Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-27 @ 5:18 AM
Study NCT ID:
NCT05858294
Status:
COMPLETED
Last Update Posted:
2023-05-15
First Post:
2023-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Safety, Acceptability and Efficacy of Alena
Sponsor:
Aya Technologies Limited
Organization:
Study Overview
Official Title:
The Safety, Acceptability and Efficacy of Alena, a Modularized CBT-based Mobile App Intervention for Social Anxiety: a Randomised Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: