Emotion RegulationNCT06183333
Efficacy of a Web-Based Emotion Regulation Training in a Transdiagnostic Sample
A study testing Heidelberg Emotion Regulation Training in people with Emotion Regulation and Anxiety Disorders, run by Heidelberg University at 1 site in Germany.
Trial summary
This two-armed randomized controlled trial investigates the efficacy of a web-based emotion regulation intervention in a transdiagnostic sample. The sample includes participants diagnosed with anxiety disorders, depression, eating disorders, borderline personality disorder, and healthy controls without a current… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Emotion Regulation, Anxiety Disorders, Depression
- What is being tested?
- Heidelberg Emotion Regulation Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2023to Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sufficient German language skills (C1)
- Permanent internet access during the study period
- ≥ 18 years of age
Who cannot join
- Acute suicidality
- Current severe substance use disorder
- Current severe depressive episode
- Lifetime bipolar disorder
- Lifetime psychotic disorders
- Body Mass Index (BMI) below 18.5
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Heidelberg University
Heidelberg, Baden-Wurttemberg, 69117
About this study
Official title: Efficacy of a Web-Based Emotion Regulation Training in a Transdiagnostic Sample: A Randomized Controlled Trial
This two-armed randomized controlled trial investigates the efficacy of a web-based emotion regulation intervention in a transdiagnostic sample. The sample includes participants diagnosed with anxiety disorders, depression, eating disorders, borderline personality disorder, and healthy controls without a current psychiatric diagnosis. Participants will be randomly assigned to either the intervention group, receiving a web-based emotion regulation program, or a waitlist control group, which will have delayed intervention access after eight weeks.
The intervention is grounded in cognitive-behavioral therapy (CBT), featuring everyday emotion regulation exercises, and psychoeducation delivered through video and audio files. Outcome measures include emotion regulation abilities, well-being, anxiety, depression, eating disorder symptoms, personality pathology, and self-esteem, evaluated at four and eight weeks post-baseline.
Read the detailed description
Background:
Emotion regulation is pivotal in the pathogenesis and persistence of diverse psychopathologies. While anxiety disorders are often marked by an impaired ability to modulate acute fear responses, depressive disorders feature enduring negative affect and frequent rumination. In eating disorders, emotional dysregulation typically leads to maladaptive coping via disordered eating behaviors, whereas in borderline personality disorder, it manifests as emotional instability. The pervasiveness of emotion regulation difficulties across these diverse clinical presentations highlights a need for treatments targeting this shared mechanism. Our study aims to address this gap by testing the effectiveness of a novel web-based emotion regulation intervention in a transdiagnostic sample.
Method:
This two-armed randomized controlled trial involves participants aged 18 and above diagnosed with anxiety disorders, depression, eating disorders, borderline personality disorder, and healthy controls without psychiatric diagnoses. Participants will be randomly assigned to one of two groups:
- Web-based emotion regulation intervention.
- Waitlist control group with delayed intervention access (eight weeks).
The intervention, accessible via mobile phones or desktop browsers, employs cognitive-behavioral therapy (CBT) techniques, offering everyday emotion regulation exercises and psychoeducation through video material and audio files.
Outcome measures, including emotion regulation abilities, well-being, anxiety, depression, eating disorder symptoms, personality pathology, and self-esteem, will be assessed at four and eight weeks post-baseline.
Hypotheses:
The intervention is expected to result in improved emotion regulation abilities and well-being, along with reduced anxiety, depression, eating disorder symptoms, personality pathology, and self-esteem compared to the waitlist control group. The transdiagnostic intervention is anticipated to demonstrate superiority in addressing the diverse emotional challenges across different psychological disorders.
Additional Laboratory Study:
A subgroup of participants will be invited for a follow-up laboratory assessment of physiological indicators of emotion regulation abilities four weeks after their initial baseline measurement. We hypothesize that the intervention will lead to notable improvements in implicit emotion regulation capacity measured during a resting period and the presentation of negative emotional images. Furthermore, we anticipate observable improvements in explicit emotion regulatory skills, specifically in the downregulation of negative emotions and the upregulation of positive emotions, as assessed through a picture-viewing paradigm.
- Conditions
- Emotion Regulation, Anxiety Disorders, Depression, Eating Disorders, Borderline Personality Disorder
- Being tested
- Heidelberg Emotion Regulation Training
- Keywords
- Internet-Based Intervention, Web-Based Training, Emotion Regulation
- Medical subject headings
- Emotional Regulation, Anxiety Disorders, Depression, Feeding and Eating Disorders, Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heidelberg Emotion Regulation TrainingBehavioural
The four-week intervention program is specifically designed to enhance the participants' emotion regulation. It focuses on developing their skills in accurately recognizing various emotions and effectively applying diverse emotion regulation strategies. To achieve this, the program includes video-based psychoeducation sessions. Alongside these sessions, the program incorporates daily short exercises, each lasting approximately five minutes. These exercises are crafted to help participants practically integrate the concepts and strategies learned from the psychoeducation sessions into their everyday lives. All components of the intervention are accessible through an online platform, ensuring ease of access and flexibility for participants.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Web-based emotion regulation intervention Receives: Behavioral: Heidelberg Emotion Regulation Training |
| Waitlist control group | No intervention | Eight-week waiting period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Emotion Regulation Difficulties
The Difficulties in Emotion Regulation Scale (DERS; Gratz \& Roemer, 2004)
Measured: 0 weeks, 4 weeks, 8 weeks
Secondary outcomes (11)
Changes in Emotion Regulation Strategy Use
The Heidelberg Form for Emotion Regulation Strategies (HFERST; Izadpanah et al., 2019)
Measured: 0 weeks, 4 weeks, 8 weeks
Changes in Well-Being
The World Health Organization Well-Being Index (WHO-5; Topp et al., 2015)
Measured: 0 weeks, 4 weeks, 8 weeks
Changes in Anxiety Symptoms
The General Anxiety Disorder Scale (GAD-7; Spitzer et al., 2006)
Measured: 0 weeks, 4 weeks, 8 weeks
Changes in Depressive Symptoms
The Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001)
Measured: 0 weeks, 4 weeks, 8 weeks
Changes in Eating Psychopathology
The Eating Disorders Examination Questionnaire (EDE-Q; Berg et al., 2012)
Measured: 0 weeks, 4 weeks, 8 weeks
Changes in Personality Pathology
The Personality Inventory for DSM-5 (PID-5; Krueger et al., 2012)
Measured: 0 weeks, 4 weeks, 8 weeks
Changes in Eating-Disorder-Related Daily Difficulties
The Clinical Impairment Assessment Questionnaire (CIA; Bohn et al., 2008)
Measured: 0 weeks, 4 weeks, 8 weeks
Changes in Self-Esteem
The Rosenberg Self-Esteem Scale (RSES; Roth et al., 2008)
Measured: 0 weeks, 4 weeks, 8 weeks
Changes in Weekly Emotion Regulation Strategy Use
Weekly assessment of emotion regulation strategies (adapted from Pruessner et al., 2023).
Measured: 0 weeks, 1 weeks, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks
Changes in Weekly Positive and Negative Affect
Positive and Negative Affect Schedule - Expanded Form (16 items; PANAS-X; Watson \& Clark, 1994)
Measured: 0 weeks, 1 weeks, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks
Changes in Weekly Eating Psychopathology
The Eating Disorders Examination Questionnaire (EDE-QS; Gideon et al., 2016)
Measured: 0 weeks, 1 weeks, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start1 May 2023
- Primary completionJun 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Emotion RegulationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial with an Intervention Group and a Waiting List Control Group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luise Pruessner, Heidelberg University
- Investigators
- Steffen Hartmann, Principal investigator, Department of Psychology, Heidelberg UniversityLuise Pruessner, Principal investigator, Department of Psychology, Heidelberg UniversitySven Barnow, PhD, Study chair, Department of Psychology, Heidelberg UniversityDaniel V. Holt, PhD, Study chair, Department of Psychology, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183333
- Sponsor's protocol ID
- ER-Training
- Status last verified
- Dec 2023
- First submitted
- 13 Dec 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified dataset
Publications
Ritschel LA, Tone EB, Schoemann AM, Lim NE. Psychometric properties of the Difficulties in Emotion Regulation Scale across demographic groups. Psychol Assess. 2015 Sep;27(3):944-54. doi: 10.1037/pas0000099. Epub 2015 Mar 16.
PubMed 25774638Izadpanah S, Barnow S, Neubauer AB, Holl J. Development and Validation of the Heidelberg Form for Emotion Regulation Strategies (HFERST): Factor Structure, Reliability, and Validity. Assessment. 2019 Jul;26(5):880-906. doi: 10.1177/1073191117720283. Epub 2017 Jul 21.
PubMed 28730850Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.
PubMed 25831962Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941Hilbert A, de Zwaan M, Braehler E. How frequent are eating disturbances in the population? Norms of the eating disorder examination-questionnaire. PLoS One. 2012;7(1):e29125. doi: 10.1371/journal.pone.0029125. Epub 2012 Jan 18.
PubMed 22279527Zimmermann J, Altenstein D, Krieger T, Holtforth MG, Pretsch J, Alexopoulos J, Spitzer C, Benecke C, Krueger RF, Markon KE, Leising D. The structure and correlates of self-reported DSM-5 maladaptive personality traits: findings from two German-speaking samples. J Pers Disord. 2014 Aug;28(4):518-40. doi: 10.1521/pedi_2014_28_130. Epub 2014 Feb 10.
PubMed 24511899Roth M, Altmann T. A Comparison of the Predictive Validity of Self-Esteem Level and Directly Measured Self-Esteem Stability in the Temporal Prediction of Psychological Distress. Front Psychol. 2020 Jul 24;11:1770. doi: 10.3389/fpsyg.2020.01770. eCollection 2020.
PubMed 32849049
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Web-Based Emotion Regulation Training in a Transdiagnostic Sample: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06183333
- Acronym / sponsor ID
- ER-Training
- Conditions
- Emotion Regulation, Anxiety Disorders, Depression, Eating Disorders, Borderline Personality Disorder
- Keywords
- Internet-Based Intervention, Web-Based Training, Emotion Regulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 27 Dec 2023 (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.
This two-armed randomized controlled trial investigates the efficacy of a web-based emotion regulation intervention in a transdiagnostic sample. The sample includes participants diagnosed with anxiety disorders, depression, eating disorders, borderline personality disorder, and healthy controls without a current psychiatric diagnosis. Participants will be randomly assigned to either the intervention group, receiving a web-based emotion regulation program, or a waitlist control group, which will have delayed intervention access after eight weeks.
The intervention is grounded in cognitive-behavioral therapy (CBT), featuring everyday emotion regulation exercises, and psychoeducation delivered through video and audio files. Outcome measures include emotion regulation abilities, well-being, anxiety, depression, eating disorder symptoms, personality pathology, and self-esteem, evaluated at four and eight weeks post-baseline.
Detailed description
Background:
Emotion regulation is pivotal in the pathogenesis and persistence of diverse psychopathologies. While anxiety disorders are often marked by an impaired ability to modulate acute fear responses, depressive disorders feature enduring negative affect and frequent rumination. In eating disorders, emotional dysregulation typically leads to maladaptive coping via disordered eating behaviors, whereas in borderline personality disorder, it manifests as emotional instability. The pervasiveness of emotion regulation difficulties across these diverse clinical presentations highlights a need for treatments targeting this shared mechanism. Our study aims to address this gap by testing the effectiveness of a novel web-based emotion regulation intervention in a transdiagnostic sample.
Method:
This two-armed randomized controlled trial involves participants aged 18 and above diagnosed with anxiety disorders, depression, eating disorders, borderline personality disorder, and healthy controls without psychiatric diagnoses. Participants will be randomly assigned to one of two groups:
- Web-based emotion regulation intervention.
- Waitlist control group with delayed intervention access (eight weeks).
The intervention, accessible via mobile phones or desktop browsers, employs cognitive-behavioral therapy (CBT) techniques, offering everyday emotion regulation exercises and psychoeducation through video material and audio files.
Outcome measures, including emotion regulation abilities, well-being, anxiety, depression, eating disorder symptoms, personality pathology, and self-esteem, will be assessed at four and eight weeks post-baseline.
Hypotheses:
The intervention is expected to result in improved emotion regulation abilities and well-being, along with reduced anxiety, depression, eating disorder symptoms, personality pathology, and self-esteem compared to the waitlist control group. The transdiagnostic intervention is anticipated to demonstrate superiority in addressing the diverse emotional challenges across different psychological disorders.
Additional Laboratory Study:
A subgroup of participants will be invited for a follow-up laboratory assessment of physiological indicators of emotion regulation abilities four weeks after their initial baseline measurement. We hypothesize that the intervention will lead to notable improvements in implicit emotion regulation capacity measured during a resting period and the presentation of negative emotional images. Furthermore, we anticipate observable improvements in explicit emotion regulatory skills, specifically in the downregulation of negative emotions and the upregulation of positive emotions, as assessed through a picture-viewing paradigm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial with an Intervention Group and a Waiting List Control Group
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Heidelberg Emotion Regulation TrainingWeb-based emotion regulation intervention |
| Waitlist control group | No intervention | –Eight-week waiting period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Sufficient German language skills (C1)
- Permanent internet access during the study period
- ≥ 18 years of age
Key exclusion criteria (6 listed)
- Acute suicidality
- Current severe substance use disorder
- Current severe depressive episode
- Lifetime bipolar disorder
- Lifetime psychotic disorders
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 |
|---|---|---|
| Heidelberg Emotion Regulation TrainingThe four-week intervention program is specifically designed to enhance the participants' emotion regulation. It focuses on developing their skills in accurately recognizing various emotions and effectively applying diverse emotion regulation strategies. To achieve this, the program includes video-based psychoeducation sessions. Alongside these sessions, the program incorporates daily short exercises, each lasting approximately five minutes. These exercises are crafted to help participants practically integrate the concepts and strategies learned from the psychoeducation sessions into their everyday lives. All components of the intervention are accessible through an online platform, ensuring ease of access and flexibility for participants. | Behavioural | Intervention group |
Primary outcome
Changes in Emotion Regulation Difficulties
Time frame: 0 weeks, 4 weeks, 8 weeks
The Difficulties in Emotion Regulation Scale (DERS; Gratz \& Roemer, 2004)
11 secondary outcomes
Changes in Emotion Regulation Strategy Use
Time frame: 0 weeks, 4 weeks, 8 weeks
Changes in Well-Being
Time frame: 0 weeks, 4 weeks, 8 weeks
Changes in Anxiety Symptoms
Time frame: 0 weeks, 4 weeks, 8 weeks
Changes in Depressive Symptoms
Time frame: 0 weeks, 4 weeks, 8 weeks
Changes in Eating Psychopathology
Time frame: 0 weeks, 4 weeks, 8 weeks
Changes in Personality Pathology
Time frame: 0 weeks, 4 weeks, 8 weeks
Changes in Eating-Disorder-Related Daily Difficulties
Time frame: 0 weeks, 4 weeks, 8 weeks
Changes in Self-Esteem
Time frame: 0 weeks, 4 weeks, 8 weeks
Changes in Weekly Emotion Regulation Strategy Use
Time frame: 0 weeks, 1 weeks, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks
Changes in Weekly Positive and Negative Affect
Time frame: 0 weeks, 1 weeks, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks
Changes in Weekly Eating Psychopathology
Time frame: 0 weeks, 1 weeks, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Background: PubMed 25774638Ritschel LA, Tone EB, Schoemann AM, Lim NE. Psychometric properties of the Difficulties in Emotion Regulation Scale across demographic groups. Psychol Assess. 2015 Sep;27(3):944-54. doi: 10.1037/pas0000099. Epub 2015 Mar 16.
- Background: PubMed 28730850Izadpanah S, Barnow S, Neubauer AB, Holl J. Development and Validation of the Heidelberg Form for Emotion Regulation Strategies (HFERST): Factor Structure, Reliability, and Validity. Assessment. 2019 Jul;26(5):880-906. doi: 10.1177/1073191117720283. Epub 2017 Jul 21.
- Background: PubMed 25831962Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.
- Background: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Background: PubMed 22279527Hilbert A, de Zwaan M, Braehler E. How frequent are eating disturbances in the population? Norms of the eating disorder examination-questionnaire. PLoS One. 2012;7(1):e29125. doi: 10.1371/journal.pone.0029125. Epub 2012 Jan 18.
- Background: PubMed 24511899Zimmermann J, Altenstein D, Krieger T, Holtforth MG, Pretsch J, Alexopoulos J, Spitzer C, Benecke C, Krueger RF, Markon KE, Leising D. The structure and correlates of self-reported DSM-5 maladaptive personality traits: findings from two German-speaking samples. J Pers Disord. 2014 Aug;28(4):518-40. doi: 10.1521/pedi_2014_28_130. Epub 2014 Feb 10.
- Background: PubMed 32849049Roth M, Altmann T. A Comparison of the Predictive Validity of Self-Esteem Level and Directly Measured Self-Esteem Stability in the Temporal Prediction of Psychological Distress. Front Psychol. 2020 Jul 24;11:1770. doi: 10.3389/fpsyg.2020.01770. eCollection 2020.
- Individual participant dataSharing planned: Yes. De-identified dataset
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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. This study is not recruiting at the moment.
Steffen Hartmann principal investigator
Department of Psychology, Heidelberg University
Luise Pruessner principal investigator
Department of Psychology, Heidelberg University
Sven Barnow, PhD study chair
Department of Psychology, Heidelberg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heidelberg Emotion Regulation Training in people with Emotion Regulation and Anxiety Disorders, run by Heidelberg University at 1 site in Germany.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 27 Dec 2023. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steffen Hartmann (+496221 / 54 7295, steffen.hartmann@psychologie.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Emotion Regulation Difficulties (time frame: 0 weeks, 4 weeks, 8 weeks). 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 NCT06183333, which also lists 8 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 27 Dec 2023.