Online Psychotherapy for Emotional Reasoning Bias in Public Speaking Anxiety
ConditionPublic Speaking Anxiety
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitat Jaume I
About this trial
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.
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
Design model
Parallel
Treatments tested in this trial
Emotional Reasoning bias correction training
BehavioralEmotional Reasoning Bias correction training involves 12 daily self-applied sessions focusing on psychoeducation about emotions and identifying ER biases and their impact on behaviour.
Module of Mindfulness of the Transdiagnostic treatment
BehavioralModule based on mindfulness using techniques for training in awareness and acceptance of experiences, observing experiences as they arise without judgment.
Treatment groups
158 Participants
are divided into 2 treatment groupsGroup A: Emotional Reasoning bias correction trainingExperimental treatment 1 intervention
Group B: Intervention based on mindfulnessActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
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.2
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.
Time frame
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
1
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 discriminant validities, and sensitivity to change.
Time frame
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.2
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.
Time frame
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.3
Changes in Quality Life Index
The QLI is a 10-item self-report instrument that assesses a single concept of quality of life across 10 dimensions using a ten-point Likert scale (1=poor; 10=excellent). The dimensions include physical well-being, psychological/emotional well-being, self-care and independent functioning, occupational functioning, interpersonal functioning, social-emotional support, community and services support, personal fulfillment, spiritual fulfillment, and overall perception of quality of life. The total score is the average of the item scores, ranging from 1 to 10 (1-4.5 = below average quality of life; 4.6-8.1 = average quality of life; 8.2-10 = above average quality of life). The QLI demonstrates high internal consistency (α=0.89) and test-retest reliability (0.89), with discriminant validity evidenced in a sample of psychiatric patients.
Time frame
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.4
Score in System Usability Scale
The SUS is a 10-item self-report instrument designed to assess opinions on system usability using a 5-point Likert scale ranging from 1 (Completely disagree) to 5 (Completely agree). The content validity index of the Spanish version of the SUS was favorable, with a rating of 0.92 for item relevance. The Cronbach's α was 0.812.
Time frame
2 evaluations: at post-treatment (just after treatment completion on the 13th day) and at 3-month follow up.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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