About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Be of legal age.
Accept the informed consent.
Adequately understand/read Spanish.
Have access to a mobile device or computer with an Internet connection.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
"HablaRÉ": Emotional Reasoning bias correction training
DeviceThe "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.
Treatment groups
Trial outcomes
Primary outcomes
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).
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.
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.
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.
Secondary outcomes
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 analogue 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.
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.
Changes in Overall Anxiety Severity and Impairment Scale
OASIS is a 5-item self-report instrument that assesses a unidimensional factor related to the severity and frequency of anxiety symptoms, as well as behavioral avoidance and functional impairment associated with these symptoms in the past week. Each item has five response options, coded from 0 to 4. The total score is calculated by adding the values of all items, ranging from 0 to 20. Scores higher than 8 indicate the presence of anxiety symptoms. This scale has been validated online in a sample of patients with depression and anxiety, demonstrating good internal consistency (α=0.86), as well as adequate convergent and discriminantvalidities and sensitivity to change.
Changes in Overall Depression Severity and Impairment Scale
ODSIS is a 5-item self-report instrument that the severity and functional impairment linked to depression over the past week. Each item has five response options coded from 0 to 4. The total score is calculated by summing the values of all items, ranging from 0 to 20. Scores of 5 or above suggest depressive symptoms. This scale was validated online using a sample of patients with depressive or anxiety disorders. It demonstrates excellent internal consistency (α=0.92), and its construct, convergent, and discriminant validities are supported.
Sponsors and contacts
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