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Anxiety DisordersNCT05569018

Efficacy of a Transdiagnostic Group Treatment for Emotional Disorders Applied in Blended Format: a Controlled Study.

A study testing Blended group transversal protocol (BLGr-TP) and Face-to-face group transversal protocol (FFGr-TP) in people with Anxiety Disorders and Depressive Disorders, run by Universitat Jaume I at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study will consist in a randomized controlled clinical trial (RCT) to test the efficacy of a blended group transversal protocol (BLGr-TP) compared to a face-to-face group transversal protocol (FFGr-TP). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anxiety Disorders, Depressive Disorders
What is being tested?
Blended group transversal protocol (BLGr-TP) and Face-to-face group transversal protocol (FFGr-TP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
1 siteSpain
Study dates
23 Nov 2024to Jul 2027
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

  • Being 18 years old or more.
  • DSM-5 (APA, 1013) diagnostic criteria for emotional disorder (panic disorder, agoraphobia, social anxiety disorder, generalized anxiety disorder, major depressive disorder, dysthymia, obsessive-compulsive disorder, non-specified anxiety disorder, non-specified depressive disorder).
  • Good understanding of Spanish.
  • Access to the Internet and email address.
  • Informed consent to participate.

Who cannot join

  • Diagnosis of a severe mental disorder (psychotic disorder, bipolar disorder, substance and/or alcohol dependence).
  • High risk of suicide.
  • Having a serious medical illness or other condition that prevents treatment from being carried out.
  • Receiving another psychological treatment during the study period.
  • Changes and/or increases in pharmacological treatment during the study period (a decrease is accepted).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Juana María Bretón-López, Dr. contact

+34 964387642 ext. 7642

breton@uji.es

Azucena García-Palacios, Dr. contact

+34 964387640 ext. 7640

azucena@uji.es

Spain1 site, 1 recruiting

  • Jaume I University, Castellón, Spain

    Castellon, Castellón, 12071

    Juana Bretón-López, Dr., +34 964387642 ext. 7642, breton@uji.es

    Recruiting

Other trials in Spain

About this study

Official title: Efficacy of a Group Treatment Based on Transdiagnostic Perspective for Emotional Disorders and Applied in Blended Format: a Randomized Controlled Trial.

This study will consist in a randomized controlled clinical trial (RCT) to test the efficacy of a blended group transversal protocol (BLGr-TP) compared to a face-to-face group transversal protocol (FFGr-TP).

The main aims of the study are the following:

Read more
  • To analyze the differential efficacy of the BLGr-TP versus the FFGr-TP for the treatment of emotional disorders in aspects of clinical measures, as well as in terms of retention and dropout rate and adherence.
  • To analyze the differential acceptability of the BLGr-TP versus the FFGr-TP for the treatment of emotional disorders.

In addition, it is intended to carry out a study of mediators and moderators of the efficacy of both interventions.

The established hypotheses in relation to the main goals are:

  • Both treatment modalities (FFGr-TP and BLGr-TP) will achieve improvements in the symptoms of emotional disorders, reflected in the scores of the clinical measures.
  • The BLGr-TP will show equivalent efficacy to the FFGr-TP.
  • The BLGr-TP will show an acceptability comparable to the face-to-face protocol. Both modalities will be well valued by the participants.
  • In both treatment modalities, the changes achieved are expected to be maintained over time (3, 6 and 12 months).
Read the detailed description

Emotional disorders (ED) are among the most common and most disabling psychological disorders. They involve important costs and a high comorbidity between them. A large number of evidence-based treatment programs (EBT) has shown to be effective; however, there is a difficulty regarding their dissemination, being that it is difficult to train clinicians in the different protocols for different disorders, and a difficulty in the management of patients with comorbidity. The transdiagnostic approach and the incorporation of technologies for the administration of the based-Internet treatments can help to overcome these barriers. In this context, blended treatments, that combine face-to-face therapy with online therapy, are gaining prominence, because they exhibit advantages over traditional intervention and over treatments totally self-administered throughout Internet. Otherwise, the application of treatments in group format also allows to provide EBTs at a lower cost, so that both blended format and group format constitute strategies that allow improve the cost-effectiveness binomial. To our knowledge, no studies that integrate blended with group format for apply a transdiagnostic protocol for ED have been published.

This study will be a two-arm, parallel-group, randomized controlled clinical trial (RCT) in which participants will be randomly assigned to one of two conditions: 1) Face-to-face group transversal protocol (FFGr-TP) and 2) Blended group transversal protocol (BLGr-TP). To carry it out, a total of 144 patients will be needed. Randomization will be stratified by primary diagnosis. Block randomization will be performed within each stratum to ensure that all major diagnoses are equally represented under all conditions. In this trial there will be five evaluation moments: pre-treatment, post-treatment and follow-up at 3, at 6 and at 12 months. During the treatment administration, two messages of support (an email and a SMS) per week will be sent to participants.

The study will be carried out following national and international standards (Declaration of Helsinki and Tokyo, and Declaration of Madrid of the World Psychiatric Association) and has been submitted to the approval of the Research Ethics Committee of the Universitat Jaume I. Participants will be adult people who contact with the Psychological Assistance Service (PAS) of the Universitat Jaume I or who write at email enabled for the study. All participants will be volunteers and they will give their informed consent to participate in the study. The confidentiality and rights of the subjects included in the study will be guaranteed in accordance with the provisions of Organic Law 3/2018, of December 5, on the Protection of Personal Data and guarantee of the digital rights (LOPDgdd), which adapts Spanish legislation to the General Data Protection Regulation of the European Union (RGPD).

Being tested
Blended group transversal protocol (BLGr-TP), Face-to-face group transversal protocol (FFGr-TP)
Keywords
Cognitive-Behavioral Therapy, Transdiagnostic CBT, Blended CBT, Group CBT, Emotional disorders
Medical subject headings
Anxiety Disorders, Depressive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blended group transversal protocol (BLGr-TP)Behavioural

    Also called BLGr-TP

    It will consist in the administration of a transdiagnostic treatment protocol composed by 16 modules focused on regulating both negative and positive affect. The intervention will be administered over a 16-week period. Face-to-face group sessions will be combined with autonomous work of patients through a web platform where they will find the contents of the program. The groups will have 6-10 patients, who will attend a total of 8 face-to-face sessions of 2 hours long each one. The online part of the treatment (self-applied Online Transversal Protocol) will consist in working the contents exposed in the face-to-face sessions during between-sessions period (2 weeks). It is an interactive program with multimedia elements (videos, images,…) that allows people to perform the modules from home and at their own pace. In addition, the program is characterized by its ease of use, presenting an agile navigation.

  • Face-to-face group transversal protocol (FFGr-TP)Behavioural

    Also called FFGr-TP

    It will consist in the administration of the transdiagnostic treatment protocol through the 16 modules focused on regulating both negative and positive affect. The intervention will be carried out in face-to-face group format and it will be administered during a 16-week period. The groups will have between 6 to 10 patients, who will attend a total of 16 face-to-face sessions of 2 hours long each one. During between-sessions period (1 week), patients will work the content of the modules exposed in the face-to-face sessions through tasks for home (traditional paper format).

Study groups in NCT05569018
Study groupRoleWhat they receive
Blended group transversal protocol (BLGr-TP)ExperimentalTreatment protocol based on the transdiagnostic perspective administered in blended (face-to-face + online) and group format. It consists of the following components: Psychoeducation about emotional disorders and emotion regulation; Motivation for change; Psychoeducation about emotions; Awareness of emotional experiences; Promotion of cognitive flexibility; Psychoeducation and awareness of avoidance strategies that maintain emotional problems; Interoceptive exposure: exposure to physical sensations; Situational and emotional exposure; Learning to move on; Learning to enjoy; Learning to live; Living and learning; Relapse prevention.
Receives: Behavioral: Blended group transversal protocol (BLGr-TP)
Face-to-face group transversal protocol (FFGr-TP)Active comparatorTreatment protocol based on the transdiagnostic perspective administered in traditional (face-to-face) group format. It consists of the following components: Psychoeducation about emotional disorders and emotion regulation; Motivation for change; Psychoeducation about emotions; Awareness of emotional experiences; Promotion of cognitive flexibility; Psychoeducation and awareness of avoidance strategies that maintain emotional problems; Interoceptive exposure: exposure to physical sensations; Situational and emotional exposure; Learning to move on; Learning to enjoy; Learning to live; Living and learning; Relapse prevention.
Receives: Behavioral: Face-to-face group transversal protocol (FFGr-TP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the Overall Anxiety Severity and Impairment Scale (OASIS) (Campbell-Sills et al., 2009; González-Robles et al., 2018) at pre-treatment, post-treatment, and at 3-, 6- and 12-month follow-up.

    The OASIS is a 5-item self-report scale that evaluates the frequency and severity of anxiety symptoms, the functional impairment related to these symptoms (i.e. school, work, home, or social impairment), and behavioral avoidance. Each item instructs respondents to endorse one of five responses that best describes their experiences over the past week. Response items are coded from 0 to 4, added together to obtain a total score ranging from 0 to 20. Previous studies have shown good internal consistency (α = 0.80), test-retest reliability, and convergent and discriminant validity. The Spanish version has shown good internal consistency (α = 0.86), and convergent and discriminant validity.

    Measured: Pre-treatment, post-modules (throughout the treatment), post-treatment (4 months), follow-up (7, 10 and 16 months)

  2. Change in the Overall Depression Severity and Impairment Scale (ODSIS) (Bentley et al., 2014; Mira et al., 2019) at pre-treatment, post-treatment, and at 3-, 6- and 12-month follow-up.

    The ODSIS is a brief self-reported scale with 5 items that assess the severity and functional impairment associated with depressive symptoms. Items are coded on a 5-point scale (0-4). The sum of the scores is used to obtain the total score, which can be a maximum of 20. The measure has shown excellent internal consistency (α = 0.94 in an outpatient sample, 0.92 in a community sample, and 0.91 in a student sample) and good convergent/discriminant validity. The Spanish validation has excellent internal consistency (α = 0.93), as well as convergent and discriminant validity.

    Measured: Pre-treatment, post-modules (throughout the treatment), post-treatment (4 months), follow-up (7, 10 and 16 months)

Secondary outcomes (8)

  1. Change in the Positive and Negative Affect Schedule (PANAS) (Watson, Clark & Tellegen, 1988; Sandín et al., 1999; Díaz-García et al., 2020) at pre-treatment, post-treatment, and at 3-, 6- and 12-month follow-up.

    The PANAS consists of 20 items that evaluate two independent dimensions: positive affect (PA) and negative affect (NA). It contains 10 descriptors evaluating PA (e.g., "enthusiastic", "inspired", "proud") and 10 others assessing NA (e.g., "scared", "irritable", "guilty"). The range for each scale (10 items on each) is from 10 to 50, and the patient has to answer how he or she usually feels regarding each of these emotions. The scale showed excellent internal consistency (α between .84 and .90) and convergent and discriminant validity. The Spanish version has demonstrated good to excellent internal consistency (α = .89 and .91 for PA and NA in women, respectively, and α = .87 and .89 for PA and NA in men, respectively) in college students.

    Measured: Pre-treatment, post-modules (throughout the treatment), post-treatment (4 months), follow-up (7, 10 and 16 months)

  2. Change in the Difficulties in Emotion Regulation Scale (DERS) (Gratz & Roemer, 2004; Hervás & Jódar, 2008) at pre-treatment, post-treatment, and at 3-, 6- and 12-month follow-up.

    The DERS is a self-report scale that assesses different clinically relevant aspects of maladaptive emotional regulation and the main difficulties that may arise in the processing of emotions. In the Spanish adaptation of the scale, the factorial analysis showed five interpretable factors, one less than the original scale: Emotional lack of control (Impulsivity and No strategies of the original scale), Emotional rejection (No acceptance), Everyday interference (No goals), Emotional inattention (No awareness) and Emotional confusion (No clarity). The Spanish validation consists of 28 items with a 5-point Likert scale, being 1 = Almost never (0-10% of the time) and 5 = Almost always (90-100% of the time). The adapted scale has good psychometric properties: internal consistency of 0.93, test-retest reliability of 0.74 and good convergent and incremental validity.

    Measured: Pre-treatment, post-treatment (4 months), follow-up (7, 10 and 16 months)

  3. Change in the NEO-Five Factor Inventory (NEO-FFI) (Costa & McCrae, 1992; Robins, Fraley, Roberts & Trzesniewski, 2001; Aluja, García, Rossier & García, 2005) at pre-treatment, post-treatmen,t and at 3-, 6- and 12-month follow-up.

    The NEO-FFI is the short version of the NEO-PI-R, designed to assess the five personality dimensions through 60 items. In this study, only the subscales of neuroticism and extraversion are used. Each scale contained 12 items with a five-point Likert response format. Two-week retest reliability is uniformly high, ranging from 0.86 to 0.90 for the five scales, and internal consistency ranges from 0.68 to 0.86. The Spanish version of the NEO-FFI has been found to be appropriate.

    Measured: Pre-treatment, post-treatment (4 months), follow-up (7, 10 and 16 months)

  4. Change in the Quality of Life Index (QLI) (Mezzich, Cohen, Ruiperez, Benzato & Zapata-Vega, 2011; Mezzich et al., 2000) at pre-treatment, post-treatment, and at 3-, 6- and 12-month follow-up.

    The QLI is a self-report questionnaire that consists of 10 items aimed at assessing quality of life in ten areas: psychological well-being, physical well-being, emotional and social support, interpersonal functioning, selfcare and independent functioning, community and service support, occupational functioning, self-realization, spiritual satisfaction, and an overall assessment of quality of life. The Spanish version of the QLI has shown good internal consistency and test-retest reliability in previous studies.

    Measured: Pre-treatment, post-treatment (4 months), follow-up (7, 10 and 16 months)

  5. Change in the Work and Social Adjustment Scale (WSAS) (Echezarraga et al., 2018; Mundt et al., 2002) at pre-treatment, post-treatment, and at 3-, 6- and 12-month follow-up.

    The WSAS is a 5-item scale that evaluates the degree of interference associated with the patients' symptoms in the following five domains: work, home management, private leisure, social leisure, and family relationships. Items are coded on a scale from 0 (not at all) to 8 (very severely), and higher scores are indicative of greater interference in the different areas. The scale has shown good to excellent internal consistency (α = 0.70 to 0.94), test-retest reliability, and sensitivity to change. The Spanish version has demonstrated excellent internal consistency and good concurrent validity.

    Measured: Pre-treatment, post-treatment (4 months), follow-up (7, 10 and 16 months)

  6. Change on the Multidimensional Emotional Disorders Inventory (MEDI) (Rosellini & Brown, 2019; Osma et al., 2023) at pre-treatment, post-treatment, and at 3-, 6- and 12-month follow-up.

    It is a self-report questionnaire that assesses nine transdiagnostic dimensions (Neurotic Temperament, Positive Temperament, Depressive Mood, Autonomic Arousal, Somatic Anxiety, Social Anxiety, Intrusive Thoughts, Traumatic Re-experiencing and Avoidance). It consists of a 49-item scale with a 9-point Likert-type response (from 0 = "It is not characteristic of me" to 8 = "Totally characteristic of me"). The Spanish validation shows good psychometric properties and strong internal consistency indices (α = 0.66 to 0.91).

    Measured: Pre-treatment, post-treatment (4 months), follow-up (7, 10 and 16 months)

  7. Change on the General Self-Efficacy Scale (GSES) (Baessler y Schwarzer, 1996; Sanjuán et al., 2000) at pre-treatment, post-treatment, and at 3-, 6- and 12-month follow-up.

    It assesses the stable feeling of personal competence to effectively handle a wide variety of stressful situations. It consists of 10 items with 10-point Likert-type scales, so that subjects' scores can range from 10 to 100.

    Measured: Pre-treatment, post-modules (throughout the treatment), post-treatment (4 months), follow-up (7, 10 and 16 months)

  8. Change on the Modulate Subscale of the S-DERS (Lavender et al., 2017).

    The S-DERS is a measure of difficulties in state emotional regulation, to assess momentary emotional regulation. Factor 2 (Modulate) includes items that reflect difficulties in responding emotionally and behaviorally in the moment, and was labeled as Limited Ability to Modulate Current Emotional and Behavioral Responses. This factor conceptually overlaps with the Strategies, Impulse, and Goals subscales of the original trait DERS, combining difficulties in modulating both emotions and behavioral responses to emotions into a single state scale. The Modulate subscale demonstrated adequate to excellent internal consistency (α=0.85). Regarding validity, the Modulate subscale was positively associated with measures of experiential avoidance, with measures of substance use problems, and with emotional reactivity.

    Measured: Throughout the treatment (post-modules measure)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2022
  2. Study start23 Nov 2024
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
144 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05569018
Sponsor's protocol ID
UJaumeI_Transd_Group_Blended_2
Status last verified
Apr 2026
First submitted
14 Jul 2022
Last updated
5 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Aluja, A., García, O., Rossier, J., et al. (2005). Comparison of the NEO-FFI, the NEOFFI-R and an alternative short version of the NEO-PI-R (NEO-60) in Swiss and Spanish samples. Pers Individ Dif, 38(3), 591-604.

  • Andrews G, Basu A, Cuijpers P, Craske MG, McEvoy P, English CL, Newby JM. Computer therapy for the anxiety and depression disorders is effective, acceptable and practical health care: An updated meta-analysis. J Anxiety Disord. 2018 Apr;55:70-78. doi: 10.1016/j.janxdis.2018.01.001. Epub 2018 Feb 1.

    PubMed 29422409

  • Bangor, A., Kortum, P.T y Miller, J.T. (2008). An empirical evaluation of the System Usability Scale. International Journal of Human-Computer Interaction, 24(6), 574-594. https://doi.org/10.1080/10447310802205776

  • Bentley KH, Gallagher MW, Carl JR, Barlow DH. Development and validation of the Overall Depression Severity and Impairment Scale. Psychol Assess. 2014 Sep;26(3):815-830. doi: 10.1037/a0036216. Epub 2014 Apr 7.

    PubMed 24708078

  • Borkovec, T. D., & Nau, S. D. (1972). Credibility of analogue therapy rationales. Journal of behavior therapy and experimental psychiatry, 3(4), 257-260.

  • Brooke, J. (1996). SUS: A 'Quick and Dirty' Usability Scale. In P. W. Jordan, B. Thomas, I. L. McClelland & B. Weerdmeester (Eds.), Usability Evaluation in Industry. London, England: CRC Press.

  • Brown TA, Barlow DH. A proposal for a dimensional classification system based on the shared features of the DSM-IV anxiety and mood disorders: implications for assessment and treatment. Psychol Assess. 2009 Sep;21(3):256-71. doi: 10.1037/a0016608.

    PubMed 19719339

  • Campbell-Sills L, Norman SB, Craske MG, Sullivan G, Lang AJ, Chavira DA, Bystritsky A, Sherbourne C, Roy-Byrne P, Stein MB. Validation of a brief measure of anxiety-related severity and impairment: the Overall Anxiety Severity and Impairment Scale (OASIS). J Affect Disord. 2009 Jan;112(1-3):92-101. doi: 10.1016/j.jad.2008.03.014. Epub 2008 May 16.

    PubMed 18486238

  • Carlbring P, Andersson G, Cuijpers P, Riper H, Hedman-Lagerlof E. Internet-based vs. face-to-face cognitive behavior therapy for psychiatric and somatic disorders: an updated systematic review and meta-analysis. Cogn Behav Ther. 2018 Jan;47(1):1-18. doi: 10.1080/16506073.2017.1401115. Epub 2017 Dec 7.

    PubMed 29215315

  • Costa, P. T. & McCrae, R. R. (1992). Normal personality assessment in clinical practice: the NEO personality inventory. Psychol. Assess., 4(1), 5-13.

  • Diaz-Garcia A, Gonzalez-Robles A, Mor S, Mira A, Quero S, Garcia-Palacios A, Banos RM, Botella C. Positive and Negative Affect Schedule (PANAS): psychometric properties of the online Spanish version in a clinical sample with emotional disorders. BMC Psychiatry. 2020 Feb 10;20(1):56. doi: 10.1186/s12888-020-2472-1.

    PubMed 32039720

  • Diaz-Garcia A, Gonzalez-Robles A, Garcia-Palacios A, Fernandez-Felipe I, Tur C, Castilla D, Botella C. Blended transdiagnostic group CBT for emotional disorders: A feasibility trial protocol. Internet Interv. 2021 Jan 7;23:100363. doi: 10.1016/j.invent.2021.100363. eCollection 2021 Mar.

    PubMed 33520670

  • Echezarraga A, Calvete E, Las Hayas C. Validation of the Spanish Version of the Work and Social Adjustment Scale in a Sample of Individuals With Bipolar Disorder. J Psychosoc Nurs Ment Health Serv. 2019 May 1;57(5):44-51. doi: 10.3928/02793695-20181128-02. Epub 2018 Dec 4.

    PubMed 30508459

  • Gonzalez-Robles A, Mira A, Miguel C, Molinari G, Diaz-Garcia A, Garcia-Palacios A, Breton-Lopez JM, Quero S, Banos RM, Botella C. A brief online transdiagnostic measure: Psychometric properties of the Overall Anxiety Severity and Impairment Scale (OASIS) among Spanish patients with emotional disorders. PLoS One. 2018 Nov 1;13(11):e0206516. doi: 10.1371/journal.pone.0206516. eCollection 2018.

    PubMed 30383797

  • Gratz, K. L., & Roemer, L. (2004). Multidimensional assessment of emotion regulation and dysregulation: Development, factor structure, and initial validation of the difficulties in emotion regulation scale. Journal of Psychopathology and Behavioral Assessment, 26, 41-54.

Questions about this trial

What is this clinical trial studying?

A study testing Blended group transversal protocol (BLGr-TP) and Face-to-face group transversal protocol (FFGr-TP) in people with Anxiety Disorders and Depressive Disorders, 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 5 inclusion and 5 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 5 May 2026. 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 Juana María Bretón-López, Dr. (+34 964387642 ext. 7642, breton@uji.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Overall Anxiety Severity and Impairment Scale (OASIS) (Campbell-Sills et al., 2009; González-Robles et al., 2018) at pre-treatment, post-treatment, and at 3-, 6- and 12-month follow-up. (time frame: Pre-treatment, post-modules (throughout the treatment), post-treatment (4 months), follow-up (7, 10 and 16 months)). The study lists 2 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 NCT05569018, which also lists 32 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 5 May 2026.

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