STUDY PROTOCOL: EXPOSURE IN VIRTUAL REALITY FOR SOCIAL ANXIETY DISORDER - a randomized controlled superiority trial comparing cognitive behavioral therapy with virtual reality based exposure to cognitive behavioral therapy with in vivo exposure.

BACKGROUND: Social Anxiety Disorder (SAD) is characterized by an intense fear of negative judgement by others. Cognitive Behavioral Therapy (CBT) is recommended for treatment, but a substantial part of individuals with SAD either do not seek treatment or drop-out. CBT with Virtual Reality (VR)-based exposure has several advantages compared to traditional exposure methods, mainly due to increased control of situational elements. The aim of the current study is to develop a CBT program containing VR-based exposure. The intervention is targeted to adult patients suffering from SAD and treatment effect will be assessed by changes in SAD symptoms. METHODS: This article describes the study protocol of a Randomized Controlled Trial with three arms: 1) CBT with VR exposure based on 360° videos 2) CBT with in vivo exposure and 3) VR relaxation therapy. There will be 30 participants in each arm with a crossover at the end of the treatment period during which the participants in the third group will be randomly re-allocated to one of the two former groups. The treatment program consists of 10 weekly individual sessions with a psychologist, and a six month follow-up consisting of a questionnaire. The primary outcome measure is reduction in SAD symptoms which will be assessed with the Social Interaction Anxiety Scale (SIAS). DISCUSSION: There are currently no published studies on CBT with VR exposure based on 360° videos for SAD treatment. Furthermore, the current study will be the first Danish SAD treatment program that includes VR technology. TRIAL REGISTRATION: clinicaltrials.gov (NCT03973541) June 3rd 2019.

Blended Treatment for Alcohol Use Disorder (Blend-A): Explorative Mixed Methods Pilot and Feasibility Study.

BACKGROUND: In Denmark, approximately 150,000 people have alcohol use disorder (AUD). However, only approximately 10% seek AUD treatment, preferably outside conventional health care settings and opening hours. The AUD treatment area experiences low adherence to treatment, as well as high numbers of no-show and premature dropouts. OBJECTIVE: The purpose of the Blend-A (Blended Treatment for Alcohol Use Disorder) feasibility and pilot study was to describe the process of translating and adapting the Dutch treatment protocol into Danish and Danish culture with a high amount of user involvement and to report how patients and therapists perceived the adapted version, when trying it out. METHODS: The settings were 3 Danish public municipal outpatient alcohol clinics. Study participants were patients and therapists from the 3 settings. Data consisted of survey data from the System Usability Scale, individual patient interviews, and therapist group interviews. Statistical analyses were conducted using the Stata software and Excel. Qualitative analysis was conducted using a theoretical thematic analysis. RESULTS: The usability of the treatment platform was rated above average. The patients chose to use the blended treatment format because it ensured anonymity and had a flexible design. Platform use formed the basis of face-to-face sessions. The use of the self-determined platform resulted in a more thorough process. Patient involvement qualified development of a feasible system. Managerial support for time use was essential. Guidance from an experienced peer was useful. CONCLUSIONS: This study indicates that, during the processes of translating, adapting, and implementing blended, guided, internet-based, and face-to-face AUD treatment, it is relevant to focus on patient involvement, managerial support, and guidance from experienced peers. Owing to the discrete and flexible design of the blended offer, it appears that it may reach patient groups who would not otherwise have sought treatment. Therefore, blended treatment may increase access to treatment and contribute to reaching people affected by excessive alcohol use, who would not otherwise have sought treatment. In addition, it seems that the blended offer may enhance the participants' perceived satisfaction and the effect of the treatment course. Thus, it appears that Blend-A may be able to contribute to existing treatment offers. Such findings highlight the need to determine the actual effect of the Blend-A offer; therefore, an effectiveness study with a controlled design is warranted.