Variations of Anonymity, Transparency, and Efficacy in Digital Health Applications

Summary

Social Anxiety Disorder (SAD) is one of the most widespread mental illnesses and it has previously been shown that online therapy and online self-help tools such as the one investigated in this study can be successful in reducing not only symptoms of SAD but also symptoms of depression and increase the quality of life of participants. A substantial concern with digital health intervention tools is data security and privacy as many such tools have been found to be unsafe and easy targets for hacker attacks, potentially endangering personal (health) data of the users.

For this research project, an internet-based program targeting social anxiety has been developed that can be used completely anonymously (i.e., without collecting an email address or other information that can or could potentially identify users). This new anonymized version will be compared in a partially randomized patient preference trial with an already well-evaluated version in which, as is common in other digital health applications, personal data such as the email address or other information from the users is used, for example, for login.

Study objectives:

1. To investigate the efficacy of a completely anonymous version of the program "JOURNeY" based on cognitive behavioral therapy (CBT) and compare it to an already evidence-based non-anonymous version of the program regarding primary social anxiety symptoms, and secondary outcomes such as depressive symptoms, quality of life, usability, adherence to the program, internalized stigma, attitudes on help-seeking, and personality functioning.
2. To investigate patients' preferences and the influence of patients' preferences on outcome.
3. To explore how patient characteristics are associated with participants' preferences.

Conditions

• Social Anxiety

Interventions

OTHER

JOURNeY anonymous

The anonymously usable version of the self-help program JOURNeY which does not require a login and does not collect personal data. Includes 4 main components: 1. psychoeducation where participants learn about SAD and the treatment, 2. cognitive restructuring where participants challenge dysfunctional social cognitions, 3. attention training where participants learn to decrease self-focused attention, and 4. exposure where participants seek out and endure fear-inducing situations. Additionally, there is a first module which discusses motivation and a conclusion module which encourages participants to keep practicing and using techniques they learned in the program in their daily life.

OTHER

JOURNeY standard

The standard version of the self-help program JOURNeY which requires a login and collects personal data. Includes 4 main components: 1. psychoeducation where participants learn about SAD and the treatment, 2. cognitive restructuring where participants challenge dysfunctional social cognitions, 3. attention training where participants learn to decrease self-focused attention, and 4. exposure where participants seek out and endure fear-inducing situations. Additionally, there is a first module which discusses motivation and a conclusion module which encourages participants to keep practicing and using techniques they learned in the program in their daily life.

Sponsors & Collaborators

• University of Bern

  lead OTHER

Principal Investigators

• Thomas Berger, Prof. Dr. · University Bern, Clinical Psychology and Psychotherapy Department

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-03

Primary Completion

2026-03-02

Completion

2026-03-02

Countries

• Switzerland

Study Locations