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Accepted Manuscript Title: Cognitive Behavior Therapy versus Interpersonal Psychotherapy for social anxiety disorder delivered via smartphone and computer: a randomized controlled trial Author: Jesper Dag¨ o Robert Persson Asplund Helene Andersson Bsenko Sofia Hjerling Anna Holmberg Susanne Westh Louise ¨ Oberg Brj´ ann Lj ´ otsson Per Carlbring Tomas Furmark Gerhard Andersson PII: S0887-6185(14)00031-0 DOI: http://dx.doi.org/doi:10.1016/j.janxdis.2014.02.003 Reference: ANXDIS 1584 To appear in: Journal of Anxiety Disorders Received date: 30-8-2013 Revised date: 26-1-2014 Accepted date: 18-2-2014 Please cite this article as: Dag¨ o, J., Asplund, R. P., Bsenko, H. A., Hjerling, S., Holmberg, A., Westh, S., ¨ Oberg, L., Lj´ otsson, B., Carlbring, P., Furmark, T., & Andersson, G.,Cognitive Behavior Therapy versus Interpersonal Psychotherapy for social anxiety disorder delivered via smartphone and computer: a randomized controlled trial, Journal of Anxiety Disorders (2014), http://dx.doi.org/10.1016/j.janxdis.2014.02.003 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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Cognitive behavior therapy versus interpersonal psychotherapy for social anxiety disorder delivered via smartphone and computer: A randomized controlled trial

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Page 1: Cognitive behavior therapy versus interpersonal psychotherapy for social anxiety disorder delivered via smartphone and computer: A randomized controlled trial

Accepted Manuscript

Title: Cognitive Behavior Therapy versus InterpersonalPsychotherapy for social anxiety disorder delivered viasmartphone and computer: a randomized controlled trial

Author: Jesper Dagoo Robert Persson Asplund HeleneAndersson Bsenko Sofia Hjerling Anna Holmberg SusanneWesth Louise Oberg Brjann Ljotsson Per Carlbring TomasFurmark Gerhard Andersson

PII: S0887-6185(14)00031-0DOI: http://dx.doi.org/doi:10.1016/j.janxdis.2014.02.003Reference: ANXDIS 1584

To appear in: Journal of Anxiety Disorders

Received date: 30-8-2013Revised date: 26-1-2014Accepted date: 18-2-2014

Please cite this article as: Dagoo, J., Asplund, R. P., Bsenko, H. A., Hjerling,S., Holmberg, A., Westh, S., Oberg, L., Ljotsson, B., Carlbring, P., Furmark,T., & Andersson, G.,Cognitive Behavior Therapy versus InterpersonalPsychotherapy for social anxiety disorder delivered via smartphone andcomputer: a randomized controlled trial, Journal of Anxiety Disorders (2014),http://dx.doi.org/10.1016/j.janxdis.2014.02.003

This is a PDF file of an unedited manuscript that has been accepted for publication.As a service to our customers we are providing this early version of the manuscript.The manuscript will undergo copyediting, typesetting, and review of the resulting proofbefore it is published in its final form. Please note that during the production processerrors may be discovered which could affect the content, and all legal disclaimers thatapply to the journal pertain.

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Cognitive Behavior Therapy versus Interpersonal Psychotherapy for social anxiety

disorder delivered via smartphone and computer: a randomized controlled trial

Jesper Dagöö1, Robert Persson Asplund1, Helene Andersson Bsenko2, Sofia Hjerling3, Anna

Holmberg4, Susanne Westh4, Louise Öberg5, Brjánn Ljótsson6, Per Carlbring7, Tomas

Furmark3, Gerhard Andersson1,8 *

1 Department of Behavioural Sciences and Learning, Linköping University, Linköping,

Sweden.

2 Department of Psychology, Umeå University, Umeå, Sweden.

3 Department of Psychology, Uppsala University, Uppsala, Sweden.

4 Department of Social Sciences, Division of Psychology, Mid Sweden University, Östersund,

Sweden.

5 Department of Psychology, Lund University, Lund, Sweden.

6 Department of Clinical Neuroscience, Division of Psychology, Karolinska Institute,

Stockholm, Sweden.

7 Department of Psychology, Stockholm University, Stockholm, Sweden.

8 Department of Clinical Neuroscience, Section of Psychiatry, Karolinska Institute,

Stockholm, Sweden.

* Corresponding author. Tel.: +46-(0)13-28 58 40. E-mail address: [email protected]

(G. Andersson).

Abstract

In this study, a previously evaluated guided Internet-based cognitive behavior therapy for

social anxiety disorder (SAD) was adapted for mobile phone administration (mCBT). The

treatment was compared with a guided self-help treatment based on interpersonal

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psychotherapy (mIPT). The treatment platform could be accessed through smartphones,

tablet computers, and standard computers. A total of 52 participants were diagnosed with

SAD and randomized to either mCBT (n=27) or mIPT (n=25). Measures were collected at

pre-treatment, during the treatment, post-treatment and 3 month follow-up. On the primary

outcome measure, the Liebowitz Social Anxiety Scale – self rated, both groups showed

statistically significant improvements. However, mCBT performed significantly better than

mIPT (between group Cohen’s d =0.64 in favor of mCBT). A larger proportion of the

mCBT group was classified as responders at post-treatment (55.6 % versus 8.0 % in the

mIPT group). We conclude that CBT for SAD can be delivered using modern information

technology. IPT delivered as a guided self-help treatment may be less effective in this

format.

Keywords: Cognitive behavior therapy; Interpersonal psychotherapy; Social

anxiety disorder; Smartphone; Internet

1. Introduction

Social anxiety disorder (SAD) is characterized by a fear of being scrutinized and negatively

evaluated by others and is associated with a substantial impairment in quality of life

(American Psychiatric Association, 2000). It is a costly disorder for society at large in terms

of direct costs in the form of pharmacotherapy and psychotherapy and indirect costs in terms

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of productivity loss (Acarturk, Cuijpers, van Straten, & de Graaf, 2009; Smit, et al., 2006).

SAD is a highly prevalent condition, although prevalence estimates differ between countries

(Furmark, 2002). Several treatments have been investigated for SAD, and the two major

evidence-based treatments are cognitive behavior therapy (CBT) (Ponniah & Hollon, 2008)

and pharmacotherapy (Stein, Ipser, & Balkom, 2004).

Since the late 1990’s guided Internet-delivered cognitive behavior therapy

(ICBT) has been developed and evaluated (Andersson, 2009), and has been found to have

large effect sizes for a range of psychiatric and health-related problems such as depression,

anxiety disorders, severe health anxiety, irritable bowel syndrome, eating disorders, and

pathological gambling (Hedman, Ljótsson, & Lindefors, 2012). ICBT for SAD has been

evaluated in several studies by independent research groups with studies from Sweden

(Andersson, et al., 2006; Carlbring, et al., 2007), Australia (Titov, Andrews, Schwencke,

Drobny, & Einstein, 2008; Titov, et al., 2010), Switzerland (Berger, et al., 2011; Berger,

Hohl, & Caspar, 2009), and Spain (Botella, et al., 2010). In addition, the research has been

summarized in reviews (Andersson, Carlbring, & Furmark, in press; Tulbure, 2011). Guided

ICBT has also been found to be cost-effective (Hedman, Andersson, Ljótsson, Andersson,

Rück, & Lindefors, 2011), and to be as effective as group-based CBT (Hedman, Andersson,

Ljótsson, Andersson, Rück, Mörtberg, et al., 2011). The common elements of ICBT for SAD

have been a structured self-help CBT program combined with therapist guidance from an

online therapist (Andersson, 2009). The ICBT treatment manual that has been used in the

Swedish studies on ICBT for SAD (Furmark, Holmström, Sparthan, Carlbring, &

Andersson, 2013) is inspired by Clark and Well’s cognitive model of SAD (Clark & Wells,

1995).

Interpersonal psychotherapy (IPT) was originally developed to provide an

effective short-term treatment for depression (Klerman, Dimascio, Weissman, Prusoff, &

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Paykel, 1974), and is recommended by numerous practice guidelines as a treatment of

choice for unipolar depressive disorder (Cuijpers, et al., 2011). IPT for SAD has been

studied less often, but has been compared with CBT in previous studies performed in

clinical, residential, and academic outpatient treatment settings (Borge, et al., 2008; Lipsitz,

Markowitz, Cherry, & Fyer, 1999; Stangier, Schramm, Heidenreich, Berger, & Clark, 2011).

As IPT focuses on how problems in interpersonal relations predispose, precipitate and

perpetuate a patient’s distress (Weissman, Markowitz, & Klerman, 2000) it is plausible to

assume that it can be helpful for persons with SAD. Several theories have been considered

influential in the development of IPT including attachment theory (Weissman, et al., 2000).

Lipsitz and Markowitz developed an IPT manual for SAD in the 1990’s in which they

incorporated content and techniques relevant for this disorder (Lipsitz, et al., 1999). They

argued that IPT had an intuitive appeal as a treatment for SAD because of the prominent

interpersonal features of the condition (Lipsitz, et al., 1999). The manual was tested in a 14

week open trial (Lipsitz, et al., 1999). Seven out of nine participants were independently

rated as much or very much improved on overall social phobia symptoms (Lipsitz, et al.,

1999). IPT was compared to CBT for SAD in a larger randomized trial conducted in a

residential setting (n=80) (Borge, et al., 2008). Effect sizes for the IPT group were medium

to large and no significant differences were found between the groups (Borge, et al., 2008).

More recently, Stangier and coworkers compared the efficacy of CBT (n=38), IPT (n=38),

and a waiting-list control condition (n=41) in two academic outpatient treatment sites. In this

randomized controlled trial both treatments were superior to a waiting-list control condition.

However, CBT performed significantly better than IPT (Stangier, et al., 2011).

Smartphone technology has the potential to make psychological and behavioral

health interventions more accessible, efficient, and interactive for patients (Boschen &

Casey, 2008). The smartphone is in essence a combined telephone and portable computer

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connected to the Internet and is increasingly used as a way to access information on the

internet (Klasnja & Pratt, 2012). Moreover, smartphone users tend to carry their phones with

them everywhere (Klasnja & Pratt, 2012), and some features of a smartphone might prove

useful and add new possibilities in psychological treatments. For example, the small

smartphone programs or applications commonly referred to as “apps”, might be used as a

platform for in vivo exposure exercises, self-assessments, monitoring of progress in real

time, visual feedback, and evaluation of treatment outcome (Ly, Dahl, Carlbring, &

Andersson, 2012). In addition, psychoeducation can be presented via video and audio

material, homework can be scheduled in the built-in calendar, and the camera can be used to

record exposure sessions (Luxton, McCann, Bush, Mishkind, & Reger, 2011). However,

there are few evidence-based behavioral and psychological smartphone applications and

there is a need for controlled studies (Luxton, et al., 2011).

In the present study, we adapted our previously tested guided Internet

treatment for SAD to a mobile format (mCBT). mCBT can be seen as an expansion of the

reach of our Internet treatments for SAD, since the principal contents were preserved even if

the format was modified to better fit the screen size and interface of a smartphone. With the

exception of applied relaxation (Furmark, et al., 2009), guided ICBT has not been compared

to an active psychological treatment. We developed a guided self-help treatment based on

IPT, which we regarded as a credible control condition. This treatment shared many

technical features of the mCBT program (e.g., administration over the Internet and a mainly

text-based format), but was distinctly different in terms of contents. The reason for

comparing mCBT against mIPT was that we wanted a control condition that was principally

different from CBT while having been tested in previous controlled trials. We expected that

the mCBT condition would lead to improvements in symptoms of SAD in line with previous

ICBT studies. Based on the low number of studies of regular face-to-face IPT for SAD and

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the absence of any web-based studies of IPT for SAD, we did not formulate any hypothesis

regarding the effects of mIPT. The novel aspects of this controlled trial are the

administration format and that to our knowledge neither CBT nor IPT has been delivered via

smartphone previously.

2. Method

2.1 Trial design

This was a randomized controlled trial within the context of a between groups repeated

measures design.

2.2 Sample and recruitment

2.2.1 Inclusion criteria

To be eligible for inclusion potential participants had to meet the following criteria; (a)

fulfilling the DSM-IV criteria for social anxiety disorder as assessed using the Structured

Clinical Interview for DSM-IV axis I disorders (SCID-I) (First, Gibbon, Spitzer, &

Williams, 1997), (b) being 18 years old or older, (c) having SAD as primary diagnosis (d)

scoring <25 on the Montgomery Åsberg Depression Rating Scale-self report (MADRS-S)

(Svanborg & Åsberg, 1994), (e) having a score of less than 4 of 6 on the suicide ideation

item 9 on MADRS-S, (f) no ongoing alcohol abuse or dependence as measured by the self-

report questionnaire Alcohol Use Disorder Identification Test (AUDIT) (Bergman &

Källmen, 2002), (g) no history of psychosis or bipolar disorder, (h) not meeting criteria for

any personality disorders within clusters A or B, (i) no ongoing other form of psychological

treatment, (j) no history of CBT the preceding four years, (k) if on medication have constant

dosage of any prescribed psychotropic medication three months prior to treatment, (l) not

having a psychiatric problem where a treatment provided by psychiatric outpatient care

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would be more appropriate, (m) having access to smartphone and computer with Internet

connection, and (n) being able to read and write in Swedish.

2.2.2 Recruitment

Recruitment for the study took place during 2011 and 2012. Participants were recruited

nation-wide via the project’s home page and advertisement in Swedish press, Google

Adwords, and Facebook. Information about the study was presented on the project’s

homepage. After application, potential participants completed the following online electronic

screening questionnaires; the Liebowitz Social Anxiety Scale – self-report (LSAS-SR)

(Baker, Heinrichs, Kim, & Hofmann, 2002), the Social Interaction Anxiety Scale (SIAS)

(Mattick & Clarke, 1998), the Social Phobia Scale (SPS) (Mattick & Clarke, 1998), the Beck

Anxiety Inventory (BAI) (Beck, Epstein, Brown, & Steer, 1988), the MADRS-S (Svanborg &

Åsberg, 1994), the Quality Of Life Inventory (QOLI) (Frisch, Cornell, Villanueva, &

Retzlaff, 1992), and the AUDIT (Bergman & Källmen, 2002; Selin, 2003). Applicants

fulfilling the initial screening criteria were invited to a diagnostic interview via telephone.

2.2.3 Diagnostic assessment and participants

Diagnoses were established using the Mini International Neuropsychiatric Interview

(Sheehan, et al., 1998), and the SAD section of the research version of the semi-structured

interview the Structured Clinical Interview for DSM-IV (SCID-I-RV; (First, Spitzer, Gibbon

M, & Williams, 2002). The SCID-I-RV was used because it can provide more detailed

information about SAD and has high inter-rater reliability (Zanarini & Frankenburg, 2001).

An evaluation of in-person and telephone interviews for the assessment of SAD patients via

the SCID has indicated excellent agreement (Crippa, et al., 2008). The AUDIT was used to

assess potential alcohol dependence or abuse and solely used as a screening instrument. In a

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study of the psychometric properties of the Swedish version of the AUDIT, both the internal

and test-retest reliabilities were satisfactory (Selin, 2003). The diagnostic interviews were

conducted by a psychologist or by psychologist students supervised by licensed

psychologists.

In total, 235 applied to participate out of which 76 were invited to a diagnostic

interview. Following the interview, 52 participants were included in the trial (see Table 1 for

demographic description of the participants, Table 2 for medication data of the participants,

and Figure 1 for Flowchart participant flow). Of the 52 participants, 20 (38,5%) fulfilled the

criteria for social anxiety disorder in a specific form and 32 (61.5%) in a generalized form.

For comorbid diagnoses, 1 (1.9%) fulfilled the criteria for depression and 1 (1.9%) the

criteria for generalized anxiety disorder (GAD). Five potential participants were referred to a

psychologist with clinical experience from outpatient psychiatric care for further assessment

of differential diagnostic issues, prior experience of cognitive behavior therapy, suicide risk

and potential alcohol dependence or abuse.

2.3 Procedure

Once potential participants were included they were informed when they would get access to

the first treatment module, which could be accessed via smartphone, computer or tablet

computer. Each treatment lasted nine weeks. Participants had to send in feedback regarding

treatment and homework progression before a new module was activated. Each week the

participants were encouraged to log in via a computer to fill in an electronic version of the

LSAS-SR questionnaire. Therapists were instructed to set aside 15 minutes per week and

participant to deliver feedback on reflections, homework, and questions from participants.

Post-treatment measurements were collected via the web-based questionnaire system.

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Randomization was performed by an independent person within the research

team who had no contact with the participants and based upon a list of anonymous

participant identification numbers. Applicants were divided into two groups using a net-

based randomization tool, “Research Randomizer” (http://randomizer.org/form.htm). The

randomization process was conducted in two steps; first applicants were randomized in 1:1

proportion to each treatment group, and then they were randomized to four Internet

therapists who were last-year students at the 5-year Swedish psychology program. Because

of a duplication of a participant code the treatment randomization of participants was not

exactly in a 1:1 proportion. The study was approved by the regional ethics committee at

Linköping University, Sweden.

2.4 Treatments

2.4.1 Cognitive behavior therapy via mobile computer solutions (mCBT)

The mCBT manual used in this study was based on a previous guided self-help ICBT for

SAD developed by our research group (Andersson, et al., 2006). It is primarily a text-based

treatment, and exercises are given as homework between each module. Both of the ICBT

and mCBT manuals consist of nine weekly modules. The mCBT modules comprised one

introduction module, three modules focusing on cognitive interventions (challenging

automatic thoughts, behavioral experiments and a video feedback exercise), three modules

focusing primarily on exposure, one module focusing on social skills and one maintenance

module. The mCBT manual was shortened as we assumed that long texts would be difficult

to read on a smartphone. Entries of anxiety levels were made in an exposure module in

which anxiety levels pre, during and post exposure were presented graphically. Other forms

of homework were entered into electronic forms as well. The anxiety hierarchy and

idiosyncratic information that had been entered into the modules during the treatment (e.g.

previous exposure exercises and safety behaviors of the participant) were automatically

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presented throughout the treatment at relevant points and were included in the maintenance

plan of the participant.

2.4.2 Interpersonal psychotherapy via mobile computer solutions (mIPT)

The mIPT treatment was modeled to resemble the mCBT treatment in terms of format and

length. The manual, which was not based on any previous self-help manual, was inspired by

texts on interpersonal psychotherapy for depression (Klerman, Weissman, Rounsaville, &

Chevron, 1984; Weissman, Markowitz, & Klerman, 2007), and treatment descriptions in the

existing trials on IPT for SAD (Stangier, et al., 2011). Unlike other IPT treatments, with the

exception of one Internet study (Donker, et al., 2013), the IPT group participants in this

study worked with all four problem areas of an IPT treatment; grief, interpersonal disputes,

role transitions, and interpersonal sensitivity (Markowitz, et al., 2000). The first module

covered psychoeducation and a short presentation of interpersonal psychotherapy. Module 2

had a focus on attachment theory and interaction patterns and number 3 on social phobia in

an interpersonal context. Modules 4 and 5 depicted role transitions (participants were

encouraged to role play problematic situations with a friend), and module 6 interpersonal

disputes. Then module 7 covered the area of grief, module 8 social skills, and module 9 a

maintenance program. Between each weekly contact with the therapists participants were

encouraged to reflect upon their work and the material that had been presented in the

modules.

2.5 Material

The treatment material of both mIPT and mCBT was presented in text format. A video

greeting and presentation by the principal investigator (G.A.) introduced and ended both

programs. Registration forms and rating scales used in the program were converted into

electronic modules designed to suit the format of a website adapted for mobile devices, but

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these could also be accessed via computers and tablet computers in an interface adapted for

these platforms. The smartphone interface layout was essentially in black/white and the

combined layout for computers and computer tablets also included some colors.

In comparison to our previous ICBT programs for SAD, mCBT differs in the

aforementioned text mass reduction, layout differences (“book-like” vs. “smart phone web

app-like”), a development from paper-and-pencil entries to entries directly into the

smartphone/computer interface system, automatic presentation at relevant points throughout

the program of previously entered information, and a continual graphic presentation of the

anxiety level development during in-vivo exposure exercises. The last two of these were

designed to enable direct and possibly more reliable entries of anxiety levels in real time and

to provide monitoring of potential progress in real time through direct visual feedback.

Participants had to use an access code to log into the treatment platform in a secure manner.

2.6 Method of delivery

An Internet application, used in previous studies e.g., (Carlbring, et al., 2013), was used to

administer outcome measures at pre- and post-treatment. Weekly measurements with the

LSAS-SR were collected within the same Internet application. In a study of psychometric

properties of Internet administration of self-report measures commonly used in research on

SAD, paper-and-pencil and versions were found to possess equivalent psychometric

properties (Hedman, et al., 2010).

2.7 Outcome measures

2.7.1 Primary outcome measure

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The LSAS-SR was used as the primary outcome measure. The LSAS-SR measures the

degree of avoidance and fear in 24 social situations (13 performance and 11 interaction

situations). Fear and avoidance are rated separately for each situation on a scale from 0 (no

fear/never avoid) to 3 (severe fear/usually avoid). The clinician-administered version of the

LSAS has good psychometric properties (Heimberg, et al., 1999). In a comparison of the

psychometric properties of the self-report and clinician-administered formats of the LSAS

there was little difference between the two versions on any scale or subscale score (Fresco,

et al., 2001). They were both internally consistent and had essentially identical subscale

intercorrelations. The discriminant validity of the two forms of the LSAS was shown to be

strong (Fresco, et al., 2001).

2.7.2 Secondary outcome measures

The SIAS and SPS were used to assess social anxiety symptoms, the BAI was used to assess

general anxiety, the MADRS-S was used to assess depressive symptoms and the QOLI was

used to assess perceived quality of life. The SPS, SIAS, BAI, MADRS-S, and the QOLI

have all demonstrated good psychometric properties for online administration for patients

with SAD (Hedman, et al., 2010).

2.8 Statistical analysis

Statistical analyses were conducted using SPSS 21. For primary and secondary outcome

measures, intention-to-treat (ITT) analyses were performed based on data from all

randomized participants, which is a more conservative approach compared to only including

those who completed the treatment. The multiple imputation module in SPSS was used to

create 5 sets of missing data imputations. In a simulation study in which several

statistical approaches to data missing data were tested the use of multiple imputation was

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shown to improve the validity of the results when analyzing datasets

with missing observations (Blankers, Koeter, & Schippers, 2010). The effects of group on

primary and secondary outcome measures were analyzed in the imputed data sets using

analysis of covariance (ANCOVA), with pre-treatment values as covariate (Vickers &

Altman, 2001). Means, standard deviations, and standard errors of effect sizes were pooled

from the 5 imputations using “Rubin’s rules” (Rubin & Schenker, 1991), and the small

sample correction for pooled degrees of freedom (Barnard & Rubin, 1999). Paired samples t-

tests were used to evaluate improvement from pre- to post-treatment for within-group

calculations and for a comparison between post-treatment and follow-up on the primary

outcome the LSAS-SR. Clinical significant improvement, using Jacobson’s procedures

(Jacobson & Truax, 1991), was used to estimate rates of responders on the primary outcome

measure (e.g., both a reliable change and a reduction to a specified level). Following the

approach used in a recent Swedish study on ICBT for SAD (Hedman, Andersson, Ljótsson,

Andersson, Rück, Mörtberg, et al., 2011), a cutoff value of a score below 43.3 on the LSAS-

SR was used. The reliable change index was established using observed data of the study

and the test-retest value used in Hedman’s study (r=.97).

3. Results

3.1 Attrition, user information, and technique

In total, 30 participants (57.7 %) completed all treatment modules within the 9-week time

frame. Corresponding figures for each group separately were 17 (63.0 %) for the mCBT

group and 13 (52.0 %) for the mIPT group. For attrition see Figure 1. When accessing the

treatment platform, participants used smartphone 42.81 % , computer 50.05 %, and tablet

computer 7.14 % of the time. 21 participants of the mCBT program logged into both the

anxiety exposure and anxiety hierarchy modules. Out of these 15 worked with both the

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exposure modules and created anxiety hierarchies. In average these participants entered data

from 8.20 exposure exercises (SD=4.95, min=1, max=21) into the platform and put 8.73

items on their anxiety hierarchies (SD=5.61, min=4, max=25). Overall, the instruction to

therapists of 15 minutes of feedback to participants delivered once a week was followed.

There were technical problems related to using the new smartphone platform and interface;

problems to enter estimated anxiety levels during exposure, complicated log-in codes and the

necessity to log out of the smartphone to enter weekly measurements on the primary

outcome measure.

3.2 Treatment effects

3.2.1 Primary outcome measure (LSAS-SR)

Results for the primary outcome measure are presented in Table 3. The two groups did not

differ significantly on the LSAS-SR at pre-treatment, M=60.19 (SD=18.95) for mCBT and

M=65.72 (SD=27.15) for the mIPT group: t(50) = -0.86, n.s. On the LSAS-SR pre/post, both

treatment groups showed significant improvements at the p < .05 level; mCBT: t(24) = 6.18,

p=.001; mIPT: t(21) = 2.75, p =.01. Within-group Cohen’s d effect sizes were large for

mCBT (d= 0.99), and small for mIPT (d = 0.43). The between group effect size was

moderate (d= 0.64). Results for the weekly measurements on the LSAS-SR are presented in

Figure 2 for illustration.

3.2.2 Secondary outcome measures

Results for the secondary self-report inventories are presented in Table 3. Within group

effect sizes on SIAS and SPS were moderate in the mCBT group and small in the mIPT

group. Between groups effect sizes for these inventories were moderate, for the SIAS and for

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the SPS. The inventories for the measurement of general anxiety (BAI) and quality of life

(QOLI) revealed small between group effect sizes. The between groups effect size for the

measurement of depression, the MADRS-S, was large (in favor of the mCBT group, but

within group effects were small for both groups (Table 3)).

3.2.3 Three-months follow-up

In addition to the pre/post analysis a post/follow-up analysis was conducted using paired

samples t-tests on the basis of the results on the primary outcome measure at the three-month

follow-up (N=39; with n=24 in the mCBT group and 15 in the mIPT group). We did not

impute the missing data at this stage and focused only on completers of the follow-up. The

results were stable for both groups: mCBT, Post M=38.21 (SD=24.50), Follow-up M=39.75

(SD =24.87), t(21) = -0.74, p=.47; mIPT, Post M=57.21 (SD =28.24), Follow-up M=59.00

(SD =28.84), t(14) = 1.27, p=.23.

3.2.4 Clinical significance

The number of participants meeting the criteria for clinically significant improvement was

calculated for the LSAS-SR. In the mCBT group there were 55.6 % (n=15) who were

classified as responders at post-treatment compared to 8.0 % (n=2) in the mIPT group, and

this difference was statistically significant χ2(1)= 9.07, p=.04.

4. Discussion

The aim of this study was to compare mCBT, a CBT treatment adapted for mobile phone

administration, with mIPT, a newly developed self-help treatment based on interpersonal

psychotherapy. On the primary outcome measure LSAS-SR both groups showed statistically

significant improvements. However, mCBT performed significantly better than mIPT on the

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social phobia measures. Moreover, a larger portion of the mCBT group was classified as

clinically improved at post-treatment (55.6 %) when compared with the mIPT group (8 %).

The within-group effect size for mCBT (Cohen’s d = 0.99) is in line with effect sizes of

both CBT and ICBT in previous SAD studies (Acarturk, et al., 2009; Tulbure, 2011). For

example, the average within group effect size in a meta-analysis of CBT treatments entailing

exposure and cognitive restructuring was Cohens’s d = 0.83 (Fedoroff & Taylor, 2001). In

five previous Swedish ICBT trials on SAD using the longer version of the self-help manual

and with the LSAS-SR as primary outcome measure the between-group effect sizes have

ranged between d= 0.82 to 1.35 (Andersson, Carlbring, Furmark, & on behalf of the SOFIE

Research Group, 2012; Andersson, et al., 2006; Carlbring, et al., 2007; Furmark, et al., 2009;

Tillfors, et al., 2008).

There are to our knowledge no previous studies on mIPT. While it is less likely that

mCBT would differ much from the previous Internet studies on SAD, the effects of mIPT

are more difficult to understand and should be interpreted with caution. A comparison with

Stangier et al.’s (2011) results from a clinical outpatient care setting is also difficult since

our study did not include a waiting list control group. However, in both studies both active

treatments produced significant results. Our material does not lend itself easily to any further

comparisons with Stangier et al.’s study given the administration format. However, as CBT

performed better than IPT in both studies it may be that the superiority of CBT is present in

other administration formats. This is probably in contrast to IPT for depression, which is as

effective as CBT (Cuijpers, et al., 2011), and may also be so when delivered via the Internet

as an unguided treatment (Donker, et al., 2013). We interpret our results as an indication that

CBT treatment delivered via smartphones might work well when the technical problems that

hampered this trial are dealt with as indicated by the fact that participants also used

computers to access the treatment. Then the unique contributions of a smartphone interface

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to a CBT treatment should be investigated further, but it is also likely that clients prefer to

have the option to choose which platform to use. However, for scientific reasons it would

have been preferable if participants had used their smartphones to a greater extent only.

The results of the mIPT treatment in our study are more difficult to interpret.

The mIPT group had initially a mean score on the LSAS-SR, that was somewhat greater than

that of the mCBT group (albeit not statistically significant). Up until the fourth week there is

limited progress in the mCBT group and no progression in the mIPT group. The fifth week

there is a sudden drop in the mean of the mIPT group and the mIPT group is this week on

par with the mCBT group on the primary outcome measure. After week five the progression

of the mCBT group gains momentum and the distance between the means of the two groups

finally reaches a point where there is a significant difference between the means at the post

level. It is hard to draw any conclusions on the basis of our material but probably could this

effect be attributed to several factors. There is a shift in content midway through the mCBT

treatment. Week five is the first of three weeks of exposure treatment modules and one

social skills module in the mCBT treatment program.

It is interesting to note that we included all problem areas as described in IPT

for depression, and that a focus of one or two would have lead to even fewer treatment

components. It is possible that IPT is a treatment that requires therapist-patient interaction

(Weissman, et al., 2000), as there arguably is less psychoeducation than in CBT for SAD.

The fact that mCBT was superior to mIPT, being an active treatment control, support that

there are components inherent in the CBT program that contribute specifically to

improvement.

There are limitations of our study that require comment. The technical

problems related to using the new smartphone platform and interface possibly made it more

favorable to access the treatment platform via a computer interface, which might explain the

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relatively large proportion of computer use of the treatment program. However, as

participants could use the different platforms as they liked we have no means to estimate if

one format differs from the other. All participants were however smartphone users and there

are no empirical strong reasons to assume that it would be much different to access a

treatment via different platforms, even if this remains to be tested for SAD as it has been

tested for depression (Watts, et al., 2013). There was no untreated or placebo-treated control

condition, as two active treatments were tested. The small sample sizes resulted in low

statistical power for comparing two active treatments. In spite of this, mCBT performed

significantly better than mIPT. A substantially larger sample size would however been better

suited to test differences between two active treatments if not large differences were

expected. The fact that we recruited patients for this study plus the relatively conservative

exclusion criteria for suicidality, secondary depression and alcohol abuse/dependence might

have resulted in a sample, which is not representative of a clinical population. The

generalizability to regular clinical patients might thus be limited. However, for ethical

reasons the groups we excluded (with secondary depression as an exception) are usually

considered too risky to include in studies similar to ours. This also applies to previous ICBT

studies on SAD. However, ICBT for SAD has been tested with regular routine care patients

and with similar results as in efficacy trials (Aydos, Titov, & Andrews, 2009; Hedman,

Andersson, Ljótsson, Andersson, Rück, Mörtberg, et al., 2011). Finally, no conclusions can

be drawn regarding treatment credibility since there was no measurement of treatment

credibility included in the trial and measurement could have been improved if diagnostic

interviews were also conducted post treatment.

In spite of these limitations we conclude that a smartphone-based mCBT

treatment interface for SAD is feasible as an alternative option for accessing online

treatment. Further studies are needed to compare mCBT and mIPT as there may be patients

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who prefer one treatment over the other. Moreover the possible advantages and client

experiences of using smartphones in treatment for SAD and other conditions should be

explored further.

Conflicts of Interest

The authors report no conflicts of interest.

Acknowledgement

This study was sponsored in part by a grant from the Swedish Science Council, Swedish

Council for Working and Life research and Linköping University.

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Captions

Figure 1. Flowchart participant flow. Abbreviations: mIPT, mobile-based

Interpersonal Psychotherapy, mCBT, mobile-based Cognitive Behavior Therapy,

SAD, Social Anxiety Disorder.

Figure 2. Weekly change on LSAS-SR. Scores for both groups at each assessment

point; pre-treatment, treatment and post-treatment. Vertical bars denote 95% CI,

confidence interval.

Table 1. Demographic description of the participants.

Variable mIPT, n = 25 mCBT, n = 27 Total, N = 52

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Gender Women (%) 14 (56) 13 (48.1) 27 (51.9)

Men (%) 11 (44) 14 (51.9) 25 (48.1)

Age Mean age (SD) 39.08 (11.3) 34.70 (11.2) 36.81 (11.4)

Min-Max 20-65 21-60 20-65

Highest

completed

educational

level

Nine-year

compulsory

school (%)

0 (0) 2 (7.4) 2 (3.8)

Senior high

school /

Secondary

school (%)

13 (52) 13 (48.1) 26 (50)

University (%) 12 (48) 12 (44.4) 24 (46.2)

Years at

university

Mean years

(SD)

1.78 (2.1) 2.07 (2.6) 1.93 (2.3)

Min – max 0-6 0-8 0-8

Table 2. Medication data of the participants.

mIPT, n = 25 mCBT, n = 27 Total, N=52

Psycho-tropic

SSRI (%)

Beta antagonists

3 (12)

0 (0)

0 (0)

3 (11.1)

3 (5.8)

3 (5.8)

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Other

medication

(%)

NaSSA (%)

Sedative-

hypnotic (%)

Thyroid

hormones (%)

ACE inhibitors

(%)

1 (4)

1 (4)

0 (0)

1 (4)

0 (0)

0 (0)

2 (7.4)

0 (0)

1 (1.9)

1 (1.9)

2 (3.8)

1 (1.9)

Abbreviations: SSRI, Selective Serotonin Reuptake Inhibitor, NaSSA, Noradrenergic and Specific Serotonergic

Antidepressant, ACE inhibitor, Angiotensin-Converting-Enzyme inhibitor.

Table 3. Means, SD’s, within and between group effect sizes (Cohen’s d), confidence

intervals,

F-values and significance levels for primary and secondary outcome variables.

Measure Group Pre Post – est. values Within group ES Between group ES F-values

n=52 n=52 (1, 49)

M (SD) M (SD) d CI lo CI hi d CI lo CI hi

LSAS-SR mCBT 60.19 (18.95) 38.93 (23.18) 0.99 0.58 1.39

0.64 0.06 1.22 5.18 *

mIPT 65.72 (27.15) 54.41 (25.19) 0.43 0.09 0.77

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SIAS mCBT 45.15 (15.81) 34.30 (14.76) 0.71 0.35 1.07

0.72 0.14 1.30

5.83 *

mIPT 50.12 (14.06) 44.54 (13.76) 0.40 0.11 0.70

SPS mCBT 32.59 (11.31) 23.42 (12.15) 0.78 0.30 1.27

0.63 0.05 1.22 2.97

mIPT 37.64 (15.07) 31.30 (12.81) 0.45 0.12 0.77

BAI mCBT 17.30 (9.25) 14.79 (10.97) 0.25 -0.31 0.81

0.46 -0.10 1.03 2.09

mIPT 19.80 (12.12) 20.02 (11.56) -0.02 -0.41 0.37

MADRS-S mCBT 11.70 (5.09) 10.44 (4.77) 0.26 -0.16 0.67

0.88 0.28 1.47 7.25 **

mIPT 14.08 (6.30) 14.62 (4.77) -0.10 -0.61 0.42

QOLI mCBT 1.09 (1.58) 1.41 (1.66) -0.20 -0.55 0.16

0.37 -0.25 0.99 0.12

mIPT 0.37 (1.59) 0.82 (1.51) -0.29 -0.72 0.13

Abbreviations: mCBT, mobile-based Cognitive Behavior Therapy; mIPT, mobile-based Interpersonal Therapy; Pre, pre- treatment; Post, post-

treatment; LSAS-SR, Liebowitz Social Anxiety Scale – Self Report; SIAS, Social Interaction Scale; SPS, Social Phobia Scale; MADRS-S,

Montgomery-Åsberg Depression Rating Scale-Self Report; BAI, Beck Anxiety Inventory; QOLI, Quality of Life Inventory.

*p < .05, ** p < .01 = significance level for effect of group (ANCOVA).

Page 33: Cognitive behavior therapy versus interpersonal psychotherapy for social anxiety disorder delivered via smartphone and computer: A randomized controlled trial

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mCBT

Allocated to intervention, n= 27 Dropouts, n=3

mIPT

Allocated to intervention, n=25 Dropouts, n=6

Included in ITT analysis, n= 27 Included in Completers analysis, n=24

Included in ITT analysis,n=25

Included in Completers analysis, n= 19

Diagnostic interview. Assessed for eligibility, n=68

235 individuals in total applied to participate via the project´s homepage

52 subjects were included in the study and randomized

Excluded, n= 142 Did not complete online screening forms at all, did not fully complete online

screening forms or applied to late.

Excluded, n= 16

Did not meet inclusion criteria for SAD, n=4 Suicide risk, n=1

History of CBT during the last four years, n=1 No access to smartphone, n=1

Referred to outpatient psychiatric care; n=3 Alcohol abuse/dependence, n=1

Declined to participate, n=1 Screened and interviewed, met inclusion criteria, but could not commence

treament in time, n= 4

Invited to participate in diagnostic interview (contacted via telephone or e-mail), n= 76

Fully completed online screening forms, n= 93

Excluded, n= 17 Did not meet inclusion criteria as judged via screening forms.

Excluded, n= 8

Could not be reached via e-mail or telephone or declined to participate.

Figure

Page 34: Cognitive behavior therapy versus interpersonal psychotherapy for social anxiety disorder delivered via smartphone and computer: A randomized controlled trial

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Figure

Page 35: Cognitive behavior therapy versus interpersonal psychotherapy for social anxiety disorder delivered via smartphone and computer: A randomized controlled trial

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Highlights The effects of CBT using mobile phone administration (mCBT) for social anxiety disorder was compared interpersonal psychotherapy (mIPT) Guided mCBT was found to be superior to mIPT. The finding add to the growing literature on guided self-help for social anxiety disorder