Social Anxiety, Social Anxiety Disorder, Social Anxiety Disorder (Social Phobia)
Conditions
Keywords
RCT, mobile applications, social anxiety, mental health, social anxiety disorder
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.
Interventions
OTHERAlena 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.
Sponsors
Aya Technologies Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Social Phobia Inventory (SPIN) | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Social Phobia Inventory (SPIN) | Change from SPIN level at the end of the intervention period at 4 weeks later | The SPIN was designed to assess the full spectrum of symptoms that characterise social anxiety, including fear, |
| Work and Social Adjustment Scale (WSAS) | At the follow-up point of 4 weeks after the end of the intervention period. | The WSAS measures the extent to which the respondent's problem impairs their ability to carry out day-to-day |
| Serious adverse events | Within the intervention period of 8 weeks | Serious adverse events are defined as those that meet the criteria for ISO:14155(A:14) |
Countries
United Kingdom
Outcome results
None listed