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The present study is a randomised controlled trial that seeks to investigate the efficacy and safety of the Alena app as a treatment for social anxiety disorder.
This will be a 10-week web-based parallel-group unblinded randomised controlled trial with an 8-week intervention period and a 2-week follow-up post-intervention. Participants will be randomly allocated to receive access to the Alena app or to a wait list control group, in a 1:1 ratio. The Alena app primarily comprises CBT-based therapy for social anxiety based on the Clark and Wells model, as well as cognitive assessments, calming exercises and a community forum.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Access to the "Alena" CBT-based mobile application intervention for 8 weeks. Instructed to complete one of the 4 main modules every 2 weeks. Also asked to complete one additional short exercise per week and engage with one forum post per week. |
|
| No intervention | No Intervention | Wait list control - Given access to the intervention at the end of the 10-week trial period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "Alena" mobile application | Other | This mobile application primarily comprises CBT-based therapy for social anxiety based on the Clark and Wells model, as well as cognitive assessments, calming exercises and a community forum. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Social Phobia Inventory (SPIN) | The SPIN was designed to assess the full spectrum of symptoms that characterise social anxiety, including fear, avoidance and physiological components. | Change from baseline SPIN at 8 weeks |
| Change in Work and Social Adjustment Scale (WSAS) | The WSAS measures the extent to which the respondent's problem impairs their ability to carry out day-to-day activities, such as work, home management and social leisure activities. | Change from baseline WSAS at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Social Phobia Inventory (SPIN) | The SPIN was designed to assess the full spectrum of symptoms that characterise social anxiety, including fear, | Change from SPIN level at the end of the intervention period at 4 weeks later |
| Work and Social Adjustment Scale (WSAS) |
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Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aya Technologies Limited | London | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40208666 | Derived | Garvert MM, McFadyen J, Linke S, McCloud T, Meyer SS, Sobanska S, Sharp PB, Long A, Huys QJM, Ahmadi M. Safety and Efficacy of Modular Digital Psychotherapy for Social Anxiety: Randomized Controlled Trial. J Med Internet Res. 2025 Apr 10;27:e64138. doi: 10.2196/64138. |
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| ID | Term |
|---|---|
| D000072861 | Phobia, Social |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
| D010549 | Personal Satisfaction |
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The WSAS measures the extent to which the respondent's problem impairs their ability to carry out day-to-day |
| At the follow-up point of 4 weeks after the end of the intervention period. |
| Serious adverse events | Serious adverse events are defined as those that meet the criteria for ISO:14155(A:14) | Within the intervention period of 8 weeks |
| D001519 |
| Behavior |