HablaRÉ: Self-applied Online Training for Correcting Emotional Reasoning Biases in Public Speaking Anxiety.

Официальное название

HablaRÉ: Self-applied Online Training for Correcting Emotional Reasoning Biases in Public Speaking Anxiety. A Feasibility, Non-randomised Pilot Study.

Обзор

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.

Подробное описание

Public Speaking Anxiety (PSA), manifests as intense fear in public speaking or performance contexts, and while it is commonly seen in individuals with SAD, it can also occur independently. Studies show that 97% of individuals with SAD experience PSA, with approximately 40% suffering from severe PSA. PSA is associated with significant distress and detrimental effects on work, education, and social life. Several interventions, grounded in cognitive-behavioural principles, such as exposure therapies, have been proven effective in treating PSA, with both traditional and technology-based therapies demonstrating significant improvements in reducing anxiety and enhancing coping behaviours.

Despite the effectiveness of these treatments, relapse, non-improvement, or treatment discontinuation remain significant challenges. Comorbidity, affecting over 75% of individuals with affective disorders, worsens treatment outcomes and suggests the potential benefit of addressing transdiagnostic factors such as Emotional Reasoning (ER), a cognitive bias where individuals make judgements based on emotional responses rather than objective facts. Although ER has been targeted in interventions for spider phobia, no specific treatment for ER in PSA exists. The present study seeks to develop and assess the feasibility of "HablaRÉ" an intervention aimed at correcting ER biases in PSA patients. The study will evaluate the intervention's usability, acceptability, adherence, and its potential for a randomised clinical trial to determine its impact on ER bias and PSA levels.

A total of 30 participants will undergo training consisting of 10 self-administered daily sessions in which components such as psychoeducation on emotions and the detection of ER biases and their impact on behaviour.

Вмешательства

• Устройство "HablaRÉ": Emotional Reasoning bias correction training
  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.

Первичные конечные точки

• Usability and acceptability [Срок оценки: 2 evaluations: at post-treatment (just after treatment completion on the 10th day) and at 1-month follow up.]
• Satisfaction with online training [Срок оценки: 2 evaluations: at post-treatment (just after treatment completion on the 10th day) and at 1-month follow up.]
• Adherence rates [Срок оценки: 2 evaluations: at post-treatment (just after treatment completion on the 10th day) and at 1-month follow up.]
• User interaction with the platform [Срок оценки: 1 evaluation: at post-treatment (just after treatment completion on the 10th day).]

Вторичные конечные точки (6)

• Changes in ERPSAS Emotional Reasoning Public Speaking Anxiety Scale [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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.]
• Reason for discontinuation of treatment [Срок оценки: 1 evaluation: at post-treatment (until the end of the last session, up to 20 days)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.
• In the case of receiving medication, changes in medication during treatment will be evaluated but will not lead to exclusion.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Оценка устройства

Центры проведения

Испания · 1 центр

• University Jaume I — Castellon

Публикации

• 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
• 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
• 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

Идентификаторы

NCT: NCT07051135 · CEISH/86/2023-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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