Variations of Anonymity, Transparency, and Efficacy in Digital Health Applications
NCT Number: NCT06465589
Acronym: PRIVATE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Social Anxiety
Interventions: OTHER: JOURNeY anonymous|OTHER: JOURNeY standard
Sponsor: University of Bern
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 452
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-02-28
Locations: University Bern, Clinical Psychology and Psychotherapy Department, Bern, 3012, Switzerland

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.

Primary Outcome Measures: Social Anxiety Symptoms, Change from baseline in the composite score of two self-report social anxiety questionnaires measuring various symptoms from time pre to time post (Social Phobia Scale \& Social Interaction Anxiety Scale; SPS \& SIAS). The scales contain a total of 40 items resulting in scores of 0 to 160 with higher scores indicating more severe social anxiety symptoms. The composite score will be the averaged z-score of both questionnaires., at baseline, 8 Weeks
Secondary Outcome Measures: Social Anxiety Symptoms, Change in the composite score and individual scores of two self-report social anxiety questionnaires measuring various symptoms from time pre to time post and follow-up (Social Phobia Scale \& Social Interaction Anxiety Scale; SPS \& SIAS). The scales contain a total of 40 items resulting in scores of 0 to 160 with higher scores indicating more severe social anxiety symptoms. The composite score will be the averaged z-score of both questionnaires., at baseline, at 8 weeks, at 24 weeks|Depressive Symptoms, Changes in depressive symptoms measured with one self-report questionnaire from time pre to time post and follow-up (Patient Health Questionnaire; PHQ-9). This nine item questionnaire results in scores ranging from 0 to 27 with higher scores indicating more severe depressive symptoms., at baseline, at 8 weeks, at 24 weeks|Quality of Life, Changes in quality of Life measured with one self-report questionnaire from time pre to time post and follow-up (Short-Form Health Survey SF-12; SF-12). The twelve items measure quality of life on the two subscales physical and mental aspects. Scores range from 0 to 100 with higher scores indicating higher quality of life., at baseline, at 8 weeks, at 24 weeks|Internalized Stigma, Changes in internalized stigma of mental illnesses measured with one self-report questionnaire from time pre to time post and follow-up (Internalized Stigma of Mental Illness Scale; ISMI). It has 29 items and measures stigma on the five subscales alienation, stereotype endorsement, discrimination experience, social withdrawal, and stigma resistance. Overall scores range from 29 to 116 with higher scores indicating higher internalized stigma., at baseline, at 8 weeks, at 24 weeks|Attitudes Towards Help-Seeking, Changes of attitudes towards seeking mental health services measured with one self-report questionnaire from time pre to time post and follow-up (Inventory of Attitudes Towards Seeking Mental Health Services; IASMHS). The questionnaire has 24 items with the three subscales psychological openness, help-seeking propensity, and indifference to stigma. Scores range from 0 to 20 for each subscale. For psychological openness and help seeking propensity, higher scores indicate more positive attitudes towards help-seeking. For stigma indifference, higher scores indicate less concern about stigma associated with help-seeking., at baseline, at 8 weeks, at 24 weeks|Personality Functioning, Changes in personality functioning measured with one self-report questionnaire from time pre to time post and follow-up (Level of Personality Functioning Scale-Brief Form 2.0; LPFS-BF). This 12-item questionnaire measures personality functioning with the two domains self (subscales: identity and self-direction) and interpersonal (subscales: empathy and intimacy) functioning. Overall scores range from 12 to 48 with higher scores indicating more severe impairment in personality functioning., at baseline, at 8 weeks, at 24 weeks