The Safety, Acceptability and Efficacy of Alena

Aya Technologies

Status: Completed

Conditions: Social Anxiety; Social Anxiety Disorder (Social Phobia); Social Anxiety Disorder

Treatments: Behavioral: Cognitive Behavioral Therapy programme

Study type: Interventional

Funder types: Industry

Identifiers

NCT05858294

Alena CBT RCT 2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

Cognitive Behavioral Therapy program

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive Behavioral Therapy programme

Waitlist control

No Intervention group

Description:

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