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

Social Anxiety Clinical Trial

— PRIVATE  

Official title:

PRIVATE - Preference Research: Investigating Variations of Anonymity, Transparency, and Efficacy in Digital Health Applications

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06465589
• Other study ID #: 2024-00842
• Secondary ID: 10002000SNCTP000
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 30, 2024
• Est. completion date: February 28, 2026

Study information

• Verified date: June 2024
• Source: University of Bern
• Contact: Stefanie Arnold, M. Sc
• Phone: +41 31 684 54 19
• Email: stefanie.arnold[@]unibe.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Social Anxiety Disorder (SAD) is one of the most widespread mental illnesses (Stein et al., 2017) 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 (Berger et al., 2011; Schulz et al., 2016; Stolz et al., 2018). A substantial concern with digital health intervention tools is data security and privacy (Batterham et al., 2023) as many such tools have been found to be unsafe and easy targets for hacker attacks, potentially endangering personal (health) data of the users (Wolfangel, 2023).

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). It is originally based on the well-established cognitive-behavioral treatment of social anxiety by Clark and Wells (1995). 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. The fully anonymized version has some disadvantages regarding usability and possibly also effectiveness, as no usage history can be stored, users cannot pick up where they left off during a new login, and instead of entering texts in diaries, for example, about anxiety-related thoughts within the program, they need to download a PDF, etc. On the other hand, the anonymized version has advantages regarding the low threshold for use and privacy. People who could benefit from such internet-based programs might be more likely to use them, as there are no data protection risks associated with their use, and a fully anonymized version could immediately be used even without entering an email address. Thus, the reach and impact of evidence-based digital tools for mental problems and disorders such as social anxiety (disorder) could be increased with an anonymous version. However, there are no studies on the effectiveness of digital tools which can be used anonymously and there is no knowledge about the preferences of users (e.g., is it important for users to be able to use an anonymous version, or do they prefer the non-anonymized version with a few practical advantages?).

Study objectives:

1. To investigate the efficacy of a completely anonymous version of the CBT-based program "JOURNeY" 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.

This study is part of a larger trial conducted with two departments at the University of Bern. One part assesses clinical research questions and the other part is concerned with psychology of digitalization which researches user behavior and concerns regarding privacy in digital health applications.

The study is a single-center partially randomized patient preference trial and for the clinical part, there are two experimental factors (program versions, i.e. anonymous and standard) each evaluated at two levels (randomized vs. preferred).

Recruitment: Participants will be recruited using reports in newspapers, through internet forums, social media (e.g., Facebook), and via a website (https://www.online-therapy.ch/) in German-speaking countries.

Sampling: After checking the inclusion criteria, participants will be randomized with equal probability to one of the two conditions; randomization vs. preference. In the second stage, if a participant is randomized to the choice arm, the participant can choose the preferred treatment; if a participant is randomized to the random arm, the participant is randomized to a program version (anonymous vs. standard) arm. This design is used to estimate the treatment, selection, and preference effect. The random allocation will be unknown to the investigators. In order to keep the sample sizes of the 16 conditions similar, the allocation list will be made using randomly permuted blocks.

A total of 452 participants who exceed pre-defined cut-off scores on social anxiety measures will be recruited for this study.

Assessment procedures: The primary outcome measure is change in symptoms of SAD at post-treatment, i.e., after 8 weeks. Secondary outcomes include sustaining change at follow up (6 months after baseline), changes in depressive symptoms, changes in quality of life, changes in internalized stigma and attitudes towards help-seeking, changes in levels of personality functioning, and negative effects. Furthermore, an exploratory preference analysis will be conducted to gain insights into digital health application users' preferences and potential preference effect.

Treatment: The internet-based self-help program ("JOURNeY") is based on the well-established cognitive-behavioral treatment of social anxiety by Clark and Wells (1995) and has been proven efficacious in previous studies. The standard version of JOURNeY is accessed through a secure website, with each participant having a password-protected account. It consists of the following four treatment components: (1) psychoeducation (knowledge about SAD and its treatment); (2) cognitive restructuring (challenging dysfunctional social cognitions); (3) attention training (decrease of self-focused attention); and (4) exposure (decrease of avoidance of feared situations and safety behaviors). The anonymous version has the same content but does not require an account and does not collect any personal data of participants.

Data analysis: Primary analyses will be conducted on the Intention-To-Treat (ITT) sample (i.e., all assigned participants) using linear mixed models with repeated measures. In addition, a completers analysis will be carried out, also with linear mixed models with repeated measures.

For the preference analysis, a more exploratory approach will be used. For binary outcome data (e.g. program preference), regression analysis will be conducted. For other data, tests such as t-test, chi-squared tests or other appropriate tests will be used.

Reporting will follow CONSORT E-Health standards.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 452
• Est. completion date: February 28, 2026
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Written informed consent

• Be 18 years or older,

• Have access to the internet

• Have access to a smartphone, computer or tablet

• Score 22 points or higher on the Social Phobia Scale or 33 points or higher on the Social Interaction Anxiety Scale (SPS & SIAS, Mattick & Clarke, 1998; German version: Stangier et al., 1999)

Exclusion Criteria:

• Score 2 points or higher on the suicide item of the PHQ-9

• Have previously been diagnosed with psychotic symptoms or bipolar disorder

Related Conditions & MeSH terms

• Social Anxiety

Intervention

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: psychoeducation where participants learn about SAD and the treatment, cognitive restructuring where participants challenge dysfunctional social cognitions, attention training where participants learn to decrease self-focused attention, and 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.
• JOURNeY standard
The standard version of the self-help program JOURNeY which requires a login and collects personal data. Includes 4 main components: psychoeducation where participants learn about SAD and the treatment, cognitive restructuring where participants challenge dysfunctional social cognitions, attention training where participants learn to decrease self-focused attention, and 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.

Locations

Country	Name	City	State
Switzerland	University Bern, Clinical Psychology and Psychotherapy Department	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University of Bern

Country where clinical trial is conducted

Switzerland, 

References & Publications (19)

Batterham P, Gulliver A, Sunderland M, Farrer L, Kay-Lambkin F, Trias A, Calear A. Factors Influencing Community Participation in Internet Interventions Compared With Research Trials: Observational Study in a Nationally Representative Adult Cohort. J Med Internet Res. 2023 Feb 2;25:e41663. doi: 10.2196/41663. — View Citation

Berger T, Caspar F, Richardson R, Kneubuhler B, Sutter D, Andersson G. Internet-based treatment of social phobia: a randomized controlled trial comparing unguided with two types of guided self-help. Behav Res Ther. 2011 Mar;49(3):158-69. doi: 10.1016/j.brat.2010.12.007. Epub 2011 Jan 1. — View Citation

Clark, D. M., & Wells, A. (1995). A cognitive model of social phobia. In R. G. Heimberg, M. R. Liebowitz, D. Hope, & F. Schneider (Eds.), Social Phobia: Diagnosis, Assessment, and Treatment (pp. 69-93). Guilford Press.

Gandek B, Ware JE, Aaronson NK, Apolone G, Bjorner JB, Brazier JE, Bullinger M, Kaasa S, Leplege A, Prieto L, Sullivan M. Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol. 1998 Nov;51(11):1171-8. doi: 10.1016/s0895-4356(98)00109-7. — View Citation

Gräfe, K., Zipfel, S., Herzog, W., & Löwe, B. (2004). Screening psychischer Störungen mit dem "Gesundheitsfragebogen für Patienten (PHQ-D)". Diagnostica, 50(4), 171-181. https://doi.org/10.1026/0012-1924.50.4.171

Hutsebaut J, Feenstra DJ, Kamphuis JH. Development and Preliminary Psychometric Evaluation of a Brief Self-Report Questionnaire for the Assessment of the DSM-5 level of Personality Functioning Scale: The LPFS Brief Form (LPFS-BF). Personal Disord. 2016 Apr;7(2):192-7. doi: 10.1037/per0000159. Epub 2015 Nov 23. — View Citation

Kessler EM, Agines S, Bowen CE. Attitudes towards seeking mental health services among older adults: personal and contextual correlates. Aging Ment Health. 2015;19(2):182-91. doi: 10.1080/13607863.2014.920300. Epub 2014 Jun 5. — View Citation

Mackenzie, C. S., Knox, V. J., Gekoski, W. L., & Macaulay, H. L. (2004). An Adaptation and Extension of the Attitudes Toward Seeking Professional Psychological Help Scale1. Journal of Applied Social Psychology, 34(11), 2410-2433. https://doi.org/10.1111/j.1559-1816.2004.tb01984.x

Mattick RP, Clarke JC. Development and validation of measures of social phobia scrutiny fear and social interaction anxiety. Behav Res Ther. 1998 Apr;36(4):455-70. doi: 10.1016/s0005-7967(97)10031-6. — View Citation

Ritsher JB, Otilingam PG, Grajales M. Internalized stigma of mental illness: psychometric properties of a new measure. Psychiatry Res. 2003 Nov 1;121(1):31-49. doi: 10.1016/j.psychres.2003.08.008. — View Citation

Schulz A, Stolz T, Vincent A, Krieger T, Andersson G, Berger T. A sorrow shared is a sorrow halved? A three-arm randomized controlled trial comparing internet-based clinician-guided individual versus group treatment for social anxiety disorder. Behav Res Ther. 2016 Sep;84:14-26. doi: 10.1016/j.brat.2016.07.001. Epub 2016 Jul 7. — View Citation

Sibitz I, Friedrich ME, Unger A, Bachmann A, Benesch T, Amering M. [Internalized Stigma of Schizophrenia: Validation of the German Version of the Internalized Stigma of Mental Illness-Scale (ISMI)]. Psychiatr Prax. 2013 Mar;40(2):83-91. doi: 10.1055/s-0032-1332878. Epub 2013 Jan 25. German. — View Citation

Spitzer C, Muller S, Kerber A, Hutsebaut J, Brahler E, Zimmermann J. [The German Version of the Level of Personality Functioning Scale-Brief Form 2.0 (LPFS-BF): Latent Structure, Convergent Validity and Norm Values in the General Population]. Psychother Psychosom Med Psychol. 2021 Jul;71(7):284-293. doi: 10.1055/a-1343-2396. Epub 2021 Mar 10. German. — View Citation

Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44. doi: 10.1001/jama.282.18.1737. — View Citation

Stein DJ, Lim CCW, Roest AM, de Jonge P, Aguilar-Gaxiola S, Al-Hamzawi A, Alonso J, Benjet C, Bromet EJ, Bruffaerts R, de Girolamo G, Florescu S, Gureje O, Haro JM, Harris MG, He Y, Hinkov H, Horiguchi I, Hu C, Karam A, Karam EG, Lee S, Lepine JP, Navarro-Mateu F, Pennell BE, Piazza M, Posada-Villa J, Ten Have M, Torres Y, Viana MC, Wojtyniak B, Xavier M, Kessler RC, Scott KM; WHO World Mental Health Survey Collaborators. The cross-national epidemiology of social anxiety disorder: Data from the World Mental Health Survey Initiative. BMC Med. 2017 Jul 31;15(1):143. doi: 10.1186/s12916-017-0889-2. — View Citation

Stolz T, Schulz A, Krieger T, Vincent A, Urech A, Moser C, Westermann S, Berger T. A mobile app for social anxiety disorder: A three-arm randomized controlled trial comparing mobile and PC-based guided self-help interventions. J Consult Clin Psychol. 2018 Jun;86(6):493-504. doi: 10.1037/ccp0000301. — View Citation

Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003. — View Citation

Weekers LC, Hutsebaut J, Kamphuis JH. The Level of Personality Functioning Scale-Brief Form 2.0: Update of a brief instrument for assessing level of personality functioning. Personal Ment Health. 2019 Feb;13(1):3-14. doi: 10.1002/pmh.1434. Epub 2018 Sep 19. — View Citation

Wolfangel, E. (2023, May 9). Datenschutz: Wenn Hacker mit Gesundheits-Apps besonders leichtes Spiel haben. ZEIT ONLINE. https://www.zeit.de/digital/datenschutz/2023-05/gesundheitsapp-datenschutz-depression-edupression-sicherheitsluecke/komplettansicht

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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; Mattick & Clarke, 1998; German version: Stangier et al., 1999). 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	Social Anxiety Symptoms	Change in the composite score 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; Mattick & Clarke, 1998; German version: Stangier et al., 1999). 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
Secondary	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; R. L. Spitzer, 1999; German version: Gräfe et al., 2004). 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
Secondary	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; Ware et al., 1996; German version: Gandek et al., 1998). 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
Secondary	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; Boyd Ritsher et al., 2003; German version: Sibitz et al., 2013). 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
Secondary	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; Mackenzie et al., 2004; German version: Kessler et al., 2015). The questionnaire has 24 items with the three subscales psychological openness, help-seeking propensity, and indifference to stigma. Scores range from 8 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
Secondary	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; Hutsebaut et al., 2016; Weekers et al., 2019; German version: Spitzer et al., 2021). 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

External Links

•   Link to Study Description on Homepage of University of Bern