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

Primary Purpose

Social Anxiety Disorder (Social Phobia), Social Anxiety, Social Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
"Alena" mobile application
Sponsored by
Aya Technologies Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Anxiety Disorder (Social Phobia) focused on measuring RCT, mobile applications, social anxiety, mental health, social anxiety disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Aya Technologies Limited

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

No intervention

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Change in Social Phobia Inventory (SPIN)
The SPIN was designed to assess the full spectrum of symptoms that characterise social anxiety, including fear,
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
Serious adverse events
Serious adverse events are defined as those that meet the criteria for ISO:14155(A:14)

Full Information

First Posted
March 15, 2023
Last Updated
August 4, 2023
Sponsor
Aya Technologies Limited
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1. Study Identification

Unique Protocol Identification Number
NCT05987969
Brief Title
Efficacy and Safety of the Alena App as a Treatment for Social Anxiety Disorder
Official Title
Efficacy, Tolerability and Safety of a Smartphone-delivered, Fully Automatic Cognitive Behavioural Therapy Programme for Social Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 20, 2023 (Actual)
Primary Completion Date
June 7, 2023 (Actual)
Study Completion Date
June 7, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aya Technologies Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder (Social Phobia), Social Anxiety, Social Anxiety Disorder
Keywords
RCT, mobile applications, social anxiety, mental health, social anxiety disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Wait list control - Given access to the intervention at the end of the 10-week trial period.
Intervention Type
Other
Intervention Name(s)
"Alena" mobile application
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Social Phobia Inventory (SPIN)
Description
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
Title
Change in Work and Social Adjustment Scale (WSAS)
Description
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
Secondary Outcome Measure Information:
Title
Change in Social Phobia Inventory (SPIN)
Description
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
Title
Work and Social Adjustment Scale (WSAS)
Description
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.
Title
Serious adverse events
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Aya Technologies Limited
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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