The Safety, Acceptability and Efficacy of Alena

May 4, 2023 updated by: Aya Technologies Limited

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive Behavioral Therapy program
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
This mobile application comprised CBT-based therapy for social anxiety based on the Clark and Wells model
No Intervention: Waitlist control
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 4 (primary endpoint)
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.
Week 6 (2-week follow-up post-intervention)
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.
Week 4 (primary endpoint)
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.
Week 6 (2-week follow-up post-intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 4 (primary endpoint)
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.
Week 6 (2-week follow-up post-intervention)
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
Week 4 (primary endpoint)
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
Week 6 (2-week follow-up post-intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aya Technologies Limited

Investigators

  • Principal Investigator: Mandana Ahmadi, PhD, Aya Technologies Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2022

Primary Completion (Actual)

December 4, 2022

Study Completion (Actual)

December 18, 2022

Study Registration Dates

First Submitted

April 21, 2023

First Submitted That Met QC Criteria

May 4, 2023

First Posted (Actual)

May 15, 2023

Study Record Updates

Last Update Posted (Actual)

May 15, 2023

Last Update Submitted That Met QC Criteria

May 4, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Alena CBT RCT 2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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