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Feasibility of a Web-based Single-session Intervention Combined With Ecological Momentary Assessment and Intervention for Patients With Complex Posttraumatic Stress Disorder Awaiting Inpatient Treatment

2. listopadu 2026 aktualizováno: Sverre Urnes Johnson, University of Oslo

Scalable Mental Health Interventions and Mechanisms for PTSD

This clinical trial examines whether a self-administered web-based single-session intervention named AWARE OUT, combined with Ecological Momentary Assessments (EMA) and Ecological Momentary Interventions (EMI), can be feasibly delivered to patients with post-traumatic stress disorder (PTSD) and dissociative symptoms who are awaiting psychological treatment.

Přehled studie

Detailní popis

Primary objective(s)

  1. To evaluate the feasibility of the transdiagnostic scalable single-session intervention AWARE OUT in conjunction with Ecological Momentary Assessments (EMA) and Ecological Momentary Interventions (EMI) for a severe clinical sample with PTSD and dissociation symptoms while on waiting list for psychological mental health treatment. This will inform whether a definitive RCT is warranted to assess the effect of the intervention among this particular patient group in this context.

    Secondary Objective(s)

  2. To descriptively explore changes in PTSD symptoms and combined depression and anxiety symptoms from baseline through the six week study period.

About assessment and usage of measurements:

The primary outcome is feasibility, conceptualized as a higher-order construct comprising several distinct but related outcomes: uptake, retention, acceptability and appropriateness, fidelity, as well as study-feasibility and safety of the intervention and study procedures. Because the intervention is measurement-based, intervention delivery and study procedures overlap, and several measures serve both purposes. We assess whether participants perceive the intervention and study participation as acceptable, appropriate, useful, and safe, as well as whether the intervention and study procedures can be successfully delivered and completed as intended. We additionally evaluate participant uptake, engagement, retention, and recruitment to determine whether a larger and more formal evaluation of intervention effectiveness would be feasible. Several measures relate specifically to the SSI, EMA, or EMI components, whereas others concern the study as a whole.

Progression criteria:

Progression to a full RCT will be guided by the traffic-light criteria below, descriptive summaries outcome measures defined above. One or more orange ratings will indicate that progression may be warranted following modifications to the intervention or study procedures. Any red rating will lead to a review of the relevant criteria before determining to redesign, conduct an additional pilot or progress after modifications. Criteria have been defined by the research team after discussions. They are based on pragmatic considerations (e.g. what recruitment levels are needed to invest in a full trial) as well as descriptions by clinical staff on site.

Green: proceed with minor/no modifications. Orange: proceed after modifications. Red: do not proceed without substantial modifications.

Recruitment Green: At least 15 participants enrolled during the recruitment period, and at least 40% of eligible invited patients consent. Orange: 10-14 participants enrolled, or 25-39% of eligible invited patients consent. Red: Fewer than 10 participants enrolled or less than 25% of eligible invited patients consent.

EMA retention/adherence Green: At least 70% of enrolled participants remain in the study through the EMA period (six weeks), and participants respond to at least 60% of scheduled EMA prompts on average. Orange: 50-69% remain through the EMA period, or mean response rate is 40-59%. Red: Less than 50% remain through the EMA period, or mean response rate is below 40%.

SSI retention/completion Green: At least 70% of enrolled participants complete at least 50% of the SSI. Orange: 50-69% of enrolled participants complete at least 50% of the SSI.

Red: Fewer than 50% of enrolled participants complete at least 50% of the SSI.

EMI retention and engagement/usage Green: Participants complete on average at least one intervention in 60% of the EMIs that provide a recommendation. Orange: Minimum one EMI completion when recommended is 40-59% on average. Red: Minimum one EMI completion when recommended is below 40% on average.

Acceptability/helpfulness/appropriateness of EMA Green: Rating of at least 6 on 1-10 quantitative feedback questions. Orange: Mean rating 5-5.99. Red: Mean rating below 5.

Acceptability/helpfulness/appropriateness of SSI Green: Rating at least 3.5 on a 1-5 scale for quantitative feedback questions. (Items on a different scale will be rescaled to 1-5). Orange: Mean rating 3-3.49. Red: Mean rating below 3.

Acceptability/helpfulness/appropriateness of EMI Green: Mean rating at least 3.5 on a 1-5 scale for quantitative feedback questions (Items on a different scale will be rescaled to 1-5). Orange: Mean rating 3-3.49. Red: Mean rating below 3.

Safety and adverse experiences Green: No serious study-related adverse events. Orange: Non-serious adverse experiences or burden concerns requiring procedural or content modifications. Red: Any serious intervention-related adverse event, or concerning deterioration in mental health outcomes reported by participants and explicitly attributed to study-participation

Typ studie

Intervenční

Zápis (Odhadovaný)

30

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Alexander Gustav F Ikonomeas, Candidate of Psychology
  • Telefonní číslo: +4746503688
  • E-mail: agikonom@uio.no

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

To be eligible for the current study, patients must be admitted to the waiting-period before in-patient treatment at the Modum bad trauma-clinic. Inclusion criteria are

  • Exposure to childhood trauma
  • Diagnosis of CPTSD, PTSD or complex dissociative disorders
  • Unsatisfactory effects from prior, standard outpatient treatment attempts
  • Provide written informed consent.
  • Speak and write Norwegian to a sufficient degree.
  • Have internet and mobile access.
  • Have sufficient self-reported internet and mobile literacy.

Exclusion criteria include:

  • Psychosis
  • Substance abuse during the last three months
  • Severe somatic illness (i.e., requiring hospitalization)
  • Acute suicidality
  • Current life crisis (e.g., loss of a child, divorce)
  • Severely disturbed group functioning (e.g., hostile, or sexually inappropriate behavior).

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Single-session intervention and ecological momentary assessment / intervention arm

Participants complete 2 weeks of EMA, followed by the self-guided AWARE OUT intervention, 2 weeks of personalized EMA/EMI via the While Waiting Application, and a final 2 weeks of EMA. The While Waiting Application is implemented within the m-Path application.

A 30-40-minute self-guided digital intervention targeting PTSD-related difficulties and transdiagnostic processes. It provides psychoeducation and brief exercises targeting avoidance, worry, rumination, and rigid attention. Exercises include behavioral activation, postponement of worry and rumination, and attentional shifting. The intervention is delivered through videos, text, examples, and written tasks.

Ostatní jména:
  • SSI
  • AWARE OUT

A mobile-based program comprising brief ecological momentary assessments completed 4 times daily and personalized, in-the-moment intervention prompts. Prompts support skills such as attention shifting, postponing worry/rumination, behavioral activation, challenging avoidance, and physiological regulation.

Ostatní jména:
  • EMA
  • EMI
  • m-Path
  • Mens-du-venter appen

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Recruitment flow counts
Časové okno: From recruitment initiation through the end of the 6-week study period.

Number of eligible patients, patients invited, participants providing informed consent, participants enrolled, dropouts, and withdrawals.

Invitation is defined as receipt of a study invitation from study administrators.

Consent is defined as submission of the consent form in Nettskjema.no. Enrollment is defined as initiation of m-Path interactions.

Dropout is defined as not initiating the SSI, not completing any EMA prompts in study weeks 3 or 4, and being unreachable for clarification.

Withdrawal is defined as communicating a wish to discontinue participation.

From recruitment initiation through the end of the 6-week study period.
Recruitment rate
Časové okno: From invitation to participate until enrollment or classification as non-enrolled, assessed up to 4 months.

Recruitment rate is calculated as the number of enrolled participants divided by the number of eligible patients invited to participate. Value ranges from 0 to 1; higher values indicate higher recruitment rate.

From invitation to participate until enrollment or classification as non-enrolled, assessed up to 4 months.
Consent rate
Časové okno: From invitation to participate until provision of informed consent or classification as non-consented, assessed up to 4 months.

Consent rate is calculated as the number of eligible invited patients who provide informed consent divided by the number of eligible patients invited to participate. Value ranges from 0 to 1; higher values indicate greater consent uptake.

From invitation to participate until provision of informed consent or classification as non-consented, assessed up to 4 months.
Consent-to-enrollment conversion rate
Časové okno: From provision of informed consent until enrollment or classification as non-enrolled, assessed up to 4 months.

Consent-to-enrollment conversion rate is calculated as the number of enrolled participants divided by the number of participants who provide informed consent. Values range from 0 to 1; higher values indicate greater consent-to-enrollment conversion rate.

From provision of informed consent until enrollment or classification as non-enrolled, assessed up to 4 months.
Dropout rate
Časové okno: After enrollment throughout the 6-week study period

Dropout rate will be calculated as the number of dropouts divided by the number of enrolled participants.

After enrollment throughout the 6-week study period
Single-session intervention (SSI) engagement and completion
Časové okno: From SSI initiation through SSI completion, approximately 2 weeks after enrollment.

SSI engagement will be measured as the proportion of the SSI completed by each participant, calculated as the number of intervention web pages submitted by the participant through the Nettskjema.no portal divided by the total number of intervention pages (24). Values range from 0 to 1, where 0 indicates no pages completed and 1 indicates completion of all 24 pages. SSI completion will additionally be summarized as mean completion proportion across participants. Time spent completing the SSI will also be summarized where available.

From SSI initiation through SSI completion, approximately 2 weeks after enrollment.
Ecological momentary assessment (EMA) engagement, adherence and missing data
Časové okno: From enrollment through the end of the 6-week study period.

EMA adherence is measured as the proportion between number of completed EMA prompts and the number of scheduled and successfully delivered EMA prompts. Values range from 0 to 1, where higher values indicate greater EMA adherence. Participant-level and mean-level EMA adherence will be calculated. Time spent completing EMA prompts will also be summarized descriptively, where available.

EMA missing-data proportion will be calculated as 1-EMA adherence.

From enrollment through the end of the 6-week study period.
Ecological momentary intervention (EMI) engagement and adherence
Časové okno: During the 2-week EMI phase, approximately weeks 2-4 after enrollment.

Engagement with EMI recommendations is calculated as the number of delivered EMI recommendations for which the participant completes at least one recommended EMI activity divided by the number of delivered EMI recommendations. Values range from 0 to 1, where higher values indicate greater engagement with EMI recommendations. Participant-level and mean-level EMI engagement with recommendations will be calculated.

Supplementary descriptive usage metrics will include the number of EMI recommendations delivered, intervention activities initiated and completed, and time spent completing intervention components, where available.

During the 2-week EMI phase, approximately weeks 2-4 after enrollment.
Ecological momentary assessment (EMA) retention
Časové okno: Enrollment through week 6

Proportion of enrolled participants who complete at least one EMA response during week 6. Values range from 0 to 1 with higher values indicate greater retention through the EMA period.

Enrollment through week 6
Adverse events
Časové okno: From consent through the end of the 6-week study period.

Number and nature of adverse events and unexpected circumstances. Participants have the opportunity to report events to the study administrators, and these will be summarized qualitatively. Evaluation of this measure is descriptive.

From consent through the end of the 6-week study period.
Ease of use of the While Waiting application
Časové okno: 1 week after enrollment.

Participant-rated ease of using the While Waiting application. Assessed with one study-specific item inspired by Bringmann et al. (2025): "How easy is it to use the While Waiting application?"

The item is rated from 1 ("very difficult") to 10 ("very easy"). Higher scores indicate greater perceived ease of use.

1 week after enrollment.
Positive emotional impact of answering Ecological momentary assessment (EMA) questions
Časové okno: 1 week after enrollment.

Participant-rated positive emotional impact of answering EMA questions in the While Waiting application, assessed with one study-specific item inspired by Bringmann et al. (2025): "To what extent are your emotions positively affected by answering questions in the While Waiting application?"

The item is rated from 1 ("not affected at all") to 10 ("very affected"). Higher scores indicate greater perceived positive emotional impact.

1 week after enrollment.
Negative emotional impact of Ecological momentary assessment (EMA) questions
Časové okno: 1 week after enrollment.

Participant-rated negative emotional impact of answering questions in the While Waiting application, assessed with one study-specific item inspired by Bringmann et al. (2025): "To what extent are your emotions negatively affected by answering questions in the While Waiting application?"

The item is rated from 1 ("not affected at all") to 10 ("very affected"). Scores will be reverse-coded such that higher scores indicate less perceived negative emotional impact.

1 week after enrollment.
Perceived burden of Ecological momentary assessment (EMA) questionnaire length
Časové okno: 1 week after enrollment.

Participant-rated burden associated with the number of questions in the While Waiting application, assessed with one study-specific item inspired by Bringmann et al. (2025): "How burdensome is the number of questions in the While Waiting application?"

The item is rated from 1 ("not burdensome") to 10 ("very burdensome"). Scores will be reverse-coded such that higher scores indicate lower perceived burden.

1 week after enrollment.
Feedback and engagement with the Single-session intervention (SSI)
Časové okno: Immediately after completion of the SSI, approximately 2 weeks after enrollment.

Participant-rated feedback and engagement with the SSI, assessed using the 7 quantitative items from the Program Feedback Scale (PFS; Schleider et al., 2019). Items assess willingness to recommend the SSI, agreement with its message, perceived helpfulness for peers, effort during the SSI, understanding of the SSI, ease of use, and enjoyment.

Each item is rated on a 1-5 Likert scale. The outcome will be the mean score across the seven selected PFS items, ranging from 1 to 5. Higher scores indicate more favorable feedback and engagement.

Immediately after completion of the SSI, approximately 2 weeks after enrollment.
Perceived appropriateness of the Single-session intervention (SSI)
Časové okno: Immediately after completion of the SSI, approximately 2 weeks after enrollment.

Participant-rated perceived appropriateness of the SSI, assessed using two selected items from the Intervention Appropriateness Measure (IAM; Weiner et al., 2017): "AWARE OUT seems applicable" and "AWARE OUT seems like a good match."

Each item is rated on a 1-5 Likert scale. The outcome will be the mean score across the two selected items, ranging from 1 to 5. Higher scores indicate greater perceived appropriateness of the SSI.

Immediately after completion of the SSI, approximately 2 weeks after enrollment.
Treatment credibility: confidence that the Single-session intervention (SSI) will help
Časové okno: Immediately after completion of the SSI, approximately 2 weeks after enrollment.

Participant confidence that the SSI will help them with their psychological challenges and troubles. Assessed using one item from the Treatment Credibility Questionnaire (TCQ; Borkovec & Nau, 1972): "How confident are you that AWARE OUT will help you with your psychological challenges and troubles?"

The item is rated on a 1-10 scale. Higher scores indicate greater perceived treatment credibility.

Immediately after completion of the SSI, approximately 2 weeks after enrollment.
Intention to use the Single-session intervention (SSI)
Časové okno: Immediately after completion of the SSI, approximately 2 weeks after enrollment.

Participant-rated intention to use the SSI, assessed using one item from the System Usability Scale (SUS; Lewis, 2018): "I think that I would use what I learnt in AWARE OUT going forward."

The item is rated on a 1-5 Likert scale. Higher scores indicate greater intention or willingness to use the SSI frequently.

Immediately after completion of the SSI, approximately 2 weeks after enrollment.
Perceived negative effects of the Single-session intervention (SSI)
Časové okno: Immediately after completion of the SSI, approximately 2 weeks after enrollment.

Participant-rated negative effects of the SSI, assessed using the study-developed item: "Completing AWARE OUT has affected me negatively."

The item is rated on a 1-5 Likert scale. The item will be reverse-coded so that higher scores indicate fewer perceived negative effects.

Immediately after completion of the SSI, approximately 2 weeks after enrollment.
Perceived novelty of the Single-session intervention (SSI)
Časové okno: Immediately after completion of the SSI, approximately 2 weeks after enrollment.

Participant-rated perceived novelty of the SSI, assessed using the study-developed item: "I learned something new through AWARE OUT."

The item is rated on a 1-5 Likert scale. Higher scores indicate greater perceived novelty or learning.

Immediately after completion of the SSI, approximately 2 weeks after enrollment.
Perceived appropriateness of Single-session intervention (SSI) length
Časové okno: Immediately after completion of the SSI, approximately 2 weeks after enrollment.

Participant-rated appropriateness of SSI length, assessed using the study-developed item: "On a scale from 1 (far too short) to 10 (far too long), where 5 is just right, what do you think about the length of AWARE OUT?"

The item is rated from 1 to 10, with 5 indicating the most appropriate length. The outcome will be the absolute deviation from 5: absolute value of (participant length rating-5).

Scores range from 0 to 5. Lower scores indicate that the participant perceived the SSI length as closer to "just right"; a score of 0 indicates a rating of exactly 5.

Immediately after completion of the SSI, approximately 2 weeks after enrollment.
Exercise preferences in the Single-session intervention (SSI)
Časové okno: Immediately after completion of the SSI, approximately 2 weeks after enrollment.

Two multiple choice questions regarding which exercise they prefer, and which they least prefer. There are three exercises in the SSI, meaning they have to chose one out of the three as their preferred / least preferred choice in each question

Immediately after completion of the SSI, approximately 2 weeks after enrollment.
Usability and quality of the While Waiting application
Časové okno: At the end of the EMI phase, approximately 4 weeks after enrollment.

Participant-rated usability and quality of the While Waiting application, assessed using 8 selected items from the User Version of the Mobile Application Rating Scale (uMARS; Stoyanov et al., 2016). Items assess engagement/interest (1 item), functionality (2 items: ease of use and navigation), aesthetics (2 items: layout and visual appeal), and information quality (3 items: quality, quantity, and visual presentation of information).

Each item is rated on a 1-5 scale. The outcome will be the mean score across the eight selected items, ranging from 1 to 5. Higher scores indicate more favorable perceived application usability and quality.

At the end of the EMI phase, approximately 4 weeks after enrollment.
Perceived impact of the While Waiting application
Časové okno: At the end of the EMI phase, approximately 4 weeks after enrollment.

Participant-rated perceived impact of the While Waiting application, assessed using 5 app-specific questions adapted from the User Version of the Mobile Application Rating Scale (uMARS; Stoyanov et al., 2016). Items assess whether use of the application increased participants' awareness of, knowledge about, attitudes toward, intention or motivation to address, and anticipated behavior change related to the target health behavior.

Each item is rated on a 1-5 Likert scale. The outcome will be the mean score across the five items, ranging from 1 to 5; higher scores indicate greater perceived positive impact of the application.

At the end of the EMI phase, approximately 4 weeks after enrollment.
While Waiting application feedback: Helpfulness, recommendation, enjoyment, and ease of use
Časové okno: At the end of the EMI phase, approximately 4 weeks after enrollment

Participant-rated feedback on the While Waiting application will be assessed using four selected items from the Program Feedback Scale (PFS; Schleider et al., 2019). The items assess perceived helpfulness for others having same difficulties, willingness to recommend the app to someone they know experiencing a difficult time, enjoyment of the app, and perceived ease of use.

Each item is rated on a 1-5 Likert scale. The primary outcome will be the mean score across the four selected items, ranging from 1 to 5. Higher scores indicate more favorable feedback, including greater perceived helpfulness, recommendation, enjoyment, and ease of use.

At the end of the EMI phase, approximately 4 weeks after enrollment
Treatment credibility: confidence that the While Waiting application will help
Časové okno: At the end of the EMI phase, approximately 4 weeks after enrollment

Participant confidence that the While waiting application will help them with their problems. Assessed with one item from the Treatment Credibility Questionnaire (TCQ; Borkovec & Nau, 1972): "How confident are you that the While Waiting application will help you with your psychological challenges and troubles?"

The item is scored on a 1-10 scale. Higher scores indicate greater perceived treatment credibility.

At the end of the EMI phase, approximately 4 weeks after enrollment
Study feedback: perceived participant experience and burden
Časové okno: At the end of the study period at approximately week 6 after enrollment.

Participant feedback on study participation and answering questions in the While Waiting application will be assessed at 6 weeks after enrollment using five study-specific items adapted from Bringmann et al. (2025). Three items assess perceived burden, positive emotions, and negative emotions associated with answering questions in the application. One item assesses how positive it was to participate in the project, and one item assesses perceived burden of participating in the project.

All items are rated on a 1-10 scale. Negatively worded items will be reverse-coded so that higher scores consistently indicate a more positive participant experience (i.e., greater positive emotions/experience and lower perceived burden and negative emotions). The outcome will be the mean score across the five recoded items, ranging from 1 to 10. Higher scores indicate a more positive overall participant experience, including greater positive emotions and lower perceived burden and negative emotions

At the end of the study period at approximately week 6 after enrollment.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
PTSD symptom severity
Časové okno: Baseline, 2 weeks, 4 weeks and 6 weeks.

PTSD symptom severity assessed using the PTSD Checklist for DSM-5 (PCL-5, Weathers et al., 2013). The PCL-5 is a 20-item questionnaire that measures DSM-5-specified symptoms of PTSD. The total score ranges from 0 to 80, with higher scores indicating more severe symptoms. Items are rated on a 0 ('not at all') to 4 ('extremely') Likert-type scale. A Norwegian version of the PCL-5 is used in the current study (Heir, T., 2014).

Baseline, 2 weeks, 4 weeks and 6 weeks.
Depression and anxiety symptom severity
Časové okno: Baseline, 2 weeks, 4 weeks and 6 weeks.

Combined depression and anxiety symptom severity assessed using the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS; Kroenke et al., 2016). PHQ-ADS consists of 16 questions and scores can range from 0 to 48 (with higher scores indicating more severe depression/anxiety). Respondents are asked how much each symptom has bothered them over the past 2 weeks, with response options of "not at all", "several days", "more than half the days", and "nearly every day", scored as 0, 1, 2, and 3, respectively. A Norwegian version of the PHQ-ADS is used in the current study (Johnson et al., 2019; Wisting et al., 2021).

Baseline, 2 weeks, 4 weeks and 6 weeks.

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Open ended feedback of the While waiting application
Časové okno: Item 1, 2 and 4 will be asked two times, after the EMI-phase (week 4 after enrollment) and at the end of the study period (week 6 after enrollment). Item 3 will only be asked after the EMI-phase (week 4 after enrollment)

Open ended feedback of the While waiting application will be measured using four items focusing on 1) what the participant liked, 2) what they wish was different, 3) what was most helpful and 4) what they disliked about the application.

Item 1, 2 and 4 will be asked two times, after the EMI-phase (week 4 after enrollment) and at the end of the study period (week 6 after enrollment). Item 3 will only be asked after the EMI-phase (week 4 after enrollment)
Open ended feedback of the Single-session intervention (SSI)
Časové okno: Immediately after completion of the SSI, approximately 2 weeks after enrollment.

Open ended feedback of the SSI will be measured using three items focusing on what the participant liked, what they wish was different and what they disliked about the intervention.

Immediately after completion of the SSI, approximately 2 weeks after enrollment.
Open ended feedback of the While waiting application
Časové okno: At the end of the EMI phase, approximately 4 weeks after enrollment

Open ended feedback of the While waiting application will be measured using three items focusing on what the participant liked, what they wish was different and what they disliked about the application overall.

At the end of the EMI phase, approximately 4 weeks after enrollment

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Spolupracovníci

Vyšetřovatelé

  • Vrchní vyšetřovatel: Sverre U Johnson, PhD, University of Oslo

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

9. října 2026

Primární dokončení (Odhadovaný)

15. února 2027

Dokončení studie (Odhadovaný)

1. října 2034

Termíny zápisu do studia

První předloženo

9. října 2026

První předloženo, které splnilo kritéria kontroly kvality

2. listopadu 2026

První zveřejněno (Aktuální)

5. listopadu 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

5. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

2. listopadu 2026

Naposledy ověřeno

1. října 2026

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

No IPD will be shared outside of the research team involved with this study.

Kritéria přístupu pro sdílení IPD

Simplified version of study Protocol is available on Open science framework (osf.io). Comprehensive study protocol can be made available upon reasonable requets.Simple SAP is available on osf.io.Simplified version of ICF can be shared upon reasonable requests. Analytic code will be made available after publication of study in peer review journal, and will be shared upon reasonable requests.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • ICF
  • ANALYTIC_CODE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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