Aim: The SoREAL-trial aims to investigate the effect of group cognitive behavioural therapy (CBT-in vivo) versus group CBT with virtual reality exposure (CBT-in virtuo) for patients diagnosed with social anxiety disorder and/or agoraphobia, in mixed groups.
Methods and analysis: The design is an investigator-initiated randomised, assessor-blinded, parallel-group and superiority-designed clinical trial. Three hundred two patients diagnosed with social anxiety disorder and/or agoraphobia will be included from the regional mental health centres of Copenhagen and North Sealand and the Northern Region of Denmark. All patients will be offered a manual-based 14-week cognitive behavioural group treatment programme, including eight sessions with exposure therapy. Therapy groups will be centrally randomised with concealed allocation sequence to either CBT-in virtuo or CBT-in vivo. Patients will be assessed at baseline, post-treatment and 1-year follow-up by treatment blinded researchers and research assistants. The primary outcome will be diagnosis-specific symptoms measured with the Liebowitz Social Anxiety Scale for patients with social anxiety disorder and the Mobility Inventory for Agoraphobia for patients with agoraphobia. Secondary outcome measures will include depression symptoms, social functioning and patient satisfaction. Exploratory outcomes will be substance and alcohol use, working alliance and quality of life.
The study aimed to examine, in the long term, what aspects of Quality of Life (QoL) changed among social anxiety disorder (SAD) patients treated with group cognitive behaviour therapy (CBT) and what predictors at baseline were associated with QoL.
Fifty-seven outpatients were enrolled into group CBT for SAD, 48 completed the whole program, and 44 and 40 completed assessments at the 3-month and 12-month follow-ups, respectively. All aspects of SAD symptomatology and psychological subscales of the QoL showed statistically significant improvement throughout follow-ups for up to 12 months. In terms of social functioning, no statistically significant improvement was observed at either follow-up point except for post-treatment. No consistently significant pre-treatment predictors were observed.
After group CBT, SAD symptomatology and some aspects of QoL improved and this improvement was maintained for up to 12 months, but the social functioning domain did not prove any significant change statistically. Considering the limited effects of CBT on QoL, especially for social functioning, more powerful treatments are needed.
Social anxiety disorder (SAD), also known as social phobia, is one of the most common psychiatric disorders, with a 12-month and lifetime prevalence of 7%  and 12% , respectively. SAD typically begins during the early teenage years and has a chronic course . For example, prospective, long-term, naturalistic studies have indicated that only one-third of individuals attain remission from SAD within 8 years . People with SAD are also at great risk for comorbid depression [4, 5] and other anxiety disorders .
With regards to treatment for SAD, a large number of randomized controlled trials (RCTs) have investigated the efficacy of various types of pharmacotherapy and psychosocial intervention, and SAD is now regarded as a treatable condition . According to meta-analyses, selective serotonin reuptake inhibitors (SSRIs) had a mean effect size between 1.3 and 1.9 in symptomatology scales in comparison with placebo , while cognitive behavioural therapy (CBT) encompassing exposure therapy and cognitive restructuring had a mean effect size of 0.8 in comparison with waiting list control .
However, these studies have several limitations. First, studies on QoL in the longer term after psychosocial therapy are scarce, although SAD typically has a chronic course , and evaluations of treatment outcomes must consider the durability of gains after initial progress has been achieved. Second, QoL has often been reported by being aggregated into one [19, 21, 22] or two scales (mental health and physical health subscales) , but assessment of QoL has been reported that it should comprise at least the following four domains: physical functional status, disease and treatment-related physical symptoms, psychological functioning and social functioning . Actually, a previous study  investigating QoL domains Short Form 36  in college students reported those with social phobia were significantly associated with lower quality of life, particularly in general health, vitality, social functioning, role functioning-emotional, and mental health dimensions. Third, to date, predictors for better outcomes in QoL in the long-term after CBT have not been established, although several factors including sex and subtype of SAD were found to be associated with better outcomes in SAD symptomatology in one study .
All patients were diagnosed with DSM-IV SAD as the primary disorder using the Structured Clinical Interview for DSM-IV . All patients also fulfilled the following criteria: (a) absence of a history of psychosis or bipolar disorder or of current substance use disorder; (b) no previous CBT treatments and no any other additional structured psychosocial therapies during the treatment period; and (c) absence of Cluster B personality disorders. Patients with current major depressive disorder, other current anxiety disorders and Cluster A and C personality disorders were included, when these symptoms abated sufficiently to allow them to attend the group CBT sessions regularly, judged by their physicians.
The SPS and the SIAS  are 20-item self-report questionnaires. The SPS was designed to measure the fear of being observed, whereas the SIAS provides a measure of fear of social interaction. The items are rated on a 4-point scale from 0 (not at all characteristic or true of me) to 4 (extremely characteristic or true of me), with scores for each scale ranging from 0 to 80 and a higher score indicating a worse condition. Excellent internal consistency and reliability and sufficient predictive and concurrent validity have been demonstrated for both Japanese versions .
First, SAD symptomatology and some aspects of QoL did improve and these improvements were maintained for at least 12 months after group CBT. However, the improvement in the social functioning domain of the SF-36, which was noted post-treatment, was not maintained over the 12 months of follow-up.
Second, social functioning at follow-up through to 12 months was not always associated with improvements in SAD symptomatology, especially the SIAS. A previous study of group CBT concluded that QoL in one aggregated scale post-treatment was associated with the SIAS among patients diagnosed with social phobia .
The most striking finding of the current study may be that the social functioning domain, which is significantly impaired in patients with SAD in comparison with the general population , improved post-treatment, but the degree of improvement was very small (effect size on social functioning, 0.30) and was not maintained at follow-up, although scores of SAD symptomatology were much improved (effect size, around 1.0). Attention should be paid to this discrepancy between QoL and SAD symptomatology, because patients may judge the outcome of therapy based on their subjective feelings of QoL while clinicians may judge outcome based on diagnostic and symptom measures . A previous report concluded that group CBT led to significant improvement in the social functioning factor of a QoL scale in SAD patients , but the magnitude of this improvement was not reported. The effect size calculated by using pre- and post-treatment scores and pre-test standard deviations of the social functioning factor in the report was 0.40, which is similar to the value of the effect size in our study, so we should be cautious about concluding that CBT offers promising improvements in social functioning.
First, the study was conducted as a single-arm, naturalistic, follow-up study and was no control condition was used. An RCT with an appropriate control group is therefore needed to investigate the efficacy of treatment. Moreover, any antidepressant and benzodiazepine medications were allowed at baseline. The information about changes in dosing were not collected. Medications might have had an effect on the outcomes and this issue should be listed among limitations, although most of the patients had suffered from social anxiety disorders for more than 10 years and had already been on medication for a long time. However, this study was intended to examine the long-term consequences of CBT through naturalistic follow-up in a typical clinical setting. We believe that the study design is appropriate for this purpose.
Third, one may argue that, instead of the SPS and SIAS, a more frequently-used measure such as the Liebowitz Social Anxiety Scale (LSAS) should have been used to evaluate SAD symptomatology. The LSAS is a 24-item scale that provides separate scores for fear and avoidance of social interaction and performance situations, and the Japanese version has sufficient validity data . We did not use it because assessments at the follow-ups were done by patient self-evaluation and the LSAS requires an assessor. Although one paper reported data supporting the use of the LSAS as a self-reporting instrument , we were not willing to use the LSAS in an unconventional way because a self-reporting version has not yet been validated in Japan.
Symptomatology of SAD and some aspects of QoL improved, and these improvements were maintained for up to 12 months, after group CBT but the social functioning domain did not significantly change. Better treatments for SAD, focusing on improving social functioning, are needed in clinical practice.
There is a strong research imperative to investigate effective treatment options for adolescents and adults with autism spectrum disorder (ASD). Elevated social anxiety, difficulties with social functioning and poor mental health have all been identified as core treatment targets for this group. While theoretical models posit a strong bidirectionality between social anxiety and ASD social functioning deficits, few interventions have targeted both domains concurrently. Of the two group interventions previously conducted with adolescents and adults with ASD, significant results have only been observed in either social anxiety or social functioning, and have not generalised to changes in overall mood. The aim of this study was to evaluate the potential benefit, tolerability and acceptability of a group cognitive-behaviour therapy (CBT) intervention in young adults with ASD. Primary treatment outcomes were social anxiety symptoms and social functioning difficulties; secondary outcomes were self-reported mood and overall distress. 2b1af7f3a8