English

Instructions for Use

This information is intended for the correct use of Mindable: Social Phobia.

Please read this information carefully and follow the instructions contained therein.

For questions or problems, the Mindable team can be reached via the contact options listed below.

1. Intended Purpose

Mindable: Social Phobia is a digital health application intended for persons aged 18 and over who suffer from symptoms of social phobia. The application aims to support these individuals in managing their disorder and alleviating their symptoms. It is designed to provide appropriate disorder-relevant content, methods, and exercises based on established psychotherapeutic guidelines, approaches, and procedures.

The application can be used independently as a supplement to usual healthcare.

2. Minimum Age

The application is intended for affected persons aged 18 and over.

3. Indications

The application supports individuals with diagnosed symptoms of social phobia (ICD-10: F40.1).

Program Content & Functionality

The program implemented in the digital application is primarily based on recognized treatment methods of cognitive behavioral therapy (CBT).

It is based on the treatment manuals "Social Anxiety Disorder" (Stangier et al., 2016) and "Understanding and Changing Social Anxiety" (Hoyer, Härtling, & Sarnowsky, 2019) and was developed in close collaboration with the authors Prof. Dr. Stangier and Prof. Dr. Hoyer.

The application comprises several modules that build upon each other.

First, users are given relevant information about the disorder as well as the cognitive explanatory models. With the help of questionnaires and targeted questions, as also used in psychotherapy, users are guided to develop an individual disorder model (anxiety model), to question dysfunctional expectations and to identify and reflect on maintaining mechanisms of action.

In the exercise area of the application, attention training and behavioral experiments are guided for execution. On the one hand, users should learn through these exercises to direct their attention specifically, and on the other hand, users continuously practice the reduction of safety behaviors and self-attention, and question anxious predictions.

The aim is to give users a tool that supports them in dealing with their fears.

Furthermore, there is the possibility of self-assessment of the course of symptoms with the help of targeted queries. These are logged and presented for users in time-dependent progressions.

For support, if desired, users are encouraged through reminder functions and notifications to actively engage with the learning content, to perform the exercises regularly and to adhere to set exercise goals.

Users can export collected data in human- and machine-readable formats.

The processing of personal data is carried out in accordance with the EU General Data Protection Regulation. Further information on data protection can be found in the privacy policy.

The application can be used completely independently to bridge waiting times, alongside therapy, and also for relapse prevention.

Frequency & Duration of Use

To achieve long-term success, we recommend using the application intensively for at least 12 weeks. The program content of the application can be worked through at one's own pace.

During the period of use, we recommend using the application at least once a week and ideally daily.

Longer use is also recommended so that behavioral changes and lifestyle adjustments can become established.

Requirements for Use & Operation

The following points must be observed for use of the application:

I) Devices & Supported Operating Systems

The application can be used via a computer, laptop and/or a mobile device (smartphone, tablet) with internet access. Use requires a current operating system with manufacturer support (Windows, macOS, Linux, iOS, Android), and on mobile devices only with an unmodified operating system (not rooted or jailbroken).

Use takes place via a web browser or, alternatively, via the Mindable Platform App:

Browser: The application is available via the common browsers (Google Chrome, Mozilla Firefox, Microsoft Edge or Apple Safari) in their respective current versions. Trouble-free operation with unsupported or outdated browser versions cannot be guaranteed.
Platform App: Alternatively, the compatible Mindable Platform App can be downloaded, through which the application can also be used.

An overview of supported operating systems, minimum requirements and information on compatibility can be found at: www.mindable.health/impressum

In order to read the electronic instructions for use (eIFU), a current internet browser is required. To save and print in PDF format, a PDF viewer is required.

II) Installation & Access

The application is directly accessible without installation via a browser on the Mindable Platform and via the Mindable Health website (www.mindable.health). Alternatively, the Mindable Platform App can be downloaded from the Google Playstore or the Apple App Store.

A one-time registration with account creation on the Mindable Platform is required for use. Registration is carried out with an email address and a self-chosen password. A valid email address is required for this. It does not need to identify the user by name. After registration, a confirmation email is sent. The email address must be verified once via the confirmation link contained therein.

An access code is required to access the program of the application. This is provided after purchase through Mindable Health or upon prescription via the statutory health insurance. Entering it activates a 90-day access, which then ends automatically. An extension is possible at any time and as often as desired by entering a new access code.

After activation, the application is available at any time via account login. For security reasons, it is recommended not to store login data in the browser, to actively log out after each use, and to close all browser windows. A logout is performed automatically after prolonged inactivity.

III) Use & Operation

During use of the application, a stable internet connection is required regardless of the access path (browser or platform app). Download rate of at least 1 Mbit/s for texts/exercises (≈ 3G), at least 5 Mbit/s for videos (recommended: 4G/LTE or Wi-Fi). 2G/EDGE is not suitable.

It is recommended to use only trusted networks. Data transmission is encrypted. Mindable Health takes protective measures against unauthorized access and modification.

It is recommended to use the application only on your own devices. On shared devices, the additional use of private mode (incognito mode) is recommended.

During use, a Video Experiment can optionally be carried out. Camera and microphone access are required. These permissions can be adjusted at any time in the device or browser settings.

The application is continuously maintained and updated by the manufacturer. Updates take place automatically in the background, as the application is provided via the internet, regardless of the chosen access path. For secure use, it is recommended to keep the device, the operating system and the browser always up to date and to activate automatic updates.

IV) End of Use

Access to the application ends automatically after the activated period has expired or can be manually deleted at any time in the settings. In the case of manual deletion, use ends immediately, regardless of the length of the activated period.

A continuation of the program is possible for a limited time after login and entry of a new access code. Without re-entering a new access code, there is no full access to the program of the application, and final deletion is initiated. Notifications regarding the upcoming final deletion are sent to the registered email address.

The specific deletion deadlines are described in the privacy policy (see settings).

Before deletion we recommend exporting collected data. Recovery is no longer possible after final deletion.

Optional Additional Function:

After the access to the application has expired, the Relapse Prevention Mode is optionally available free of charge. This mode with a limited range of functions makes it possible to view previous progress, export collected data, track the further symptom progression through regular checkups and, in case of a relapse, easily return to full use (e.g. upon receipt of a new access code).

The Relapse Prevention Mode can be particularly relevant when program use is not or only partially possible for a longer period of time, or when the complete transfer of what has been learned into everyday life is to be tested without program support. The mode can be activated upon consent at the end of the activated period or at any time in the application settings.

When using the Mindable Platform App:

The Mindable Platform App can be removed from the device and reinstalled at any time without losing account, program access or collected data. After re-logging in, program progress and all collected data are available again. The deletion deadlines of the application continue to apply.

V) Languages

The application is available in three languages (German, English, French). Good knowledge of one of the available languages is required.

Clinical Benefit

As a medical device, the application can contribute to reducing the severity of symptoms of social phobia.

Contraindications

When should the application not be used?

The application must not be used in the presence of suicidal risk or acute self-harming tendencies.

Clarification: Suicidal risk applies if there has been a serious intention to take one's own life within the last 90 days (regardless of whether a concrete plan for implementation existed).

Safety Information & Side Effects

It may happen that not every user can achieve a relief of symptoms with the program of the application. This may possibly trigger a feeling of disappointment.

Engaging with distressing topics can be burdensome. If the burden within the program use is felt to be too great, the application should be paused immediately, program use should be suspended for some time, and the treating physician / psychotherapist should be contacted.

Not every exercise is equally suitable for every user. If an exercise causes difficulties or is felt to be impairing, this exercise should not be continued and the treating physician / psychotherapist should be contacted. It is further recommended, in the presence of one or more severe underlying health conditions, such as chronic cardiovascular disease, to discuss the suitability of the application in advance with the treating physician / psychotherapist.

Should one of the following cases occur during use, the treating physician / psychotherapist should be sought out immediately:

if suicidal thoughts or thoughts of inflicting harm on oneself acutely arise or occur

Note: This may occur as a symptom of a mental illness.
if no improvement of the mental condition of the users occurs over an extended period or if it acutely deteriorates

Note: Initial slight deteriorations are entirely normal. An improvement should be observable with regular use after approximately 4 weeks.

Should unknown side effects occur in connection with the use of the application, please immediately contact the treating physician / psychotherapist and the Mindable team at: support@mindable.health (see further contact options listed below).

Interactions

With simultaneous use of sedating substances, such as benzodiazepines (e.g. alprazolam, clonazepam, diazepam, lorazepam), alcohol or drugs, and the performance of behavioral experiments, the effects can cancel each other out. The central-depressant effect of these substances counteracts the conscious experience of the anxiety reaction in exercises and behavioral experiments. It is therefore not recommended to use the application under the influence of such substances.

Please contact the treating physician / psychotherapist to inform yourself about possible interactions.

Emergency Information

In case of suicide risk, acute crises or emergencies, contact the treating physician / psychotherapist immediately or call the emergency and crisis hotline numbers applicable in the country.

European emergency call: 112

Further country-specific crisis hotline numbers can be found at: findahelpline.com

Contact Information

For technical questions, please contact us by email at: support@mindable.health

Further information and contact options can be found on our website (www.mindable.health).