The Safety, Acceptability and Efficacy of Alena

NCT05858294 | Completed

• 1 other identifier: Alena CBT RCT 2022
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Social Anxiety; Social Anxiety Disorder; Social Anxiety Disorder (Social Phobia)

Keywords

RCT; CBT

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Social phobia inventory (SPIN)

  Week 4 (primary endpoint)

• Social phobia inventory (SPIN)

  Week 6 (2-week follow-up post-intervention)

• Work and Social Adjustment Scale (WSAS)

  Week 4 (primary endpoint)

• Work and Social Adjustment Scale (WSAS)

  Week 6 (2-week follow-up post-intervention)

Study Arms (2)

Cognitive Behavioral Therapy program

EXPERIMENTAL

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

Waitlist control

NO INTERVENTION

Waitlist control. Participants in this arm were given access to the CBT content at the end of the 4-week trial period.

Interventions

Cognitive Behavioral Therapy programme BEHAVIORAL

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

Cognitive Behavioral Therapy program

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Aya Technologies Limited: lead

Study Sites (1)

Aya Technologies Limited

London, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 10827888 BACKGROUND

• 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.

  PMID: 11983645 BACKGROUND

• Garvert MM, McFadyen J, Linke S, McCloud T, Meyer SS, Sobanska S, Sharp PB, Long A, Huys QJM, Ahmadi M. Safety and Efficacy of Modular Digital Psychotherapy for Social Anxiety: Randomized Controlled Trial. J Med Internet Res. 2025 Apr 10;27:e64138. doi: 10.2196/64138.

  PMID: 40208666 DERIVED

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Mandana Ahmadi, PhD

  Aya Technologies Limited

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: May 15, 2023
• Study Start: October 31, 2022
• Primary Completion: December 4, 2022
• Study Completion: December 18, 2022
• Last Updated: May 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)