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Reaktion på akut træning ved spiseforstyrrelser

31. juli 2026 opdateret af: University of Wisconsin, Madison

Karakterisering af akut træningsrespons ved restriktive spiseforstyrrelser

Individer med spiseforstyrrelser (ED) repræsenterer en højprioriteret klinisk population med blandt de højeste dødelighedsrater for enhver psykiatrisk lidelse, og drevet motion (DEx) er et symptom, der ses hos op til 80 % af dem med ED'er, der øger svækkelse og negativt påvirker behandlingsresultatet. Denne undersøgelse vil udvikle opgaver til at karakterisere kognitiv, affektiv og biologisk respons på træning blandt teenagere og unge voksne kvinder med ED'er og afgøre, om akut træningsrespons associerer med frit levende aktivitet og DEx. Dette R21-projekt vil give grundlæggende data til at guide forskning og udvikling af behandlinger, der er mere præcist målrettet mod symptomet på drevet træning og til i sidste ende at forbedre de kliniske resultater forbundet med ED'er.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Spiseforstyrrelser (ED'er) er blandt de dødeligste af alle psykiatriske lidelser. Imidlertid er førstelinjebehandlinger for ED'er kun effektive for omkring 40 % af de unge patienter. En barriere for behandlingseffektivitet er vedholdenheden af ​​drevet træning (DEx; træning på en tvangsmæssig måde for at kontrollere vægten og/eller regulere følelser), et kendetegnende symptom rapporteret blandt mange unge diagnosticeret med restriktive ED'er (59-73%). Blandt andre negative følgesygdomme er DEx forbundet med selvmordsadfærd, dårligere behandlingsresultat, øget komorbid psykopatologi og risiko for tilbagefald. Ydermere, mens flere spiserelaterede opgaver er blevet valideret, der skelner mellem individer med ED'er og sunde populationer, er der i øjeblikket ingen velvaliderede opgaver, der direkte vurderer følsomhed og reaktionsevne over for træning i ED-populationer. Da DEx er et dårligt forstået symptom, der spiller en nøglerolle i ED-vedligeholdelse, er det af afgørende betydning at undersøge dets bioadfærdsmæssige grundlag. Eksisterende forskning peger mod både belønnings- og trusselsfunktioner ved træning, som kan drive og fastholde DEx blandt dem med ED'er. Evaluering af både belønnings- og trusselsfunktioner ved træning blandt dem med ED'er vil forbedre den mekanistiske forståelse af denne ED-funktion; i sidste ende vil forbedret forståelse af DEx informere behandlingsmålene. Det foreslåede projekt vil rekruttere teenagere og unge voksne kvinder (16-22 år) med (n = 67) og uden (n = 33) ED'er fra to steder til at deltage i en omfattende evaluering af akut træningsrespons. Det nuværende projekt vil 1) karakterisere variabiliteten i bioadfærdsreaktion på eksponering i laboratoriet for moderat intensitetstræning blandt dem med og uden ED'er; 2) skabe og forfine opgaver, der fanger engagement af belønnings- og trusselsrelaterede systemer under træning; og 3) test hypoteser om, at akut træningsrespons er mere udtalt blandt personer med ED'er, og at akut træningsrespons relaterer sig til ED-symptomernes sværhedsgrad, DEx og frit levende aktivitet. Detaljeret forklaring af akutte træningseffekter blandt individer med ED'er i et kontrolleret miljø vil have betydelig indvirkning på det empiriske studie af ED'er, specifikt for (i) at forbedre vurderingen af ​​DEx-risiko og funktion (ii) belyse en testbar model for DEx-risiko og (iii) ) foreslår mål for DEx-intervention. Metoderne valideret i dette projekt vil forbedre forståelsen af ​​DEx, en behandlingsresistent ED-funktion. Disse metoder vil også lægge grunden til større, klinisk forskning, som afklarer optimale mål for DEx i ED-behandling.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

74

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • San Francisco, California, Forenede Stater, 94158
        • University of California San Francisco
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53719
        • University of Wisconsin-Madison

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inklusionskriterier:

  • I alderen 16-22
  • ED-deltagere skal opfylde fulde kriterier for DSM-5 restriktive-spektrum spiseforstyrrelser karakteriseret ved vægt og form bekymring, dvs. anorexia nervosa (AN); mild, moderat eller delvis remission), kun atypisk AN og OSFED -AN type)
  • ED-deltagere skal være medicinsk stabile og egnede til ambulant behandling
  • Biologiske Hunner, Tildelt Hun ved fødslen
  • Engelsktalende

Ekskluderingskriterier:

  • Dem med en medicinsk tilstand, der udelukker træning (f.eks. svær astma), vil blive udelukket for eventuelle kontraindikationer

    • Biologiske hanner, tildelt mand ved fødslen
    • BMI mindre end 16 (over 18 år) eller mindre end 75 % forventet kropsvægt (under 18 år)
    • Rapporteret indtag ved spiseforstyrrelsesundersøgelse <1000kcal dagligt
    • Nuværende udrensning >1x pr. dag
    • Aktuelle regelmæssige episoder med objektiv overspisning (>1x/uge)
    • Aktuel selvrapportering af tab af kontrol med spisning i henhold til spiseforstyrrelsesundersøgelsessamtalen
    • ED-relateret hospitalsindlæggelse, delvis hospitalsindlæggelse eller boligbehandling inden for den seneste måned
    • Alle godkendte medicinske bekymringer relateret til fysisk aktivitet (som undersøgt i telefonens screeningsspørgsmål vedrørende hjerte-kar-, lunge- eller metabolisk sygdom).
    • Større medicinske lidelser (f.eks. kræft, AIDS)
    • Fysisk ubehag eller besvær med blodudtagninger
    • Psykotiske lidelser
    • Intellektuelle handicap
    • Udviklingsforstyrrelser
    • Forstyrrelse i brugen af ​​aktive stoffer
    • Aktuel selvmordsrisiko ifølge Spørg selvmordsscreeningsspørgeskemaet
    • Graviditet
    • Psykiatrisk medicin, der ikke har været stabil i mindst 4 uger
    • Akutte beroligende midler / smertestillende midler (f.eks. benzodiazepiner, opioider) og receptpligtige stimulanser (f.eks. methylphenidat, amfetamin) er ikke tilladt hele dagen før laboratoriesessionen. Den nævnte korttidsmedicin gælder kun for personer, der tager den nævnte medicin i tilfælde, der bruges til at behandle ADHD eller andre psykiatriske tilstande
    • Hvilepuls <50 slag i minuttet (vurderet ved screeningsbesøg)
    • Lavt blodtryk (<90/60), (vurderet ved screeningsbesøg)
    • Daglig cannabisbrug
    • Anamnese med ørhed eller besvimelse under blodudtagninger eller fysisk aktivitet
    • Anamnese med brystsmerter under fysisk aktivitet
    • Knogle-, led-, hjerte-, lunge-, metaboliske eller andre medicinske tilstande, der kan forværres af fysisk aktivitet (f.eks. KOL, diabetes, hypertension), som i øjeblikket ikke behandles via medicin eller livsstilsændringer.
    • Fysiske handicap, der forbyder opgaveudførelse (såsom blindhed eller døvhed)
    • Enhver anden betingelse, som efterforskeren mener, kan sætte deltageren i fare for negative resultater
    • Personer med en restriktiv spiseforstyrrelse, der ikke inkluderer vægt- og formproblemer (ARFID), eller som har primær overspisning (bulimia nervosa)
    • Angivelse af sundhedsrisiko forbundet med træning på spørgeskemaet om fysisk aktivitetsparathed

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Healthy Controls
Study participants undergo Prescribed Exercise, Self-Paced Exercise, and Rest conditions over the course of 3 study days
Andet: Biobehavioral Response to in-lab exposure to physical activity

ED severity, biological and affective markers of physical activity response, and both exercise-specific and general positive (reward) and negative (avoidance/escape) valence sensitivities associate with physical activity will be comprehensively examined.

During three different days, participants will:

  • A: Complete 2 different tasks, a reward task (prescribed rest condition) with self-report measures and two blood draws before and after completing the 30 minute rest condition, and a threat task (self-paced exercise condition) with self-report measures, a food challenge (to drink a milkshake) and 30 minutes of exercise.
  • B: Complete a reward task (prescribe exercise condition) where participants will earn points for exercise and have 2 blood draws before and after completing 30 minutes of exercise
  • C: Complete a threat task (self-paced rest condition) with self-report measures, a food challenge, and 30 minutes of rest.
Eksperimentel: Participants with Eating Disorders
Study participants undergo Prescribed Exercise, Self-Paced Exercise, and Rest conditions over the course of 3 study days
Andet: Biobehavioral Response to in-lab exposure to physical activity

ED severity, biological and affective markers of physical activity response, and both exercise-specific and general positive (reward) and negative (avoidance/escape) valence sensitivities associate with physical activity will be comprehensively examined.

During three different days, participants will:

  • A: Complete 2 different tasks, a reward task (prescribed rest condition) with self-report measures and two blood draws before and after completing the 30 minute rest condition, and a threat task (self-paced exercise condition) with self-report measures, a food challenge (to drink a milkshake) and 30 minutes of exercise.
  • B: Complete a reward task (prescribe exercise condition) where participants will earn points for exercise and have 2 blood draws before and after completing 30 minutes of exercise
  • C: Complete a threat task (self-paced rest condition) with self-report measures, a food challenge, and 30 minutes of rest.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Body Image State Scale (BISS) Score: Average of All BISS 6-items
Tidsramme: Every 5 minutes during 30 minute bout of activity . There is no follow up beyond the study day itself.
Response to body image was measured using the BISS which is a 6-item scale that asks participants to report on their momentary body satisfaction on a 9-point Likert scale (1-9, higher scores, higher satisfaction). Each item begins with the sentence "Right now, I feel" [for instance: "Right now, I feel (Extremely dissatisfied to Extremely satisfied)"]. Participants are asked to rate their momentary body satisfaction every five minutes during each of 4 conditions: Prescribed Exercise (Reward Task), Self-Paced Exercise (Threat Task), Prescribed Rest (Reward Task), or Self-Paced Rest (Threat Task).
Every 5 minutes during 30 minute bout of activity . There is no follow up beyond the study day itself.
Appearance-Item Score From Body Image State Scale (BISS)
Tidsramme: Every 5 minutes during 30 minute bout of activity . There is no follow up beyond the study day itself.
Response to body image was measured using the BISS which is a 6-item scale that asks participants to report on their momentary body satisfaction on a 9-point Likert scale(1-9, higher scores, higher satisfaction). Each item begins with the sentence "Right now, I feel" [for instance: "Right now, I feel (Extremely dissatisfied to Extremely satisfied)"]. Participants are asked to rate their momentary body satisfaction every five minutes during each of 4 conditions: Prescribed Exercise (Reward Task), Self-Paced Exercise (Threat Task), Prescribed Rest (Reward Task), or Self-Paced Rest (Threat Task).
Every 5 minutes during 30 minute bout of activity . There is no follow up beyond the study day itself.
Average Person-Item Score From Body Image State Scale (BISS)
Tidsramme: Every 5 minutes during 30 minute bout of activity . There is no follow up beyond the study day itself.
Response to body image was measured using the BISS which is a 6 item scale that asks participants to report on their momentary body satisfaction on a 9-point Likert scale (1-9, higher scores, higher satisfaction). The Average Person item asks participants to rate how they feel like they look compared to the average person from a great deal worse (1) to a great deal better (9). Participants are asked to rate their momentary body satisfaction every five minutes during each of 4 conditions: Prescribed Exercise (Reward Task), Self-Paced Exercise (Threat Task), Prescribed Rest (Reward Task), or Self-Paced Rest (Threat Task).
Every 5 minutes during 30 minute bout of activity . There is no follow up beyond the study day itself.
Looks-Item Score From Body Image State Scale (BISS)
Tidsramme: Every 5 minutes during 30 minute bout of activity . There is no follow up beyond the study day itself.
Response to body image was measured using the BISS which is a 6 item scale that asks participants to report on their momentary body satisfaction on a 9-point Likert scale (1-9, higher scores, higher satisfaction). Each item begins with the sentence "Right now, I feel" [for instance: "Right now, I feel (Extremely dissatisfied to Extremely satisfied)"]. Participants are asked to rate their momentary body satisfaction every five minutes during each of 4 conditions: Prescribed Exercise (Reward Task), Self-Paced Exercise (Threat Task), Prescribed Rest (Reward Task), or Self-Paced Rest (Threat Task).
Every 5 minutes during 30 minute bout of activity . There is no follow up beyond the study day itself.
Physical Attraction-Item Score From Body Image State Scale (BISS)
Tidsramme: Every 5 minutes during 30 minute bout of activity . There is no follow up beyond the study day itself.
Response to body image was measured using the BISS which is a 6 item scale that asks participants to report on their momentary body satisfaction on a 9-point Likert scale (1-9, higher scores, higher satisfaction). Each item begins with the sentence "Right now, I feel" [for instance: "Right now, I feel (Extremely dissatisfied to Extremely satisfied)"]. Participants are asked to rate their momentary body satisfaction every five minutes during each of 4 conditions: Prescribed Exercise (Reward Task), Self-Paced Exercise (Threat Task), Prescribed Rest (Reward Task), or Self-Paced Rest (Threat Task).
Every 5 minutes during 30 minute bout of activity . There is no follow up beyond the study day itself.
Shape-Item Score From Body Image State Scale (BISS)
Tidsramme: Every 5 minutes during 30 minute bout of activity . There is no follow up beyond the study day itself.
Response to body image was measured using the BISS which is a 6 item scale that asks participants to report on their momentary body satisfaction on a 9-point Likert scale (1-9, higher scores, higher satisfaction). Each item begins with the sentence "Right now, I feel" [for instance: "Right now, I feel (Extremely dissatisfied to Extremely satisfied)"]. Participants are asked to rate their momentary body satisfaction every five minutes during each of 4 conditions: Prescribed Exercise (Reward Task), Self-Paced Exercise (Threat Task), Prescribed Rest (Reward Task), or Self-Paced Rest (Threat Task).
Every 5 minutes during 30 minute bout of activity . There is no follow up beyond the study day itself.
Weight-Item Score From Body Image State Scale (BISS)
Tidsramme: Every 5 minutes during 30 minute bout of activity . There is no follow up beyond the study day itself.
Response to body image was measured using the BISS which is a 6 item scale that asks participants to report on their momentary body satisfaction on a 9-point Likert scale (1-9, higher scores, higher satisfaction). Each item begins with the sentence "Right now, I feel" [for instance: "Right now, I feel (Extremely dissatisfied to Extremely satisfied)"]. Participants are asked to rate their momentary body satisfaction every five minutes during each of 4 conditions: Prescribed Exercise (Reward Task), Self-Paced Exercise (Threat Task), Prescribed Rest (Reward Task), or Self-Paced Rest (Threat Task).
Every 5 minutes during 30 minute bout of activity . There is no follow up beyond the study day itself.
Physical Activity Affect Scale (PAAS): Anxious-Item Score
Tidsramme: Every 5 minutes during a 30 minute bout of activity. There is no follow up beyond the study day itself.
Participants self-report items representing the highest loading items from the Physical Activity Affect Scale (PAAS) every 5 minutes during exercise. These items include feeling 'Anxious', 'Crummy', 'Enthusiastic', 'Fatigued' and 'Calm'. Participants rate each item using a 5-point scale (0=do not feel-4=feel very strongly).
Every 5 minutes during a 30 minute bout of activity. There is no follow up beyond the study day itself.
Physical Activity Affect Scale (PAAS): Calm-Item Score
Tidsramme: Every 5 minutes during a 30 minute bout of activity. There is no follow up beyond the study day itself.
Participants self-report items representing the highest loading items from the Physical Activity Affect Scale (PAAS) every 5 minutes during exercise. These items include feeling 'Anxious', 'Crummy', 'Enthusiastic', 'Fatigued' and 'Calm'. Participants rate each item using a 5-point scale (0=do not feel-4=feel very strongly).
Every 5 minutes during a 30 minute bout of activity. There is no follow up beyond the study day itself.
Physical Activity Affect Scale (PAAS): Crummy-Item Score
Tidsramme: Every 5 minutes during a 30 minute bout of activity. There is no follow up beyond the study day itself.
Participants self-report items representing the highest loading items from the Physical Activity Affect Scale (PAAS) every 5 minutes during exercise. These items include feeling 'Anxious', 'Crummy', 'Enthusiastic', 'Fatigued' and 'Calm'. Participants rate each item using a 5-point scale (0=do not feel-4=feel very strongly).
Every 5 minutes during a 30 minute bout of activity. There is no follow up beyond the study day itself.
Physical Activity Affect Scale (PAAS): Enthusiastic-Item Score
Tidsramme: Every 5 minutes during a 30 minute bout of activity. There is no follow up beyond the study day itself.
Participants self-report items representing the highest loading items from the Physical Activity Affect Scale (PAAS) every 5 minutes during exercise. These items include feeling 'Anxious', 'Crummy', 'Enthusiastic', 'Fatigued' and 'Calm'. Participants rate each item using a 5-point scale (0=do not feel-4=feel very strongly).
Every 5 minutes during a 30 minute bout of activity. There is no follow up beyond the study day itself.
Physical Activity Affect Scale (PAAS): Fatigued-Item Score
Tidsramme: Every 5 minutes during a 30 minute bout of activity. There is no follow up beyond the study day itself.
Participants self-report items representing the highest loading items from the Physical Activity Affect Scale (PAAS) every 5 minutes during exercise. These items include feeling 'Anxious', 'Crummy', 'Enthusiastic', 'Fatigued' and 'Calm'. Participants rate each item using a 5-point scale (0=do not feel-4=feel very strongly).
Every 5 minutes during a 30 minute bout of activity. There is no follow up beyond the study day itself.
Borg Rating of Perceived Exertion (RPE) Score
Tidsramme: Every 5 minutes during a 30 minute bout of activity. There is no follow up beyond the study day itself.
Participants were surveyed for their perceived exertion throughout the exercise conditions only. The Borg Rating of Perceived Exertion (RPE) scale was used to measure perceived exertion, rated 6 to 20 (no exertion to maximal exertion).
Every 5 minutes during a 30 minute bout of activity. There is no follow up beyond the study day itself.
Response to In-lab Exercise - Biomarkers: Circulating BDNF (ng/mL)
Tidsramme: pre-exercise (Baseline), post-exercise (30 minutes), pre-rest (Baseline), post-rest (30 minutes). There is no follow up beyond the study day itself.

Biomarkers will be collected via blood samples taken before and after exercise and rest and measured via Enzyme-linked immunosorbent assay (ELISA) kits:

  • circulating leptin (leptin immunoassay)
  • circulating endocannabinoids (2-arachidonoylglycerol (2-AG) and anandamide (AEA) plasma-based immunoassays)
  • circulating brain-derived neurotrophic factor (BDNF immunoassay)
  • circulating cortisol (Cortisol immunoassay)
pre-exercise (Baseline), post-exercise (30 minutes), pre-rest (Baseline), post-rest (30 minutes). There is no follow up beyond the study day itself.
Response to In-lab Exercise - Biomarkers: Circulating Leptin (ng/mL)
Tidsramme: pre-exercise (Baseline), post-exercise (30 minutes), pre-rest (Baseline), post-rest (30 minutes). There is no follow up beyond the study day itself.

Biomarkers will be collected via blood samples taken before and after exercise and rest and measured via Enzyme-linked immunosorbent assay (ELISA) kits:

  • circulating leptin (leptin immunoassay)
  • circulating endocannabinoids (2-arachidonoylglycerol (2-AG) and anandamide (AEA) plasma-based immunoassays)
  • circulating brain-derived neurotrophic factor (BDNF immunoassay)
  • circulating cortisol (Cortisol immunoassay)
pre-exercise (Baseline), post-exercise (30 minutes), pre-rest (Baseline), post-rest (30 minutes). There is no follow up beyond the study day itself.
Response to In-lab Exercise - Biomarkers: Circulating Cortisol (μg/dL)
Tidsramme: pre-exercise (Baseline), post-exercise (30 minutes), pre-rest (Baseline), post-rest (30 minutes). There is no follow up beyond the study day itself.

Biomarkers will be collected via blood samples taken before and after exercise and rest and measured via Enzyme-linked immunosorbent assay (ELISA) kits:

  • circulating leptin (leptin immunoassay)
  • circulating endocannabinoids (2-arachidonoylglycerol (2-AG) and anandamide (AEA) plasma-based immunoassays)
  • circulating brain-derived neurotrophic factor (BDNF immunoassay)
  • circulating cortisol (Cortisol immunoassay)
pre-exercise (Baseline), post-exercise (30 minutes), pre-rest (Baseline), post-rest (30 minutes). There is no follow up beyond the study day itself.
Response to In-lab Exercise - Biomarkers: Circulating Anandamide (AEA) (ng/mL)
Tidsramme: pre-exercise (Baseline), post-exercise (30 minutes), pre-rest (Baseline), post-rest (30 minutes). There is no follow up beyond the study day itself.

Biomarkers will be collected via blood samples taken before and after exercise and rest and measured via Enzyme-linked immunosorbent assay (ELISA) kits:

  • circulating leptin (leptin immunoassay)
  • circulating endocannabinoids (2-arachidonoylglycerol (2-AG) and anandamide (AEA) plasma-based immunoassays)
  • circulating brain-derived neurotrophic factor (BDNF immunoassay)
  • circulating cortisol (Cortisol immunoassay)
pre-exercise (Baseline), post-exercise (30 minutes), pre-rest (Baseline), post-rest (30 minutes). There is no follow up beyond the study day itself.
Response to In-lab Exercise - Biomarkers: Circulating 2-arachidonoylglycerol (2-AG) (ng/mL)
Tidsramme: pre-exercise (Baseline), post-exercise (30 minutes), pre-rest (Baseline), post-rest (30 minutes). There is no follow up beyond the study day itself.

Biomarkers will be collected via blood samples taken before and after exercise and rest and measured via Enzyme-linked immunosorbent assay (ELISA) kits:

  • circulating leptin (leptin immunoassay)
  • circulating endocannabinoids (2-arachidonoylglycerol (2-AG) and anandamide (AEA) plasma-based immunoassays)
  • circulating brain-derived neurotrophic factor (BDNF immunoassay)
  • circulating cortisol (Cortisol immunoassay)
pre-exercise (Baseline), post-exercise (30 minutes), pre-rest (Baseline), post-rest (30 minutes). There is no follow up beyond the study day itself.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Wisconsin, Madison

Samarbejdspartnere

National Institute of Mental Health (NIMH)

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. november 2023

Primær færdiggørelse (Faktiske)

31. juli 2025

Studieafslutning (Faktiske)

31. juli 2025

Datoer for studieregistrering

Først indsendt

9. januar 2024

Først indsendt, der opfyldte QC-kriterier

18. januar 2024

Først opslået (Faktiske)

19. januar 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2019-1585
  • 1R21MH131787-01A1 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Projektpublikationer vil give fuld information om procedurer og analyser for at muliggøre replikering. Vi deler data og kode på en institutionel webside for reproducerbarhed.

IPD-delingstidsramme

Ved undersøgelsens konklusion

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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