Journal of Affective Disorders 162 (2014) 73–80

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Journal of Affective Disorders journal homepage: www.elsevier.com/locate/jad

Research report

Internet-based trauma-focused cognitive behavioural therapy for PTSD with and without exposure components: A randomised controlled trial Jay Spence a,n, Nickolai Titov a, Luke Johnston a, Michael P. Jones a, Blake F. Dear b, Karen Solley a,b a b

Macquarie University, Sydney, NSW, Australia NHMRC Public Health Fellow, Macquarie University, Sydney, NSW, Australia

art ic l e i nf o

a b s t r a c t

Article history: Received 17 August 2013 Received in revised form 8 March 2014 Accepted 8 March 2014 Available online 25 March 2014

Background: Internet-delivered trauma-focused cognitive behavioural therapy is efficacious for PTSD; however, no studies have investigated the roles of individual treatment components or the safety of online treatments. Aims: To compare the efficacy and safety of an online treatment for PTSD comprised of psychoeducation, stress management, cognitive restructuring and exposure components with the equivalent protocol without the exposure components, using a randomised controlled trial design. Methods: Sixty-six individuals were randomised to a non-exposure condition and 59 to the full protocol with exposure components. Treatment duration was 8 weeks and pre-, post-treatment and three-month follow-up outcomes were analysed using a mixed linear modelling approach. Results: Both groups achieved improvements in symptoms with no differences between groups on any primary or secondary outcome measures, diagnostic remission rates or adverse events. Limitations: The study included several secondary measures that have not been previously validated and treatments were not time matched in terms of number of lessons. Conclusions: These findings indicate that trauma-focused cognitive behavioural therapy for PTSD with or without exposure components can be safe and efficacious. Crown Copyright & 2014 Published by Elsevier B.V. All rights reserved.

Keywords: Posttraumatic stress disorder Trauma PTSD Internet Cognitive behavioural therapy Randomized controlled trial

1. 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 nonexposure-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, 2008). However,

n Correspondence to: eCentreClinic, Centre for Emotional Health, Department of Psychology, Macquarie University, North Ryde, NSW 2109, Australia. Tel.: þ 61 408 202 680. E-mail addresses: [email protected] (J. Spence), [email protected] (N. Titov), [email protected] (L. Johnston), [email protected] (M.P. Jones), [email protected] (B.F. Dear).

http://dx.doi.org/10.1016/j.jad.2014.03.009 0165-0327/Crown Copyright & 2014 Published by Elsevier B.V. All rights reserved.

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, 2010; Klein et al., 2009, 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

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(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.

2. 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).

supportive group and individual counselling that did not specifically target PTSD symptoms was permitted, for example, seeing a psychiatrist for review); (iv) if using psychotropic medication, no change in dosage or type of medication one month prior to or during treatment; (v) resident of Australia, (vi) at least 18 years of age, (vii) had computer and internet access, (viii) not currently experiencing a psychotic mental illness (past psychosis was permitted), extremely severe symptoms of depression (defined as a total score 422 or responding 4 2 to Question 9 (suicidal ideation) on the Patient Health Questionnaire-9 Item (PHQ-9 (Kroenke et al., 2001)), current suicidal intent and plan (although suicidal ideation was permitted), or highly dissociative (defined as a total score above 22 on the Dissociative Experiences Scale-Brief Version (DES-B (Dalenberg and Carlson, 2010)). Participants were not paid for participation. The 144 eligible applicants were contacted by a therapist (JS) via telephone to complete the PTSD Symptom Scale-Interview version (PSS-I) (Foa et al., 1993) and the Mini International Neuropsychiatric Interview Version 5.0.0 (MINI) (Sheehan et al., 1998). The primary trauma was assessed according to the PSS-I and impairment was assessed according to DSM-IV criteria for PTSD. Entry into the trial was offered to 125 participants, including 18 participants who reported high levels of PTSD symptoms but did not meet criterion A for a DSM-IV diagnosis of PTSD. This subset of non-criterion A participants were included to examine the effects of treatment on those presenting with traumas consistent with those reported by patients of mental health services, including loss of child custody, termination, and workplace bullying. The final treatment sample comprised 108 (86%) women and 17 (14%) men (N ¼125) who commenced treatment. Recruitment was conducted in four phases over a total of eight months. Each phase involved a treatment period of eight weeks and phases were run consecutively except during January 2012.

2.1. Design and sample size 2.3. Measures This study comprised a RCT comparing an internet-delivered exposureþCR protocol (exposure; EXP) with a CR (non-exposure; No-EXP) protocol across pre- to post-treatment, and pre- to 3-month follow-up time points. A sample of n ¼ 57 per group was calculated to provide statistical power of 0.8 at the 0.01 level of statistical significance for interaction effects that correspond to a Cohen's d effect size of 0.65. 2.2. Participants and recruitment Participant flow is shown in Fig. 1. Participants were recruited from visitors to a research website that evaluates new internetdelivered psychological treatments (www.ecentreclinic.org) and has approximately 8000 visitors per month. A description of this study and recruitment requirements was advertised via newsletters and websites of relevant non-government organisations, media releases from the Macquarie University Media Office, announcements on Australian-based online mental health forums, advertisements in local papers, printed flyers and emails that were distributed to general practitioners, psychiatrists and specialist clinics across Australia. During the eight month recruitment period between July 2011 and February 2012, 223 individuals applied online and 144 met the following inclusion criteria: (i) selfidentified as having a principal complaint of PTSD as indicated by total scores above a clinical cut-off recommended to indicate probable diagnosis of PTSD (defined as 4 32 on the Impact of Events Scale-Revised Version (IES-R) (Creamer et al., 2003)); (ii) at least one month had elapsed since the primary trauma; (iii) no psychotherapy for PTSD during the treatment period (however,

The primary outcome measures were severity of symptoms of PTSD, measured by the PSS-I and the IES-R (Weiss and Marmer, 1997). The PSS-I is a 17-item semi-structured clinicianadministered interview based on the DSM-IV criteria for PTSD. The IES-R is a 22- item, self-report scale of PTSD. Secondary outcomes measures included the Generalised Anxiety Disorder 7-Item Scale (GAD-7, which measures symptoms of anxiety) (Spitzer et al., 2006), the PHQ-9 (which measures depression) (Kroenke et al., 2001), and the MINI (which was used to determine the presence of a comorbid major depressive episode, panic, agoraphobia, social phobia, obsessive compulsive disorder, and generalised anxiety disorder) (Sheehan et al., 1998). Traumatic experiences were assessed using the Life Events Checklist (LEC) (Grey et al., 2004). Additional outcomes included completion rates (percentage of participants who read all the online lessons within the eight weeks of the course), and treatment satisfaction (percentage who reported feeling satisfied with the course or who would recommend it to a friend), time spent practicing the components (self-reported average number of hours spent per week) and adherence (percentage of exposure group participants who completed at least two sessions of in vivo exposure, imaginal exposure or both where a session of exposure was defined as at least 40 min of continual in vivo or imaginal exposure according to clinician assessment). All clinician-assessed measures (PSS-I and MINI) were conducted by one therapist (JS) via telephone, who was not blinded to group allocation. All self-report measures (IES-R, GAD-7, PHQ-9, LEC, satisfaction, adherence) were conducted online.

J. Spence et al. / Journal of Affective Disorders 162 (2014) 73–80

75

Fig. 1. Participant flow chart.

2.4. Intervention An exposure and non-exposure version of the PTSD Course, an online intervention utilising evidence-based principles of TF-CBT (Foa et al., 2007; Taylor, 2006), were used. The TF-CBT components were similar to those used in our previous trial (Spence et al., 2011) (see Table 1 for a comparison). The exposure and nonexposure versions included 4 and 6 online lessons, respectively, which comprised text-based information and instructions and educational case stories presented in a slideshow format. Each lesson required between 10 and 20 min reading time and the content was designed to be readable at a 12-year-old reading age level. Additional written materials were available to supplement the content of the lessons as downloadable PDF documents that were released in the order shown in Table 1. Participants were also able to download weekly PDF documents that contained written information from previous participants of iCBT programs at the

eCentreClinic including encouragement or testimonials about their experiences of participating in previous courses. 2.5. Therapist One nationally registered Clinical Psychologist (JS) who had completed a Master degree in clinical psychology provided all clinical contact with participants, which occurred via weekly telephone calls or secure email. The therapist had four years' experience in treating trauma in face-to-face settings, and had two years' experience in administering iCBT. The therapist was supervised by NT. The average total therapist time (not including administration time for diagnostic interviews) per participant is shown in Table 2. This included an average of 6.6 (SD ¼0.9) and 7.4 (SD ¼1.5) phone calls in the NoEXP and EXP groups respectively, and 4.8 (SD ¼0.6) and 6.1 (SD ¼0.9) emails respectively. Independent samples t-tests failed to reveal any differences across these variables (all p 40.05).

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J. Spence et al. / Journal of Affective Disorders 162 (2014) 73–80

Table 1 Differences between the current protocol and the original protocol. Week Original protocol 1

2

3

Lesson: PTSD psychoeduction Resources: Vignettes Lesson: PTSD psychoeducation plus stress from participants of other trials at the Virtual Clinic. management (controlled breathing and grounding instructions). Resources: Emotion regulation strategies, FAQ1, vignettes from participants of our previous trial. Lesson: Basic strategies for cognitive restructuring. Lesson: Stress management (controlled breathing and grounding instructions). Resources: Information Resources: Cognitive distortions, additional questions for cognitive restructuring, downward arrow about diet, exercise and substance use. technique, FAQ2, vignettes from participants of our previous trial. Lesson: Basic strategies for cognitive restructuring. Resources: Managing panic attacks.

4

Lesson: Education and guidelines about practicing in vivo exposure.

5

Lesson: Education and guidelines about practicing imaginal exposure using repeated written exposure and/or audio-recording and repeatedly listening to the recording. Lesson: Education and guidelines about challenging dysfunctional beliefs, including trauma related beliefs. Resources: anger management, assertiveness training. Lesson: Relapse prevention Resources: Behavioural activation and pleasant event scheduling.

6

7

Current protocol: NoEXP

Lesson: Cognitive restructuring for challenging trauma-related beliefs based on the framework of cognitive processing therapy. Resources: Additional questions for cognitive restructuring, FAQ3, vignettes from participants of our previous trial.

Lesson: Information about assertiveness skills and relapse prevention.

Current protocol: EXP Lesson: PTSD psychoeducation plus stress management (controlled breathing and grounding instructions). Resources: Emotion regulation strategies, FAQ1, vignettes from participants of our previous trial. Lesson: Basic strategies for cognitive restructuring. Resources: Cognitive distortions, additional questions for cognitive restructuring, downward arrow technique, FAQ2, vignettes from participants of our previous trial. Lesson: Cognitive restructuring for challenging trauma-related beliefs based on the framework of cognitive processing therapy. Resources: Additional questions for cognitive restructuring, FAQ3, vignettes from participants of our previous trial. Lesson: Education and guidelines about practicing in vivo exposure. Resources: Example graded in vivo exposure hierarchies.

Lesson: Education and guidelines about practicing imaginal exposure using repeated written exposure Resources: Using imagery rehearsal training for nightmares.

Resources: Additional assertiveness training skills, anger management, forgiveness, problem solving skills, managing panic attacks, vignettes from participants of our previous trial.

8

2.6. Procedure Following online screening participants were contacted by telephone to complete clinician-administered assessments (PSS-I and the MINI) and to discuss safety plans and emergency contact resources. Pre-treatment self-report measures were collected online at the start of week 1, and this occurred between 0 and 5 weeks after application to the trial. Participants were contacted via telephone or email once per week, according to their preference. The purpose of contact was to answer questions about the course content, normalise the experience of some symptoms and encourage and facilitate progress. Participants also received at least two automated emails per week during the course. Emails were triggered by participant behaviour or sent at specific times during the course, including when a participant read an online lesson, had not read a lesson within a recommended timeframe, or at the start of each week. Post-treatment self-report and clinicianadministered questionnaires were collected at the start of week 9. 2.7. Statistical methods Group differences in demographic data, pre-treatment measures, and differences in rates of engagement or dropout from treatment were analysed with one-way analyses of variance (ANOVAs) or chi-square tests. A mixed linear model (MLM) analysis of covariance was used to model scores at each measurement occasion with subject treated as a random effect, and the interaction between measurement occasion and treatment group in order to test the central hypothesis of differential treatment

Lesson: Information about assertiveness skills and relapse prevention. Resources: Additional assertiveness training skills, anger management, forgiveness, problem solving skills, managing panic attacks, vignettes from participants of our previous trial.

response (compared with pre-treatment) between treatment modalities. Measurement occasion was treated as a categorical variable and compound symmetry was specified as the covariance structure. Maximum Likelihood (ML) was used to produce parameter estimates. Univariate ANCOVAs on post-treatment scores controlling for age for participants who completed the programme and responded to post-treatment assessments was also conducted in order to determine the effects of treatment dosage. Two sets of analyses of change were conducted, one using the MLM analysis with the overall sample (N ¼125), the other on the PTSD sample, which was restricted to individuals who met full criteria for PTSD (N ¼107). Effect sizes (Cohen's d) (Cohen, 1992) were calculated both within- and between-groups, based on the pooled standard deviation and we report 95% confidence intervals for these. All analyses were performed in PASW version 18.0 (SPSS, Inc., Chicago, IL). Changes in prevalence of PTSD and comorbid disorders were calculated based on the results of telephone administered diagnostic interviews administered at pre-treatment, post-treatment and follow-up. These calculations involved an intention-to-treat (ITT) approach using last-observation-carried-forward (LOCF).

3. Results 3.1. Baseline data Demographic details are included in Table 2. Chi-squared tests failed to identify between-group differences across any

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Table 2 Demographic characteristics, trauma background and therapist time requirements of treatment groups and the total sample. Variable

Gender Male Female Age Mean SD Range Marital status Single/never married Married/de facto Separated/divorced Education High school Tertiary Other certificate None Employment status Part time/student Full time Unemployed, retired or disabled Previous mental health treatment Current medication use Non-criterion A PTSD cases Trauma type Sexual assault Physical assault Other stressful event Sudden death Death of someone close Captivity Illness/injury Assault with a weapon Transportation accident Natural disaster Combat Accident Unwanted sexual contact Therapist time requirements Time spent (logged on/min) Therapist time (min)

Non-EXP (n¼ 66)

EXP (n¼59)

n

% (SD)

n

% (SD)

n

% (SD)

17 83

6 53

10 90

17 108

14 86

11 55 43 10.9 19–65

Total (N¼ 125)

39 11.7 20–63

Statistical significance

χ 2 (1, N ¼ 125) ¼ 1.1, p ¼0.290

t (123) ¼2.0., p ¼ 0.047

41 11.4 19–65

21 31 14

32 47 21

27 22 10

46 37 17

48 53 24

38 42 42

χ 2 (1, N ¼125)¼ 2.6, p ¼0.278

6 42 13 5

9 64 20 8

9 28 15 7

15 48 25 12

15 70 28 12

12 56 22 10

χ 2 (1, N ¼125)¼ 3.5, p ¼0.321

19 29 18 27 29 44 38 58 38 58 13 20 Overall (N ¼ 125) 26 39 7 11 13 20 6 9 3 5 2 3 1 2 2 3 1 2 2 3 1 2 1 2 1 2

21 13 25 34 34 5

36 22 42 58 58 9

40 31 54 72 72 18

32 25 43 58 58 14

χ 2 (1, N ¼125)¼ 0.8, p ¼0.666

21 12 5 4 4 4 4 2 2 0 1 0 0

36 20 8 7 7 7 7 3 3 0 2 0 0

47 19 18 10 7 6 5 4 3 2 2 1 1

38 15 14 8 6 5 4 3 2 2 2 1 1

χ 2 (1, N ¼125)¼ 0.0, p ¼0.995 χ 2 (1, N ¼125)¼ 0.0, p ¼0.995 χ 2 (1, N ¼125)¼ 3.2, p ¼0.062 PTSD (N ¼107) (n/%) 47 44 19 18 – – 10 9 8 7 6 6 5 5 4 4 3 3 2 2 2 2 1 1  

106 59

98 58

76 14

102 59

17

p¼ 0.626 p¼ 0.920

93 27

demographic characteristics. However, an independent-samples ttest indicated that the non-exposure group (NoEXP) were significantly older (M ¼43; SD ¼10.9) than the exposure (EXP) group (M ¼39; SD ¼11.7) (t123 ¼2.01, p ¼0.047). Thus, age was used as a covariate in subsequent relevant group comparisons. There were no pre-treatment differences in any other demographic characteristics for the PTSD sample (all p 40.05). No participants in the NoEXP group reported receiving exposure therapy as part of supportive counselling. There were no differences between the groups for any outcome measure in presence of supportive counselling between pre- and posttreatment (F2, 123 ¼0.5–0.9, p¼ 0.453  0.956), or between posttreatment and follow-up (F2, 123 ¼0.3–1.0, p ¼0.336–777). Ten of 43 (23%) respondents in the NoEXP group reported pharmacotherapy changes (started, stopped or changed dose of a psychotropic) between post-treatment and follow-up, compared with 8/37 (22%) respondents in the EXP group (χ2 ¼ 0.0; p¼ 0.861). Again, there were no differences on outcome measures due to change in medication between groups (F2, 123 ¼ 0.6–1.2, p ¼ 0.265  0.865). There were no differences between groups in the amount of contact time with the therapist (F2, 123 ¼0.01, p ¼0.920), amount of time spent logged on to the PTSD Course (F2, 123 ¼2.4, p ¼ 0.626), or the amount of time spent practicing the recommended exercises (F2, 107 ¼2.71, p ¼0.604).

3.2. Trauma history Information about the trauma history of the overall sample and PTSD sample is included in Table 2. On average, the primary trauma had occurred 18 years prior (SD ¼ 15.6). According to the LEC, participants in the NoEXP group reported having experienced an average of 8.8 (SD ¼3.6) types of trauma during their lifetime, compared with 8.2 (SD ¼3.8) types of trauma in the EXP group. 3.3. Attrition and adherence The flow is shown in Fig. 1. There were no differences in completion rates for NoEXP participants (52/66; 79%) defined as reading the four lessons, compared with EXP (43/59: 73%) participants, defined as reading the six lessons (χ 2 (1)¼0.6, p¼ 0.440). Completers did not differ from non-completers on pre-treatment scores on any outcome measures (F1, 123 ¼ 1.1–2.5, p 40.05). Post-treatment data were collected from 88% of participants in both groups except for self-report data from the NoEXP group, which had an 86% (57/66) response rate since one participant in this group completed the clinician assessments but not self-report questionnaires. Three-month follow-up self-report data were collected from 79% (52/66) NoEXP and 80% (47/59) EXP participants, and clinician-assessed data were collected from 77% (51/66) NoEXP and 81% (48/59) EXP participants.

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The average number of hours spent practicing the recommended skills each week was 4.7 (SD ¼3.9) in the NoEXP group and 4.3 (SD ¼3.9) in the EXP group with no significant difference between groups (t104 ¼5.2, p¼ 0.604). In the EXP group, 30/47 (63%) completed at least 2 sessions of in vivo exposure and 22/47 (47%) completed at least two sessions of imaginal exposure and 20/47 (43%) completed at least 2 sessions of each. We examined whether adherence to recommendations for exposure influenced outcomes using a Generalised Linear Model approach. Adherence to recommendations for in vivo or imaginal exposure or both (42 in vivo and 42 imaginal) did not influence outcomes on any of the primary or secondary outcome measures (F2, 45 ¼0.5–3.5, p ¼0.069  0.508).

3.4. Adverse events For the overall sample at post-treatment, 2/66 (3%) of NoEXP and 3/59 (5%) of the EXP group deteriorated on the PSS-I compared with pre-treatment. By follow-up this had decreased to 1/66 (2%) in the NoEXP group and 2/59 (3%) in the EXP group. These participants all met criteria for PTSD meaning that this result was equivalent for the PTSD sample as well. Chi squared analysis failed to indicate differences between groups at any time point (all p 40.05). With respect to serious adverse events, two participants in the NoEXP group reported being hospitalised during treatment on account of their symptoms and two participants in the EXP group reported serious adverse events (one for relapse to drug use and the other for self-harm requiring medical attention).

3.5. Treatment satisfaction At post-treatment, 47/56 (84%) of NoEXP respondents and 42/ 51 (82%) of EXP respondents reported that they were mostly satisfied or very satisfied with the course. In the NoEXP group 55/ 56 (98%) and 48/51 (94%) respondents in the EXP group reported that they would feel confident in recommending the treatment to a friend with PTSD. Chi-squared analyses failed to reveal any between-group differences in these satisfaction ratings (all p 40.05).

3.6. Overall sample vs. PTSD sample Differential outcome changes between pre-, post-treatment and follow-up did not differ between the Criterion A PTSD sample and the non-Criterion A PTSD sample on the PSS-I (F2, 123 ¼ 0.8, p ¼0.461) or the IES-R (F2, 123 ¼0.6, p ¼0.533). There were also no differences in completer outcomes according to separate ANCOVAs on post-treatment and follow-up measures for the overall sample or the PTSD sample (all p 40.05). For these reasons, only results for the entire sample according to an MLM analysis are reported. Means for the outcome measures are included in Table 3. For both the overall sample and the PTSD sample, the MLM analysis controlling for age failed to provide evidence of significant differential changes from baseline to post-treatment or follow-up between groups on the PSS-I (F2, 123 ¼ 2.1, p ¼ 0.123), IES-R (F2, 123 ¼0.1, p ¼0.946), GAD-7 (F2, 123 ¼ 0.8, p¼ 0.451) or PHQ-9 (F2, 123 ¼ 1.7, p ¼0.181). Statistically significant within-group changes were found between pre-treatment and follow-up for both groups on the PSS-I (F1, 66 ¼81.0–149.2, po 0.001), IES-R (F1, 66 ¼53.8–83.6, p o0.001), GAD-7 (F1, 66 ¼ 51.0–51.3, p o0.001) and PHQ-9 (F1, 66 ¼ 22.6–42.4, p o0.001).

3.7. Effect sizes Within- and between-group effect sizes for the outcome measures are included in Table 3. Again, there were no differences in effect sizes between the overall and PTSD samples. Large (d Z0.8) within-group effect sizes were found for both groups at post-treatment and follow-up on the PSS-I, IES-R, GAD-7 and PHQ9 except for the NoEXP group which had a moderate (0.5 o do 0.8) within-group effect size at post-treatment on the PHQ-9. Small between group effects sizes (d o0.5) were found for both the overall and PTSD samples. 3.8. Change in diagnostic status Based on the results of the clinician telephone-administered PSS-I at post-treatment using an ITT LOCF approach, there were no significant differences in the rates of diagnostic remission between the overall sample and the PTSD sample. At post-treatment, 25/66 (38%) of the NoEXP group and 19/59 (32%) of the EXP group no longer met diagnostic criteria for PTSD (χ2 ¼ 0.4; p ¼0.507). At follow-up the remission rate had increased to 29/66 (44%) in the NoEXP group, and decreased to 20/59 (34%) in the EXP group (χ2 ¼1.3; p ¼0.251). With regard to co-morbid diagnoses, as measured by the clinician-administered MINI and using an ITT LOCF approach, the average number of co-morbid diagnoses for the NoEXP reduced from 2.1 (SD ¼1.4) at intake to 1.3 (SD ¼ 1.2) at post-treatment, and to 1.2 (SD ¼1.5) at follow up. In the EXP group, the average number of co-morbid diagnoses reduced from 2.5 (SD ¼ 1.5) at intake to 1.8 (SD ¼1.6) at post-treatment, and to 1.6 (SD ¼ 1.6) at follow up.

4. 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 nonexposure-based protocol but that there would be no differences between rates of adverse events, attrition or treatment satisfaction between groups. Treatment using both the NoEXP and EXP protocols resulted in large effect sizes and diagnostic remission in 34–44% of the entire sample at follow-up. The present outcomes are similar to previous outcomes reported in the iCBT for PTSD literature (Amstadter et al., 2009) as well as in studies of face-to-face treatment of PTSD (Bisson and Andrew, 2007). For the overall and PTSD samples, there were no significant differences between the EXP and NoEXP group on any measure at any time point. The between-group effect sizes were small at post-treatment and follow-up, slightly favouring treatment without exposure components. These results were not related to the amount of therapist time, time spent logged on to the course or time spent practicing the recommended exercises, which was equivalent between groups, nor to adherence with exposure recommendations, which did not affect outcomes. However, concluding that the protocols produced equivalent outcomes may be premature due to the possibility that participants in the EXP group may have failed to receive an adequate therapeutic dose of in vivo or imaginal exposure. Evidence indicates that fewer than four sessions of treatment using written imaginal exposure is unlikely to result in significant treatment effects (Possemato et al., 2011, Sloan et al., 2011). Although the study by Bryant et al. (Bryant et al., 2008) found a significant advantage for the combination of CR with in vivo and imaginal exposure after controlling for time

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Table 3 Results of outcome measures for the overall sample: Estimated marginal means, standard deviations, confidence intervals and effect sizes (Cohen's d) for each group (mixed linear model analysis). Outcome measure

Group

N

Pre

Post

Effect sizes (95% CI)

Follow-up

Effect sizes (95% CI)

Mean (SD)

Mean (SD)

Within group

NoEXP vs. EXP

Mean (SD)

Within Group

NoEXP vs. EXP

PSS-I

NoEXP EXP

66 59

31.98 (9.25) 31.66 (9.55)

14.43 (9.31) 17.10 (12.57)

1.89 (1.47–2.29) 1.31 (0.90–1.69)

0.24 (  0.11–0.59)

13.02 (10.89) 15.69 (13.38)

1.88 (1.46–2.28) 1.37 (0.96–1.77)

0.22 (  0.13–0.57)

IES-R

NoEXP EXP

66 59

46.23 (14.66) 51.27 (15.71)

26.65 (16.77) 32.23 (21.56)

1.24 (0.86–1.61) 1.01 (0.62–1.39)

0.29 (0.0.06–0.64)

22.69 (14.90) 26.61 (21.91)

1.59 (1.19–1.97) 1.29 (0.89–1.68)

0.21 (  0.14–0.56)

GAD-7

NoEXP EXP

66 59

12.08 (5.42) 13.54 (4.95)

6.37 (4.67) 7.67 (5.98)

1.13 (0.75–1.49) 1.07 (0.68–1.45)

0.24 (  0.11–0.59)

6.52 (4.99) 6.33 (5.43)

1.07 (0.70–1.42) 1.39 (0.98–1.78)

 0.04 (  0.39–0.31)

PHQ-9

NoEXP EXP

66 59

13.98 (5.42) 15.64 (6.19)

9.19 (6.97) 9.98 (7.47)

0.77 (0.41–1.12) 0.83 (0.44–1.20)

0.11 (0.0.24–0.46)

9.48 (7.23) 8.02 (7.30)

0.71 (0.35–1.05) 1.13 (0.73–1.51)

 0.20 (  0.55–0.15)

Note. A mixed linear model (N ¼ 125) was used. Abbreviations: PSS-I: PTSD Symptom Scale-Interview Version; IES-R: Impact of Events Scale-Revised; GAD-7: Generalised Anxiety Disorder 7-Item; PHQ-9: Patient Health Questionnaire-9 Item.

dosage, a similar study comparing CPT (which contains only a minor dose of imaginal exposure) that also controlled for time failed to find any outcome differences when compared to CR alone (Resick et al., 2008). This issue requires consideration by future research. An important finding from this trial was that there were no significant differences in adverse events or treatment satisfaction ratings between groups. Incidences of adverse events were not higher than other face-to-face treatments of PTSD such as traumafocused CBT (Taylor et al., 2003) and appear to be lower than rates of worsening that occur for individuals who are on waiting lists (Riggs et al., 2006; Neuner, 2012) suggesting that withholding treatment may be worse than providing either exposure or nonexposure-based treatments. Furthermore, there were no differences in attrition or treatment satisfaction ratings, providing preliminary evidence that, with appropriate training and supervision, both exposure therapy and cognitive therapy for PTSD may be safely administered via the internet with telephone support from a specialist therapist. It is important to note that group allocation appears to have influenced pre-treatment scores on the IES-R. After being informed of their allocation and whether or not they would receive exposure, participants' scores at pre-treatment assessment in the NoEXP decreased by a mean of 5.4 (SD ¼10.9) from their initial IES-R score at screening, compared to 2.7 (SD ¼9.1) in the EXP group. This difference was not significant (t123 ¼1.34, p ¼0.182), but was sufficiently obvious to raise our concerns. Although the use of a MLM analysis controlled for pre-treatment scores in this study, future research could explore the role of expectations due to allocation to exposure- or non-exposurebased treatments. A secondary aim of this study was to explore the effect of nonCriterion A trauma. There were no significant differences in primary outcome measures between those who endorsed PTSD symptoms due to a DSM-IV (2000) Criterion A trauma (the PTSD sample) compared with a non-Criterion A trauma such as workplace bullying, divorce/separation or adoption. The validity of excluding these types of trauma has been debated (Feeny et al., 2009; Mcnally, 2003), since expanding the criteria could lead to increases in prevalence rates and increased heterogeneity of the diagnosis. Nonetheless, these findings tentatively support the potential for trauma-focused iCBT to reduce PTSD symptoms from non-Criterion A traumas. A final contribution of this study was the use of the GAD-7 as a secondary outcome measure. This measure has previously been reported as sensitive to detecting PTSD (Spitzer et al., 2006), but to

our knowledge has not previously been reported as an outcome measure. Post-treatment and follow-up effect sizes were large on the GAD-7, and although smaller and presumably less sensitive than the PTSD specific measures, the magnitude of change on this measure indicate that the GAD-7 may have potential as a brief measure of change in symptoms of PTSD. 4.1. Limitations Limitations in the design of this study include the lack of assessor blinding (the therapist's assessment of progress may have influenced post-treatment scores) and lack of fidelity checks on the communication between the therapist and participants. Several of the secondary measures have not been previously validated. The large range for some measures such as adherence raises the issue of whether inadequate dosing and non-adherence may offer plausible explanations of the results. Furthermore, having participants informed about their allocation to an exposure-based treatment prior to pre-treatment assessment may have biased data at this collection point. Generalisability is limited since the sample tended to have severe, chronic PTSD, and findings may not generalise to milder samples or single-incident trauma populations. Findings were limited to three-month follow-up; however, an investigation of 12-month follow-up is currently being conducted and will be reported. These findings should be considered in light of the duration of therapy required by each protocol. The NoEXP group had eight weeks to complete four lessons and learn two key skills, stress management and cognitive restructuring. The EXP group was asked to complete six lessons and learn two additional key skills in the same period: in vivo and imaginal exposure. In a previous study comparing Prolonged Exposure (PE) to Stress Inoculation Therapy (SIT) and PEþSIT (Foa et al., 1999) the authors cautioned that the lack of significant difference between the combined treatment and the standalone treatments may have been due to information overload… (and) a lack of sufficient time to practice each of the procedures. (p.199). The optimum ratio between the number of skills taught and the duration of treatment remains to be determined by future research studies.

4.2. Conclusions and future research These results indicate that the exposure and non-exposurebased protocols for internet-delivered PTSD treatment resulted in

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clinically significant improvements on measures of PTSD, anxiety and depression in the short and medium term. Both forms of treatment appeared equally efficacious, acceptable to consumers, and safe. Collectively, these findings indicate that good clinical outcomes can be obtained without an emphasis on exposure when treating PTSD via the internet. Replication is required in milder samples or those with single-incident traumas to determine benefits in less chronic populations. Importantly, future studies will need to control for the effects of adherence to exposure recommendations before ruling out the need for any component as well as controlling for the effects of time and number of skills taught. Expanding assessment to investigate the effects of treatment on other outcomes such as disability and service utilisation will provide important data about the economic feasibility of iCBT and assist in policy decisions about broader rollout of such interventions. 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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Internet-based trauma-focused cognitive behavioural therapy for PTSD with and without exposure components: a randomised controlled trial.

Internet-delivered trauma-focused cognitive behavioural therapy is efficacious for PTSD; however, no studies have investigated the roles of individual...
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