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Completed

NCT Number: NCT05987969

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

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.

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Key information

Conditions

Social Anxiety Disorder (Social Phobia) Anxiety Disorders Behavior Mental Disorders Personal Satisfaction Phobia, Social Phobic Disorders Psychological Well-Being Social Anxiety Social Anxiety Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aya Technologies Limited

London, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

"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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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,

  2. 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

  3. 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)

Sponsors and collaborators

Lead sponsor

Aya Technologies Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 14, 2023
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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