EMDR Versus Imagery Rescripting for Trauma-Related Intrusions

March 10, 2025 updated by: Justine De Rous, Geestelijke Gezondheidszorg Eindhoven (GGzE)

EMDR Versus Imagery Rescripting as a Treatment for Trauma-Related Intrusive Images

The goal of this clinical trial is to investigate the effectiveness and mechanisms of action of trauma treatments in a sample of patients meeting criteria for posttraumatic stress disorder (PTSD), unipolar depression, or both disorders. The main questions it aims to answer are:

  • which first line treatment (Eye Movement Desensitization and Reprocessing [EMDR] vs. Imaginary Rescripting [IR]) works better for intrusive experiences in patients with PTSD, patients with a depression, and patients who meet criteria for both diagnoses.
  • which mechanisms of action cause the treatment effects.

Participants will

  • be randomly assigned to a standard treatment of EMDR or IR
  • complete daily questionnaires measuring the outcome measures two weeks before the start of their treatment, during their EMDR or IR treatment, and for one month after their treatment.
  • complete questionnaires measuring the outcome measures and secondary outcome measures at pre-intervention, post-treatment (i.e., 4 weeks after the last intervention session, at the end of the withdrawal phase), and at 6-month follow-up.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Rationale: Patients with post-traumatic stress disorder (PTSD) experience highly frequent and distressing intrusive images depicting earlier aversive experiences. Not only patients with PTSD experience these intrusions; they are also very common in depression. Therefore, trauma treatments that target these intrusions may also benefit patients with depression. Additionally, comorbid depression in patients with PTSD reduces the effects of trauma treatment. It is currently unknown which treatment for traumatic intrusions is most effective for patients who meet criteria for PTSD, depression, or both, and treatment selection is often a process of trial and error. The mechanisms of action of trauma treatments may inform us how to select the most appropriate treatment for a particular individual.

Objective:

The investigators' primary objective is to investigate which treatment (EMDR vs. IR) is most effective for different groups of patients who experience intrusions: patients with PTSD, patients with depression, or patients with PTSD and a comorbid depression. To this end, the investigators will examine the reduction in the severity of intrusions (i.e., frequency, uncontrollability, and degree of interference with daily life). The investigators' secondary objective is to gain more insight into the mechanisms of action of EMDR and IR. To this end, the investigators will examine the role of various mediators of the treatment effects (i.e., the reduction in the severity of intrusions). The investigators will specifically investigate the potential mediating roles of self-compassion, emotion regulation, positive affect, rumination, and the vividness, distress, and associated meaning of intrusions.

Study design: This study will use a single-case experimental design (SCED). In this design, a small group of patients is followed throughout their treatment. It is a within-subjects design in which each patient undergoes a baseline phase (2 weeks prior to the start of treatment) in which no intervention takes place, an experimental phase with treatment interventions (at least 2.5 weeks), and finally a withdrawal phase (4 weeks following the last intervention session) in which no further treatment takes place.

Study population: This study will recruit 42 patients meeting criteria for either PTSD or depression, or for both disorders.

Intervention (if applicable): Patients will be randomly assigned to standard treatments EMDR or IR. In each condition, patients will receive two 75-minute sessions of EMDR or IR each week, as well as an additional coaching session each week. Treatment length depends on patients' needs and varies between 2.5 and 6 weeks.

Main study parameters/endpoints: The primary outcome is a brief measure of characteristics of intrusions (specifically, the frequency, uncontrollability, and degree of interference with daily life), which will be assessed twice daily via an online mobile app.

Additionally, process measures indexing possible mediators concern brief questionnaires on emotion regulation, self-compassion, rumination, positive affect, and the vividness, distress, and related meaning of intrusions, which also serve as the investigators' primary outcome measures. These questionnaires will be assessed daily. All primary outcome measures will be administered during the baseline, experimental, and withdrawal phase. Secondary outcome measures concern questionnaires on quality of life, depression symptoms, and PTSD symptoms which are endorsed at the pre-intervention assessment (i.e., 2 weeks prior to the first intervention session), post-treatment assessment (i.e., 4 weeks after the last intervention session, at the end of the withdrawal phase), and at 6-month follow-up assessment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Netherlands
    • Noord-Brabant
      • Eindhoven, Noord-Brabant, Netherlands, 5626 ND
        • Geestelijke Gezondheidszorg Eindhoven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age between 18 and 70 years
  • experiencing intrusions and/or nightmares
  • meet criteria for unipolar depressive disorder, PTSD, or both disorders
  • past aversive events still cause considerable distress
  • be available for trauma treatment twice a week, with an additional coaching session each week
  • be proficient in the Dutch language.

Exclusion Criteria:

  • the presence of a dissociative identity disorder
  • acute suicide risk
  • acute psychosis
  • substance use disorder
  • bipolar disorder type 1 and 2. Other comorbid disorders are allowed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Patients with PTSD
Patients with PTSD will be randomly assigned to either EMDR or IR. They will receive two 75-minute sessions of either EMDR or IR each week, with one additional coaching session in both conditions (EMDR and IR).
Behavioral: Eye Movement Desensitization and Reprocessing
In the EMDR condition, the Dutch version of the treatment protocol based on Shapiro's original work (2001) is followed. In the first session, the rationale of EMDR is explained. The patient describes the memory, and identifies the most aversive still image, the associated negative cognition, desired positive cognition, feelings, somatic sensations, and perceived tension, as measured by Subjective Unit of Distress (SUDs). Desensitization then begins by asking patients to focus on the still image while following the movement of a light bar or the therapist's fingers with their eyes (i.e., eye tracking task). Then, in the installation phase, the patient focuses on the positive cognition during the eye tracking task. When the validity of the positive cognition is 6 to 7 on a 7-point Likert scale, a body scan is performed to ensure that no unresolved traumatic material remains. Each session ends with a reflection and debriefing.
Other Names:
  • EMDR
Behavioral: Imagery Rescripting
The IR condition, following Arntz and Weertman's (1999) protocol, addresses traumatic or aversive memories by creating alternative scenarios. In the first session, the method is explained. The patient describes their memory in the present tense, from the first-person perspective, and describes associated feelings, thoughts, and emotional needs. The therapist then seeks permission to 'enter' the scene, guiding the patient to visualise an alternative, emotionally satisfying course of events. This may involve the therapist or patient intervening in the situation, ensuring the patient's emotional needs are met. The patient then relives the memory from the point of view of their younger self, with the adult-self intervening in the scene. The process continues until all emotional needs are fulfilled. Generally, one trauma memory is rescripted per session. The initial IR session involves therapist-led rescripting, with subsequent sessions encouraging patient-led rescripting whenever possible.
Other Names:
  • IR
Experimental: Patients with depression
Patients with depression will be randomly assigned to either EMDR or IR. They will receive two 75-minute sessions of either EMDR or IR each week, with one additional coaching session in both conditions (EMDR and IR).
Behavioral: Eye Movement Desensitization and Reprocessing
In the EMDR condition, the Dutch version of the treatment protocol based on Shapiro's original work (2001) is followed. In the first session, the rationale of EMDR is explained. The patient describes the memory, and identifies the most aversive still image, the associated negative cognition, desired positive cognition, feelings, somatic sensations, and perceived tension, as measured by Subjective Unit of Distress (SUDs). Desensitization then begins by asking patients to focus on the still image while following the movement of a light bar or the therapist's fingers with their eyes (i.e., eye tracking task). Then, in the installation phase, the patient focuses on the positive cognition during the eye tracking task. When the validity of the positive cognition is 6 to 7 on a 7-point Likert scale, a body scan is performed to ensure that no unresolved traumatic material remains. Each session ends with a reflection and debriefing.
Other Names:
  • EMDR
Behavioral: Imagery Rescripting
The IR condition, following Arntz and Weertman's (1999) protocol, addresses traumatic or aversive memories by creating alternative scenarios. In the first session, the method is explained. The patient describes their memory in the present tense, from the first-person perspective, and describes associated feelings, thoughts, and emotional needs. The therapist then seeks permission to 'enter' the scene, guiding the patient to visualise an alternative, emotionally satisfying course of events. This may involve the therapist or patient intervening in the situation, ensuring the patient's emotional needs are met. The patient then relives the memory from the point of view of their younger self, with the adult-self intervening in the scene. The process continues until all emotional needs are fulfilled. Generally, one trauma memory is rescripted per session. The initial IR session involves therapist-led rescripting, with subsequent sessions encouraging patient-led rescripting whenever possible.
Other Names:
  • IR
Experimental: Patients with PTSD and depression
Patients with PTSD and depression will be randomly assigned to either EMDR or IR. They will receive two 75-minute sessions of either EMDR or IR each week, with one additional coaching session in both conditions (EMDR and IR).
Behavioral: Eye Movement Desensitization and Reprocessing
In the EMDR condition, the Dutch version of the treatment protocol based on Shapiro's original work (2001) is followed. In the first session, the rationale of EMDR is explained. The patient describes the memory, and identifies the most aversive still image, the associated negative cognition, desired positive cognition, feelings, somatic sensations, and perceived tension, as measured by Subjective Unit of Distress (SUDs). Desensitization then begins by asking patients to focus on the still image while following the movement of a light bar or the therapist's fingers with their eyes (i.e., eye tracking task). Then, in the installation phase, the patient focuses on the positive cognition during the eye tracking task. When the validity of the positive cognition is 6 to 7 on a 7-point Likert scale, a body scan is performed to ensure that no unresolved traumatic material remains. Each session ends with a reflection and debriefing.
Other Names:
  • EMDR
Behavioral: Imagery Rescripting
The IR condition, following Arntz and Weertman's (1999) protocol, addresses traumatic or aversive memories by creating alternative scenarios. In the first session, the method is explained. The patient describes their memory in the present tense, from the first-person perspective, and describes associated feelings, thoughts, and emotional needs. The therapist then seeks permission to 'enter' the scene, guiding the patient to visualise an alternative, emotionally satisfying course of events. This may involve the therapist or patient intervening in the situation, ensuring the patient's emotional needs are met. The patient then relives the memory from the point of view of their younger self, with the adult-self intervening in the scene. The process continues until all emotional needs are fulfilled. Generally, one trauma memory is rescripted per session. The initial IR session involves therapist-led rescripting, with subsequent sessions encouraging patient-led rescripting whenever possible.
Other Names:
  • IR

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Severity of intrusions
Time Frame: Severity of intrusions is assessed 2x daily from 2 weeks before treatment up to 1 month after treatment. The severity of intrusions is also assessed 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.
The severity of intrusions will be computed as a composite score of the frequency, uncontrollability, and degree of interference with daily life. A questionnaire inquiring about the frequency, uncontrollability, and degree of interference with daily life of intrusions over the previous 4 hours will be administered twice daily via an online questionnaire. A time frame of 2 hours is set within which patients are asked to complete the questionnaire to increase reliability. The items are "How many intrusions did you experience over the previous 4 hours?", "To what extent do these intrusions interfere with your daily life?", and "To what extent do you perceive these intrusions as uncontrollable?". The frequency of intrusions is presented as an open-ended question, while uncontrollability and interference with daily life are measured on a 10-point Likert scale.
Severity of intrusions is assessed 2x daily from 2 weeks before treatment up to 1 month after treatment. The severity of intrusions is also assessed 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.
Anxiety and depression
Time Frame: Anxiety and depression are assessed 2x daily from 2 weeks before treatment up to 1 month after treatment. Anxiety and depression are also assessed 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.
Anxiety and depression will be assessed twice daily using two items (specifically, "How anxious did you feel over the last couple of hours?" and "How depressed did you feel over the last couple of hours?"), using a 10-point VAS scale with as anchor labels 0: "not at all", and 10: "very extreme".
Anxiety and depression are assessed 2x daily from 2 weeks before treatment up to 1 month after treatment. Anxiety and depression are also assessed 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.
Emotion regulation
Time Frame: The DERS-18 Strategies subscale (3 items) is assessed daily from 2 weeks before treatment up to 1 month after treatment. The entire DERS-SF is administered 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.
Emotion regulation is measured by the Difficulties in Emotion Regulation Scale (DERS). A short version has been developed (DERS-SF) and is available in Dutch. Possible scores vary from 18 to 90, with higher scores reflecting greater difficulty with emotion regulation.
The DERS-18 Strategies subscale (3 items) is assessed daily from 2 weeks before treatment up to 1 month after treatment. The entire DERS-SF is administered 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.
Self-compassion
Time Frame: Self-compassion subscale (6 items) is administered daily from 2 weeks before treatment up to 1 month after treatment. The entire SCS-SF is administered 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.
Self-compassion is measured using a shortened version of the Self-Compassion Scale (i.e., SCS-SF). Possible scores range from 12-60, with higher scores reflecting higher self-compassion, and lower scores reflecting lower self-compassion.
Self-compassion subscale (6 items) is administered daily from 2 weeks before treatment up to 1 month after treatment. The entire SCS-SF is administered 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.
Rumination
Time Frame: Brooding and reflection subscales (5 items) are assessed daily from 2 weeks before treatment up to 1 month after treatment. The entire RRS is administered 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.
The Ruminative Response Scale (RRS) measures the degree of depressive rumination, or repetitive thinking in response to a low mood. Total scores on the RRS-NL range from 22 to 88, with higher scores reflecting a greater tendency towards ruminative thinking.
Brooding and reflection subscales (5 items) are assessed daily from 2 weeks before treatment up to 1 month after treatment. The entire RRS is administered 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.
Positive affect
Time Frame: Positive affect items (10 items) are assessed daily from 2 weeks before treatment up to 1 month after treatment. The entire PANAS will be assessed 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.
Positive affect is measured using the Positive Affect scale (10 items) of the Positive and Negative Affect Scale (PANAS). High positive affect refers to the extent to which the person feels positively involved in the environment and experiences positive emotions such as enthusiasm, whereas low positive affect refers to the absence of positive feelings. Total scores for the Positive Affect scale range from 10 to 50, with higher scores reflecting greater positive affect.
Positive affect items (10 items) are assessed daily from 2 weeks before treatment up to 1 month after treatment. The entire PANAS will be assessed 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.
Vividness of intrusions
Time Frame: Vividness of intrusions is assessed daily from 2 weeks before treatment up to 1 month after treatment. The vividness of intrusions is also assessed 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.
The investigators will measure the degree of 'vividness' of intrusions to measure the impact of the interventions. The vividness of intrusions will be measured using an online questionnaire, with the specific item "How vivid are your intrusions right now, on a scale from 0 to 100?", with higher scores reflecting higher vividness.
Vividness of intrusions is assessed daily from 2 weeks before treatment up to 1 month after treatment. The vividness of intrusions is also assessed 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.
Distress of intrusions
Time Frame: Distress of intrusions is assessed daily from 2 weeks before treatment up to 1 month after treatment. Additionally, the distress of intrusions is assessed 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.
The investigators will measure the level of 'distress' of intrusions to measure the impact of the interventions. The distress of intrusions will be measured using an online questionnaire, with the specific item "How distressing are your intrusions right now, on a scale from 0 to 100?", with higher scores reflecting higher distress.
Distress of intrusions is assessed daily from 2 weeks before treatment up to 1 month after treatment. Additionally, the distress of intrusions is assessed 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.
Intrusion-related beliefs
Time Frame: Intrusion-related beliefs are assessed 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.
The investigators will assess the content and believability of 'intrusion-related beliefs about oneself', in order to measure the change in the meanings associated with the intrusions. This outcome measure will be assessed using an online questionnaire, with the specific items "What do your intrusions say about you?" (open ended question), and "How believable is this belief right now, on a scale from 0 to 100?", with higher scores reflecting stronger intrusion-related beliefs about oneself.
Intrusion-related beliefs are assessed 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Posttraumatic Stress Disorder Checklist for DSM-5
Time Frame: The PCL-5 will be administered 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) is a 20-item self-report questionnaire that measures the severity of PTSD symptoms in the past month. The PCL-5 contains four subscales: Intrusions (items 1-5), Avoidance (items 6-7), Negative Change in Cognitions and Mood (NACM; items 8-14), and Change in Arousal and Reactivity (AR; items 15-20).
The PCL-5 will be administered 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.
The Beck Depression Inventory II
Time Frame: The BDI-II will be administered 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.
The Beck Depression Inventory II (BDI-II) is a 21-item self-report questionnaire that measures the severity of depressive symptoms over the past 2 weeks. Possible scores range from 21 to 63, with higher scores reflecting more severe depressive symptoms.
The BDI-II will be administered 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.
Mental Health Quality of Life 7D
Time Frame: The MHQoL will be administered 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.
The Dutch version of the Mental Health Quality of Life 7D (MHQoL) measures quality of life in people with mental health problems. The instrument consists of 7 self-report items in the domains of self-image, independence, mood, relationships, daily activities, physical health, and future. Possible scores range from 0 to 21, with higher scores reflecting a higher quality of life.
The MHQoL will be administered 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.
The Credibility/Expectancy Questionnaire
Time Frame: The CEQ is assessed twice weekly from 2 weeks before treatment up to 1 month after treatment. The CEQ is also assessed 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.
The Credibility/Expectancy Questionnaire (CEQ) is a questionnaire that consists of six questions: four questions considering the treatment credibility, and two questions considering treatment expectancy.
The CEQ is assessed twice weekly from 2 weeks before treatment up to 1 month after treatment. The CEQ is also assessed 2 weeks prior to the first treatment session, and 1 and 6 months after the last treatment session.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
MINI Neuropsychiatric Interview
Time Frame: The MINI Interview will be administered at the pre-intervention assessment (2 weeks prior to the first treatment session) to determine whether a patient meets the inclusion criteria and to describe other comorbidities in the sample.
The MINI Neuropsychiatric Interview (MINI-S for DSM-5 version) is a structured diagnostic interview that will be used to screen for mental health diagnoses (i.e., both inclusion and exclusion criteria).
The MINI Interview will be administered at the pre-intervention assessment (2 weeks prior to the first treatment session) to determine whether a patient meets the inclusion criteria and to describe other comorbidities in the sample.
Life Events Checklist for the DSM-5
Time Frame: The LEC-5 will be administered at the pre-intervention assessment (2 weeks prior to the first treatment session).
The purpose of the administration of the LEC-5 is to gather information about potentially traumatic experiences that patients may have experienced. The LEC-5 does not have an official scoring protocol or interpretation of scores. Rather, it is used to identify whether a patient has experienced a traumatic event.
The LEC-5 will be administered at the pre-intervention assessment (2 weeks prior to the first treatment session).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Geestelijke Gezondheidszorg Eindhoven (GGzE)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Maastricht University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 28, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

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Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL85848.068.23

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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