Online Psychotherapy for Emotional Reasoning Bias in Public Speaking Anxiety

Universitat Jaume I

Status: Not yet enrolling

Conditions: Public Speaking Anxiety

Treatments: Behavioral: Emotional Reasoning bias correction training; Behavioral: Module of Mindfulness of the Transdiagnostic treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06552273

CEISH/86/2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 158 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

158 participants in 2 patient groups

Emotional Reasoning bias correction training

Experimental group

Description:

The experimental arm will receive an Emotional Reasoning bias correction training. The training consists of 12 self-administrated sessions, delivered online.

Treatment:

Behavioral: Emotional Reasoning bias correction training

Intervention based on mindfulness

Active Comparator group

Description:

The control group refers to an intervention based on mindfulness skills. This treatment is part of a Transdiagnostic treatment developed in our laboratory, for the treatment of patients with emotional disorders (Díaz-García et al., 2017).

Treatment:

Behavioral: Module of Mindfulness of the Transdiagnostic treatment