NCT05858294

The Safety, Acceptability and Efficacy of Alena

The Safety, Acceptability and Efficacy of Alena, a Modularized CBT-based Mobile App Intervention for Social Anxiety: a Randomised Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Aya Technologies Limited · Industry
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

The present study is a randomised controlled trial that seeks to investigate the safety, acceptability and efficacy and safety of the Alena CBT programme as a treatment for social anxiety disorder.

Detailed description

This is a 6-week web-based parallel-group unblinded randomised controlled trial with a 4-week intervention period and a 2-week follow-up post intervention. Participants are randomly allocated to receive access to the Alena CBT programme or to a wait list control group, in a 1:1 ratio. The programme consists of CBT-based therapy for social anxiety based on the Clark and Wells model.

Conditions

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

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Behavioral Therapy programme	This mobile application comprised CBT-based therapy for social anxiety based on the Clark and Wells model

Timeline

• Start date: 2022-10-31
• Primary completion: 2022-12-04
• Completion: 2022-12-18
• First posted: 2023-05-15
• Last updated: 2023-05-15

Locations

1 site across 1 country: United Kingdom