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

NCT06465589 | Completed DMC

• 3 other identifiers: 2024-0084210002000SNCTP000005924
• Study Type: interventional
• Target: 452
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.To investigate patients' preferences and the influence of patients' preferences on outcome.
3. 3.To explore how patient characteristics are associated with participants' preferences.

Conditions

Social Anxiety

Keywords

Social Anxiety; Mental Disorders; Internet Intervention; Self Help; Preference

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Social Anxiety Symptoms

  at baseline, at 8 weeks, at 24 weeks

• Depressive Symptoms

  at baseline, at 8 weeks, at 24 weeks

• Quality of Life QoL

  at baseline, at 8 weeks, at 24 weeks

• Internalized Stigma

  at baseline, at 8 weeks, at 24 weeks

• Attitudes Towards Help-Seeking

  at baseline, at 8 weeks, at 24 weeks

Study Arms (4)

Randomized Anonymous

EXPERIMENTAL

After participants are randomized to the randomization arm, they will once again be randomized to the program versions. Participants in this arm will use the anonymous program.

Other: JOURNeY anonymous

Randomized Standard

ACTIVE COMPARATOR

After participants are randomized to the randomization arm, they will once again be randomized to the program versions. Participants in this arm will use the standard program.

Other: JOURNeY standard

Preferred Anonymous

OTHER

After participants are randomized to the preference arm, they will be given access to the program version they indicate a preference for after having read two descriptive texts about both versions. Participants in this arm will use the anonymous program.

Other: JOURNeY anonymous

Preferred Standard

OTHER

After participants are randomized to the preference arm, they will be given access to the program version they indicate a preference for after having read two descriptive texts about both versions. Participants in this arm will use the standard program.

Other: JOURNeY standard

Interventions

JOURNeY anonymous OTHER

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.

Preferred Anonymous; Randomized Anonymous

JOURNeY standard OTHER

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.

Preferred Standard; Randomized Standard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Score 2 points or higher on the suicide item of the PHQ-9
• Have previously been diagnosed with psychotic symptoms or bipolar disorder

Sponsors & Collaborators

• University of Bern: lead

Study Sites (1)

University Bern, Clinical Psychology and Psychotherapy Department

Bern, 3012, Switzerland

Location

Related Publications (20)

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  BACKGROUND

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  PMID: 23354628 BACKGROUND

• 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.

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  BACKGROUND

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  PMID: 24898327 BACKGROUND

• 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

  BACKGROUND

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  PMID: 36729613 BACKGROUND

• 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.

  PMID: 33694153 BACKGROUND

• 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.

  PMID: 28756776 BACKGROUND

• 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.

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• 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.

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  PMID: 8628042 BACKGROUND

• 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.

  PMID: 14572622 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 26595344 BACKGROUND

• 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.

  PMID: 30230242 BACKGROUND

• Arnold S, Vogt MF, Boettcher J, Fenski F, Sipka D, Elson M, Berger T. A Freely Accessible, Anonymous Online Treatment for Social Anxiety: Protocol for a Partially Randomized Patient Preference Trial. JMIR Res Protoc. 2025 Nov 5;14:e77573. doi: 10.2196/77573.

  PMID: 41192825 DERIVED

Related Links

• Link to Study Description on Homepage of University of Bern

MeSH Terms

Conditions

Mental Disorders

Study Officials

• Thomas Berger, Prof. Dr.

  University Bern, Clinical Psychology and Psychotherapy Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigators will not know which specific condition the participants were in for the initial analysis. The blind will be broken for the investigators after first interpretation of the results.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a single-center partially randomized patient preference trial with four conditions (program version: standard vs. anonymous and allocation: randomized vs. preferred)

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 20, 2024
• Study Start: September 3, 2024
• Primary Completion: March 2, 2026
• Study Completion: March 2, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CH (1)