HablaRÉ: Self-applied Online Training for Correcting Emotional Reasoning Biases in Public Speaking Anxiety. A Feasibility, Non-randomised Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Usability and acceptability
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Online treatment: Emotional Reasoning bias correction training
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.
干预措施: "HablaRÉ": Emotional Reasoning bias correction training (Device)
结局指标
主要结局
Usability and acceptability
时间窗: 2 evaluations: at post-treatment (just after treatment completion on the 10th day) and at 1-month follow up.
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).
Satisfaction with online training
时间窗: 2 evaluations: at post-treatment (just after treatment completion on the 10th day) and at 1-month follow up.
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.
Adherence rates
时间窗: 2 evaluations: at post-treatment (just after treatment completion on the 10th day) and at 1-month follow up.
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.
User interaction with the platform
时间窗: 1 evaluation: at post-treatment (just after treatment completion on the 10th day).
Interaction with the platform will be measured using access logs, specifically tracking the number of times participants log in for each session.
次要结局
- 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 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.)
- Reason for discontinuation of treatment(1 evaluation: at post-treatment (until the end of the last session, up to 20 days))
- 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.)
研究者
Macarena Paredes Mealla
Principal investigator
Universitat Jaume I