Efficacy, Tolerability and Safety of a Smartphone-delivered, Fully Automatic Cognitive Behavioural Therapy Programme for Social Anxiety
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Social Anxiety Disorder (Social Phobia)
- Sponsor
- Aya Technologies Limited
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Change in Social Phobia Inventory (SPIN)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in Social Phobia Inventory (SPIN)
Time Frame: Change from baseline SPIN at 8 weeks
The SPIN was designed to assess the full spectrum of symptoms that characterise social anxiety, including fear, avoidance and physiological components.
Change in Work and Social Adjustment Scale (WSAS)
Time Frame: Change from baseline WSAS at 8 weeks
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.
Secondary Outcomes
- Change in Social Phobia Inventory (SPIN)(Change from SPIN level at the end of the intervention period at 4 weeks later)
- Work and Social Adjustment Scale (WSAS)(At the follow-up point of 4 weeks after the end of the intervention period.)
- Serious adverse events(Within the intervention period of 8 weeks)