Efficacy and Safety of the Alena App as a Treatment for Social Anxiety Disorder

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy, Tolerability and Safety of a Smartphone-delivered, Fully Automatic Cognitive Behavioural Therapy Programme for Social Anxiety

Conditions
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Social Anxiety Disorder (Social Phobia), Social Anxiety, Social Anxiety Disorder

Intervention / Treatment
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* Other: Alena mobile application


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Scored over 30 on the SPIN (indicating at least moderate social anxiety) Aged 18 or over Fluent in English Has access to a smartphone (iOS or Android) and the internet UK resident Exclusion criteria: Currently receiving therapy for their mental health Mental health medication has changed (dosage or presence) in the last 8 weeks Scores over 7 on the AUDIT-C and/or yes on either drug dependence question taken from the DUDIT (indicating drug or alcohol abuse) Previous experience with the Alena app through prior studies or user testing

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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. | Other: Alena mobile application<br>* 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.<br>|
| No Intervention: No intervention<br>Wait list control - Given access to the intervention at the end of the 10-week trial period. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RCT, mobile applications, social anxiety, mental health, social anxiety disorder