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Completed

NCT Number: NCT05858294

The Safety, Acceptability and Efficacy of Alena

The present study is a randomised controlled trial that seeks to investigate the safety, acceptability and efficacy and safety of the Alena CBT programme as a treatment for social anxiety disorder.

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Key information

Conditions

Social Anxiety Anxiety Disorders Mental Disorders Phobia, Social Phobic Disorders Social Anxiety Disorder Social Anxiety Disorder (Social Phobia)

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aya Technologies Limited

London, United Kingdom

About this study

This is a 6-week web-based parallel-group unblinded randomised controlled trial with a 4-week intervention period and a 2-week follow-up post intervention. Participants are randomly allocated to receive access to the Alena CBT programme or to a wait list control group, in a 1:1 ratio. The programme consists of CBT-based therapy for social anxiety based on the Clark and Wells model.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • female
  • aged between 18 and 35 years old (inclusive)
  • located in the UK
  • fluent in English
  • comfortable taking part in a study that included deception (due to the nature of the cognitive assessments)
  • had an iPhone and daily access to an internet connection
  • scored over 30 on the Social Phobia Inventory (SPIN; indicating at least moderate social anxiety).

Exclusion criteria

  • currently undergoing any mental health therapy
  • changed the usual mental health medication or dosage within the past eight weeks
  • scored eight or above on the Alcohol Use Disorders Identification Test for consumption (AUDIT-C; indicating higher risk of alcohol dependence)
  • scored two or above on the adapted drug questions (indicating higher risk of drug dependence)
  • had previously participated in scientific studies or user research undertaken by Alena

Treatment and study plan

Cognitive Behavioral Therapy programme

Behavioral

This mobile application comprised CBT-based therapy for social anxiety based on the Clark and Wells model

Primary outcomes

  1. Questionnaires assessing negative effects from using the app and adverse health events

    Time frame: Week 4 (primary endpoint)

    The Intervention group was asked "Have you experienced any negative effects from using the Alena app? This could be a physical or emotional effect that you believe you have experienced as a result of using the app and/or engaging in the app therapy." Both groups were asked: "Have you experienced any new, serious negative health effects in the past week? This includes having to see your GP for a new reason, going to hospital, or being otherwise very unwell in terms of your physical or mental health." If participants responded positively to either question, they were prompted for additional details and to rate the severity of the experience.

  2. Questionnaires assessing negative effects from using the app and adverse health events

    Time frame: Week 6 (2-week follow-up post-intervention)

    The Intervention group was asked "Have you experienced any negative effects from using the Alena app? This could be a physical or emotional effect that you believe you have experienced as a result of using the app and/or engaging in the app therapy." Both groups were asked: "Have you experienced any new, serious negative health effects in the past week? This includes having to see your GP for a new reason, going to hospital, or being otherwise very unwell in terms of your physical or mental health." If participants responded positively to either question, they were prompted for additional details and to rate the severity of the experience.

  3. Questionnaire assessing satisfaction, helpfulness and ease of use

    Time frame: Week 4 (primary endpoint)

    Participants were asked how satisfied they were with the app overall (Likert rating scale from very dissatisfied to very satisfied); how helpful they found the app (Likert ratings from very unhelpful to very helpful); how likely they would be to recommend the app (Likert ratings from very unlikely to very likely); how easy they found using the app (Likert ratings from very difficult to very easy); whether they got to the end of the weekly exercise (yes/no), and what got in the way of completing the exercises, with options provided.

  4. Questionnaire assessing satisfaction, helpfulness and ease of use

    Time frame: Week 6 (2-week follow-up post-intervention)

    Participants were asked how satisfied they were with the app overall (Likert rating scale from very dissatisfied to very satisfied); how helpful they found the app (Likert ratings from very unhelpful to very helpful); how likely they would be to recommend the app (Likert ratings from very unlikely to very likely); how easy they found using the app (Likert ratings from very difficult to very easy); whether they got to the end of the weekly exercise (yes/no), and what got in the way of completing the exercises, with options provided.

Secondary outcomes

  1. Social phobia inventory (SPIN)

    Time frame: Week 4 (primary endpoint)

    The SPIN was designed to assess the full spectrum of symptoms that characterise social anxiety, including fear, avoidance and physiological components. Total score ranging from 0 to 68, with higher scores indicating a worse outcome.

  2. Social phobia inventory (SPIN)

    Time frame: Week 6 (2-week follow-up post-intervention)

    The SPIN was designed to assess the full spectrum of symptoms that characterise social anxiety, including fear, avoidance and physiological components. Total score ranging from 0 to 68, with higher scores indicating a worse outcome.

  3. Work and Social Adjustment Scale (WSAS)

    Time frame: Week 4 (primary endpoint)

    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. Total score ranging from 0 to 40, with higher scores indicating higher impairment

  4. Work and Social Adjustment Scale (WSAS)

    Time frame: Week 6 (2-week follow-up post-intervention)

    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. Total score ranging from 0 to 40, with higher scores indicating higher impairment

Sponsors and collaborators

Lead sponsor

Aya Technologies Limited

Industry

Registry information

Official study title

The Safety, Acceptability and Efficacy of Alena, a Modularized CBT-based Mobile App Intervention for Social Anxiety: a Randomised Controlled Trial

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 15, 2023
Registry last updated
May 15, 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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