Clinical trial NCT06552273: Online Psychotherapy for Emotional Reasoning Bias in Public Speaking Anxiety
Official title: Implementation of a Self-applied Online Psychological Intervention for Emotional Reasoning Bias in People With Public Speaking Anxiety: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Public Speaking Anxiety
Keywords: Bias correction training
Emotional reasoning
Public speaking anxiety
Internet intervention
Self-applied intervention
Randomized controlled trial
Scared of speaking in public
Transdiagnostic process
Social anxiety
Lead sponsor: Universitat Jaume I
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arms are compared, an experimental group to which bias correction training will be applied and a control group, to which a non-specific mindfulness intervention will be used. Subjects will be randomly assigned to one group or the other.
Primary purpose: TREATMENT

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, i.e., 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 G\*Power program will be randomly allocated to an intervention group (N=79) and a control group (N=79). 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.

Eligibility criteria: Inclusion Criteria:

1. Be of legal age.
2. Accept the informed consent.
3. Adequately understand/read Spanish.
4. Have access to a mobile device or computer with an Internet connection.
5. Not receiving any other psychological treatment for public speaking anxiety during the study period.
6. Have a score of 43 or higher on the Emotional reasoning scale (ERPSAS) AND a score of 55 or higher on the Spanish version of the Public Speaking Anxiety Scale (PSAS-S) for fear of public speaking.
7. If taking prescribed medication for anxiety/depression, have had no changes in dosage for at least one month before the procedure.

Exclusion Criteria:

1. Not accepting the informed consent.
2. Being a minor.
3. Having a severe mental disorder (bipolar disorder, schizophrenia, or other psychotic disorders) or substance abuse (alcohol or other substances) or having active suicidal plans (suicide item in the ODSIS depression questionnaire ≥ 2) that would prevent participation in the program.
4. In the case of receiving medication, changes in medication during treatment will be evaluated but will not lead to exclusion.

Primary outcomes:
measure: Changes in ERPSAS Emotional Reasoning Public Speaking Anxiety Scale
timeFrame: 3 evaluations: at baseline before treatment onset, at treatment completion on the 13th day (Post-treatment evaluation) and 3-month follow up. Changes will be evaluated from pre-treatment to post-treatment and from post-treatment to 3 month follow-up.
measure: Changes in Public Speaking Anxiety Scale
timeFrame: 3 evaluations: at baseline before treatment onset, at treatment completion on the 13th day (Post-treatment evaluation) and 3-month follow up. Changes will be evaluated from pre-treatment to post-treatment and from post-treatment to 3 month follow-up.
Secondary outcomes:
measure: Changes in Overall Anxiety Severity and Impairment Scale
timeFrame: 3 evaluations: at baseline before treatment onset, at treatment completion on the 13th day (Post-treatment evaluation) and 3-month follow up. Changes will be evaluated from pre-treatment to post-treatment and from post-treatment to 3 month follow-up.
measure: Changes in Overall Depression Severity and Impairment Scale
timeFrame: 3 evaluations: at baseline before treatment onset, at treatment completion on the 13th day (Post-treatment evaluation) and 3-month follow up. Changes will be evaluated from pre-treatment to post-treatment and from post-treatment to 3 month follow-up.
measure: Changes in Quality Life Index
timeFrame: 3 evaluations: at baseline before treatment onset, at treatment completion on the 13th day(Post-treatment evaluation) and 3-month follow up. Changes will be evaluated from pre-treatment to post-treatment and from post-treatment to 3 month follow-up.
measure: Score in System Usability Scale
timeFrame: 2 evaluations: at post-treatment (just after treatment completion on the 13th day) and at 3-month follow up.
measure: Score in Satisfaction and acceptance with the training
timeFrame: 2 evaluations: at post-treatment (just after treatment completion on the 13th day) and at 3-month follow up.
Other outcomes:
Locations:
Study officials:
affiliation: Universitat Jaume I
name: Macarena Paredes Mealla, PhD Student
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitat Jaume I
name: Carlos Suso Ribera, Dr.
role: STUDY_DIRECTOR
affiliation: Universitat Jaume I
name: Azucena García Palacios, Dr.
role: STUDY_DIRECTOR
References:
citation: Diaz-Garcia A, Gonzalez-Robles A, Fernandez-Alvarez J, Garcia-Palacios A, Banos RM, Botella C. Efficacy of a Transdiagnostic internet-based treatment for emotional disorders with a specific component to address positive affect: Study protocol for a randomized controlled trial. BMC Psychiatry. 2017 Apr 20;17(1):145. doi: 10.1186/s12888-017-1297-z.
citation: Paredes-Mealla M, Martinez-Borba V, Miragall M, Garcia-Palacios A, Banos RM, Suso-Ribera C. Is there evidence that emotional reasoning processing underlies emotional disorders in adults? A systematic review. Curr Psychol. 2022 Nov 9:1-17. doi: 10.1007/s12144-022-03884-4. Online ahead of print.
citation: Arntz A, Rauner M, van den Hout M. "If I feel anxious, there must be danger": ex-consequentia reasoning in inferring danger in anxiety disorders. Behav Res Ther. 1995 Nov;33(8):917-25. doi: 10.1016/0005-7967(95)00032-s.
citation: Lommen MJ, Engelhard IM, van den Hout MA, Arntz A. Reducing emotional reasoning: an experimental manipulation in individuals with fear of spiders. Cogn Emot. 2013;27(8):1504-12. doi: 10.1080/02699931.2013.795482. Epub 2013 May 16.