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

Social Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05987969
• Other study ID #: Alena App RCT 2023 #1
• Status: Completed
• Phase: N/A
• Start date: March 20, 2023
• Est. completion date: June 7, 2023

Study information

• Verified date: August 2023
• Source: Aya Technologies Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: June 7, 2023
• Est. primary completion date: June 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Phobia, Social
• Social Anxiety
• Social Anxiety Disorder

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Aya Technologies Limited	London

Sponsors (1)

Lead Sponsor	Collaborator
Aya Technologies Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

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