The Safety, Acceptability and Efficacy of Alena

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-31

Study Completion Date

2022-12-18

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.

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy programme

Intervention Type BEHAVIORAL

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

Waitlist control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cognitive Behavioral Therapy programme

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

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes