Remote treatment of obsessive-compulsive disorder_ ...

Journal of Obsessive-Compulsive and Related Disorders 2 (2013) 375–384

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Remote treatment of obsessive-compulsive disorder: A randomized controlled trial Bethany M. Wootton n, Blake F. Dear, Luke Johnston, Matthew D. Terides, Nickolai Titov eCentreClinic, The Centre for Emotional Health, Department of Psychology, Macquarie University, Sydney, NSW, 2109, Australia

art ic l e i nf o

a b s t r a c t

Article history: Received 20 January 2013 Received in revised form 8 July 2013 Accepted 16 July 2013 Available online 24 July 2013

Obsessive-compulsive disorder (OCD) is a common anxiety disorder. Although effective treatments exist many patients experience difficulties accessing treatment. Treatments that are delivered remotely, such as bibliotherapy-administered CBT (bCBT) and internet-administered CBT (iCBT) have the potential to improve access to treatment. This study was a three group randomized controlled trial that aimed to examine the benefits and acceptability of these two remote treatment options in the treatment of OCD, compared to a waitlist control group. Participants in the bCBT and iCBT groups read five lessons and received twice-weekly contact from a remote therapist. The control group did not receive any clinical contact during this time. The results indicated that participants in both remote treatment conditions (bCBT and iCBT) improved from pre-treatment to post-treatment and pre-treatment to 3-month followup on the Yale-Brown Obsessive Compulsive Scale. Once the bCBT and iCBT groups completed treatment, the control group was provided the iCBT protocol but with clinician contact only once per week. Results from the control group, after receiving iCBT treatment, indicated that large effect sizes can be obtained with weekly contact. These results provide preliminary support for the use of either bCBT or iCBT in the remote treatment of OCD. & 2013 Elsevier Inc. All rights reserved.

Keywords: Obsessive-compulsive Anxiety Internet Treatment Bibliotherapy

1. Introduction Obsessive-compulsive disorder (OCD) is a common anxiety disorder characterized by unwanted obsessive thoughts, images or urges and repetitive, time-consuming compulsions (American Psychiatric Association, 2000). Effective treatments exist, however, many patients experience barriers to accessing treatments including direct and indirect costs of treatment, a lack of trained mental health professionals, and stigma (Baer & Minichiello, 2008; Belloch, del Valle, Morillo, Carrió, & Cabedo, 2009; Goodwin, Koenen, Hellman, Guardino, & Struening, 2002; Marques et al., 2010; Wootton, Titov, Dear, Spence, & Kemp, 2011). Recently, remote treatments have been utilized as a way to reduce these barriers. Remote treatments are those that can be administered without seeing the individual face-to-face and, thus, have the potential to improve access to evidence-based treatment (Wootton & Titov, 2010). The two most commonly used remote treatments include bibliotherapy-administered cognitive behavioral therapy (bCBT) and internet-administered CBT (iCBT). bCBT involves the provision of psycho-education and evidence-based treatment techniques in a paper copy workbook (Kavanagh, Connolly, White, Kelly, & Parr,

n

Corresponding author. Tel.: +61 2 98508724; fax: þ612 98508062. E-mail address: [email protected] (B.M. Wootton).

2211-3649/$ - see front matter & 2013 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jocrd.2013.07.002

2010). bCBT interventions have been found to significantly reduce symptoms across several disorders including problematic alcohol use (Apodaca & Miller, 2003), depression (McNaughton, 2009), and anxiety disorders (den Boer, Wiersma, & Van den Bosch, 2004; Marrs, 1995). Two randomized controlled trials (RCTs) demonstrated the efficacy of bCBT for OCD. In the first RCT, 41 participants were randomly allocated to either 7.5 weeks of twiceweekly face-to-face clinician-administered CBT or 6 weeks of unguided bCBT (Tolin et al., 2007). Both groups showed a statistically significant decrease in symptoms on the Yale-Brown Obsessive-Compulsive Scale (YBOCS) and a moderate within-group effect size for the unguided bCBT group (Cohen's d ¼0.65) and a large effect size for the face-to-face clinician-guided group (Cohen's d¼ 1.44) (Tolin et al., 2007). In the second RCT, 86 participants were randomised to either unguided bCBT or to a waitlist control group (Moritz, Jelinek, Hauschildt, & Naber, 2010). Results indicated significantly greater improvement on the selfreport YBOCS for the bCBT group and a moderate between-group effect size at post-treatment (Cohen's d ¼0.63) (Moritz et al., 2010). Further support for the efficacy of bCBT for OCD has been reported from uncontrolled studies (Tolin, Diefenbach, Maltby, & Hannan, 2005) and it has been demonstrated that using bCBT as part of a stepped-care package results in a magnitude of improvement similar to face-to-face treatment, but is associated with considerably improved cost-effectiveness (Tolin, Diefenbach, & Gilliam, 2011). A previous study has also demonstrated the

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B.M. Wootton et al. / Journal of Obsessive-Compulsive and Related Disorders 2 (2013) 375–384

acceptability of bCBT specifically for OCD (Graham, Franses, Kenwright, & Marks, 2000). These results provide promising but preliminary evidence that guided and unguided bCBT may be an effective remote treatment for OCD. Several recent studies have explored the efficacy of internetadministered treatments for OCD (Lind, Boschen, & Morrissey, 2013). iCBT involves the administration of highly structured online lessons or modules that present the same information and skills typically taught in face-to-face treatment, often with telephoneadministered or email support (Titov, 2011). In the largest study of iCBT for OCD to date, 101 participants were randomly allocated to a 10-week iCBT treatment, or to a Control online supportive therapy condition (Andersson et al., 2012). The iCBT condition produced a within-group effect size of 1.55 on the YBOCS, compared to 0.47 for the control group. Similar results have also been demonstrated in two pilot studies (Andersson et al., 2011; Wootton et al., 2011), suggesting that iCBT is a promising method for treatment delivery in OCD. Whilst bCBT and iCBT are both remote treatments, little is known about their relative benefits. These two models of service delivery are associated with different advantages and disadvantages, and individuals may prefer one form of treatment delivery to the other. One study compared these two forms of remote treatment for insomnia and the results indicated that both forms of treatment administration resulted in similar treatment gains (Lancee, van den Bout, van Straten, & Spoormaker, 2012). However, to the authors' knowledge, no studies have yet compared the treatment modalities in the treatment of OCD. An additional question about the remote treatment of OCD concerns the amount of clinician contact required to achieve positive clinical outcomes while maintaining a high level of acceptability to participants. Studies conducted across various disorders have produced equivocal results (Kenwright, Marks, Graham, Franses, & Mataix-Cols, 2005; Klein et al., 2009; Palmqvist, Carlbring, & Andersson, 2007). One study that explored the effect of level of therapist guidance on a typically self-guided protocol found that the addition of clinician contact increased efficacy and adherence to treatment (Kenwright et al., 2005). In published studies of guided remote treatment for OCD, participants were contacted between two and four times each week via telephone or email (Andersson et al., 2011, 2012; Wootton, Titov, Dear, Spence,& Andrews, 2011), an intensity of contact that may not be sustainable in clinical practice. Reduced therapist contact could possibly improve the cost-effectiveness of this type of treatment and increase the number of people who can access the treatment. However, few studies have systematically examined the effect of varying the intensity of clinician guidance in iCBT studies, and there are currently no studies investigating this in an OCD population.

(5–10 min per call). Once the bCBT and iCBT groups had finished treatment, the Control Group was administered the iCBT treatment but with brief contact from a therapist only once a week (5–10 min per call). The present study tested three primary hypotheses. First, it was expected that participants in both treatment groups would show significant improvements on the primary and secondary outcome measures compared with the Control Group, and would rate the program as similarly acceptable. It was also expected that gains would be sustained at 3-month follow-up. Second, based on previous research, it was hypothesized that there would not be a significant difference in the efficacy or acceptability of the treatment for the guided bCBT and iCBT groups. Third, it was hypothesized that the Control Group, who received the iCBT treatment after the two Treatment Groups completed treatment, would still show similarly significant improvements on the primary and secondary measures despite receiving a reduced amount of clinical contact.

2. Method The RCT design compared the three-abovementioned groups from pretreatment to post-treatment. The randomization sequence was computer generated by an independent overseas colleague using www.random.org. At posttreatment the Control Group was provided with treatment, and the two initial treatment groups were followed up from post-treatment to 3-month follow-up. Unlike the treatment groups, the Control Group also received weekly, automated emails after the active treatment period (8 weeks) in order to encourage participants to continue to practice the skills described in the treatment.

2.1. Participants and recruitment Interested applicants applied online at the eCentreClinic website (www. ecentreclinic.org). One hundred and fifty-six participants provided consent between July 2011 and February 2012, and 88 completed an application. Of these, 56 were eligible to participate. Twenty participants were randomly allocated to the guided bCBT Group, 17 to the guided iCBT Group and 19 to the Control Group. However, two participants in the iCBT Group and two participants in the Control Group did not complete the pre-treatment (baseline) questionnaires and were withdrawn. Participant flow is shown in Fig. 1 and demographic information is shown in Table 1. Inclusion and exclusion criteria were: (1) Australian resident; (2) aged 18–64 years; (3) not currently participating in CBT for OCD; (4) no current drug or alcohol abuse or history of psychosis or mania; (5) had not commenced or changed dose of medication over the past month; (6) no current suicidal plans or severe depression (defined as a total score422 or responding42 to Question 9 (suicidal ideation) on the Patient Health Questionnaire-9 Item (Kroenke, Spitzer, & Williams, 2001), and; (7) hoarding was not the primary symptom subtype. Applicants who met the inclusion criteria were administered the MINI International Neuropsychiatric Interview (MINI) Version 5.0.0 (Sheehan et al., 1997a) and the YBOCS (Goodman et al., 1989) during a telephone interview to confirm they met DSM-IV criteria (American Psychiatric Association, 2000) for OCD. The study was approved by local Human Research Ethics Committees and registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12611000116921).

1.1. Design and hypotheses 2.2. Outcome measures

The present study had two main aims. First, the study aimed to examine the relative benefits and acceptability of guided bCBT and iCBT, which involved twice weekly contact from a clinician, compared to a waitlist control group. The second aim was to examine the effect of reduced therapist contact on the clinical outcomes and acceptability of the iCBT treatment when contact was provided weekly during treatment. To meet these aims, the present study employed a RCT design and compared three groups from pre-treatment to post-treatment: the bibliotherapy CBT group (bCBT Group) received a remote CBT protocol via bibliotherapy; the internet CBT Group (iCBT) received the same remote CBT protocol via the internet; and a deferred waitlist control group (Control Group) did not receive any active treatment. Both the bCBT and iCBT groups received brief twice-weekly therapist contact

The outcome measures included the following:

2.2.1. Mini international neuropsychiatric interview (MINI) (Sheehan et al., 1997a) The MINI is a structured, clinician-administered interview that assesses the presence of DSM-IV criteria for common mental disorders. It has inter-rater reliability of 1.00 and test re-test reliability of 0.85 for the OCD scale (Sheehan et al., 1997a, b).

2.2.2. Yale Brown Obsessive Compulsive Scale (YBOCS) (Goodman et al., 1989) The YBOCS is a 10-item clinician-administered semi-structured questionnaire that measures the severity of OCD symptoms independently of the symptom subtype. The scale has good internal consistency with reports of Cronbach's alpha ranging from 0.86 to 0.91 (Goodman et al., 1989; Sulkowski et al. 2008). Total scores range from 0 to 40, and Cronbach's alpha in the current study was 0.79.


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Fig. 1. Participant flow. Note—MINI: Mini international neuropsychiatric interview, PHQ-9: Patient Health Questionnaire-9 item, CBT: Cognitive Behavioral Therapy. The Control Group participant who was excluded from the RCT for commencing an SSRI was eligible to enter the Control Group treatment and was included in these analyses. nParticipants in the control group commenced the iCBT treatment at post-treatment; however, clinical contact was reduced in this group to once per week.

2.2.3. The Dimensional Obsessive Compulsive Scale (DOCS) (Abramowitz et al., 2010) The DOCS is a 20-item self-report scale that measures four empirically validated dimensions of OCD including: (1) contamination obsessions and washing and cleaning compulsions; (2) obsessions about responsibility for causing harm/ making mistakes and checking compulsions; (3) obsessions about order/symmetry

and ordering/arranging compulsions, and; (4) repugnant obsessional thoughts and repeating or mental compulsive rituals. Scores on the DOCS range from 0 to 80 for the total score, and 0–20 on each of the subscales. In the results below, the participant's score on their predominant subscale was used as the DOCS outcome measure (range¼ 0–20), rather than the total score. In the event that participants scored equally on more than one subscale at pre-treatment the post-treatment

378


Table 1 Characteristics of the bibliotherapy, internet, and control groups for the total sample. Variable

Bibliotherapy group (n¼20) n %

Internet group (n¼ 15) n %

Control group (n¼ 17) n %

Significance statistics

Gender Male Female

6 14

30.0 70.0

1 14

6.7 93.3

6 11

35.3 64.7

χ2(2, N ¼52) ¼ 3.92, p ¼0.14a

Age Mean (SD) Range

35.55 23–59

(9.68)

39.93 20–68

(12.57)

38.58 18–53

(10.51)

F(2,49) ¼ 0.77, p ¼0.47

Marital status Single/never married Married/defacto Separated/divorced/widowed

10 9 1

50.0 45.0 5.0

5 9 1

33.3 60.0 6.7

7 9 1

41.2 52.9 5.9

χ2(4, N ¼52) ¼ 0.99 p ¼0.91a

Education High school Other certificate Tertiary

5 6 9

25.0 30.0 45.0

3 3 9

20.0 20.0 60.0

3 7 7

17.6 41.2 41.2

χ2(4, N ¼52) ¼ 2.07, p ¼0.72a

Employment Full-time Part-time Unemployed

14 4 2

70.0 20.0 10.0

7 4 4

46.7 26.7 26.7

7 6 4

41.2 35.3 23.5

χ2(4, N ¼52) ¼ 3.90, p ¼0.42a

Previous treatment (% yes)

17

85.0

12

80.0

15

88.2

χ2(2, N ¼52) ¼ 0.42, p ¼0.81a

Taking SSRI (% yes)

10

50.0

9

60.0

13

76.5

χ2(2, N ¼52) ¼ 2.74, p ¼ 0.25

YBOCS severity Mild Moderate Severe Extremely severe

3 9 8 0

15.0 45.0 40.0 0.0

0 9 4 2

0.0 60.0 26.7 13.3

3 9 5 0

17.6 52.9 29.4 0.0

χ2(6, N ¼52) ¼ 8.35, p¼ 0.21a

Dominant DOCS subscalec Contamination Responsibility Unacceptable thoughts Symmetry

4 8 5 5

20.0 40.0 25.0 25.0

6 6 3 2

40.0 40.0 20.0 13.3

4 6 9 2

23.5 35.3 52.9 11.8

χ2(2, χ2(2, χ2(2, χ2(2,

N ¼52) ¼ 1.89, p ¼0.39a N ¼52) ¼ 0.11, p ¼ 0.95 N ¼52) ¼ 4.80, p ¼0.09 N ¼52) ¼ 1.36, p ¼0.51a

Comorbidities Major depressive disorder Social phobia Generalized anxiety disorder Panic disorder Post-traumatic stress disorder

7 9 6 2 3

35.0 45.0 30.0 10.0 15.0

5 2 5 1 1

33.3 13.3 33.3 6.7 6.7

8 3 10 5 2

47.1 17.6 58.8 29.4 11.8

χ2(2, χ2(2, χ2(2, χ2(2, χ2(2,

N ¼52) ¼ 0.80, p ¼0.67 N ¼52) ¼ 5.47, p ¼ 0.07a N ¼52) ¼ 3.61, p ¼ 0.17 N ¼52) ¼ 3.89, p ¼0.14 a N ¼52) ¼ 0.58, p ¼0.75a

Number of disorders at baselineb Mean (SD) Range

2.35 1–5

(1.31)

1.93 1–3

(0.80)

2.64 1–5

(1.06)

F(2,49) ¼ 1.68, p ¼ 0.20

a

Indicated that more than 20% of the cells had expected counts less than 5 and should be interpreted with caution. Number of disorders at baseline includes OCD as well as other anxiety disorders and depression. Total possible range is from 1 to 5. SSRI: selective serotonin reuptake inhibitor. YBOCS: Yale Brown Obsessive Compulsive Scale. c Counts do not equal to 100% as some individuals scored equally on multiple DOCS subscales. b

score was calculated from the mean of the subscale scores, a method used in previous studies (Abramowitz et al., 2010). The reliability of the DOCS is excellent with a reported Cronbach's alpha of 0.90 for the total score and 0.94 to 0.96 for the subscales (Abramowitz et al., 2010). In the current study Cronbach's alpha was 0.90.

telephone. The primary outcome measures were the YBOCS and DOCS and the secondary measures the GAD-7 and PHQ-9.

Generalized Anxiety Disorder Scale (7 item) (GAD-7) (Spitzer, Kroenke, Williams, & Löwe, 2006) The GAD-7 is a 7-item self-report questionnaire that measures symptoms of generalized anxiety. Items are scored on a 4-point scale from 0 (not at all) to 3 (nearly every day) and total scores range from 0 to 21. The GAD-7 has a high internal consistency, ranging from 0.79 to 0.92 (Dear et al. 2011; Spitzer et al., 2006). The internal consistency in the current study was 0.90.

The remote protocol used in the study (The OCD Course) was developed by the first three authors and contains 5 Lessons, designed to be read by participants over 8 weeks. Lesson 1 provides education about the symptoms of OCD, how they are maintained, and the rationale for CBT treatment. Each lesson thereafter discusses ERP, and Lessons 2 to 4 each describe each of the 6 cognitive biases described by the Obsessive-Compulsive Cognitions Working Group (OCCWG) (Obsessive Compulsive Cognitions Working Group, 2001) and worked examples of cognitivebehavioral techniques to address them. Lesson 5 comprises information about relapse prevention.

2.2.4. Patient Health Questionnaire (9 item) (PHQ-9) (Kroenke et al., 2001) The PHQ-9 is a 9-item self-report questionnaire measuring symptoms of depression. Items are scored on a 4-point scale from 0 (not at all) to 3 (nearly every day) with total scores ranging from 0 to 27. The internal consistency of the scale ranges from 0.74 to 0.89 (Kroenke et al., 2001; Titov et al., 2011) and was 0.85 in the current study. Self-report questionnaires were administered online and the clinicianadministered interviews (YBOCS and the MINI) were administered via the

2.3. Intervention

2.4. Procedure Participants in the treatment groups were telephoned twice a week by the therapist to briefly discuss progress, homework tasks, and to answer questions. The frequency and duration of every contact with participants was recorded. Participants were asked to practice their homework tasks, which consisted of practicing exposure tasks and relevant cognitive techniques for at least one hour per day. In

B.M. Wootton et al. / Journal of Obsessive-Compulsive and Related Disorders 2 (2013) 375–384 contrast to our previous study (Wootton et al., 2011), and other iCBT treatments for OCD (Andersson et al., 2011, 2012), automatic email reminders were not employed in order to make the treatments comparable between the iCBT and bCBT group. Participants in the Control Group commenced treatment after participants in the treatment groups completed the 8-week course. Control Group participants were provided with access to the same treatment protocol that was used with the iCBT Group. To test the effect of reduced therapist contact participants in the Control Group were telephoned only once each week. During active treatment of the Control Group, participants were also sent one automated email per week in order to encourage the long-term use of the skills.

2.5. Therapist The first author (BMW), a Clinical Psychologist, provided all clinical contact with participants (telephone calls, emails, and diagnostic interviews) and collated all the data.

2.6. Statistical methods Group differences in demographic data and pre-treatment measures were analyzed with one-way ANOVAs followed by t-tests with Bonferroni corrected p-values and chi-square tests. Pre-treatment to post-treatment and pre-treatment to 3-month follow-up changes on outcome measures were analyzed with mixed linear models using an unstructured covariance structure. Effect sizes using Cohen's d were calculated for within-group and between-group differences, based on pooled standard deviations for both the entire sample using the estimated marginal means and completer sample (i.e., those who completed post-treatment and 3-month follow-up questionnaires). Independent sample t-tests were used to compare iCBT and bCBT Groups on measures of treatment satisfaction. All analyses were performed using SPSS Version 19 (IBM Inc, USA). Significant change was determined if participants met criteria for the Jacobson and Truax (1991) reliable change index and scored two standard deviations (SD) below the pre-treatment mean on the YBOCS (≤12).

3. Results 3.1. Randomized controlled trial 3.1.1. Adherence and attrition Post-treatment questionnaires were completed by 15/20 (75%) participants in the bCBT Group, 10/15 (67%) in the iCBT Group, and 16/17 (94%) in the Control Group. Follow-up questionnaires were

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completed by 14/20 (70%) participants in the bCBT Group and 10/15 (67%) in the iCBT Group. Post-treatment telephone administered interviews (YBOCS and MINI) were completed with 15/20 (75%) participants in the bCBT Group, 11/15 (73%) in the iCBT Group, and 14/17 (82%) in the Control Group. Follow-up telephone interviews were completed with 13/20 (65%) participants in the bCBT Group and 10/15 (67%) in the iCBT Group. The average number of completed Lessons was 4.33 (SD ¼ 1.11) in the bCBT Group and 4.30 (SD ¼1.06) in the iCBT Group, which was not significantly different (t23 ¼ 0.08, p ¼0.94).

3.1.2. Outcome measures Pre-treatment, post-treatment, and 3-month follow-up estimated marginal means and standard deviations on the primary and secondary outcome measures, and effect sizes with 95% confidence intervals are included in Table 2. Pre-treatment, posttreatment, and 3-month follow-up means and standard deviations on the primary and secondary outcome measures, and effect sizes with 95% confidence intervals for the completer sample (those who completed post-treatment measures) are included in Table 3. The mixed linear models indicated that there were no significant differences between each of the groups on any of the outcome measures at pre-treatment (p's 40.05). The mixed-models analyses examining the YBOCS revealed a significant effect for Time (F(2, 34) ¼ 63.62, p ¼ o0.001) and a significant Time by Group interaction, (F(3, 43) ¼19.34, p ¼ o0.001). There was no significant effect for Group (F(2, 48) ¼2.64, p¼ 0.82). Pairwise comparisons revealed that both the active treatment groups differed from control at post-treatment (bCBT: p¼ o0.001; iCBT: p¼ o0.001). There were no significant differences between the bCBT or iCBT groups at post-treatment (p ¼0.62) or 3-month follow-up (p ¼0.48). From pre- to posttreatment there was a 39% reduction on the YBOCS total score for the bCBT group and a 47% reduction in the iCBT group. From pre-treatment to 3-month follow-up the percentage reduction in symptoms as measured by the YBOCS was 39% and 35% for the bCBT and iCBT groups, respectively.

Table 2 Estimated marginal means, standard deviations and effect sizes (Cohen's d) for each group. Measure and Group

Mean (SD)

Effect sizes (95% CI)

Follow-up


Pretreatment

Posttreatment

Within group

bCBT vs. iCBT

vs. Control

Mean (SD)

Within group

bCBT vs. iCBT

RCT YBOCS bCBT (n¼20) iCBT (n¼ 15) Waitlist control group (n¼17)

21.80 (5.10) 23.53 (5.07) 21.06 (5.11)

13.27 (5.23) 12.38 (5.27) 20.49 (5.07)

1.65 (0.90–2.33) 2.16 (1.21–2.99) 0.11 ( 0.56–0.78)

0.17 ( 0.50–0.84) – –

1.40 (0.65–2.09) 1.57 (0.74–2.32) –

13.32 (7.74) 15.21 (7.71) –

1.29 (0.59–1.95) 1.28 (0.46–2.02) –

0.24 ( 0.43–0.91) – –

DOCS bCBT (n¼20) iCBT (n¼ 15) Waitlist control group (n¼17)

12.50 (3.49) 12.07 (3.49) 11.94 (3.50)

8.05 (4.25) 7.93 (4.38) 10.66 (4.04)

1.14 (0.45–1.79) 1.05 (0.26–1.78) 0.34 ( 0.35–1.01)

0.03 ( 0.64–0.70) – –

0.63 ( 0.05–1.28) 0.65 ( 0.08-1.34) –

8.12 (4.07) 7.49 (4.14) –

1.16 (0.46-1.80) 1.20 (0.39–1.94) –

0.15 ( 0.52–0.82) – –

PHQ-9 bCBT (n¼20) iCBT (n¼ 15) Waitlist control group (n¼17)

12.15 (5.99) 10.00 (6.00) 11.06 (6.02)

8.43 (6.31) 6.63 (6.39) 10.04 (5.85)

0.60 ( 0.04–1.23) 0.54 ( 0.20–1.26) 0.17 ( 0.51–0.84)

0.28 ( 0.40–0.95) – –

0.26 ( 0.39-0.91) 0.56 ( 0.16–1.25) –

8.79 (7.69) 6.51 (7.78) –

0.49 ( 0.15-1.11) 0.50 ( 0.24–1.22) –

0.30 ( 0.38–0.96) – –

GAD-7 bCBT (n¼20) iCBT (n¼ 15) Waitlist control group (n¼17)

12.10 (5.63) 10.13 (5.62) 12.00 (5.61)

6.99 (5.55) 5.77 (5.62) 11.56 (5.20)

0.91 (0.25–1.55) 0.78 (0.01–1.50) 0.08 ( 0.59–0.75)

0.22 ( 0.46–0.88) – –

0.85 (0.16–1.50) 1.07 (0.31–1.79) –

7.80 (7.42) 6.62 (7.47) –

0.65 (0.00–1.28) 0.53 ( 0.21–1.24) –

0.16 ( 0.52–0.82) – –

– – – –

– – – –

12.10 (4.92) 6.09 (4.25) 8.57 (5.94) 8.38 (6.76)

1.50 (0.66–2.27) 1.19 (0.43–1.88) 0.13 ( 0.55–0.80) 0.43 ( 0.26–1.10)

– – – –

iCBT with reduced therapist contact (Control group in treatment) YBOCS (n¼15) 19.87 (5.42) 13.24 (6.43) 1.11 (0.32–1.85) DOCS (n¼17) 10.82 (3.71) 6.46 (4.00) 1.13 (0.38-1.83) PHQ-9 (n ¼17) 9.35 (6.06) 7.39 (6.39) 0.31 ( 0.37–0.98) GAD-7 (n¼17) 11.12 (6.06) 7.42 (6.06) 0.61 ( 0.09–1.28)

Note—YBOCS: Yale Brown Obsessive Compulsive Scale, DOCS: Dimensional Obsessive Compulsive Scale, PHQ-9: Patient Health Questionnaire (9 item), GAD-7: Generalized Anxiety Disorder Scale (7-item), effect sizes (Cohen's d) were calculated based on pooled standard deviations, CI: confidence intervals.

380

Table 3 Means, standard deviations and effect sizes (Cohen's d) for each group (Completer analysis). n

Pre-treatment

Mean (SD)


Mean (SD)


n

Post-treatment

Within group

bCBT vs. iCBT

vs. Control

n

Follow-up

Within group

bCBT vs. iCBT

YBOCS bCBT iCBT Waitlist control group

20 15 17

21.80 (5.18) 23.53 (4.91) 21.06 (5.61)

15 11 14

13.80 (5.78) 11.18 (2.96) 20.50 (5.26)

1.47 (0.69–2.19) 2.93 (1.75–3.94) 0.10 ( 0.61–0.81)

0.54 ( 0.26–1.32) – –

1.21 (0.39–1.97) 2.11 (1.07-3.02) –

13 10 –

15.23 (7.19) 13.10 (5.65) –

1.05 (0.32–1.81) 2.00 (0.97–2.00) –

0.32 ( 0.52–1.14) – –

DOCS bCBT iCBT Waitlist control group

20 15 17

12.40 (4.19) 12.07 (3.03) 11.88 (3.20)

15 10 16

8.23 (3.13) 6.70 (4.22) 10.25 (4.45)

1.10 (0.36–1.79) 1.52 (0.57 2.36) 0.42 ( 0.28–1.10)

0.43 ( 0.40–1.22) – –

0.52 ( 0.21–1.22) 0.81 ( 0.03–1.61) –

14 10 –

8.71 (3.75) 7.15 (3.32) –

0.92 (0.16–1.63) 1.56 (0.61–2.42) –

0.44 ( 0.40–1.24) – –

PHQ-9 bCBT iCBT Waitlist control group

20 15 17

12.15 (5.69) 10.00 (6.20) 11.06 (6.72)

15 10 16

8.13 (5.88) 5.20 (6.07) 9.81 (6.01)

0.70 ( 0.01–1.37) 0.78 ( 0.07–1.58) 0.20 ( 0.49–0.88)

0.49 ( 0.34–1.29) – –

0.28 ( 0.43–0.98) 0.76 (-0.08-1.56) –

14 10 –

8.79 (7.63) 5.80 (7.10) –

0.52 ( 0.21–1.21) 0.64 ( 0.20–1.44 –

0.40 ( 0.43–1.21) – –

GAD-7 bCBT iCBT Waitlist control group

20 15 17

12.10 (5.67) 10.13 (5.97) 12.00 (5.76)

15 10 16

6.67 (4.22) 5.40 (5.50) 11.56 (6.19)

1.06 (0.33–1.75) 0.82 ( 0.04–1.62) 0.07 ( 0.62–0.75)

0.27 ( 0.55–1.06) – –

0.85 (0.09–1.56) 0.96 (0.10–1.76) –

14 10 –

7.71 (6.68) 5.90 (5.74) –

0.72 (0.00–1.41) 0.72 ( 0.13–1.52) –

0.29 0.54–1.09) – –

1.11 (0.29–1.88) 1.08 (0.31–1.79) 0.36 ( 0.35-1.05) 0.61 ( 0.11–1.30)

– – – –

– – – –

11 14 14 14

11.45 (5.18) 5.96 (4.40) 8.50 (5.80) 8.50 (6.88)

1.56 (0.63–2.39) 1.19 (0.39–1.92) 0.14 ( 0.57–0.85) 0.40 (0.32–1.10)

– – – –

iCBT with reduced therapist contact (Control group YBOCS 15 19.87 (5.63) DOCS 17 10.82 (3.81) PHQ9 17 9.35 (6.23) GAD7 17 11.12 (6.26)

in treatment) 13 13.00 (6.92) 15 6.50 (4.20) 15 7.13 (6.28) 15 7.33 (6.16)

Note—YBOCS: Yale Brown Obsessive Compulsive Scale, DOCS: Dimensional Obsessive Compulsive Scale, PHQ-9: Patient Health Questionnaire (9 item), GAD-7: Generalized Anxiety Disorder Scale (7-item), Effect sizes (Cohen's d) were calculated based on pooled standard deviations, CI: Confidence intervals.


Measure and group


The analyses examining the DOCS scores revealed a significant effect for Time (F(2, 34) ¼44.42, p¼ o0.001) and a significant Time by Group interaction, (F(3, 41) ¼4.12, p ¼ 0.01). There was no significant effect for Group (F(2, 47) ¼ 0.65, p ¼0.53) and pairwise comparisons revealed no significant differences from control at post-treatment (bCBT: p ¼ 0.06; iCBT: p¼ 0.08) for either active treatment group. There were no significant differences between the groups at post-treatment (p ¼0.94) or follow-up (p ¼0.66). Mann Whitney U-tests were also conducted to ascertain whether there were differences in outcome based on the DOCS subscales. Using the Bonferroni correction (α¼0.01) there was no significant difference in outcome (ps ¼0.04–0.94); however, there was a trend for those with the responsibility subtype to outperform those with other subtypes (U¼86.0, z ¼ 2.06, p¼ 0.04). On the GAD-7 there was a significant effect for Time (F(2, 44) ¼13.93, p ¼ o0.001) and a significant Time by Group interaction, (F(3, 40) ¼ 3.82, p¼ 0.02). There was no significant effect for Group (F(2, 51) ¼2.27, p¼ 0.11). Pairwise comparisons revealed that both the active treatment groups differed from control at posttreatment (bCBT: p ¼ o 0.01; iCBT: p ¼0.01). There were no significant differences between the groups at post-treatment (p ¼0.52) or 3-month follow-up (p ¼0.65). Finally, analyses examining the PHQ-9 scores revealed a significant effect for Time (F(2, 36) ¼6.27, p¼ o0.01), but not Group (F(2, 52) ¼ 0.77, p¼0.47) or Time by Group interaction, (F(3, 35) ¼ 0.95, p¼ 0.43). Pairwise comparisons revealed that neither of the active treatment groups differed from control at post-treatment (bCBT: p¼0.12; iCBT: p¼0.43). There were no significant differences between the groups at post-treatment (p¼ 0.41) or 3-month follow-up (p¼0.39). 3.1.3. Effect sizes The within- and between-group effect sizes for all outcome measures are described in Tables 2 and 3. Large within-group effect sizes were found for the total and complete samples in both bCBT and iCBT treatment groups on the YBOCS, DOCS and GAD-7. A moderate effect size was found for the PHQ-9. For the Control Group, all effect sizes were nil to small. Using the total sample, effect sizes between the two active treatment groups on the YBOCS were 0.17 at post-treatment and 0.24 at follow-up. Between-group effect sizes for the two active treatment groups on the YBOCS were larger in the completer sample than the total sample, 0.54 at post-treatment and 0.32 at follow-up. 3.1.4. Clinical significance Using an ITT design 8/20 (40%; 95% CI ¼19%–61%) participants in the bCBT Group, 7/15 (47%; 95% CI ¼21%–72%) in the iCBT Group, and 0/14 (0%) in the Control Group met the criteria for clinically significant change at post-treatment. At 3-month followup 4/20 (20%; 95% CI ¼2%–38%) of the bCBT Group and 4/15 (27%; 95% CI ¼4%–49%) in the iCBT Group met criteria for clinically significant change. There were no significant differences between the groups in terms of level of significant change at post treatment χ2 (1, N¼ 35)¼0.156, p ¼0.69 or follow-up χ2 (1, N ¼35)¼0.22, p ¼0.64. 3.1.5. Treatment satisfaction Of those who completed post-treatment questionnaires, 6/15 (40%) of participants in the bCBT Group reported feeling extremely satisfied, 5/15 (33%) were satisfied, 3/15 (20%) were neutral, 1/15 (7%) was dissatisfied and 0/15 (0%) were extremely dissatisfied with the Course. In the iCBT Group 1/10 (10%) were extremely satisfied, 6/10 (60%) were satisfied, 3/10 (30%) were neutral, 0/10 (0%) were dissatisfied or extremely dissatisfied. There was no significant difference between groups in level of satisfaction (t22 ¼ 0.50, p ¼0.62).

381

3.1.6. Time spent/contact events per participant The clinician made a total of 517 telephone calls to participants in the treatment groups, with no difference in the number of calls made to participants in the bCBT Group (M ¼14.40, SD ¼3.58) compared to those in the iCBT Group (M¼15.05, SD ¼3.93) (t33 ¼ 0.503, p¼ 0.62). The mean total therapist time per participant was 102.73 min (SD ¼50.52 min) in the bCBT Group and 88.63 min (SD ¼46.41 min) in the iCBT Group, which was not statistically different (t24 ¼ 0.73, p ¼0.47). 3.2. iCBT with reduced therapist contact 3.2.1. Adherence and attrition For the Control Group pre-treatment YBOCS results were only available for 15/17 (88%) of participants. Post-treatment questionnaires were collected from 15/17 (88%) participants and posttreatment interviews were conducted with 13/15 (86%) participants. Three-month follow-up questionnaires were collected from 14/17 (82%) participants and 3-month follow-up interviews were collected from 11/15 (73%) participants. Ten out of seventeen (59%) of Control Group participants completed the 5 Lessons within the 8 weeks of the Course. The average number of completed Lessons was 4.00 (SD ¼ 1.37).

3.2.2. Outcome measures The mixed-models analyses examining the YBOCS revealed a significant effect for Time (F(2, 14) ¼31.36, p ¼ o 0.001). Pairwise comparisons revealed a significant difference from pre- to posttreatment (p ¼ o 0.001) and pre-treatment to 3-month follow-up (p ¼ o0.001). There were no significant differences from posttreatment to follow-up (p¼ 0.31). The percentage reduction on the YBOCS from pre- to post-treatment was 33%, and from pretreatment to 3-month follow-up was 39%. A similar pattern of results emerged for the DOCS with mixedmodels analyses showing a significant effect for Time (F(2, 15) ¼ 27.61, p ¼ o 0.001) and pairwise comparisons demonstrating a significant difference from pre- to post-treatment (p ¼ o0.001) and pre-treatment to 3-month follow-up (p ¼ o0.001) and no significant differences from post-treatment to follow-up (p ¼ 0.56). Using the Bonferroni correction there were no significant differences in outcome based on the DOCS subscales for the reduced contact group (ps ¼0.02–0.94). However, there was a trend for those with the unacceptable thoughts subtype on the DOCS to outperform those in other subtypes (U¼ 7.50, z ¼ 2.38, p ¼0.02). On the GAD-7 a significant effect for time was also demonstrated (F(2, 15) ¼5.83, p¼ 0.01). Pairwise comparisons revealed a significant reduction in scores from pre-treatment to posttreatment (p¼ o0.01), but no significant difference from pretreatment to follow-up (p ¼0.06). On the PHQ-9 there were no significant effects for time (F(2, 15) ¼2.91, p ¼0.09).

3.2.3. Effect sizes Large pre- to post-treatment within-group effect sizes were found on the YBOCS and DOCS. A medium effect was found on the GAD-7 and a small effect was found for the PHQ-9. From pretreatment to follow-up effect sizes remained large on the YBOCS and DOCS. The effect size on the PHQ-9 and GAD-7 reduced to the small range.

3.2.4. Clinical significance The percentage of Control Group participants meeting criteria for clinically significant change was 33% (5/15; 95% CI ¼11%–61%) at both post-treatment and 3-month follow-up.

382


3.2.5. Treatment satisfaction For the Control Group, 3/14 participants (21%) were extremely satisfied, 8/14 (57%) were satisfied, 2/14 (14%) were neutral/ dissatisfied and 1/14 (7%) was extremely dissatisfied.

3.2.6. Time spent/contact events per participant The clinician made a mean of 7.71 telephone calls to each Control Group participant (SD ¼1.90/participant) during their treatment. Calls were made once per week and the total mean therapist time per participant was 57.06 min (SD ¼ 47.70 min).

4. Discussion This study had two main aims: first, to examine the relative benefits and acceptability of two forms of guided remote treatment compared to a waitlist control group and second to examine the effect of reduced therapist contact for control group participants when receiving active treatment. Our first hypothesis was that participants in both treatment groups would demonstrate reduced symptoms of OCD and find the program acceptable. The results indicated that participants in both treatment groups improved from pre-post treatment (within-group effect size of 1.65 in the bCBT Group and 2.16 in the iCBT group on the YBOCS). These results are consistent with those reported by meta-analyses of internet-administered psychological therapies for anxiety and depression more generally (Andersson & Cuijpers, 2009; Andrews, Cuijpers, Craske, McEvoy, & Titov, 2010; Spek et al., 2007), and other iCBT research for OCD (Andersson et al., 2011, 2012; Wootton et al., 2011). The results also compare favorably with the face-to-face treatment literature on OCD. For example, when an ITT design has been employed, effect sizes in face-to-face studies generally range from 0.92 (Jaurrieta et al., 2008) to 2.23 (Anand, Sudhir, Math, Thennarasu, & Janardhan Reddy, 2011). The results also indicated that outcomes did not significantly differ across the DOCS subtypes, suggesting the program is appropriate for all individuals with OCD, however this analysis requires replication in a larger sample. Additionally, 40% of participants in the guided bCBT group and 47% of participants in the guided iCBT group met the conservative criteria for clinically significant reduction in symptoms at posttreatment. Furthermore, there were no significant differences in outcomes between the two treatment modalities. These findings are consistent with recent evidence from a study of insomnia treatment which found that internet and bibliotherapy administered interventions resulted in equivalent outcomes (Lancee et al., 2012). In terms of acceptability of the remote treatments the results indicated that overall the intervention was acceptable to participants in both groups. Whilst the proportion of participants meeting clinically significant reduction in symptoms in the current study is promising, it is difficult to compare these outcomes with other studies due to the presence of divergent definitions of clinically significant change. A more consistent and commonly used way to contrast studies in the OCD literature is to compare the percentage reduction in symptoms on the YBOCS. In the current study the percentage reduction on the YBOCS (39% and 47% in the bCBT and iCBT group, respectively) was comparable those reported in faceto-face studies. For instance, those studies that have used an intention to treat design have demonstrated a reduction in symptoms on the YBOCS ranging from 29% (Jaurrieta et al., 2008) to 58% (Freeston et al., 1997). However those studies that have reported on outcomes of completers only have seen a percentage reduction in symptoms as high as 72% (Storch et al., 2007).

The second hypothesis that participants in the Control Group who received once weekly, rather than twice weekly, clinician contact would also obtain significant benefits was also supported. Results from the Control Group after they received treatment revealed a large pre-post within-group effect size on the YBOCS (Cohen's d¼ 1.11) and DOCS (Cohen's d¼ 1.13). The proportion of participants who met criteria for clinically significant change was 33%, a similar level to those achieved by the initial bCBT and iCBT treatments. Despite the reduced contact received by the Control Group relatively high levels of acceptability of the Course were reported. These results indicate that good outcomes may still be obtained when participants are contacted once a week and that this frequency of clinician contact is equally as acceptable to participants as twice-weekly contact. It is possible, however, that not all participants require or desire the same amount of clinician support and this may be particularly relevant in OCD where stigma is a considerable barrier for individuals entering treatment (Baer & Minichiello, 2008; Belloch et al., 2009; Goodwin et al., 2002; Marques et al., 2010). Similarly, support may only be required at critical times in the program, for example, when developing exposure hierarchies, rather than at weekly intervals. However, these hypotheses require further investigation using randomized controlled designs. The Control Group also received weekly, automated emails during the follow-up period, the aim of which were to facilitate the continued practice of skills taught in the Course. Outcomes from the Control Group were more stable from post-treatment to 3-month follow-up than they were for either of the active treatments in the RCT, indicating that automated email prompts may help to prevent relapse and maintain treatment gains in remote treatment interventions. These findings may also potentially extend to face-to-face treatment, but this requires further investigation, again using randomized controlled trials. One limitation of this study was the lack of independent evaluation when administering the YBOCS. However, data from self-report questionnaires such as the DOCS, which indicated improvement following treatment, provided converging evidence that the results from the YBOCS were valid. It is important to note however that the mean pre-treatment YBOCS scores in the current study (bCBT, 21.80; iCBT, 23.53, Control 21.06) were lower than previous studies of face-to-face treatments, where the pretreatment YBOCS score has ranged from 23.95 to 30.50 (Nakatani et al., 2005; Tolin et al., 2007; Van Oppen et al., 2010; Whittal, Thordarson, & McLean, 2005; Wilhelm et al., 2008). Unfortunately, it is unclear from the current research whether people with more elevated YBOCS scores or OCD symptoms would benefit from remote iCBT or bCBT, especially when provided with minimal therapist support. This is, however, an important issue and further research with larger sample sizes is needed to better understand who benefits and is appropriate for iCBT and bCBT treatments. A second limitation is the small sample size used in the study. While a large number of applications were received, fewer were completed compared to trials of internet treatments for anxiety disorders that have used similar recruitment strategies (Titov, Andrews, Choi, Schwencke, & Johnston, 2009; Titov et al., 2010). Our clinical impression is that applicants with OCD may experience greater stigma than applicants with other anxiety disorders, and that this may have contributed to the low completion rates of applications. Finally, whilst the number of individuals who met criteria for clinically significant change decreased from posttreatment to follow-up in both active treatments groups, it was not possible to examine whether these changes were statistically significant due to the small sample size. This deserves attention in future studies. Notwithstanding these issues, future research should aim to replicate the present design with a larger sample


in order to conduct more sensitive and robust comparisons of the treatment conditions, using superiority or non-inferiority designs (Christensen, 2007; Durkalski, Silbergleit, & Lowenstein, 2011). To our knowledge this is the first study comparing two forms of guided remote treatment for OCD. The results from this study extend the previous findings reported in the literature by providing preliminary evidence for the efficacy of two common remote treatment approaches: iCBT and bCBT. Significant clinical outcomes were also obtained with reduced therapist contact, although effect sizes are smaller, indicating a possible doseresponse relationship in OCD, as indicated by previous research (Palmqvist et al., 2007). These results also indicate that weekly automatic reminders in the post-treatment period may help to maintain treatment gains and prevent relapse in remote treatment. In conclusion, these results indicate the potential of remote treatments in improving access to evidence-based treatments for people with OCD.

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