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

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.

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