and the National Health and Medical Research Council for funding this research, Prof. Richard Bryant for providing a treatment manual on which the protocols in this study are based, and Prof. Gavin Andrews for his original input into the design.
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