Online Psychotherapy for Emotional Reasoning Bias in Public Speaking Anxiety

NCT ID: NCT06552273

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-11-01

Brief Summary

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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

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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.

Conditions

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Public Speaking Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Emotional Reasoning bias correction training

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

Group Type EXPERIMENTAL

Emotional Reasoning bias correction training

Intervention Type BEHAVIORAL

Emotional Reasoning Bias correction training involves 12 daily self-applied sessions focusing on psychoeducation about emotions and identifying ER biases and their impact on behaviour.

Intervention based on mindfulness

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).

Group Type ACTIVE_COMPARATOR

Module of Mindfulness of the Transdiagnostic treatment

Intervention Type BEHAVIORAL

Module based on mindfulness using techniques for training in awareness and acceptance of experiences, observing experiences as they arise without judgment.

Interventions

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Emotional Reasoning bias correction training

Emotional Reasoning Bias correction training involves 12 daily self-applied sessions focusing on psychoeducation about emotions and identifying ER biases and their impact on behaviour.

Intervention Type BEHAVIORAL

Module of Mindfulness of the Transdiagnostic treatment

Module based on mindfulness using techniques for training in awareness and acceptance of experiences, observing experiences as they arise without judgment.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitat Jaume I

OTHER

Sponsor Role lead

Responsible Party

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Macarena Paredes Mealla

PhD Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Macarena Paredes Mealla, PhD Student

Role: PRINCIPAL_INVESTIGATOR

Universitat Jaume I

Carlos Suso Ribera, Dr.

Role: STUDY_DIRECTOR

Universitat Jaume I

Azucena García Palacios, Dr.

Role: STUDY_DIRECTOR

Universitat Jaume I

Central Contacts

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Macarena Paredes Mealla, PhD Student

Role: CONTACT

+34 695891145

Carlos Suso Ribera, Dr.

Role: CONTACT

References

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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.

Reference Type BACKGROUND
PMID: 28424068 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36406838 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7487851 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23679871 (View on PubMed)

Other Identifiers

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CEISH/86/2023

Identifier Type: -

Identifier Source: org_study_id

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