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

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.

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.

Inclusion Criteria:

• female
• aged between 18 and 35 years old (inclusive)
• located in the UK
• fluent in English
• comfortable taking part in a study that included deception (due to the nature of the cognitive assessments)
• had an iPhone and daily access to an internet connection
• scored over 30 on the Social Phobia Inventory (SPIN; indicating at least moderate social anxiety).

Exclusion Criteria:

• currently undergoing any mental health therapy
• changed the usual mental health medication or dosage within the past eight weeks
• scored eight or above on the Alcohol Use Disorders Identification Test for consumption (AUDIT-C; indicating higher risk of alcohol dependence)
• scored two or above on the adapted drug questions (indicating higher risk of drug dependence)
• had previously participated in scientific studies or user research undertaken by Alena