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

Sponsor

Aya Technologies Limited (Industry)

Overall Status

Completed

CT.gov ID

NCT05987969

Collaborator

(none)

250

Enrollment

Location

Arms

2.6

Actual Duration (Months)

96.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Social Anxiety Disorder (Social Phobia) Social Anxiety Social Anxiety Disorder	Other: "Alena" mobile application	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 20, 2023

Actual Primary Completion Date :

Jun 7, 2023

Actual Study Completion Date :

Jun 7, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Access to the "Alena" CBT-based mobile application intervention for 8 weeks. Instructed to complete one of the 4 main modules every 2 weeks. Also asked to complete one additional short exercise per week and engage with one forum post per week.	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.
No Intervention: No intervention Wait list control - Given access to the intervention at the end of the 10-week trial period.

Arm

Intervention/Treatment

Experimental: Intervention

Access to the "Alena" CBT-based mobile application intervention for 8 weeks. Instructed to complete one of the 4 main modules every 2 weeks. Also asked to complete one additional short exercise per week and engage with one forum post per week.

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.

No Intervention: No intervention

Wait list control - Given access to the intervention at the end of the 10-week trial period.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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