NCT05987969

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Aya Technologies Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Social Anxiety Disorder (Social Phobia)
• Social Anxiety
• Social Anxiety Disorder

Interventions

Type	Name	Description
OTHER	"Alena" mobile application	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.

Timeline

• Start date: 2023-03-20
• Primary completion: 2023-06-07
• Completion: 2023-06-07
• First posted: 2023-08-14
• Last updated: 2023-08-14

Locations

1 site across 1 country: United Kingdom