Public Speaking AnxietyNCT07051135
HablaRÉ: Self-applied Online Training for Correcting Emotional Reasoning Biases in Public Speaking Anxiety.
A study testing "HablaRÉ": Emotional Reasoning bias correction training in people with Public Speaking Anxiety, run by Universitat Jaume I at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Public Speaking Anxiety
- What is being tested?
- "HablaRÉ": Emotional Reasoning bias correction training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2025to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Carlos Suso-Ribera, Dr. contact
Spain1 site, 1 recruiting
- Recruiting
University Jaume I
Castellon, Castellón, 12071
Macarena Paredes-Mealla, PhD Student, + 34 964376252, dparedes@uji.es
About this study
Official title: HablaRÉ: Self-applied Online Training for Correcting Emotional Reasoning Biases in Public Speaking Anxiety. A Feasibility, Non-randomised Pilot Study.
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.
Read the detailed description
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.
- Conditions
- Public Speaking Anxiety
- Being tested
- "HablaRÉ": Emotional Reasoning bias correction training
- Keywords
- Emotional Reasoning, Public Speaking Anxiety, Anxiety, Emotional disorders, Feasibility, Internet intervention, Psychological treatment
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"HablaRÉ": Emotional Reasoning bias correction trainingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: "HablaRÉ": Emotional Reasoning bias correction training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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 fulfilment, spiritual fulfilment, 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.
Measured: 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
For participants who do not complete treatment, they will be asked voluntarily for the reason for discontinuing treatment.
Measured: 1 evaluation: at post-treatment (until the end of the last session, up to 20 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start1 May 2025
- Primary completionJul 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Public Speaking AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Jaume I
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Macarena Paredes Mealla, Universitat Jaume I
- Investigators
- Macarena Paredes-Mealla, PhD Student, Principal investigator, Universitat Jaume ICarlos Suso-Ribera, PhD, Study director, Universitat Jaume IAzucena García Palacios, PhD, Study director, Universitat Jaume I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07051135
- Sponsor's protocol ID
- CEISH/86/2023-01
- Status last verified
- Jun 2025
- First submitted
- 26 May 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23679871Arntz 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.
PubMed 7487851Paredes-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.
PubMed 36406838
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HablaRÉ: Self-applied Online Training for Correcting Emotional Reasoning Biases in Public Speaking Anxiety. A Feasibility, Non-randomised Pilot Study.
- ClinicalTrials.gov ID
- NCT07051135
- Acronym / sponsor ID
- CEISH/86/2023-01
- Conditions
- Public Speaking Anxiety
- Keywords
- Emotional Reasoning, Public Speaking Anxiety, Anxiety, Emotional disorders, Feasibility, Internet intervention, Psychological treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universitat Jaume IUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Online treatment: Emotional Reasoning bias correction training | Experimental | Device: "HablaRÉ": Emotional Reasoning bias correction trainingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "HablaRÉ": Emotional Reasoning bias correction trainingThe "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. | Device | Online treatment: Emotional Reasoning bias correction training |
Primary outcome
Usability and acceptability
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
6 secondary outcomes
Changes in ERPSAS Emotional Reasoning Public Speaking Anxiety Scale
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1 evaluation: at post-treatment (until the end of the last session, up to 20 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Results publication: PubMed 23679871Lommen 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.
- Results publication: PubMed 7487851Arntz 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.
- Results publication: PubMed 36406838Paredes-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carlos Suso-Ribera, Dr. contact
Macarena Paredes-Mealla, PhD Student principal investigator
Universitat Jaume I
Carlos Suso-Ribera, PhD study director
Universitat Jaume I
Azucena García Palacios, PhD study director
Universitat Jaume I
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "HablaRÉ": Emotional Reasoning bias correction training in people with Public Speaking Anxiety, run by Universitat Jaume I at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Macarena Paredes-Mealla, PhD Student (+34 964376252, dparedes@uji.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability and acceptability (time frame: 2 evaluations: at post-treatment (just after treatment completion on the 10th day) and at 1-month follow up.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07051135, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.