NCT07051135

Brief Summary

The project aims to assess the feasibility of self-administered training for individuals with public speaking anxiety, specifically targeting the reduction of emotional reasoning bias. It seeks to evaluate the interventions' usability, acceptability, satisfaction and adherence/compliance rates. In addition, the study intends to determine the feasibility of conducting a potential randomised clinical trial to evaluate the true impact of the intervention on emotional reasoning biases and public speaking anxiety levels.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2025

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

July 3, 2025

Status Verified

June 1, 2025

Enrollment Period

2 months

First QC Date

May 26, 2025

Last Update Submit

June 26, 2025

Conditions

Keywords

Emotional ReasoningPublic Speaking AnxietyAnxietyEmotional disordersFeasibilityInternet interventionPsychological treatment

Outcome Measures

Primary Outcomes (4)

  • Usability and acceptability

    The System Usability Scale (SUS) will be used to measure usability and acceptability (Brooke, 1996; Castilla et al., 2023). Patients rate their agreement with statements on a 5-point Likert scale (from 1, "Strongly Disagree", to 5, "Strongly Agree") as part of the SUS, which evaluates the usability of ICT applications using 10 items. The item values, which range from 0 to 4, are added up, and the total is multiplied by 2.5 to determine the overall score, which is expressed as a percentage (0-100). Better perceived usability are indicated by a larger percentage (Bangor et al., 2008).

    2 evaluations: at post-treatment (just after treatment completion on the 10th day) and at 1-month follow up.

  • Satisfaction with online training

    Using questions created by our team and previously used in technology-related studies, satisfaction with the intervention will be evaluated (Suso-Ribera, Castilla, Zaragozá, Ribera-Canudas, Botella, \& García-Palacios, 2018). "To what extent are you satisfied with the app?" and "To what extent would you recommend the app?" are two examples of questions.

    2 evaluations: at post-treatment (just after treatment completion on the 10th day) and at 1-month follow up.

  • Adherence rates

    Adherence rates will be assessed according to the number of sessions completed by participants. Both the number of participants who fully complete the intervention (including the intervention, the final evaluation and the follow-up) and those who drop out will be considered. In these cases, it will be specifically identified at which stage of the process the drop-out occurred.

    2 evaluations: at post-treatment (just after treatment completion on the 10th day) and at 1-month follow up.

  • User interaction with the platform

    Interaction with the platform will be measured using access logs, specifically tracking the number of times participants log in for each session.

    1 evaluation: at post-treatment (just after treatment completion on the 10th day).

Secondary Outcomes (6)

  • Changes in ERPSAS Emotional Reasoning Public Speaking Anxiety Scale

    3 evaluations: at baseline before treatment onset, at treatment completion on the 10th day (Post-treatment evaluation) and 1-month follow up. Changes will be evaluated from pre-treatment to post-treatment and from post-treatment to 1 month follow-up.

  • Changes in Public Speaking Anxiety Scale

    3 evaluations: at baseline before treatment onset, at treatment completion on the 10th day (Post-treatment evaluation) and 1-month follow up. Changes will be evaluated from pre-treatment to post-treatment and from post-treatment to 1 month follow-up.

  • Changes in Overall Anxiety Severity and Impairment Scale

    3 evaluations: at baseline before treatment onset, at treatment completion on the 10th day (Post-treatment evaluation) and 1-month follow up. Changes will be evaluated from pre-treatment to post-treatment and from post-treatment to 1 month follow-up.

  • Changes in Overall Depression Severity and Impairment Scale

    3 evaluations: at baseline before treatment onset, at treatment completion on the 10th day (Post-treatment evaluation) and 1-month follow up. Changes will be evaluated from pre-treatment to post-treatment and from post-treatment to 1 month follow-up.

  • Changes in Quality Life Index

    3 evaluations: at baseline before treatment onset, at treatment completion on the 10th day (Post-treatment evaluation) and 1-month follow up. Changes will be evaluated from pre-treatment to post-treatment and from post-treatment to 1 month follow-up.

  • +1 more secondary outcomes

Study Arms (1)

Online treatment: Emotional Reasoning bias correction training

EXPERIMENTAL

Participants who meet the inclusion criteria will receive an Emotional Reasoning bias correction training called 'HablaRÉ' consisting of 10 self- administered sessions, delivered online with a duration of no more than 30 minutes each.

Device: "HablaRÉ": Emotional Reasoning bias correction training

Interventions

The "HablaRÉ" bias correction training for Emotional Reasoning consists of ten online, self-administered sessions that last no more than 30 minutes each. These courses include practice tasks in addition to textual and audio-visual content. The explanation of ER bias, motivation to change, emotional psychoeducation, and the distinction between emotionally biassed and objective information are all addressed.

Online treatment: Emotional Reasoning bias correction training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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/OR 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Jaume I

Castellon, Castellón, 12071, Spain

RECRUITING

Related Publications (3)

  • 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: 23679871BACKGROUND
  • 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: 7487851BACKGROUND
  • 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: 36406838BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Macarena Paredes-Mealla, PhD Student

    Universitat Jaume I

    PRINCIPAL INVESTIGATOR
  • Carlos Suso-Ribera, PhD

    Universitat Jaume I

    STUDY DIRECTOR
  • Azucena García Palacios, PhD

    Universitat Jaume I

    STUDY DIRECTOR

Central Study Contacts

Macarena Paredes-Mealla, PhD Student

CONTACT

Carlos Suso-Ribera, Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 26, 2025

First Posted

July 3, 2025

Study Start

May 1, 2025

Primary Completion

July 1, 2025

Study Completion

September 1, 2025

Last Updated

July 3, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations