BMJ...Mataix-Cols, Professor in child and adolescent psychiatric science 1 3, Linn Lichtenstein,...

Confidential: For Review O

nly

Therapist-guided Internet-based cognitive behavioural

therapy for body dysmorphic disorder: A single-blind randomised controlled trial and cost-effectiveness study

Journal: BMJ

Manuscript ID: BMJ.2015.027352

Article Type: Research

BMJ Journal: BMJ

Date Submitted by the Author: 04-Jun-2015

Complete List of Authors: Enander, Jesper; Karolinska Institutet, Department of Clinical Neuroscience, Center for Psychiatry Research Andersson, Erik; Karolinska Institutet, Department of Clinical Neuroscience, Center for Psychiatry Research; Karolinska Institutet, Department of Clinical Neuroscience, Division of Psychology Mataix-Cols, David; Karolinska Institutet, Department of Clinical Neuroscience, Center for Psychiatry Research; Institute of Psychiatry, Psychology and Neuroscience. King’s College London, Department of Psychosis Studies Lichtenstein, Linn; Linköping University, Department of Behavioural Sciences and Learning Alström, Katarina; Linköping University, Department of Behavioural Sciences and Learning Andersson, Gerhard; Linköping University, Department of Behavioural Sciences and Learning Ljótsson, Brjánn; Karolinska Institutet, Department of Clinical Neuroscience, Division of Psychology Rück, Christian; Karolinska Institutet, Department of Clinical Neuroscience, Center for Psychiatry Research

Keywords: Body dysmorphic disorder, Obsessive-compulsive disorder, Cognitive behavioural therapy, Randomised controlled trial

https://mc.manuscriptcentral.com/bmj

BMJ


nly

Internet-based CBT for BDD (BDD-NET) 1

Therapist-guided Internet-based cognitive behavioural therapy

for body dysmorphic disorder: A single-blind randomised

controlled trial and cost-effectiveness study

Jesper Enander, Clinical psychologist 1, Erik Andersson, Clinical psychologist 1 2, David

Mataix-Cols, Professor in child and adolescent psychiatric science 1 3, Linn Lichtenstein,

Assistant psychologist 4, Katarina Alström, Assistant psychologist 4, Gerhard Andersson,

Professor in clinical psychology 4, Brjánn Ljótsson, Senior lecturer 2 & Christian Rück, Senior

lecturer and consultant psychiatrist 1

1 Department of Clinical Neuroscience, Center for Psychiatry Research, Karolinska Institutet,

Stockholm, Sweden 2 Department of Clinical Neuroscience, Division of Psychology, Karolinska Institutet,

Stockholm, Sweden

3 Department of Psychosis Studies. Institute of Psychiatry, Psychology and Neuroscience.

King’s College London, UK 4 Department of Behavioural Sciences and Learning, Linköping University, Linköping,

Sweden

Corresponding author:

Jesper Enander

M46, Karolinska University Hospital Huddinge

SE-141 86 Stockholm, Sweden

E-mail: [email protected]

Page 1 of 28


BMJ

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


nly


What is already known on this subject

The NICE guidelines recommend Cognitive Behavioural Therapy (CBT) for body

dysmorphic disorder (BDD) but most sufferers do not have access to this treatment.

The UK Government’s mental health strategy recommends the increased use of information

and communication technology to improve care and access to services. Internet-based CBT

(ICBT) is a burgeoning area of mental health aimed at increasing access to evidence-based

treatments for a range of mental disorders and other conditions.

A pilot study suggested that therapist-guided ICBT may be a highly acceptable, feasible and

potentially cost-effective treatment option for BDD. A randomised controlled trial is now

needed.

What this study adds

This is the largest clinical trial of BDD ever conducted, and the first RCT to evaluate the

efficacy and cost-effectiveness of therapist-guided ICBT for BDD (BDD-NET).

Our study suggests that BDD-NET is an efficacious and cost-effective way to dramatically

increase access to evidence based care for people with BDD.

BDD-NET may be particularly useful in a stepped-care approach, where mild to moderate

cases with low suicide risk can be offered BDD-NET by their general practitioner or other

health professional, thus freeing resources to treat more severe and complex cases in

specialised settings.

Page 2 of 28


BMJ

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


nly


ABSTRACT

Objectives: Cognitive behavioural therapy (CBT) is an effective treatment for body

dysmorphic disorder (BDD). However, most sufferers do not have access to such specialised

treatment. In line with NICE recommendations, there is an urgent need to increase access to

treatment for BDD sufferers. We aimed to evaluate the efficacy and cost-effectiveness of a

therapist-guided, Internet-based CBT programme for BDD (BDD-NET), compared to an

active control condition, online supportive therapy.

Design: A 12-week, single-blind, parallel-group randomised controlled trial.

Setting: Academic medical centre.

Participants: 94 adult outpatients with a diagnosis of BDD, and a Yale-Brown Obsessive

Compulsive Scale modified for BDD (BDD-YBOCS) score of ≥20. Concurrent psychotropic

medication was permitted if the dose had been stable for at least 2 months prior to enrolment

and remained unchanged during the trial.

Interventions: Participants received either BDD-NET (n=47) or supportive therapy (n=47)

delivered via the Internet.

Main outcome measure: The primary outcome was the masked assessor BDD-YBOCS score

at week 12, and at 3-month follow-up. Responder status was defined as a ≥30% symptom

reduction on the BDD-YBOCS.

Results: BDD-NET was superior to supportive therapy and was associated with significant

improvements of BDD symptom severity, depression, and quality of life. At follow-up, the

proportion of responders was 56% (95% CI 40% to 71%) amongst those receiving BDD-

NET, compared to 13% (95% CI 6% to 27%) in the supportive therapy group. The number

needed to treat was 2.34 (95% CI 1.71 to 4.35). BDD-NET had a 95% probability of being

cost-effective given a willingness to pay of £6000 for one additional remission and the

corresponding cost for one additional quality adjusted life year was £11000. Self-reported

satisfaction was high.

Conclusions: CBT can be delivered safely and cost-effectively via the Internet to patients

with BDD, thus dramatically increasing access to care for this severely under-detected and

under-treated mental disorder.

Trial registration: ClinicalTrials.gov ID: NCT02010619.

Page 3 of 28


BMJ

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


nly


INTRODUCTION

Body dysmorphic disorder (BDD) is a psychiatric disorder characterized by a pervasive

preoccupation with perceived defects in physical appearance accompanied by avoidance and

time-consuming compulsive behaviours, such as mirror gazing and excessive camouflaging to

hide perceived defects.[1] If left untreated, BDD is a chronic and unremitting disorder that is

associated with functional impairment across multiple life domains, relatively high rates of

psychiatric hospitalization, substance dependence, and suicidality.[2-4] Although the disorder

is frequently under-detected and underdiagnosed within the mental health services,[5,6]

epidemiological studies show that BDD is a common mental health problem with a

prevalence ranging from 0.7 to 2.2% in the general population. [7-10] It is common for

sufferers of BDD to seek non-psychiatric care, such as dermatological treatment or plastic

surgery, in an attempt to ‘fix’ the perceived defects; however, such interventions rarely work,

and can lead to a deterioration of the BDD symptoms.[11,12]

Evidence-based treatments for BDD include psychopharmacological treatment

and cognitive behaviour therapy (CBT).[13-16] Guidance from the National Institute for

Health and Clinical Excellence (NICE) recommends that adults with BDD should be offered

the choice of either a course of a selective serotonin response inhibitor (SSRI) or specialised

CBT that addresses the key features of BDD.[17] There is, however, a gap between supply

and demand of CBT due to various factors, such as a lack of trained therapists, direct and

indirect costs associated with treatment, and geographical barriers that prevent BDD sufferers

from receiving specialised CBT.[18-20]. In two surveys, only 10%-17% of people with body

dysmorphic concerns reported that they had received an empirically supported psychotherapy

(i.e., CBT), and 19%-34% reported that they had received an SSRI.[19,20] Thus, one of

NICE’s key priorities for implementation, namely that each primary care trust, mental

healthcare trust and children's trust that provides mental health services should have access to

a specialist BDD multidisciplinary team offering age-appropriate care is currently far from

reality.[17] The growth in demand for mental healthcare exceeds available UK National

Health Service (NHS) resources, and this gap is likely to increase up to 2020.[21] Cost

pressures require that providers find innovative ways to deliver services. The UK

Government’s mental health strategy ‘No health without mental health’[22] recommends the

increased use of information and communication technology to improve care and access to

services. UK Government initiatives such as ‘Digital First’ aim to reduce unnecessary face-to-

face contact between patients and healthcare professionals.[21] Many BDD sufferers report

that one important reason for not being in treatment is related to feelings of shame and stigma

Page 4 of 28


BMJ

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


nly


associated with their appearance concerns, making tele-care options potentially suitable for

this patient group.[19,20]

Internet-based CBT (ICBT) is a burgeoning area of mental health aimed at

increasing access to specialized behavioural treatments. In some countries (e.g., Sweden,

Australia and the Netherlands) ICBT has been implemented as part of the regular health care

system, and is efficacious and cost-effective for a wide range of mental health disorders.

[23,24] With the primary aim to increase access to evidence based care for BDD, we recently

developed a therapist-guided ICBT program for BDD (BDD-NET). In a pilot study, BDD-

NET was found to be safe, highly acceptable to patients and potentially efficacious.[25]

Crucially, the treatment only required a fraction of the therapist time associated with regular

CBT.

Here, we aimed to evaluate the efficacy and cost-effectiveness of BDD-NET

compared to online supportive therapy in the management of adults with BDD. Supportive

therapy was chosen as a control as most patients with BDD report that they receive non-

specific talking therapy when they seek help for their BDD.[19] We hypothesized that BDD-

NET would be superior to online supportive therapy in reducing BDD symptoms, as well as

other psychiatric symptoms, and improve quality of life. We also predicted that BDD-NET

would be cost-effective.

METHOD

Trial design

This was a single-blind, parallel-group, superiority trial conducted at the Karolinska Institutet,

between November 2013 and January 2015. Participants were randomly assigned to 12 weeks

of BDD-NET (n=47) or online supportive therapy (n=47) in a 1:1 ratio without restriction.

Participants randomised to supportive therapy were offered BDD-NET after the 3-month

follow-up. No changes to methods were made after trial commencement. The regional ethical

review board in Stockholm approved the protocol (registration ID: 2013/1773-31/4). US

National Institutes of Health (ClinicalTrials.gov) registration ID: NCT02010619. The study is

reported in accordance to the CONSORT statement for nonpharmacological treatments.[26]

Participants

Eligible participants were individuals with access to the Internet, aged 18 or over, and with a

principal diagnosis of BDD according to the DSM-5,[1] with a score of at least 20 on the

Yale-Brown Obsessive-Compulsive Scale Modified for BDD (BDD-YBOCS).[27] Exclusion

Page 5 of 28


BMJ

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


nly


criteria were: a) psychotropic medication changes within two months prior to enrolment, b)

completed CBT for BDD within the last 12 months, c) current substance dependence, d)

bipolar disorder or psychosis, e) acute suicidal ideation, f) a severe personality disorder that

could jeopardize treatment participation (e.g., borderline personality disorder with self-harm),

and g) concurrent psychological treatment. Participants who were taking psychotropic

medication, and had been on a stable dose for at least two months prior to enrolment were

asked to keep their dose stable during the study period. After complete description of the

study to the subjects, written informed consent was obtained.

Recruitment and determination of eligibility

Participants were recruited from all over Sweden. Flyers were distributed to psychiatrists and

general practitioners throughout Sweden with information about the study. In addition, the

study was advertised in national newspapers. Interested applicants had to register on the

study’s secure website and complete an online screening consisting of Montgomery-Åsberg

Depression Rating Scale Self-report (MADRS-S),[28] Alcohol Use Disorders Identification

Test,[29] Drug User Disorders Identification Test,[30] Body Dysmorphic Disorder

Questionnaire (BDDQ),[31] and general background information. The BDDQ is a screening

instrument for BDD, and has shown excellent sensitivity and specificity.[31] Potentially

suitable participants underwent a structured diagnostic interview with a clinical psychologist

or with a trained student in the final semester of a 5-year clinical psychology programme. The

interviews were conducted over telephone, which is a reliable administration format for

structured psychiatric assessments.[32] To establish a diagnosis of BDD, the Structured

Clinical Interview for DSM-IV Axis I Disorders was used, with an added question about the

presence of repetitive behaviours to reflect the updates made to the diagnostic criteria of

BDD in DSM-5. The Mini-International Neuropsychiatric Interview was used to determine

the presence of other comorbid psychiatric disorders.[33] All assessors had received extensive

training in structured diagnostic interviews. To ensure reliability of diagnostic procedure and

eligibility criteria, a consultant psychiatrist reviewed each case and made the final decision on

enrolment.

Interventions

BDD-NET

BDD-NET is delivered via a tailored online platform using a dedicated hospital server with

encrypted traffic and an authentication login function in order to guarantee participant

Page 6 of 28


BMJ

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


nly


confidentiality. Treatment length was 12-weeks, and none of the participants had any face-to-

face contact with a therapist. The treatment protocol is based on a CBT model for BDD,

emphasizing the role of negatively reinforced avoidance, and safety behaviours (e.g., mirror

checking, and camouflaging perceived physical defects) as maintaining factors of BDD. The

treatment protocol has been validated in a previous trial, and the treatment effects are

comparable to those gained in traditional face-to-face CBT.[25] The main intervention in

BDD-NET is systematic exposure to fear eliciting situations or events combined with

response prevention (E/RP) until anxiety and urges to ritualise subside (e.g., leaving one’s

apartment and refraining from compulsive mirror-checking).

In total, BDD-NET consists of eight interactive modules delivered over 12

weeks, with the first five modules containing the core treatment components.[23] Each

module is devoted to a special theme and covers: 1) psychoeducation, 2) a cognitive-behaviour

conceptualization of BDD, 3) cognitive restructuring, 4) E/RP, 5) more on E/RP, 6) values-based

behavior change, 7) difficulties encountered during treatment, and 8) relapse prevention. In

order to progress to the next module participants have to complete homework assignments

(e.g., reading text material, answering a quiz a the end of each module, filling out worksheets,

or doing E/RP), and report to their therapist. The participants had contact with an identified

therapist throughout the entire treatment using a built-in e-mail system on the BDD-NET

webpage. Participants could log in and send e-mails at any time. All homework assignments

and questions from the participants were reviewed and answered within 36 hours, except on

weekends. The role of the therapist was mainly to guide and coach the participant throughout

the treatment, provide feedback on homework assignments, answer questions from the

participants, and consecutively grant access to the next treatment module. The participants

were notified by an automated text-message (SMS) when they had a new e-mail in the

treatment platform from their therapist.

The therapists guiding the participants through the treatment were four clinical

psychology students in their final year of training with no prior experience of BDD. The

duration of therapist contact, and sent e-mails was automatically recorded by the BDD-NET

platform. Median therapist time spent weekly per participant reading and answering e-mails

was 13.2 minutes. To ensure treatment integrity and adherence to protocol, a clinical

psychologist monitored the messages sent by the therapists throughout the entire treatment,

and provided supervision. A screen-shot of BDD-NET appears in Figure S1.

Online supportive therapy

Page 7 of 28


BMJ

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


nly


Participants had access to the integrated e-mail system on the BDD-NET webpage and

unlimited access to an identified therapist. The therapist sent an email at least once a week,

encouraging the participant to discuss distressing life events and to promote problem solving.

All e-mails from the participants were reviewed and answered within 36 hours and the

participants were notified by an SMS when they had a new e-mail in the treatment platform.

Treatment length was 12-weeks, and none of the participants had any face-to-face contact

with a therapist. Non-directive supportive therapy has shown to reduce symptoms associated

with obsessive-compulsive disorder when delivered via the Internet,[34] however, there are

no reports of its efficacy for BDD. The supportive therapy served as a control for caregiver

attention and the possible anxiety-alleviating effect of sharing one’s distress with a therapist.

The same therapists that guided the participants through BDD-NET delivered the supportive

therapy. Median therapist time spent per participant per week reading and answering e-mails

was 6.3 minutes. To ensure treatment integrity, a clinical psychologist monitored the

messages sent by the therapists throughout the entire treatment, and provided supervision.

Randomisation and masking

An external person not involved in the trial used a true random number service

(www.random.org) allocating participants in a 1:1 ratio using simple randomization. The

random sequence was generated after inclusion to make sure that assignment of intervention

was concealed from the researchers involved in the study. Immediately after randomisation,

the participants received information about which treatment they had been allocated to, and

how they could log in to the secure website. Assessors in the trial remained masked to

treatment allocation at baseline, post-treatment and at 3-month follow-up. Due to the nature of

the intervention, participants and therapists were not blinded to treatment.

Assessment points and outcomes

Assessments were conducted at baseline, post-treatment, and 3 months after treatment. After

the 3-month follow-up, participants in the supportive therapy group who still wanted

treatment were offered to crossover to BDD-NET and re-assessed after receiving 12-weeks of

BDD-NET. Participants also completed online-self report measures at these time points, a

method which has been shown to be as reliable and as valid as pen-and-paper

administration.[35,36]

The primary outcome was change in BDD symptom severity assessed with the

clinician administered BDD-YBOCS.[27] The BDD-YBOCS can be considered the gold

Page 8 of 28


BMJ

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


nly


standard for assessing BDD symptom severity, and has a total score of 0-48, with a higher

score indicating more severe BDD. To ensure quality of assessments, clinicians in this trial

practiced together on case examples with excellent inter-rater reliability (intra class

correlation =.95, 95% CI .89 to .98).

Secondary outcomes included responder status defined as an empirically derived

cut-off point of ≥30% reduction from baseline on the BDD-YBOCS.[37] Remission was

defined as no longer meeting diagnostic criteria for BDD. Clinician rated global functioning

and improvement was assessed with the Global Assessment of Functioning scale (GAF),[38]

and the Clinical global improvement scale (CGI-I).[39] Depressive symptoms were assessed

with the MADRS-S.[28] Quality of life was assessed with the EQ5D EuroQol (EQ5D).[40]

Health economic cost data were collected using the Trimbos and Institute of Medical

Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)[41] and includes data on

monthly health care visits, medication consumption, unemployment, sick leave, and work-

and household cutback. The occurrences of adverse events were recorded mid-treatment and

post-treatment using a self-report form.[42]

Power calculation and statistical analysis

A sample size of 39 per group was required to give 80% power and a two-sided 5%

significance for detecting at least a beneficial mean difference of 4 and a standard deviation of

6.24 on the BDD-YBOCS between BDD-NET and supportive therapy. These assumptions

were made based on a previous pilot trial of BDD-NET.[25] There was an anticipated 10%

dropout rate, giving a planned sample size of at least 44 per group, or 88 in total. There were

no planned interim analysis or stopping rules.

Analyses were by intention to treat, with participants analysed in the group to

which they had been randomised. Missing data were deemed to be missing at random using

Little’s MCAR test. Linear mixed models (LMM) with maximum likelihood estimations were

used to evaluate the effect of treatment group on the different outcomes. LMMs take into

account the inter-individual differences in intra-individual change with repeated responses

and use all the available data on each participant.[43] The fixed part of the model included a

treatment indicator variable (supportive therapy=0; BDD-NET=1), a time indicator variable

(baseline=0; post-treatment=1; follow-up=2), and a treatment � time interaction with

participant varying intercepts included as a random effect in the model. As therapist support

time varied between the two treatment arms it was included as a covariate, however, because

it did not predict outcome (p=0.22-0.95) it was dropped from the final model. Categorical

Page 9 of 28


BMJ

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


nly


data were analysed using Chi-square tests, and independent t-tests were used for assessing

between-group differences when time was not a factor on the outcome variable. The dose-

response of BDD-NET was investigated by regressing the post-treatment BDD-YBOCS score

on the number of completed modules, while controlling for the baseline BDD-YBOCS score.

Between-group effect sizes were calculated using Cohen’s d.

Costs of medication and health care visits were estimated using national tariffs

in Sweden, and were extrapolated to a 6-month period in order to get an estimate covering the

entire trial period. That is, monthly costs were extrapolated to the next measurement point

from baseline to post-treatment to follow-up. Productivity losses were based on the human

capital approach, and the costs of reduced work productivity were estimated based on the

average gross earnings in Sweden for 2013. The domestic loss hourly tariff was estimated to

£7.[44] Costs were converted from Swedish kronor (SEK) to pound sterling (£) using

purchasing power parities for the reference year 2013.[45] The net benefit of each individual

was calculated according to the following formula: (λ x E) – ∆C where λ is the willingness to

pay, E is the efficacy (i.e., remission or gain on the EQ5D), and ∆C is the cost change from

baseline to follow-up. We calculated individual net benefits by assuming different values for

λ and a regression model with non-parametric bootstrapping (1000 replications) to estimate

the difference between BDD-NET and supportive therapy. Cost-effectiveness acceptability

curves were used to get a visual estimate of the total net benefit of BDD-NET. We used

remission as outcome variable and also gain on the EQ5D to estimate the cost of one quality-

adjusted life-year (QALY). The analysis used a societal perspective, including both direct and

indirect costs obtained from the TIC-P. All statistical analyses were done in STATA 13.1.

RESULTS

The flow of participants through the trial is depicted in Figure 1. At post-treatment, and at 3-

month follow-up there was a 1%, and 9% loss of data, respectively. Little’s MCAR test

suggested that the missing data met the assumption of missing at random (χ=42.57, df=52,

p=0.82). There were no significant differences in dropout rates across conditions at post-

treatment (χ=1.01, df=1, p=0.32), or at the 3-month follow-up (χ=1.11, df=1, p=0.29) and

dropouts did not significantly differ from completers on baseline demographics or on

symptom measures. Participants that first received supportive therapy were offered BDD-

NET at the 3-month follow-up; 6 declined and the remaining 41 crossed over to BDD-NET.

Sample characteristics at baseline are presented in Table 1.

Page 10 of 28


BMJ

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


nly


<INSERT FIGURE 1 ABOUT HERE>

<INSERT TABLE 1 ABOUT HERE>

Primary outcome

There was a significant group by time interaction effect on the BDD-YBOCS both from

baseline to post-treatment (β= -7.32, 95% CI -9.00 to -4.84, p=<0.001), and from baseline to

follow-up (β= -6.46, 95% CI -9.00 to -3.91, p=<0.001). Though the BDD-NET group

improved significantly more, the supportive therapy group also showed significant gains at

post-treatment (β= -1.87, 95% CI -3.62 to -0.13, p=0.036), and at follow-up (β= -3.23, 95%

CI -5.00 to -1.46, p=<0.001).

The mean reduction on the BDD-YBOCS score from baseline to follow-up was

-9.68 (95 % CI -11.51 to -7.85) in the BDD-NET group, and the corresponding number for

the supportive therapy group was -3.22 (95% CI -5.00 to -1.45). At follow-up, the mean

difference between the groups on the BDD-YBOCS score was -5.84 (95% CI -8.51 to -3.17),

in favour of BDD-NET, indicating a larger treatment effect of BDD-NET compared to

supportive therapy. The effects of treatment on masked assessor BDD-YBOCS by condition

over time are presented in Figure 2A.

<INSERT FIGURE 2 AROUND HERE>

Secondary outcomes

The proportion of participants classified as responders was significantly higher in the BDD-

NET group both at post-treatment, 54% (95% CI 40 to 69) vs 6% (95% CI 2 to 19; χ=25.42,

df=1, p<0.001), and at follow-up, 56% (95% CI 40 to 71) vs 13% (95% CI 6 to 27; χ=17.55,

df=1, p<0.001). The number needed to treat (NNT) was 2.34 (95% CI 1.71 to 4.35). The

corresponding number of participants in remission at post-treatment was 32% (95% CI 20 to

47) vs 2% (95% CI 0.2 to 15; χ=15.16, df=1, p<0.001), and 40% (95% CI 26 to 56) vs 9%

(95% CI 3 to 22%; χ=10.92, df=1, p=0.001) favouring the BDD-NET group. At 3-month

follow-up, 56% (95% CI 40 to 71) of the participants in the BDD-NET group were classified

as improved or much improved on the CGI-I, compared to 16% (95% CI 7 to 30) in the

supportive therapy group (χ=15.52, df=1, p<0.001).

Page 11 of 28


BMJ

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


nly


Depressive symptoms as measured with the MADRS-S decreased over the

course of the trial in the BDD-NET group, and there was a significant group by time

interaction effect from baseline to post-treatment (β= -4.53, 95% CI -7.60 to -1.46, p=0.004),

and from baseline to follow-up (β= -5.26, 95% CI -8.51 to -2.00, p=0.002). In the supportive

therapy group, there was no effect of time on the MADRS-S from baseline to post-treatment

(β= -0.53, 95% CI -2.69 to 1.63, p=0.630), or from baseline to follow-up (β= -0.77, 95% CI -

2.98 to 1.44, p=0.495).

On the GAF there was a significant group by time interaction effect; the BDD-

NET group improved from baseline to post-treatment (β= 7.07, 95% CI 4.97 to 9.17,

p=<0.001), and from baseline to follow-up (β= 7.17, 95% CI 5.02 to 9.34, p=<0.001). No

significant improvements were seen in the supportive therapy group at post-treatment (β=

0.58, 95% CI -0.90 to 2.05, p=0.446) or at follow-up (β= 0.71, 95% CI -0.79 to 2.22,

p=0.353).

Health related quality of life (EQ5D) did not improve for the BDD-NET group

at post-treatment (β= 0.86, 95% CI -0.21 to 0.19, p=0.114). However, at the follow-up the

group by time interaction effect was significant, showing an improvement in quality of life

(β= 0.16, 95% CI 0.05 to 0.27, p=0.005). In the supportive therapy group there was a non-

significant decrease of quality of life at both post-treatment (β= -0.07, 95% CI -0.15 to 0.00,

p=0.061), and at follow-up (β= -0.08, 95% CI -0.15 to 0.00, p=0.051). Predicted means of the

outcomes across the different assessment points, and treatment effects are presented in Table

2.

<INSERT TABLE 2 ABOUT HERE>

Intervention delivery and dose-response effects

Thirty-nine participants (83%) completed the core components of BDD-NET (modules 1-5)

and there was a dose response relationship between the number of completed modules and the

post-treatment BDD-YBOCS score (β= -1.05, 95% CI -2.05 to -0.06, p=0.039). This implies

that for every completed module the post-treatment BDD-YBOCS score would decrease by

1.05 points.

Treatment acceptability

Overall, BDD-NET was deemed highly acceptable by participants, as 29% were very pleased

with the treatment provided, 47% were pleased, 20% indifferent or somewhat displeased, and

Page 12 of 28


BMJ

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


nly


4% were very displeased. In total, 82% reported that if they were in need of additional CBT in

the future they would use BDD-NET, and 89% would recommend BDD-NET to a friend with

similar problems.

Cost effectiveness

BDD-NET had a 60% probability of being cost-effective given a societal willingness to pay

of £0 (Figure 3). If the willingness to pay for one additional remission rose to £6000, BDD-

NET had a 95% probability of being cost-effective. The corresponding price for one QALY

was £11000, with a 95% probability of being cost-effective. Detailed information about the

economic data at the different time points is presented in Table 3, and cost tariffs for health

care services used by the participants are presented in Table S1.

<INSERT TABLE 3 AROUND HERE>

<INSERT FIGURE 3 AROUND HERE>

Crossover patients

Participants in the supportive therapy group who crossed over to BDD-NET after the 3-month

follow-up (N=41) showed a significant decrease on the BDD-YBOCS after receiving BDD-

NET (β= -7.28, 95% CI -9.06 to -5.50, p<0.001; Figure 2B). In total, 43% (95% CI 27 to

60%) of the crossed over cases were classified as responders, and 29% (95% CI 16 to 46%)

were in remission at post-treatment.

Similar improvements were observed on the MADRS-S (β= -2.45, 95% CI -4.43

to -0.46, p=<0.016) and the GAF (β= 4.78, 95% CI 3.12 to 6.43, p=<0.001), but not on the

EQ5D (β= 0.07, 95% CI -0.02 to 0.16, p=0.131).

Adverse events and protocol deviations

No serious adverse events (AE) were reported (i.e., events leading to acute health risks

demanding admission to a hospital). However, 15 (32%) participants in the BDD-NET group

and 6 (13%) participants in the supportive therapy group reported mild AE (i.e., increased

levels of anxiety and general negative well-being) at the beginning of the trial, which had

subsided for everyone at post-treatment, except for four participants in the BDD-NET group

who still reported feelings of general negative well-being that they attributed to the treatment.

The occurrence of AE during treatment was not related to responder status at post-treatment

(χ=0.91, df=1, p=0.34).

Page 13 of 28


BMJ

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


nly


All participants on psychotropic medication at baseline reported that they had

kept their dose stable during the treatment period. After commencing the treatment, one

participant in the BDD-NET group had been prescribed an antidepressant, but was classified

as a non-responder at post-treatment. None of the other participants reported that they had

received any other type of health care during treatment. From post-treatment to follow-up,

three participants in the BDD-NET group, and two participants in the supportive therapy

group had received additional health care in the form of CBT, pharmacological treatment, or

both.

DISCUSSION

In this trial, the efficacy and cost-effectiveness of BDD-NET, a novel therapist-guided

Internet-based CBT programme for BDD was compared to online supportive therapy, a kind

of non-specific talking therapy that mimics the psychosocial support that most patients with

BDD report receiving in the real world.[19,20] Overall, BDD-NET was superior to supportive

therapy, and was associated with significant improvements of BDD symptom severity,

depression, global functioning, and quality of life. These gains were maintained up to 3

months after treatment. At the 3-month follow-up, the proportion of responders was 56%

amongst those receiving BDD-NET, and 39% no longer met diagnostic criteria for BDD, with

a NNT of 2.34. A majority of participants were satisfied with BDD-NET, despite no face-to-

face contact with a therapist and deemed the treatment as highly acceptable. Furthermore, the

cost-effectiveness analysis showed that BDD-NET produced both additional responders as

well as QALYs for a low cost, and at the £30 000 threshold (associated with NICE

recommendations), the probability of cost-effectiveness was practically 100%. The results

indicate that BDD-NET has great potential to greatly increase access to evidence-based

psychiatric treatment for patients with BDD, in line with the NICE priority recommendations

[17].

Strengths of this trial include the large sample size, the inclusion of a control

intervention, the use of masked assessors and minimal patient attrition. One potential

limitation of the trial is that the results may not be generalizable to the entire BDD population

as the participants were self-referred. However, most had been ill for many years, had had

previous contact with mental health services, and a fifth had undergone plastic surgery. We

took the precaution, on safety grounds, to exclude participants with substance dependence and

severe suicidal ideation, both of which are common among patients with BDD. Participants in

the supportive therapy group were less engaged in the treatment, compared to the participants

Page 14 of 28


BMJ

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


nly


receiving BDD-NET. This is reflected in the amount of time that the therapist spent reviewing

and answering e-mails. However, unspecific talking therapy is the most common type of

psychosocial intervention that BDD sufferers receive, making it ecologically valid as a

control. Furthermore, the estimated differences in treatment effects remained unchanged when

statistically controlling for amount of therapist contact. Another limitation is the use of a self-

reported questionnaire for assessing cost data. However, self-reported cost data have been

shown to be as reliable as hospital register data.[46]

Overall, our results are in line with previous studies of face-to-face CBT for

BDD,[14,15] but most participants in this trial had moderate symptom severity and reasonable

good insight. Thus, our sample might differ from the average BDD patient seen in specialist

clinical settings. Furthermore, although the proportion of comorbidities were the same in our

sample as in previous clinical trials, the average participant in our sample endorsed mild

depression, compared to moderate to severe depression as seen in the two recent RCTs of

CBT for BDD.[14,15] BDD-NET is not intended for the most risky and severe end of the

BDD spectrum.

The therapists providing online support had no prior experience of treating

BDD. BDD-NET is delivered online as a series of interactive modules, and the role of the

therapist is mainly to encourage the participant to engage in the treatment, making it

reasonable to assume that BDD-NET can be used in non-specialist settings. BDD-NET may

be particularly useful in a stepped-care approach, where mild to moderate cases can be

offered BDD-NET by their general practitioner, or other health professionals, thus freeing

resources for more severe and complex cases to be treated in specialized settings. Logistic

barriers are also eliminated, as patients receiving BDD-NET do not have to travel to the clinic

once a week to receive the treatment. This makes BDD-NET particularly promising in more

rural areas where the access to trained CBT therapists is limited.[18] Future stepped-care

trials of BDD-NET in non-specialist settings are warranted.

Page 15 of 28


BMJ

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


nly


FUNDING

Financial support was provided through the regional agreement on medical training and

clinical research (ALF) between the Stockholm County Council and Karolinska Institutet, the

Swedish Research Council (grant number: K2013-61X-22168-01-3), and the Swedish Society

of Medicine (Söderströmska Königska sjukhemmet, grant number: SLS3B4451) provided

funding for this study.

ACKNOWLEDGMENTS

The authors would like to thank Monica Hellberg, Sofia Eriksson, Vania Panes Lundmark,

Martin Runeborg, and Lina Anderhell for their invaluable help.

DATA SHARING

No additional data available.

COMPETING INTERESTS

All authors have completed the ICMJE uniform disclosure form at

www.icmje.org/coi_disclosure.pdf and declare: no support from any organisation for the

submitted work; no financial relationships with any organisations that might have an interest

in the submitted work in the previous three years; no other relationships or activities that

could appear to have influenced the submitted work.

CONTRIBUTORS

JE and CR had the original idea for the study and with DM-C, and BJ designed the trial

variables and obtained the funding. JE and CR were responsible for study supervision. JE,

CR, LL, KA, EA, BJ, GA and DM-C were responsible for the acquisition of the data. JE, EA

and CR carried out the statistical analysis. JE drafted the manuscript, which was revised by all

authors. All researchers were independent of the funders. The funders had no part in the study

design, in the collection, analysis, and interpretation of data, in the writing of the report or in

the decision to submit the article for publication.

TRANSPARENCY

The lead author JE (the manuscript’s guarantor) affirms that the manuscript is an honest,

accurate and transparent account of the study being reported; that no important aspects of the

Page 16 of 28


BMJ

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


nly


study have been omitted; and that and discrepancies from the study as planned (and if

relevant, registered) have been explained.

Page 17 of 28


BMJ

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


nly


REFERENCES

1 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th edn. Arlington, VA: American Psychiatric Publishing, 2013.

2 Phillips KA, Menard W, Quinn E, et al. A 4-year prospective observational follow-up study of course and predictors of course in body dysmorphic disorder. Psychol Med 2012;43:1109–17. doi:10.1017/S0033291712001730

3 Phillips KA, Menard W, Fay C, et al. Psychosocial functioning and quality of life in body dysmorphic disorder. Compr Psychiatry 2005;46:254–60. doi:10.1016/j.comppsych.2004.10.004

4 Phillips KA, Menard W. Suicidality in body dysmorphic disorder: a prospective study. Am J Psychiatry 2006;163:1280–2. doi:10.1176/appi.ajp.163.7.1280

5 Grant JE, Kim SW, Crow SJ. Prevalence and clinical features of body dysmorphic disorder in adolescent and adult psychiatric inpatients. J Clin Psychiatry 2001;62:517–22.

6 Kollei I, Martin A, Rein K, et al. Prevalance of body dysmorphic disorder in a German psychiatric inpatient sample. Psychiatry Res 2011;189:153–5. doi:10.1016/j.psychres.2011.02.009

7 Brohede S, Wingren G, Wijma B, et al. Prevalence of body dysmorphic disorder among Swedish women: a population-based study. Compr Psychiatry 2015;58:108–15. doi:10.1016/j.comppsych.2014.12.014

8 Otto MW, Wilhelm S, Cohen LS, et al. Prevalence of body dysmorphic disorder in a community sample of women. Am J Psychiatry 2001;158:2061–3.

9 Rief W, Buhlmann U, Wilhelm S, et al. The prevalence of body dysmorphic disorder: a population-based survey. Psychol Med 2006;36:877. doi:10.1017/S0033291706007264

10 Buhlmann U, Glaesmer H, Mewes R, et al. Updates on the prevalence of body dysmorphic disorder: A population-based survey. Psychiatry Res 2010;178:171–5. doi:10.1016/j.psychres.2009.05.002

11 Crerand CE, Phillips KA, Menard W, et al. Nonpsychiatric medical treatment of body dysmorphic disorder. Psychosomatics 2005;46:549–55. doi:10.1176/appi.psy.46.6.549

12 Sarwer DB, Spitzer JC. Body image dysmorphic disorder in persons who undergo aesthetic medical treatments. Aesthet Surg J 2012;32:999–1009. doi:10.1177/1090820X12462715

13 Ipser JC, Sander C, Stein DJ. Pharmacotherapy and psychotherapy for body dysmorphic disorder. Cochrane Database Syst Rev 2009;1:CD005332. doi:10.1002/14651858.CD005332.pub2

14 Wilhelm S, Phillips KA, Didie E, et al. Modular cognitive-behavioral therapy for body dysmorphic disorder: a randomized controlled trial. Behav Ther 2014;45:314–27. doi:10.1016/j.beth.2013.12.007

Page 18 of 28


BMJ

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


nly


15 Veale D, Anson M, Miles S, et al. Efficacy of Cognitive Behaviour Therapy versus Anxiety Management for Body Dysmorphic Disorder: A Randomised Controlled Trial. Psychother Psychosom 2014;83:341–53. doi:10.1159/000360740

16 Mataix-Cols D, Fernández de la Cruz L, Isomura K, et al. A pilot randomized controlled trial of cognitive-behavior therapy for adolescents with body dysmorphic disorder. Submitted

17 National Institute for Health and Care Excellence (2005) Obsessive-compulsive Disorder: Core Interventions in the Treatment of Obsessive-compulsive Disorder and Body Dysmorphic Disorder. CG31. London: National Institute for Health and Care Excellence.

18 Cavanagh K. Geographic inequity in the availability of cognitive behavioural therapy in England and Wales: a 10-year update. Behav Cogn Psychother 2014;42:497–501. doi:10.1017/S1352465813000568

19 Marques L, Weingarden HM, Leblanc NJ, et al. Treatment utilization and barriers to treatment engagement among people with body dysmorphic symptoms. J Psychosom Res 2011;70:286–93. doi:10.1016/j.jpsychores.2010.10.002

20 Buhlmann U. Treatment barriers for individuals with body dysmorphic disorder: an internet survey. J Nerv Ment Dis 2011;199:268–71. doi:10.1097/NMD.0b013e31821245ce

21 Hollis C, Morriss R, Martin J, et al. Technological innovations in mental healthcare: harnessing the digital revolution. Br J Psychiatry 2015;206:263–5. doi:10.1192/bjp.bp.113.142612

22 HM Government. No Health Without Mental Health. Department of Health, 2011.

23 Hedman E. Therapist guided internet delivered cognitive behavioural therapy. BMJ 2014;348:g1977.

24 Andersson G, Cuijpers P, Carlbring P, et al. Guided Internet-based vs. face-to-face cognitive behavior therapy for psychiatric and somatic disorders: a systematic review and meta-analysis. World Psychiatry 2014;13:288–95. doi:10.1002/wps.20151

25 Enander J, Ivanov VZ, Andersson E, et al. Therapist-guided, Internet-based cognitive-behavioural therapy for body dysmorphic disorder (BDD-NET): a feasibility study. BMJ Open 2014;4:e005923. doi:10.1136/bmjopen-2014-005923

26 Boutron I, Moher D, Altman DG, et al. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med 2008;148:295–309.

27 Phillips KA, Hollander E, Rasmussen SA, et al. A severity rating scale for body dysmorphic disorder: development, reliability, and validity of a modified version of the Yale-Brown Obsessive Compulsive Scale. Psychopharmacol Bull 1997;33:17–22.

28 Svanborg P, Asberg M. A new self-rating scale for depression and anxiety states based on the Comprehensive Psychopathological Rating Scale. Acta Psychiatr Scand

Page 19 of 28


BMJ

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


nly


1994;89:21–8.

29 Saunders JB, Aasland OG, Babor TF, et al. Development of the alcohol use disorders identification test (AUDIT): WHO collaborative project on early detection of persons with harmful alcohol consumption. Addiction 1993;88:791-804.

30 Berman AH, Bergman H, Palmstierna T, et al. Evaluation of the Drug Use Disorders Identification Test (DUDIT) in criminal justice and detoxification settings and in a Swedish population sample. Eur Addict Res 2005;11:22–31. doi:10.1159/000081413

31 Brohede S, Wingren G, Wijma B, et al. Validation of the body dysmorphic disorder questionnaire in a community sample of Swedish women. Psychiatry Res 2013;210:647-52 doi:10.1016/j.psychres.2013.07.019

32 Rohde P, Lewinsohn PM, Seeley JR. Comparability of telephone and face-to-face interviews in assessing axis I and II disorders. Am J Psychiatry 1997;154:1593–8.

33 Sheehan DV, Lecrubier Y, Sheehan KH, et al. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry 1998;59(Suppl 20):22–33.

34 Andersson E, Enander J, Andrén P, et al. Internet-based cognitive behaviour therapy for obsessive-compulsive disorder: a randomized controlled trial. Psychol Med 2012;42:2193–203. doi:10.1017/S0033291712000244

35 Coles ME, Cook LM, Blake TR. Assessing obsessive compulsive symptoms and cognitions on the internet: evidence for the comparability of paper and Internet administration. Behav Res Ther 2007;45:2232–40. doi:10.1016/j.brat.2006.12.009

36 Enander J, Andersson E, Kaldo V, et al. Internet administration of the Dimensional Obsessive-Compulsive Scale: a psychometric evaluation. J Obsessive Compuls Disord 2012;1:325-30.

37 Phillips KA, Hart AS, Menard W. Psychometric evaluation of the Yale-Brown obsessive-compulsive scale modified for body dysmorphic disorder (BDD-YBOCS). J Obsessive Compuls Relat Disord 2014;3:205–8. doi:10.1016/j.jocrd.2014.04.004

38 American Psychiatric Association. Diagnostic and statistical manual of mental disorders: DSM-IV-TR. 4th edn. Washington, DC: American Psychiatric Association, 2000.

39 Guy W, ed. Clinical global impressions. Rockville: US Department of Health and Human services, 1976.

40 EuroQol Group. EuroQol - a new facility for the measurement of health-related quality of life. Health Policy 1990;16:199–208.

41 Hakkaart-Van Roiijen L. Manual. Trimbos/iMTA questionnaire for costs associated with psychiatric illness (TIC-P) 2010. http://www.bmg.eur.nl/english/imta/publications/questionnaires_manuals.

Page 20 of 28


BMJ

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


nly


42 Ljótsson B, Hesser H, Andersson E, et al. Provoking symptoms to relieve symptoms: a randomized controlled dismantling study of exposure therapy in irritable bowel syndrome. Behav Res Ther 2014;55:27–39. doi:10.1016/j.brat.2014.01.007

43 Verbeke G, Molenberghs G. Linear Mixed Models for Longitudinal Data. Springer Science & Business Media 2009.

44 Smit F, Willemse G, Koopmanschap M, et al. Cost-effectiveness of preventing depression in primary care patients: randomised trial. Br J Psychiatry 2006;188:330–6. doi:10.1192/bjp.188.4.330

45 Organisation for economic co-operation and devlopment (OECD). Power purchasing parities and exchange rates. http://www.oecd.org/

46 Patel A, Rendu A, Moran P, et al. A comparison of two methods of collecting economic data in primary care. Fam Pract 2005;22:323–7. doi:10.1093/fampra/cmi027

Page 21 of 28


BMJ

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


nly


Table 1: Socio-demographic and clinical characteristics of the sample. Variable BDD-NET

(N=47) Supportive therapy (N=47)

Gender Women 39 (83%) 41 (87%) Men 8 (17%) 6 (13%)

Age Mean age (SD) 33.87 (13.55) 31.32 (11.12) Min-max 18-72 19-66

Highest

education

Primary school 4 (9%) 6 (13%) High school 31 (66%) 23 (49%) College/university 11 (23%) 17 (36%) Doctorate 1 (2%) 1 (2%)

Occupational

status

Working 25 (53%) 28 (60%) Student 13 (28%) 10 (21%) Retired 2 (4%) 1 (2%) Unemployed 7 (15%) 6 (13%)

Disability pension 0 (0%) 2 (4%)

BDD-YBOCS Mean score (SD) 29.13 (5.02) 28.51 (4.56)

Min-max 20-40 20-42

Insight Good 19 (40%) 18 (38%)

Poor 22 (47%) 21 (45%)

Delusional 6 (13%) 8 (17%)

BDD duration Median length in years 16 16 Body areas of

concern

Mean number of body areas (SD) 8.17 (4.83) 7.4 (4.53)

Comorbidity

Current depressive episode 28 (60%) 23 (49%) Panic disorder 2 (4%) 0 (0%) Social anxiety disorder 15 (32%) 14 (30%) Generalized anxiety disorder 9 (19%) 9 (19%) Bulimia nervosa 2 (4%) 2 (4%) Attention deficit hyperactivity disorder

1 (2%) 1 (2%)

Obsessive-compulsive disorder 8 (17%) 3 (6%)

Current

medication SSRI 5 (11%) 8 (17%) SNRI 1 (2%) 1 (2%) Other antidepressants 4 (9%) 4 (9%) Mood stabilizers 3 (6%) 1 (2%)

Benzodiazepines 3 (6%) 0 (0%) Neuroleptics 2 (4%) 0 (0%) Methylphenidate 1 (2%) 1 (2%)

Plastic surgery Previous plastic surgery 13 (28%) 8 (17%) Mean no. of surgeries (SD) 2.61 (1.89) 1.88 (1.36) Min-max no. of surgeries 1-6 1-5

Abbreviations: BDD-NET, Internet-based Cognitive Behaviour Therapy for Body Dysmorphic Disorder; BDD-YBOCS, Yale-Brown Obsessive Compulsive Scale Modified for BDD, BDD, Body Dysmorphic Disorder; SSRI, Selective Serotonin Reuptake Inhibitors; SNRI, Serotonin–Norepinephrine Reuptake Inhibitors.

Page 22 of 28


BMJ

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


nly


Table 2: Predicted means and treatment effects (BDD-NET vs. supportive therapy) at baseline, post-treatment, and 3-month follow-up.

Outcome Predicted mean (SE) Treatment

effect 95% CI P

Effect size*

BDD-NET ST

BDD-YBOCS

Baseline 29.13 (0.94) 28.51 (0.94) – – – – Post-treatment 19.94 (0.94) 26.64 (0.94) –6.70 –9.31 to –4.10 <.001 0.95 Follow-up 19.45 (0.98) 25.29 (0.95) –5.84 –8.51 to –3.17 <.001 0.87 MADRS-S Baseline 18.92 (1.36) 18.83 (1.32) – – – – Post-treatment 13.85 (1.37) 18.30 (1.36) –4.45 –8.24 to –0.66 0.021 0.43 Follow-up 12.89 (1.46) 18.06 (1.38) –5.17 –9.11 to –1.23 0.010 0.58 GAF Baseline 55.32 (1.03) 57.32 (1.03) – – – – Post-treatment 62.97 (1.03) 57.89 (1.03) 5.07 2.22 to 7.93 <.001 0.68 Follow-up 63.20 (1.06) 58.03 (1.04) 5.17 2.27 to 8.07 <.001 0.71 EQ5D Baseline 0.71 (0.03) 0.75 (0.03) – – – – Post-treatment 0.73 (0.03) 0.67 (0.03) 0.05 –0.04 to 1.47 0.255 0.21 Follow-up 0.80 (0.04) 0.67 (0.03) 0.13 0.03 to 0.23 0.011 0.53 *Cohen’s d effect sizes calculated from observed data. BDD-NET, Internet-based cognitive behavioural therapy for body dysmorphic disorder; ST, supportive therapy; BDD-YBOCS, Yale-Brown obsessive compulsive scale modified for body dysmorphic disorder, MADRS-S; Montgomery-Åsberg depression rating scale – self report; GAF, Global assessment of functioning; EQ5D, EuroQol EQ5D. SE, standard error; CI, confidence interval.

Table 3: Mean societal costs in sterling pound (extrapolated to a 6-month period)

Baseline Post-treatment Follow-up BDD-NET (SD) Control (SD) BDD-NET (SD) Control (SD) BDD-NET (SD) Control (SD)

Direct medical 1168 (2445) 2007 (3889) 894 (1900) 885 (1610) 706 (1158) 538 (912)

Health care visits

1036 (2405) 1932 (3800) 773 (1760) 742 (1480) 633 (1037) 507 (896)

Medications 131 (357) 75 (113) 120 (325) 142 (735) 74 (231) 32 (60)

Direct non-

medical 129 (192) 102 (238) 75 (207) 49 (136) 82 (242) 90 (279)

Indirect non-

medical 1637 (3546) 1290 (2955) 920 (2001) 1282 (1705) 920 (2001) 1282 (1705)

Sick leave 740 (2418) 597 (2300) 274 (944) 467 (1245) 500 (2140) 285 (1185)

Work loss 631 (2212) 501 (1507) 385 (1175) 601 (1446) 339 (1173) 848 (1989)

Domestic 267 (700) 189 (529) 145 (309) 188 (342) 81 (177) 149 (285)

Total costs

(excl.

intervention

costs)

2935 (4844) 3397 (5525) 1775 (2831) 2192 (2705) 1710 (2831) 1911 (3329)

Therapist cost 325 (239) 158 (119) 325 (239) 158 (119)

Total costs

(incl. therapist

cost)

2935 (4844) 3397 (5525) 2100 (2865) 2350 (2758) 2090 (2891) 2076 (3347)

Abbreviations: BDD-NET, Internet-based Cognitive Behaviour Therapy for Body Dysmorphic Disorder; SD, Standard deviation.

Page 23 of 28


BMJ

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


nly

Figure 1: CONSORT flow diagram of study selection 168x211mm (300 x 300 DPI)

Page 24 of 28


BMJ

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


nly

Figure 2: Effect of treatment over time on the Yale-Brown Obsessive-Compulsive Scale modified for body dysmorphic disorder (BDD-YBOCS) with 95% confidence intervals.

Figure legend: Figure 2A depicts the predicted mean BDD-YBOCS scores at each time point with 95%

confidence intervals, broken down by treatment group. Figure 2B Depicts the predicted mean BDD-YBOCS scores with 95% confidence intervals of the participants that got crossed over to BDD-NET after the 3-

month follow-up. The 3-month follow-up was used as baseline (pre-treatment) and the participants were re-assessed after receiving 12 weeks of BDD-NET.

335x216mm (72 x 72 DPI)

Page 25 of 28


BMJ

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


nly

Figure 3: Cost-effectiveness acceptability curves: Quality-adjusted life years (QALY) and remission 173x86mm (300 x 300 DPI)

Page 26 of 28


BMJ

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


nly

Figure S1: Screen-shot of BDD-NET

173x106mm (300 x 300 DPI)

Page 27 of 28


BMJ

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


nlyTable S1: Cost tariffs for the most common types of health services

Type of visit Unit Cost (£) a

General practitioner Consultation 123

Clinical psychologist Session 108

Medical specialist Consultation 270

Physiotherapist Contact 48

Nurse Consultation 63

Alternative care b Session 39

Self-help group Hour 7

a Costs are in pound sterling (£) for 2013.

b Costs for alternative care vary. If unknown, the mean price of £7 per session was

used.

Page 28 of 28


BMJ

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960

BMJ...Mataix-Cols, Professor in child and adolescent psychiatric science 1 3, Linn Lichtenstein,...

Documents

Transcript of BMJ...Mataix-Cols, Professor in child and adolescent psychiatric science 1 3, Linn Lichtenstein,...