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

NCT05987969 | Completed

• 1 other identifier: Alena App RCT 2023 #1
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Anxiety Disorder (Social Phobia); Social Anxiety; Social Anxiety Disorder

Keywords

RCT; mobile applications; social anxiety; mental health; social anxiety disorder

Outcome Measures

Primary Outcomes (2)

• 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 from baseline SPIN at 8 weeks

• 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.

  Change from baseline WSAS at 8 weeks

Secondary Outcomes (3)

• Change in Social Phobia Inventory (SPIN)

  Change from SPIN level at the end of the intervention period at 4 weeks later

• Work and Social Adjustment Scale (WSAS)

  At the follow-up point of 4 weeks after the end of the intervention period.

• Serious adverse events

  Within the intervention period of 8 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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

No intervention

NO INTERVENTION

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

Interventions

"Alena" mobile application OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aya Technologies Limited: lead

Study Sites (1)

Aya Technologies Limited

London, United Kingdom

Location

Related Publications (1)

• Garvert MM, McFadyen J, Linke S, McCloud T, Meyer SS, Sobanska S, Sharp PB, Long A, Huys QJM, Ahmadi M. Safety and Efficacy of Modular Digital Psychotherapy for Social Anxiety: Randomized Controlled Trial. J Med Internet Res. 2025 Apr 10;27:e64138. doi: 10.2196/64138.

  PMID: 40208666 DERIVED

MeSH Terms

Conditions

Phobia, Social; Psychological Well-Being

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders; Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: August 14, 2023
• Study Start: March 20, 2023
• Primary Completion: June 7, 2023
• Study Completion: June 7, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)