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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
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.
Aya Technologies Limited
London, United Kingdom
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.
Time frame: Change from baseline SPIN at 8 weeks
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.
Time frame: Change from baseline WSAS at 8 weeks
Change in Social Phobia Inventory (SPIN)
The SPIN was designed to assess the full spectrum of symptoms that characterise social anxiety, including fear,
Time frame: Change from SPIN level at the end of the intervention period at 4 weeks later
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
Time frame: At the follow-up point of 4 weeks after the end of the intervention period.
Serious adverse events
Serious adverse events are defined as those that meet the criteria for ISO:14155(A:14)
Time frame: Within the intervention period of 8 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.