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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
102
This mobile application comprised CBT-based therapy for social anxiety based on the Clark and Wells model
Aya Technologies Limited
London, United Kingdom
Questionnaires assessing negative effects from using the app and adverse health events
The Intervention group was asked "Have you experienced any negative effects from using the Alena app? This could be a physical or emotional effect that you believe you have experienced as a result of using the app and/or engaging in the app therapy." Both groups were asked: "Have you experienced any new, serious negative health effects in the past week? This includes having to see your GP for a new reason, going to hospital, or being otherwise very unwell in terms of your physical or mental health." If participants responded positively to either question, they were prompted for additional details and to rate the severity of the experience.
Time frame: Week 4 (primary endpoint)
Questionnaires assessing negative effects from using the app and adverse health events
The Intervention group was asked "Have you experienced any negative effects from using the Alena app? This could be a physical or emotional effect that you believe you have experienced as a result of using the app and/or engaging in the app therapy." Both groups were asked: "Have you experienced any new, serious negative health effects in the past week? This includes having to see your GP for a new reason, going to hospital, or being otherwise very unwell in terms of your physical or mental health." If participants responded positively to either question, they were prompted for additional details and to rate the severity of the experience.
Time frame: Week 6 (2-week follow-up post-intervention)
Questionnaire assessing satisfaction, helpfulness and ease of use
Participants were asked how satisfied they were with the app overall (Likert rating scale from very dissatisfied to very satisfied); how helpful they found the app (Likert ratings from very unhelpful to very helpful); how likely they would be to recommend the app (Likert ratings from very unlikely to very likely); how easy they found using the app (Likert ratings from very difficult to very easy); whether they got to the end of the weekly exercise (yes/no), and what got in the way of completing the exercises, with options provided.
Time frame: Week 4 (primary endpoint)
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Questionnaire assessing satisfaction, helpfulness and ease of use
Participants were asked how satisfied they were with the app overall (Likert rating scale from very dissatisfied to very satisfied); how helpful they found the app (Likert ratings from very unhelpful to very helpful); how likely they would be to recommend the app (Likert ratings from very unlikely to very likely); how easy they found using the app (Likert ratings from very difficult to very easy); whether they got to the end of the weekly exercise (yes/no), and what got in the way of completing the exercises, with options provided.
Time frame: Week 6 (2-week follow-up post-intervention)
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. Total score ranging from 0 to 68, with higher scores indicating a worse outcome.
Time frame: Week 4 (primary endpoint)
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. Total score ranging from 0 to 68, with higher scores indicating a worse outcome.
Time frame: Week 6 (2-week follow-up post-intervention)
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. Total score ranging from 0 to 40, with higher scores indicating higher impairment
Time frame: Week 4 (primary endpoint)
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. Total score ranging from 0 to 40, with higher scores indicating higher impairment
Time frame: Week 6 (2-week follow-up post-intervention)