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

August 4, 2023 updated by: Aya Technologies Limited

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 from baseline SPIN at 8 weeks
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.
Change from baseline WSAS at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Social Phobia Inventory (SPIN)
Time Frame: 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,
Change from SPIN level at the end of the intervention period at 4 weeks later
Work and Social Adjustment Scale (WSAS)
Time Frame: 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
At the follow-up point of 4 weeks after the end of the intervention period.
Serious adverse events
Time Frame: Within the intervention period of 8 weeks
Serious adverse events are defined as those that meet the criteria for ISO:14155(A:14)
Within the intervention period of 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aya Technologies Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2023

Primary Completion (Actual)

June 7, 2023

Study Completion (Actual)

June 7, 2023

Study Registration Dates

First Submitted

March 15, 2023

First Submitted That Met QC Criteria

August 4, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 4, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Alena App RCT 2023 #1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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