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

Not Applicable

Completed

• Conditions: Social Anxiety; Social Anxiety Disorder; Social Anxiety Disorder (Social Phobia)
• Interventions: Other: "Alena" mobile application

• Registration Number: NCT05987969
• Lead Sponsor: Aya Technologies Limited

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-03-15
• Study Start: 2023-03-20
• Primary Completion: 2023-06-07
• Study Completion: 2023-06-07
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-04
• Last Update Submitted: 2023-08-04
• Study First Posted: 2023-08-14
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	"Alena" mobile application	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.

Primary Outcome Measures

Name	Time	Method
Change in Social Phobia Inventory (SPIN)	Change from baseline SPIN at 8 weeks	The SPIN was designed to assess the full spectrum of symptoms that characterise social anxiety, including fear, avoidance and physiological components.
Change in Work and Social Adjustment Scale (WSAS)	Change from baseline WSAS at 8 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in Social Phobia Inventory (SPIN)	Change from SPIN level at the end of the intervention period at 4 weeks later	The SPIN was designed to assess the full spectrum of symptoms that characterise social anxiety, including fear,
Work and Social Adjustment Scale (WSAS)	At the follow-up point of 4 weeks after the end of the intervention period.	The WSAS measures the extent to which the respondent's problem impairs their ability to carry out day-to-day
Serious adverse events	Within the intervention period of 8 weeks	Serious adverse events are defined as those that meet the criteria for ISO:14155(A:14)

Trial Locations

Locations (1)

Aya Technologies Limited; 🇬🇧 London, United Kingdom