The Safety, Acceptability and Efficacy of Alena

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Social Anxiety, Social Anxiety Disorder, Social Anxiety Disorder (Social Phobia)

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy programme


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Behavioral Therapy program<br>Access to the Alena CBT-based therapy programme for 4 weeks. Each of the four therapy modules gradually became available on a weekly basis until all four were available in the final intervention week. Participants were instructed to complete one module per week. Each therapy module consisted of psychoeducational content, guided psychological reflection and perspective-taking exercises, and, where appropriate, skills training exercises such as attention training, public speaking, and exposure experiments to be completed in real life. | Behavioral: Cognitive Behavioral Therapy programme<br>* This mobile application comprised CBT-based therapy for social anxiety based on the Clark and Wells model<br>|
| No Intervention: Waitlist control<br>Waitlist control. Participants in this arm were given access to the CBT content at the end of the 4-week trial period. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RCT, CBT