Clinical trial NCT05858294: The Safety, Acceptability and Efficacy of Alena
Official title: The Safety, Acceptability and Efficacy of Alena, a Modularized CBT-based Mobile App Intervention for Social Anxiety: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety
Social Anxiety Disorder
Social Anxiety Disorder (Social Phobia)
Keywords: RCT
CBT
Lead sponsor: Aya Technologies Limited
Sponsor class: INDUSTRY
First posted: 2023-05-15
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Questionnaires assessing negative effects from using the app and adverse health events
timeFrame: Week 4 (primary endpoint)
measure: Questionnaires assessing negative effects from using the app and adverse health events
timeFrame: Week 6 (2-week follow-up post-intervention)
measure: Questionnaire assessing satisfaction, helpfulness and ease of use
timeFrame: Week 4 (primary endpoint)
measure: Questionnaire assessing satisfaction, helpfulness and ease of use
timeFrame: Week 6 (2-week follow-up post-intervention)
Secondary outcomes:
measure: Social phobia inventory (SPIN)
timeFrame: Week 4 (primary endpoint)
measure: Social phobia inventory (SPIN)
timeFrame: Week 6 (2-week follow-up post-intervention)
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: Week 4 (primary endpoint)
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: Week 6 (2-week follow-up post-intervention)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Aya Technologies Limited
Study officials:
affiliation: Aya Technologies Limited
name: Mandana Ahmadi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.