Online Psychotherapy for Emotional Reasoning Bias in Public Speaking Anxiety

NCT06552273 | Not Yet Recruiting DMC

• 1 other identifier: CEISH/86/2023
• Study Type: interventional
• Target: 158
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (2)

• Changes in ERPSAS Emotional Reasoning Public Speaking Anxiety Scale

  ERPSAS is a self-report instrument consisting of the presentation of 4 scenarios with different endings depending on whether objective safety or danger information is presented and whether there is an anxiety response or not. Based on these scenarios the participant must measure, on a visual analog scale (VAS) from 0 to 100, the degree of danger, safety, controllability, desire to avoid the situation and degree of discomfort. The sum of these scales provides a single perceived threat score providing a measure to determine the presence of the Emotional Reasoning Bias. If the participant evaluates emotional situations as threatening without objective information of danger, the presence of an Emotional Reasoning bias arises. The scale has a range of 0-96 points (M= 36.57; SD= 14.18). The higher the score, the greater the emotional reasoning bias, with the cut-off point being a score of 47. Participants scoring above half a standard deviation above the mean will be included.

  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.

• Changes in Public Speaking Anxiety Scale

  The Public Speaking Anxiety Scale, which contains 17 items with a 5-point Likert-type response format (1=Not at all, 5=Extremely). This scale measures the presence and severity of cognitive, behavioural, and physiological symptomatology related to fear of public speaking, with a cut-off point of 73 (M= 49.33; SD= 12.88). Participants scoring above half a standard deviation above the mean will be included.

  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 (5)

• Changes in Overall Anxiety Severity and Impairment Scale

  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.

• Changes in Overall Depression Severity and Impairment Scale

  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.

• Changes in Quality Life Index

  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.

• Score in System Usability Scale

  2 evaluations: at post-treatment (just after treatment completion on the 13th day) and at 3-month follow up.

• Score in Satisfaction and acceptance with the training

  2 evaluations: at post-treatment (just after treatment completion on the 13th day) and at 3-month follow up.

Study Arms (2)

Emotional Reasoning bias correction training

EXPERIMENTAL

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

Behavioral: Emotional Reasoning bias correction training

Intervention based on mindfulness

ACTIVE COMPARATOR

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).

Behavioral: Module of Mindfulness of the Transdiagnostic treatment

Interventions

Emotional Reasoning bias correction training 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.

Emotional Reasoning bias correction training

Module of Mindfulness of the Transdiagnostic treatment BEHAVIORAL

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

Intervention based on mindfulness

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be of legal age.
• Accept the informed consent.
• Adequately understand/read Spanish.
• Have access to a mobile device or computer with an Internet connection.
• Not receiving any other psychological treatment for public speaking anxiety during the study period.
• 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.
• If taking prescribed medication for anxiety/depression, have had no changes in dosage for at least one month before the procedure.

You may not qualify if:

• Not accepting the informed consent.
• Being a minor.
• 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.

Sponsors & Collaborators

• Universitat Jaume I: lead

Related Publications (4)

• 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.

  PMID: 28424068 BACKGROUND

• 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.

  PMID: 36406838 BACKGROUND

• 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.

  PMID: 7487851 BACKGROUND

• 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.

  PMID: 23679871 BACKGROUND

Study Officials

• Macarena Paredes Mealla, PhD Student

  Universitat Jaume I

  PRINCIPAL INVESTIGATOR

• Carlos Suso Ribera, Dr.

  Universitat Jaume I

  STUDY DIRECTOR

• Azucena García Palacios, Dr.

  Universitat Jaume I

  STUDY DIRECTOR

Central Study Contacts

Macarena Paredes Mealla, PhD Student

CONTACT

+34 695891145; [email protected]

Carlos Suso Ribera, Dr.

CONTACT

[email protected]

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Model Details: 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.

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: August 13, 2024
• Study Start: November 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: November 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share