The Safety, Acceptability and Efficacy of Alena

Social Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05858294
• Other study ID #: Alena CBT RCT 2022
• Status: Completed
• Phase: N/A
• Start date: October 31, 2022
• Est. completion date: December 18, 2022

Study information

• Verified date: May 2023
• Source: Aya Technologies Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: December 18, 2022
• Est. primary completion date: December 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Phobia, Social
• Social Anxiety
• Social Anxiety Disorder

Intervention

Behavioral:
• Cognitive Behavioral Therapy programme
This mobile application comprised CBT-based therapy for social anxiety based on the Clark and Wells model

Locations

Country	Name	City	State
United Kingdom	Aya Technologies Limited	London

Sponsors (1)

Lead Sponsor	Collaborator
Aya Technologies Limited

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Connor KM, Davidson JR, Churchill LE, Sherwood A, Foa E, Weisler RH. Psychometric properties of the Social Phobia Inventory (SPIN). New self-rating scale. Br J Psychiatry. 2000 Apr;176:379-86. doi: 10.1192/bjp.176.4.379. — View Citation

Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Questionnaires assessing negative effects from using the app and adverse health events	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.	Week 4 (primary endpoint)
Primary	Questionnaires assessing negative effects from using the app and adverse health events	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.	Week 6 (2-week follow-up post-intervention)
Primary	Questionnaire assessing satisfaction, helpfulness and ease of use	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.	Week 4 (primary endpoint)
Primary	Questionnaire assessing satisfaction, helpfulness and ease of use	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.	Week 6 (2-week follow-up post-intervention)
Secondary	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. Total score ranging from 0 to 68, with higher scores indicating a worse outcome.	Week 4 (primary endpoint)
Secondary	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. Total score ranging from 0 to 68, with higher scores indicating a worse outcome.	Week 6 (2-week follow-up post-intervention)
Secondary	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. Total score ranging from 0 to 40, with higher scores indicating higher impairment	Week 4 (primary endpoint)
Secondary	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. Total score ranging from 0 to 40, with higher scores indicating higher impairment	Week 6 (2-week follow-up post-intervention)