Therapist-Guided Internet-Delivered Cognitive Behavioral Therapy
vs Internet-Delivered Supportive Therapy for Children and Adolescents
With Social Anxiety Disorder
A Randomized Clinical Trial
Martina Nordh, PhD; Tove Wahlund, PhD; Maral Jolstedt, PhD; Hanna Sahlin, PhD; Johan Bjureberg, PhD; Johan Ahlen, PhD; Maria Lalouni, PhD; Sigrid Salomonsson, PhD; Sarah Vigerland, PhD; Malin Lavner, MSc; Lars-Göran Öst, PhD;
Fabian Lenhard, PhD; Hugo Hesser, PhD; David Mataix-Cols, PhD; Jens Högström, PhD; Eva Serlachius, MD, PhD
IMPORTANCESocial anxiety disorder (SAD) is a prevalent childhood-onset disorder associated with lifelong adversity and high costs for the individual and society at large. Cognitive behavioral therapy (CBT) is an established evidence-based treatment for SAD, but its availability is limited.
OBJECTIVETo assess the efficacy and cost-effectiveness of therapist-guided internet-delivered cognitive behavioral therapy (ICBT) for SAD in youths vs an active comparator, internet-delivered supportive therapy (ISUPPORT).
DESIGN, SETTING, AND PARTICIPANTSThis single-masked, superiority randomized clinical trial enrolled participants at a clinical research unit integrated within the child and adolescent mental health services in Stockholm, Sweden, from September 1, 2017, to October 31, 2018. The final participant reached the 3-month follow-up (primary end point) in May 2019. Children and adolescents 10 to 17 years of age with a principal diagnosis of SAD and their parents were included in the study.
INTERVENTIONSICBT and ISUPPORT, both including 10 online modules, 5 separate parental modules, and 3 video call sessions with a therapist.
MAIN OUTCOMES AND MEASURESThe Clinician Severity Rating (CSR), derived from the Anxiety Disorder Interview Schedule, rated by masked assessors 3 months after the end of treatment. The CSR ranges from 0 to 8, with scores of 4 or higher indicating caseness. Secondary outcomes included masked assessor–rated diagnostic status of SAD and global functioning, child- and parent-reported social anxiety and depressive symptoms, and health-related costs. RESULTSOf the 307 youths assessed for eligibility, 103 were randomized to 10 weeks of therapist-guided ICBT (n = 51) or therapist-guided ISUPPORT (n = 52) for SAD. The sample consisted of 103 youths (mean [SD] age, 14.1 [2.1] years; 79 [77%] female). Internet-delivered cognitive behavioral therapy was significantly more efficacious than ISUPPORT in reducing the severity of SAD symptoms. Mean (SD) CSR scores for ICBT at baseline and at the 3-month follow-up were 5.06 (0.95) and 3.96 (1.46), respectively, compared with 4.94 (0.94) and 4.48 (1.30) for ISUPPORT. There was a significant between-group effect size of d = 0.67 (95% CI, 0.21-1.12) at the 3-month follow-up. Similarly, all of the secondary outcome measures demonstrated significant differences with small to large effect sizes, except for child-rated quality of life (nonsignificant). The cost-effectiveness analyses indicated cost savings associated with ICBT compared with ISUPPORT, with the main drivers of the savings being lower medication costs (z = 2.38, P = .02) and increased school productivity (z = 1.99, P = .047) in the ICBT group. There was 1 suicide attempt in the ISUPPORT group; no other serious adverse events occurred in either group.
CONCLUSIONS AND RELEVANCEIn this randomized clinical trial, internet-delivered cognitive behavioral therapy was an efficacious and cost-effective intervention for children and adolescents with SAD. Implementation in clinical practice could markedly increase the availability of effective interventions for SAD.
TRIAL REGISTRATIONClinicalTrials.gov Identifier:NCT03247075 JAMA Psychiatry. doi:10.1001/jamapsychiatry.2021.0469
Published online May 12, 2021.
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Author Affiliations: Author affiliations are listed at the end of this article.
Corresponding Author: Martina Nordh, PhD, Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet and Stockholm Health Care Services, Region Stockholm, CAP Research Centre, Gävlegatan 22, SE-113 30, Stockholm, Sweden (martina.nord@ ki.se).
S
ocial anxiety disorder (SAD) is a prevalent childhood-onset disorder associated with lifelong impairment and high societal costs.1,2Cognitive behavioral therapy (CBT) is effective for children and adolescents with SAD3
and is con-sidered the first-line treatment in clinical guidelines.4
How-ever, only approximately 10% of individuals with SAD have re-portedly ever been in contact with a health care professional about their social fears, and few have received an effective treatment.5,6Barriers to treatment access include low
avail-ability of trained therapists, high treatment costs, long dis-tances to clinics, and the nature of the social anxiety symp-toms themselves, which makes it difficult for the individual to seek help.7
The digital revolution has brought great opportunities to increase access to evidence-based treatments for mental disorders.8There is increasing support for the efficacy of
tech-nology-delivered CBT for anxiety disorders in youths, with ef-fect sizes in the moderate to large range compared with wait-list controls.9,10The efficacy of internet-delivered CBT (ICBT)
for adults with SAD has been well established,11but only 1 large
randomized clinical trial of ICBT for youths specifically tar-geting SAD has been conducted, comparing a generic ICBT pro-gram suitable for all childhood anxiety disorders and a SAD-specific ICBT program with a waitlist control. Both active treatments were significantly more effective than the waitlist control, but no significant difference was observed between the 2 active treatments.12
To our knowledge, no study evalu-ating ICBT for SAD has yet used an active comparator, which is essential to distill the true effect of a behavioral interven-tion beyond the effects of practiinterven-tioner atteninterven-tion and frequent monitoring and reporting of symptoms.13
Furthermore, no for-mal health economic evaluations of ICBT for SAD in youths have previously been conducted. Cost-effectiveness analy-ses are important when evaluating new interventions to guide policy makers on how to best allocate resources.8This trial
aimed to evaluate the efficacy and cost-effectiveness of thera-pist-guided ICBT for youths with SAD compared with an ac-tive comparator. We hypothesized that ICBT would be more efficacious and cost-effective than the active comparator.
Methods
Study Design
This single-masked randomized clinical trial (RCT) compared therapist-guided ICBT with therapist-guided internet-delivered supportive therapy (ISUPPORT) for children and ado-lescents (10-17 years of age) with a principal diagnosis of SAD. The trial was conducted at a clinical research unit integrated within the Child and Adolescent Mental Health Services in Stockholm, Sweden. Recruitment took place from Septem-ber 1, 2017, to OctoSeptem-ber 31, 2018. Participants (N = 103) were ran-domized to 10 weeks of ICBT (n = 51) or ISUPPORT (n = 52). The primary end point was set to 3 months after the treatment pe-riod (May 2019) because of a previously observed tendency for participants in ICBT trials to report continued improvement beyond treatment termination.14,15Participants randomized
to ISUPPORT were offered ICBT after the 3-month follow-up.
The trial was approved by the Stockholm Regional Ethical Review Board and publicly registered. Following the Swedish law, younger participants (10-14 years of age) provided verbal assent, whereas older participants (15-17 years of age) and their parents provided written consent. The trial protocol can be found inSupplement 1. Moderation and mediation analyses described in the trial protocol, as well as results from the ge-netic part of the study, will be reported separately. This study followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline.
Participants
Referrals from health care professionals and self-referrals from families living anywhere in Sweden were accepted. The trial was advertised at the Child and Adolescent Mental Health Services clinics in Stockholm, Sweden, in newspapers, and on social media. Inclusion criteria were as follows: a principal di-agnosis of SAD according to the DSM-516
criteria; age of 10 to 17 years; ability to read and write Swedish; access to the inter-net; a parent able to coparticipate in the treatment; and if tak-ing psychotropic medication, havtak-ing been taktak-ing a stable dose for 6 weeks or more before enrollment. Exclusion criteria were as follows: diagnosed autism spectrum disorder, psychosis, bi-polar disorder, or severe eating disorder; high risk of suicide; ongoing alcohol or substance abuse; and having received CBT for any anxiety disorder within the last 6 months (defined as ≥5 sessions of CBT including in vivo exposure). Table 1 gives the baseline demographic and clinical characteristics of the participants.
Procedures
The inclusion procedure consisted of 2 steps: an initial tele-phone screening and a face-to-face assessment at the clinic. Figure 1 is the CONSORT flowchart. During the face-to-face as-sessment, a trained psychologist (M.N., T.W., M.J., M.L., and J.H.) administered the Anxiety Disorders Interview Schedule, Child Version (ADIS-C)17
jointly with young persons and their parents to ascertain the presence of a diagnosis of SAD or any comorbid disorders according to the DSM-5.16Verbal and
writ-ten information was provided to the youths and the parents.
Key Points
QuestionIs internet-delivered cognitive behavioral therapy (ICBT) an efficacious and cost-effective treatment for youths with social anxiety disorder (SAD)?
FindingsIn this randomized clinical trial of 103 children and adolescents with a principal diagnosis of SAD and their parents, a 10-week course of ICBT was efficacious and cost-effective compared with an active comparator.
MeaningInternet-delivered cognitive behavioral therapy has the potential to overcome common treatment barriers and increase the availability of evidence-based psychological treatments for young people with SAD; policy makers could consider ICBT with minimal therapist support a promising, low-intensity treatment for children and adolescents with SAD.
The ADIS-C diagnostic interview and child- and parent-report measures were administered before treatment, after treat-ment (10 weeks), and at 3-month follow-up (22 weeks). Trained psychologists masked to treatment allocation conducted the posttreatment and 3-month follow-up assessments.
The random allocation sequence was generated by an in-dependent clinical trials unit, the Karolinska Trial Alliance, in blocks of 4 or 6 and placed in opaque and sealed envelopes. The envelopes were managed by an independent administra-tor not otherwise involved in the study. An external observer from the Karolinska Trial Alliance also monitored the trial regu-larly (eMethods inSupplement 2).
Outcomes
The primary outcome measure was the masked Clinician Severity Rating (CSR) score derived from the ADIS-C
interview. The CSR ranges from 0 to 8, with scores of 4 or higher indicating caseness. Secondary outcomes included masked assessor–rated clinical improvement, presence of a SAD diagnosis, global function and treatment adherence, and a range of child- and parent-reported measures of social anxiety, psychopathology, global function, quality of life, treatment credibility, and costs (eMethods in Supple-ment 2). All child- and parent-report measures were admin-istered via a secure online platform (accessible via personal login, password, and a single-use code) at all time points. The complete lists of measures and assessment points are provided in eResults and eTables 1 and 2 inSupplement 2. Extensive measures were taken to ensure the reliability of measurements, integrity of the masked assessments, and fidelity to the treatment protocols (eMethods in Supple-ment 2).
Table 1. Baseline Sociodemographic and Clinical Characteristics of the Study Participants Assigned to ICBT or ISUPPORT
Characteristic ICBT (n = 51) ISUPPORT (n = 52) Total (N = 103) Female, No. (%) 41 (80) 38 (73) 79 (77) Male, No. (%) 10 (20) 14 (27) 24 (23) Age, mean (SD), y 13.6 (2.0) 14.5 (2.1) 14.1 (2.1)
Duration of SAD, mean (SD), y 6.2 (3.8) 5.5 (3.3) 5.9 (3.6) Previous treatmenta
SAD 12 (24) 17 (33) 29 (28)
Another disorder 27 (53) 29 (56) 56 (54)
No. of comorbid diagnoses
0 19 (37) 31 (60) 50 (49) 1 21 (41) 13 (25) 34 (33) 2 7 (14) 5 (10) 12 (12) ≥3 4 (8) 3 (6) 7 (7) Comorbid diagnoses Specific phobia 9 (17) 8 (16) 17 (17)
Generalized anxiety disorder 9 (17) 6 (12) 15 (15)
Major depressive disorder 7 (14) 4 (8) 11 (11)
ADHD/ADD 4 (8) 4 (8) 8 (8)
Dyslexia 3 (6) 2 (4) 5 (5)
Selective mutism 4 (8) 1 (2) 5 (5)
Panic disorder and/or agoraphobia 1 (2) 2 (4) 3 (3)
Separation anxiety disorder 2 (4) 0 2 (2)
OCD and related disorders (eg, BDD and tics) 2 (4) 1 (2) 3 (3) Medication
None 47 (92) 47 (90) 94 (91)
SSRI 2 (4) 1 (2) 3 (3)
Otherb 3 (6) 4 (8) 7 (7)
Parental level of educationc
<12 y 3 (6) 4 (8) 7 (7)
12 y 4 (8) 3 (6) 7 (7)
Undergraduate studies/university studies 10 (20) 17 (33) 27 (26)
Graduate degree 31 (61) 23 (44) 54 (52)
Postgraduate degree 3 (6) 5 (10) 8 (8)
Parental occupational statusc
Employed or self-employed 46 (90) 49 (94) 95 (92)
Otherd 5 (10) 3 (6) 8 (8)
Parental HADS score, mean (SD)c
Anxiety 7.24 (4.47) 5.37 (3.52) 6.29 (4.10)
Depression 4.06 (3.17) 3.15 (2.94) 3.60 (3.08)
Abbreviations:
ADHD/ADD, attention-deficit/ hyperactivity disorder; BDD, body dysmorphic disorder; HADS, Hospital Anxiety and Depression Scale; ICBT, internet-delivered cognitive behavioral therapy;
ISUPPORT, internet-delivered supportive therapy;
OCD, obsessive-compulsive disorder; SAD, social anxiety disorder; SSRI, selective serotonin reuptake inhibitor. a Psychological treatment. bPsychostimulants, hypnotics, or antihistamine. c
The parent mainly responsible for study participation.
dStudent, unemployed, retired, or on
Interventions
The therapist-guided ICBT program is a revised version of the treatment previously developed and piloted by our research group.18The main components are psychoeducation about
SAD, gradual exposure to social situations, social skills train-ing, focus shifting (from internal to external attention), reduc-tion of safety behaviors and avoidance, replacement of overly
negative thinking with adaptive thoughts, and construction of a plan for relapse prevention.
The active comparator ISUPPORT included psychoeduca-tion about SAD and informapsychoeduca-tion about healthy habits (such as the importance of physical activities) and interpersonal rela-tions (such as the significance friendships may have for one’s well-being). Mimicking supportive therapy, ISUPPORT also Figure 1. Study Flowchart
307 Applied for study
24 Excluded 24 Unreachable 283 Underwent telephone screening 136 Received baseline diagnostic interview 103 Randomized 147 Excluded 91 26 2 6 1 5 16 Declined participation or unreachable Diagnosed with ASD Suicidal or other severe disorder CBT in past 6 mo or ongoing Unstable medication use Not 10-17 y of age SAD not primary or subclinical
33 Excluded 7 3 1 22 Declined participation Suicidal CBT in past 6 mo
SAD not primary or subclinical
51 Randomized to 10 wk of
internet-delivered CBT and video call sessions
52 Randomized to 10 wk of
internet-delivered supportive therapy and video call sessions
51 Received postintervention assessment 49
2
Provided data Lost to follow-up
52 Received postintervention assessment 52
0
Provided data Lost to follow-up
51 Received 3-mo follow-up assessment 49
2
Provided data Lost to follow-up
52 Received 3-mo follow-up assessment 50 2 Provided data Lost to follow-up 51 Analyzed 52 Analyzed 17 Excluded 4 11 1 1
Preferred regular CAMHS Declined ICBT Study dropout Reason not specified
35 Received 10 wk of internet-delivered
and video call sessions
35 Received postintervention assessment 32
3
Provided data Lost to follow-up
35 Received 3-mo follow-up assessment 30
5
Provided data Lost to follow-up
ASD indicates autism spectrum disorder; CAMHS, Child and Adolescent Mental Health Services; CBT, cognitive behavioral therapy; SAD, social anxiety disorder.
included encouragement from the therapists to generate and try strategies for handling challenging social situations and to continue to use strategies that the participant found helpful. Crucially, none of the key components thought to constitute the active elements of CBT for SAD (eg, exposure) were in-cluded.
In both conditions, three 20- to 30-minute video call ses-sions were provided at weeks 3, 5, and 7, and parents were pro-vided with parallel access to 5 specifically designed modules, which they accessed through a separate login to the secure on-line platform (eMethods inSupplement 2).
Dedicated therapists provided asynchronous support throughout the treatment in both groups. For a full descrip-tion of the secure online platform, the treatment content, and supporting therapists, see the eMethods and eTables 3 and 4 inSupplement 2.
Statistical Analysis
The power calculation was made in G*power19(assuming
re-peated measures with within-between interaction). A recent trial14comparing ICBT with an active comparator for mixed
anxiety disorders in children found a between-group effect size of d = 0.77. However, SAD may be more challenging to treat than other kinds of anxiety disorders20; thus, we opted for a
more conservative estimate of effect size (d = 0.40). A sample size of 101 was calculated to be sufficient using a power of 85%, with a 2-tailed α = .05 and assuming a maximum dropout rate of 10%.
Following the intention-to-treat principle, the primary and secondary outcome analyses included all participants who were randomized. Continuous variables measured at the 3 as-sessment points (before treatment, after treatment, and 3-month follow-up) were analyzed with linear mixed models with subject-specific intercepts and slopes (random effects), fitted with full maximum likelihood. Linear mixed models use all available data, account for dependence among repeated ob-servations, and provide unbiased estimates in the presence of missing information under a fairly unrestrictive assumption.21
Estimates of population mean effect of time and differential change over time as a function of treatment group were de-termined with a fixed time and time × group interaction ef-fects (with Satterthwaite approximation for denominator de-grees of freedom). As a secondary categorical outcome, we estimated the probability that participants in either group would no longer meet diagnostic criteria for SAD at the 3-month follow-up, using a logistic regression analysis, fitted with maxi-mum likelihood with nonnormality robust SEs.
On the basis of model estimates, we computed effect sizes in the form of standardized mean difference between-group effect size (Cohen d) for continuous variables and odds ratio (OR) for the categorical variable (ie, remission). The α level was set to P < .05 (2-tailed).
Costs were estimated using the Trimbos/iMTA Question-naire for Costs Associated With Psychiatric Illness–Parent Version22
unit cost frequencies multiplied by unit costs (eTables 8 and 9 inSupplement 2). Treatment costs for ICBT and ISUPPORT were estimated from treatment time in hours (for written therapist feedback, video calls, and telephone calls)
(eTable 5 inSupplement 2) multiplied by the mean psycholo-gist salary in Sweden (SEK 41 000/month [$4476], reference year 2019). Cost differences at baseline were analyzed using the Wilcoxon rank sum test. Costs were accumulated from pre-treatment until the 3-month follow-up. All costs were con-verted into euros, with the reference year July 2018 to June 2019 and according to the European Central Bank’s conver-sion rate (10.4523 SEK = €1, $1.1412). Cost-effectiveness analy-ses were conducted using diagnostic status as the health out-come as well as a cost-utility analysis using Child Health Utility 9D23for estimation of quality-adjusted life-years. Both
analy-ses were conducted from the societal perspective, including all available costs, as well as from the health care profes-sional perspective, including treatment costs (eMethods in Supplement 2). As a global estimate of cost-effectiveness, in-cremental cost-effectiveness ratios were calculated as follows: (Cost of ICBT – Cost of ISUPPORT)/(Effect of ICBT – Effect of ISUPPORT). Additional details about the statistical analyses, including sensitivity analyses, are described in the eMethods inSupplement 2.
Results
The sample consisted of 103 youths (mean [SD] age, 14.1 [2.1] years; 79 [77%] female). Table 2 presents the results from the linear mixed models for the primary and secondary outcome measures. The main effect of time was statistically signifi-cant for all continuous variables, indicating improvement over time across groups. The within-group effect sizes for the pri-mary outcome measure (CSR scores) from before treatment to the primary end point were large (d = 1.24) for ICBT and mod-erate (d = 0.52) for ISUPPORT. Mean (SD) CSR scores for ICBT at baseline and at the 3-month follow-up were 5.06 (0.95) and 3.96 (1.46), respectively, compared with 4.94 (0.94) and 4.48 (1.30) for ISUPPORT. We observed a statistically significant time × group interaction effect (β [SE] = −0.27 [0.09]; P = .005), with a model-implied between-group effect size of moderate strength for the primary outcome measure (CSR) (d = 0.67; 95% CI, 0.21-1.12) at the primary end point, favoring ICBT (Figure 2). Statistically significant time × group interaction effects were also observed on all continuous secondary outcomes, with the only exception being quality of life (Child Health Utility 9D) (β [SE] = −0.58 [0.51]; P = .26). In all cases, results favored ICBT, and most between-group effect sizes at 3-month follow-up were in the moderate range (d = 0.64; 95% CI, 0.27-1.01 for child-reported SAD symptoms; d = 0.83; 95% CI, 0.43-1.22 for parent-reported SAD symptoms; d = 0.47; 95% CI, 0.07-0.88 for child-reported depressive symptoms; d = 0.78; 95% CI, 0.38-1.17 for parent-reported anxiety and depressive symp-toms; d = 0.39; 95% CI, 0.03-0.74 for masked assessor– reported global functioning; and d = 0.48; 95% CI, 0.08-0.89 for parent-reported general functioning) (Table 2). For com-pleteness, we report the outcomes from the posttreatment as-sessment in eTable 6 inSupplement 2and the results for par-ticipants crossing over from ISUPPORT to ICBT after the 3-month follow-up in the eResults and eTable 7 in Supple-ment 2.
The observed proportion of SAD-free participants was larger in the ICBT group than in the ISUPPORT group at the 3-month follow-up (30.6% vs 18.0%). However, the differ-ence was not statistically significant (OR, 2.44; 95% CI, 0.88-6.75; P = .09). Treatment completion, adherence, satisfac-tion, and credibility are reported in the eResults and eTable 5 inSupplement 2.
The interrater reliability was excellent for the CSR before treatment (intraclass correlation coefficient = 0.91; 95% CI, 0.55-0.97) and very good for the presence of a SAD diagnosis before treatment (κ = 0.86). Treatment fidelity during the video call sessions was excellent because the external assessors noted no protocol violations. Masking integrity checks found that masked assessors were slightly better than chance at
guess-ing the participants’ group allocation, but no significant dif-ference was found in SAD severity at the 3-month follow-up between participants whose group allocation was guessed cor-rectly compared with those whose allocation was guessed incorrectly (t96= 0.12, P = .91). For more details, see the
eResults inSupplement 2.
One suicide attempt was reported and managed in ISUP-PORT. No other serious adverse events were reported in either condition (eResults inSupplement 2).
Before treatment, no statistically significant between-group difference was found in health-related costs (eg, health care consumption and school absenteeism) (z = 0.77, P = .44). During the period from before treatment to 3-month follow-up, the average societal cost was €2426.2 (95% CI, €1805.7-Table 2. Results From the Linear Mixed-Effects Models and Effect Sizes at the 3-Month Follow-upa
Outcome
ICBT ISUPPORT Linear mixed model Unstandardized
mean difference (95% CI)
Effect size at 3-mo follow-up
No. Mean (SD) No. Mean (SD) β (SE) P value d (95% CI)
Masked assessor–rated SAD severity (CSR) Before treatment 51 5.06 (0.95) 52 4.94 (0.94) NA NA NA NA 3-mo Follow-up 49 3.96 (1.46) 50 4.48 (1.30) −0.27 (0.09) .005 −0.62 (−1.04 to −0.20) 0.67 (0.21 to 1.12) Child-reported SAD symptoms (LSAS-C) Before treatment 51 85.25 (24.54) 52 77.44 (28.45) NA NA NA NA 3-mo Follow-up 43 63.02 (28.69) 43 75.93 (28.93) −6.99 (2.06) .001 −16.40 (−25.88 to −6.91) 0.64 (0.27 to 1.01) Parent-reported SAD symptoms (LSAS-P) Before treatment 51 96.22 (21.87) 52 86.02 (26.68) NA NA NA NA 3-mo Follow-up 45 70.38 (32.10) 51 82.10 (34.03) −8.72 (2.13) <.001 −20.46 (−30.25 to −10.67) 0.83 (0.43 to 1.22) Child-reported depressive symptoms (RCADS-C-dep) Before treatment 51 4.35 (3.07) 52 3.92 (2.71) NA NA NA NA 3-mo Follow-up 43 2.93 (3.07) 43 3.91 (3.08) −0.58 (0.25) .02 −1.36 (−2.53 to −0.19) 0.47 (0.07 to 0.88) Parent-reported
anxiety and depressive symptoms (RCADS-P) Before treatment 51 45.96 (17.20) 52 39.54 (14.89) NA NA NA NA 3-mo Follow-up 45 32.18 (20.01) 51 39.08 (20.38) −5.59 (1.45) <.001 −13.11 (−19.78 to −6.44) 0.78 (0.38 to 1.17) Masked assessor–rated global functioning (CGAS) Before treatment 51 54.51 (7.31) 52 56.96 (9.47) NA NA NA NA 3-mo Follow-up 49 59.45 (10.55) 50 58.88 (9.55) 1.38 (0.64) .03 3.26 (0.26 to 6.19) 0.39 (0.03 to 0.74) Parent-reported general functioning (WSAS-P) Before treatment 51 14.65 (7.14) 52 13.04 (6.96) NA NA NA NA 3-mo Follow-up 45 10.47 (8.47) 51 13.14 (9.06) −1.43 (0.62) .02 −3.35 (−6.18 to −0.53) 0.48 (0.08 to 0.89) Child-reported quality of life (CHU9D) Before treatment 51 12.69 (6.25) 52 12.71 (6.42) NA NA NA NA 3-mo Follow-up 43 8.70 (6.89) 43 10.35 (6.02) −0.58 (0.51) .26 −1.35 (−3.69 to 0.99) 0.21 (0.15 to 0.57) Abbreviations: CGAS, Children’s Global Assessment Scale; CHU9D, Child Health
Utility 9D; CSR, Clinician Severity Rating; ICBT, internet-delivered cognitive behavioral therapy; ISUPPORT, internet-delivered supportive therapy; LSAS-C, Liebowitz Social Anxiety Scale, Child Version; LSAS-P, Liebowitz Social Anxiety Scale, Parent Version; NA, not applicable; RCADS-C-dep, Revised Children’s Anxiety and Depression Scale, Child Version, depression; RCADS-P, Revised Children’s Anxiety and Depression Scale, Parent Version;
SAD, social anxiety disorder; WSAS-P, Work and Social Adjustment Scale, Parent Version.
aFixed-effects parameter estimates β (SE) represent the time × group
interaction for continuous outcomes, with all randomized individuals (n = 103). Positive effect sizes (d) indicate results favoring ICBT. Means (SDs) are observed values.
€3046.7) ($2768.80 [95% CI, $2060.70-$3476.90]) for the ICBT group and €3502.5 (95% CI, €2543.0-€4462.1) ($3997.10 [95% CI, $2902.10-$5092.10]) for the ISUPPORT group. The incre-mental cost-effectiveness ratio regarding total societal cost dif-ferences and difdif-ferences in remitter status was −€17 900.7 (95% CI, −€19 493.9 to −€16 307.5) (−$20 428.30 [95% CI, −$22 246.40 to −$18 610.10]), indicating that ICBT was asso-ciated with cost savings while generating more participants free of SAD compared with ISUPPORT. The cost-effectiveness plane for societal cost and diagnostic status differences is pre-sented in Figure 3. Subtotal cost analyses demonstrated that the main drivers of the cost differences between the groups were decreases in medication use (z = 2.38, P = .02) and de-creases of school productivity losses (z = 1.99, P = .047) in the ICBT group (eFigure 4 inSupplement 2). School productivity loss refers to days that the child attends school but performs suboptimally because of social anxiety (eResults in Supple-ment 2). Additional cost-effectiveness results are presented in eResults and eFigures 1, 2, and 3 inSupplement 2.
Discussion
In this randomized clinical trial, therapist-guided ICBT was sig-nificantly more efficacious than ISUPPORT in reducing social anxiety symptoms, as well as depression, anxiety, and func-tional impairment, with between-group effect sizes in the mod-erate range. From a societal perspective, ICBT was cost sav-ing, with the main drivers of the savings being explained by a greater decrease in medication use and an increase in school productivity for youths receiving ICBT compared with those receiving ISUPPORT. From a health care professional perspec-tive, ICBT was more costly because of longer mean therapist support times but also more effective than ISUPPORT. Only 1 serious adverse event was recorded (a suicide attempt in the ISUPPORT group).
The characteristics of the sample are similar to those in pre-vious face-to-face trials of CBT for SAD regarding age and sex composition,16
symptom severity,24,25
frequency of comor-bid disorders,26,27
and duration of SAD symptoms.28
For the ICBT group, a large within-group effect size was observed on the primary outcome measure, which is comparable to the re-sults of a previous ICBT trial.12
Child- and parent-reported symptoms of social anxiety were reduced by more than 25%, corresponding to a large effect. The proportion of SAD-free par-ticipants (30.6%) was similar to that of previous ICBT trials of youths12and adults29with SAD but lower than in previous
face-to-face CBT trials (approximately 50%-60%).26,30
Guided self-help treatments such as ICBT should not be regarded as a sub-stitute for the criterion standard face-to-face treatment but rather a low-intensity treatment to be deployed as a first step, thus freeing resources for young people who require more in-tensive treatments.
A previous ICBT trial14
of children with mixed anxiety dis-orders, including SAD, found that ICBT was cost-effective, with the main cost saving being reduced health care costs. In the current trial, the main cost savings originated from reduced medication use and increased school productivity (parent-reported measure of the child’s ability to perform on days when he/she is present in school).
Going forward, some modifications could be considered regarding, for example, treatment length and therapist sup-port. Because young persons with SAD seem to require more time to remit than those with other anxiety disorders, ICBT may require longer periods and/or intensified therapist sup-port. Furthermore, parental involvement in ICBT may be par-ticularly important for preadolescents and younger children to engage in the treatment.31
The optimal amount of thera-pist support and parental involvement in ICBT, in relation to child age, should be formally investigated. Identifying clini-cally useful variables associated with ICBT outcome would be valuable to identify and target more specific mechanisms that may be involved in the maintenance of SAD. In addition, dismantling studies are needed to better understand what components of ICBT contribute the most to the observed reduction of social anxiety. Because SAD often occurs with comorbid anxiety disorders (37% of youths in the current sample), it would also be important to compare disorder-specific forms with transdiagnostic forms of ICBT with regard to their efficacy on comorbid conditions. Furthermore, long-term follow-ups are warranted to establish the durability of the results. Participants in the current trial will be followed up 12 months after treatment, but the results will be pre-sented separately.
Strengths and Limitations
This study has several strengths. First, the use of an active com-parator effectively controlled for nonspecific aspects of treat-ment. Second, extensive measures were taken to ensure the reliability of the measurements, integrity of the masked as-sessments, and adherence to treatment protocols. Third, par-ticipant retention was high and data loss minimal (<4% miss-ing on the primary outcome measure). Fourth, the trial was externally monitored.
Figure 2. Mean Masked Assessor–Rated Severity of Social Anxiety Disorder
8 6 4 7 5 3 2 1 0 Clinician Se v erit y Rating Study period 3-mo Follow-up After treatment Before treatment ICBT ISUPPORT
Participants randomized to 10 weeks of internet-delivered cognitive behavioral therapy (ICBT) or internet-delivered supportive therapy (ISUPPORT). Error bars indicate SEs.
The study also has limitations. One is that most partici-pants were self-referred and could therefore have been more motivated to work with the mostly self-guided treatment com-pared with typical patients with SAD seen in Child and Adolescent Mental Health Services. Another limitation is that despite best efforts to mimic the format of the active treat-ment and to make the control treattreat-ment as convincing and rel-evant as possible, the comparator ISUPPORT was seen as some-what less credible than ICBT. The difference in credibility may have affected treatment expectations, although post hoc analy-ses (eResults inSupplement 2) found that credibility was not associated with the number of completed modules, total thera-pist time, change in CSR score, or diagnostic status at the 3-month follow-up. Thus, the slightly superior credibility
associated with ICBT did not seem to explain why partici-pants in this group improved more.
Conclusions
In this randomized clinical trial of children and adolescents with a principal diagnosis of SAD and their parents, a 10-week course of ICBT was efficacious and cost-effective compared with an active comparator. Internet-delivered cognitive behavioral therapy has the potential to overcome common treatment barriers and increase availability of evidence-based psychological treatments for this patient group.
ARTICLE INFORMATION
Accepted for Publication: February 22, 2021. Published Online: May 12, 2021.
doi:10.1001/jamapsychiatry.2021.0469 Open Access: This is an open access article distributed under the terms of theCC-BY License. © 2021 Nordh M et al. JAMA Psychiatry. Author Affiliations: Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet and Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden (Nordh, Wahlund, Jolstedt, Sahlin, Bjureberg, Ahlen, Lalouni, Salomonsson, Vigerland, Lavner, Lenhard, Mataix-Cols, Högström, Serlachius); Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden (Ahlen); Division of Neuro, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden (Lalouni); Department of Psychology, Stockholm University, Stockholm, Sweden (Öst); Center for Health and Medical Psychology, Örebro University, Örebro, Sweden (Hesser); Department of Behavioral Sciences and Learning, Linköping University, Linköping, Sweden (Hesser).
Author Contributions: Drs Högström and Serlachius contributed equally to this work and
share last authorship. Drs Nordh and Serlachius had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Nordh, Salomonsson, Lenhard, Mataix-Cols, Högström, Serlachius.
Acquisition, analysis, or interpretation of data: Nordh, Wahlund, Jolstedt, Sahlin, Bjureberg, Ahlen, Lalouni, Vigerland, Lavner, Öst, Lenhard, Hesser, Mataix-Cols, Högström, Serlachius.
Drafting of the manuscript: Nordh, Jolstedt, Lenhard, Hesser, Högström.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Nordh, Lenhard, Hesser. Obtained funding: Vigerland, Mataix-Cols, Serlachius.
Administrative, technical, or material support: Nordh, Wahlund, Jolstedt, Sahlin, Bjureberg, Ahlen, Lalouni, Salomonsson, Vigerland, Lavner, Högström, Serlachius.
Supervision: Nordh, Öst, Mataix-Cols, Högström, Serlachius.
Conflict of Interest Disclosures: Dr Mataix-Cols reported receiving personal fees from UpToDate, Wolters Kluwer Health, and Elsevier outside the submitted work. Dr Serlachius reported receiving
grants from the Swedish Research Council for Health, Working Life, and Welfare and Region Stockholm during the conduct of the study. No other disclosures were reported.
Funding/Support: This work was funded by grant Forte 2014-4052 from the Swedish Research Council for Health, Working Life, and Welfare and grant HNSV 14099 from Region Stockholm. Dr Högström was supported by grant K0173-2016 from Region Stockholm (clinical postdoctoral appointment: 2017-2020). Dr Serlachius was supported by Region Stockholm (clinical research appointment: 2017-0605).
Role of the Funder/Sponsor: The funding sources had no role in the design and conduct of the study; collection, management, analysis, and
interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Data Sharing Statement: SeeSupplement 3. Additional Contributions: Karin Sundström, MSc, and Viktor Eriksson, MSc, provided invaluable clinical work, Mathilde Annerstedt, MSc, assisted with participant assessments, and Malin Burman, BSc, provided administrative support. All were compensated with salaries funded by grant Figure 3. Cost-effectiveness Plane for Societal Cost and Diagnostic Status Differences
5000 2500 0 –2500 –5000 Difference in costs, €
Difference in effect (diagnosis free)
0 0.5 1.0 –1.0 –0.5
Northwest quadrant: ICBT more costly and less effective
Northeast quadrant: ICBT more costly and more effective
Southwest quadrant: ICBT less costly and less effective
Southeast quadrant: ICBT less costly and more effective
A concentration of dots in the southeast quadrant indicates a higher probability that internet-delivered cognitive behavioral therapy (ICBT) is more cost-effective than
internet-delivered supportive therapy (ISUPPORT); €1 = $1.1412.
2014-4052 from the Swedish Research Council for Health, Working Life, and Welfare and grant HNSV 14099 from Region Stockholm. We thank all participating families and Child and Adolescent Mental Health Services practitioners who made the study possible.
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