Ignite Creation Date:
2024-10-25 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06552273
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Online Psychotherapy for Emotional Reasoning Bias in Public Speaking Anxiety
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Implementation of a Self-applied Online Psychological Intervention for Emotional Reasoning Bias in People With Public Speaking Anxiety A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study aims to develop and implement a self-applied online psychological intervention for the correction of Emotional Reasoning bias for people with public speaking anxiety By comparing the effects of this training for ER biases vs a non-specific mindfulness intervention the newly developed intervention is expected to promote a greater reduction in emotional reasoning bias and the severity of symptomatology associated with public speaking anxiety
Detailed Description:
Among anxiety disorders one of the most common is Social Anxiety Disorder Particularly the specific subtype performance only ie public speaking anxiety has a prevalence rate of 33 in community samples being one of the disorders that cause major occupational educational and social interferences which represent a high impact on daily functioning Several cognitive factors may prevent patients from correcting negative thinking one is the Emotional Reasoning bias Therefore in the present study the aim is to implement training for correcting Emotional Reasoning biases as a transdiagnostic process in people with public speaking anxiety Regarding implementation and dissemination it is proposed that this treatment be Internet-based and delivered through information and communication technologies ICT
To evaluate the effects of this intervention a randomized controlled trial will be conducted comparing two arms an experimental group to which the bias correction training will be applied and a control group to which a non-specific intervention will be used A total of 158 participants based on calculations with the GPower program will be randomly allocated to an intervention group N79 and a control group N79 Bias correction training consists of 12 daily self-applied sessions in which components such as psychoeducation in emotions and the detection of ER biases and their impact on behavior are targeted The primary outcome measure will be Emotional reasoning bias severity and symptomatology associated with public speaking anxiety Secondary outcome measures will be the severity of depressive and anxious symptomatology quality of life usability and perceived acceptance of participants
Individuals will be assessed thrice at baseline post-treatment and 3-month follow-up
Data will be analyzed both per protocol and intention-to-treat This study will pioneer this type of intervention by bringing together an underdeveloped concept with implementing new technologies It is intended to increase our knowledge about treatments administered through the Internet and will contribute to improving the dissemination of treatments
To evaluate the effects of this intervention a randomized controlled trial will be conducted comparing two arms an experimental group to which the bias correction training will be applied and a control group to which a non-specific intervention will be used A total of 158 participants based on calculations with the GPower program will be randomly allocated to an intervention group N79 and a control group N79 Bias correction training consists of 12 daily self-applied sessions in which components such as psychoeducation in emotions and the detection of ER biases and their impact on behavior are targeted The primary outcome measure will be Emotional reasoning bias severity and symptomatology associated with public speaking anxiety Secondary outcome measures will be the severity of depressive and anxious symptomatology quality of life usability and perceived acceptance of participants
Individuals will be assessed thrice at baseline post-treatment and 3-month follow-up
Data will be analyzed both per protocol and intention-to-treat This study will pioneer this type of intervention by bringing together an underdeveloped concept with implementing new technologies It is intended to increase our knowledge about treatments administered through the Internet and will contribute to improving the dissemination of treatments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None