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| ID | Type | Description | Link |
|---|---|---|---|
| 10002000 | Other Identifier | University of Bern, Department of Clinical Psychology and Psychotherapy, internal ID | |
| SNCTP000005924 | Registry Identifier | Swiss National Clinical Trials Portal (SNCTP) |
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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:
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). It is originally based on the well-established cognitive-behavioral treatment of social anxiety by Clark and Wells from 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:
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 from 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Berger, Prof. Dr. | University Bern, Clinical Psychology and Psychotherapy Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Bern, Clinical Psychology and Psychotherapy Department | Bern | 3012 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 27423374 | Background | 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. | |
| 23354628 |
| Label | URL |
|---|---|
| Link to Study Description on Homepage of University of Bern | View source |
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| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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The study is a single-center partially randomized patient preference trial with four conditions (program version: standard vs. anonymous and allocation: randomized vs. preferred)
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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.
|
| JOURNeY standard | Other | The standard version of the self-help program JOURNeY which requires a login and collects personal data. Includes 4 main components:
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. |
|
| 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 QoL | 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 |
| Background |
| 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. |
| 29781648 | 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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| 21255767 | Background | 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. |
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| 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 |
| 26595344 | 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. |
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| 41192825 | Derived | 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. |