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Internet-delivered Emotion Regulation Individual Therapy or Adolescents (IERITA) With Self-injury Within Child and Adolescent Mental Health Services

22. maj 2026 opdateret af: Olivia Ojala, Karolinska Institutet
The overall purpose of the study is to implement and evaluate IERITA (Internet-delivered Emotion Regulation Individual Therapy for Adolescents) within child and adolescent mental health services for adolescents engaging in nonsuicidal self-injury (NSSI) and optimize treatment outcomes for those adolescents at risk of non-remission (continued NSSI).

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Nonsuicidal self-injury (NSSI) is a growing and urgent global health crisis among youth. It is associated with substantial individual and societal costs, including increased risk of suicide attempts. Scalable and evidence-based treatments are needed but lacking. Digital interventions can be one promising solution. A recent study shows that a novel brief digital treatment, IERITA, can be efficacious compared to treatment as usual only. However, not all respond sufficiently to standardized treatment, such as IERITA, and continued NSSI entails risks and suffering.

In this randomized controlled trial, participants will be randomly allocated (1:1) to standard IERITA or adaptable IERITA. All participants will first receive standard IERITA for four weeks. In treatment week four, or earlier if the adolescent is at risk of discontinuation, classification of non-remission/remission will be conducted. Adolescents allocated to adaptable IERITA and classified as likely non-remission, will change to adapted IERITA (e.g., personalized dose and delivery of treatment) for the remaining weeks (until week 12) while all other participants will continue with standard IERITA. Data will be collected pre-treatment, during treatment, post-treatment, one- three- and twelve-month post-treatment, and in public registers up to ten years post-treatment. The primary endpoint is one-month post-treatment.

The primary aim is to evaluate efficacy of an adaptable treatment strategy for adolescents at risk of non-remission. Secondary aims include implementation, cost-effectiveness, moderators and predictors, distal effects, algorithm performance, and psychometrical evaluations. The specific objectives are:

PRIMARY AIM

  1. Determine the efficacy of adaptable IERITA compared to standard IERITA for adolescents at risk of non-remission at one-month post-treatment (primary endpoint) and to assess the durability of effects at three-month follow-up

    SECONDARY AIMS

  2. Determine the cost-effectiveness of adaptable IERITA compared to a standard IERITA.
  3. Explore the implementation (reach, satisfaction, adherence, level and type of resources, utility) of IERITA in child and adolescent mental health services care.
  4. Investigate predictors and moderators of treatment outcome.
  5. Evaluate distal outcomes and long-term effects of adaptable IERITA compared to a standard IERITA.
  6. Explore the experience of being an IERITA therapist.
  7. Evaluate the performance of the algorithm predicting treatment non-remission.
  8. Evaluate the psychometric properties of the Deliberate Self-harm Inventory - Youth version (DSHI-Y).
  9. Evaluate the agreement between self- and assessor-rated NSSI.

Statistical plan is found at: https://osf.io/6h7fe/overview

This project is sponsored by the Swedish Research Council (number 2024-03122), Fonden för Psykisk Hälsa, Stiftelsen Söderströmska Königska (number SLS-1031985), and Thuring Foundation (2025-186).

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

341

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Sverige
      • Stockholm, Sverige, 113 64
        • Rekruttering
        • Karolinska Institutet
        • Kontakt:
        • Ledende efterforsker:
          • Johan Bjureberg, PhD
        • Underforsker:
          • Olivia Ojala, PhD

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

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • 13-17 years old
  • At least one self-injury episode in the past three months
  • A parent willing to engage in the parent program

Exclusion Criteria:

  • Immediate suicide risk
  • Global functioning corresponding to a rating ≤40 of the Children's Global Assessment Scale (CGAS)
  • Social problems needing immediate intervention (e.g., violence within the family)
  • Ongoing dialectical behavior therapy for adolescents

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Standard internetleveret følelsesregulering Individuel terapi supplerende til behandling som sædvanligt
Deltagerne vil modtage internetleveret følelsesregulering individuel terapi (Ierita) i 12 uger. Alle deltagere vil fortsætte standard Ierita i hele behandlingsperioden. Foruden Ierita vil deltagerne frit modtage enhver form for behandling som sædvanligt i 12 uger, som det er angivet i samfundet.
Andet: Behandling som sædvanligt
Deltagerne er fri til enhver modtagelse af regelmæssig pleje (dvs. psykosocial behandling, medicin eller en kombination af begge dele) efter behov under forsøget.
Adfærdsmæssigt: Standard Ierita
Ierita er en 12-ugers acceptbaseret adfærdsterapi. Målet er at reducere selvskadet gennem læring og bruge andre måder til at regulere følelser. Ierita inkluderer moduler, hvor deltagerne kan læse tekst, se videoer, lytte til lyd og sende besked til deres tildelte terapeuter. Den unge behandling er 11 moduler, og overordnet kursus er seks. Både unge og forældre modtager separate asynkron online terapeutstøtte.
Eksperimentel: Adaptable Internet-delivered emotion regulation individual therapy adjunctive to treatment as usual
Participants will receive Internet-delivered Emotion Regulation Individual Therapy (IERITA) for 12 weeks. Adolescents allocated to experimental arm and classified as likely non-remission, will change to adapted IERITA in treatment week four (or earlier if the adolescent is at risk of discontinuation). Adolescents allocated to experimental arm and classified as likely remission will continue standard IERITA. In addition to IERITA, participants are free to will receive any type of treatment as usual for 12 weeks as provided in the community.
Andet: Behandling som sædvanligt
Deltagerne er fri til enhver modtagelse af regelmæssig pleje (dvs. psykosocial behandling, medicin eller en kombination af begge dele) efter behov under forsøget.
Adfærdsmæssigt: Adaptable IERITA

IERITA is a 12-week acceptance-based behavioral therapy. The goal is to reduce self-injury through learning and using other ways to regulate emotions. IERITA includes modules where the participants can read text, watch videos, listen to audio, and message their allocated therapists. The adolescent treatment is 11 modules, and the parent course is six. Both adolescents and parents receive separate asynchronous online therapist support.

In the adapted IERITA intervention, the therapists develop an individual case conceptualization that forms the basis for a brief interview with the adolescent after the classification phase (from randomization to treatment week four), during which potential obstacles and necessary adaptations are explored. Adaption can entail scheduled or regular chats or videoconferences, selecting specific material to focus on, and involving additional support persons. The adapted IERITA intervention is offered after the classification phase until treatment week 12.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Deliberate Self-harm Inventory - Youth version (DSHI-Y)
Tidsramme: One-, three- and twelve-months post-treatment
The DSHI-Y measures the frequency of the most common NSSI behaviors. The primary outcome will be the proportion of treatment remission. Remission will be defined as the absence of self-injury the past 30 days. The primary outcome measure will be the clinician-rated DSHI-Y. In cases where clinician ratings are unavailable, the self-rated DSHI-Y will be used.
One-, three- and twelve-months post-treatment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Børns Global Assessment Scale (CGAS)
Tidsramme: Baseline, en-, tre- og tolv-måneders efterbehandling
CGA'erne måler global funktion på et enkelt emne, der spænder fra 1 til 100, med en højere værdi, der indikerer bedre funktion. Kliniker-klassificeret.
Baseline, en-, tre- og tolv-måneders efterbehandling
Vanskeligheder i følelsesreguleringsskala - 16 vare version (DERS -16)
Tidsramme: Baseline, en-, tre- og tolv-måneders efterbehandling
DERS-16 måler vanskeligheder i følelsesregulering. Den samlede score varierer fra 16 til 80, med højere score, der indikerer større vanskeligheder. Selvklassificeret (ungdom og forælder).
Baseline, en-, tre- og tolv-måneders efterbehandling
Child Health Utility 9D (CHU-9D)
Tidsramme: Baseline, en-, tre- og tolv-måneders efterbehandling
CHU-9D måler sundhedsrelateret livskvalitet. Skalaen har 9 poster med en sammenfattende score mellem 9 og 45, hvor en højere score indikerer større sundhedsrelateret livskvalitet. Selvklassificeret (ungdom).
Baseline, en-, tre- og tolv-måneders efterbehandling
Den reviderede børneangst og depression skala-short version (RCADS-25)
Tidsramme: Baseline, en-, tre- og tolv-måneders efterbehandling
RCADS-25 måler symptomer på depression og angst hos børn og unge. Denne version har 25 poster med en total score mellem 0 og 75, med højere score, der indikerer større niveauer af symptomer. Selvklassificeret (ungdom).
Baseline, en-, tre- og tolv-måneders efterbehandling
Trimbos/IMTA-spørgeskema for omkostninger forbundet med psykiatrisk sygdom (TIC-P)
Tidsramme: Baseline, en-, tre- og tolv-måneders efterbehandling
TIC-P måler brug af sundhedsydelser og samfundsmæssig ressourceforbrug, herunder f.eks. Varer om brug af sundhedsressourcer, medicin, skolefravær og tab af forældrenes produktivitet. Selvklassificeret (forælder).
Baseline, en-, tre- og tolv-måneders efterbehandling
Deliberate Self-harm Inventory - Youth version (DSHI-Y)
Tidsramme: Baseline, one-, three- and twelve-months post-treatment
The DSHI-Y measures the frequency of the most common NSSI behaviors. Change in NSSI frequency from baseline to respective follow-up will be a secondary outcome. The primary outcome measure will be the clinician-rated DSHI-Y. In cases where clinician ratings are unavailable, the self-rated DSHI-Y will be used.
Baseline, one-, three- and twelve-months post-treatment
Borderline symtom checklist supplement (BSL)
Tidsramme: Baseline, one-, three- and twelve-months post-treatment
The BSL supplement measures the frequency of self-destructive behaviors. We will measure behaviors of self-harm, suicide attempt, binge eating, self-induced vomiting, high-risk activities, getting drunk, substance use, medication misuse, outbreaks of anger/physical attacks and impulsive/shameful sexual encounters, resulting in a total score between 0 to 40 where a higher score indicates greater frequency of self-destructive behaviors. Self-rated (adolescent).
Baseline, one-, three- and twelve-months post-treatment
The Coping with Children's Negative Emotions Scale Adolescent Version (CCNES-A)
Tidsramme: Baseline, one-, three- and twelve-months post-treatment
The CCNES-A measures parental coping in response to adolescents' negative emotions. The CCNES-A consists of nine hypothetical scenarios accompanied by six types of responses (i.e., emotion focused, problem-focused, minimization, punitive, expressive encouragement, and distress responses). Separate summary scores are calculated per subscale (type of response) and ranges from 1 to 7, with higher scores indicating greater usage of a certain parental coping style. Self-rated (parent and adolescent).
Baseline, one-, three- and twelve-months post-treatment

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Internet Intervention Patient Adhæsion Scale (IIPAS)
Tidsramme: Behandling uge 3 og efterbehandling (uge 12)
IIPAS måler patientens overholdelse af guidede internetleverede adfærdsinterventioner. Denne skala har 5 poster og en total score i området fra 0 til 20, hvor 0 ikke angiver nogen adhæsion og 20 perfekt overholdelse. Kliniker-klassificeret.
Behandling uge 3 og efterbehandling (uge 12)
Klogtilfredshedsspørgeskemaet (CSQ)
Tidsramme: Efterbehandling (uge 12)
CSQ måler tilfredshed med behandlingen. Denne skala har 8 poster og et resuméresultat fra 8 til 32, med højere score, der indikerer større behandlingstilfredshed. Selvklassificeret (ungdom og forælder).
Efterbehandling (uge 12)
Terapeut tid
Tidsramme: Efterbehandling (uge 12)
Klinikere rapporterer tid brugt på behandling.
Efterbehandling (uge 12)
Antal afsluttede sessioner og moduler
Tidsramme: Efterbehandling (uge 12)
Klinikere rapporterer antal afsluttede sessioner og moduler for unge og forældre.
Efterbehandling (uge 12)
Behandlingsfrekvenstilpasninger
Tidsramme: Efterbehandling (uge 12)
Klinikere rapporterer tilstedeværelse eller fravær af mulige behandlingsadaptioner (f.eks. Ændringer i terapeutkontakt eller hvilket materiale der skal fokuseres på).
Efterbehandling (uge 12)
Tilpasset ICBT Terapeut Rating Scale (ICBT-TRS)
Tidsramme: Gennem undersøgelsesafslutning, i gennemsnit 1 år
Terapeutadfærd vurderes separat som 0 (fravær af adfærd), 1 (utilstrækkelig ydelse) eller 2 (kompetent). Bedømt af erfarne kliniske tilsynsførere.
Gennem undersøgelsesafslutning, i gennemsnit 1 år
Deltager-klassificeret tilslutning
Tidsramme: Behandling uge 3
To varer, der beder deltageren om at bedømme deres egen overholdelse den sidste uge. Selvklassificeret (ungdom).
Behandling uge 3
Troværdighed
Tidsramme: Behandling uge 3
To varer, der beder deltageren om at bedømme ændring i behandlings troværdighed fra den forrige behandlingsuge. Selvklassificeret (ungdom).
Behandling uge 3
Bivirkninger
Tidsramme: Efterbehandling (uge 12)
En skala var deltagere bliver bedt om at rapportere, beskrive og bedømme ubehag/virkning af eventuelle negative effekter eller bivirkninger forårsaget af deres deltagelse i behandlingen. Deltagerne vurderer virkningen af ​​potentielle bivirkninger, når det skete, og i dag på en skala fra 1 til 4, hvor en højere score indikerer større indflydelse. Selvklassificeret (ungdom og forælder).
Efterbehandling (uge 12)
Samtidig behandling
Tidsramme: Efterbehandling (uge 12), en og tre måneder efter behandling
Deltagerne rapporterer tilstedeværelse, type, fokus og ændrer en potentiel anden samtidig behandling under forsøget. Selvklassificeret (ungdom og forælder).
Efterbehandling (uge 12), en og tre måneder efter behandling
Klinikerens tilfredshed med behandlingsadaptioner
Tidsramme: Efterbehandling (uge 12)
Klinikere rapporterer deres eget tilfredshedsniveau med de givne behandlingsadaptioner (en vare).
Efterbehandling (uge 12)
Beholdning af udsagn om selvskade (ISAS)
Tidsramme: Baseline
ISAS måler frekvens, funktion, alder på begyndelse, erfaring med og vilje til at stoppe med at engagere sig i selvskadet. Der er 39 genstande, der beskriver almindelige funktioner i selvskade. Deltagerne bliver bedt om at bedømme, hvis en bestemt funktion gælder for dem ved at markere udsagnet som "ikke relevant", "delvis relevant" eller "meget relevant". Selvklassificeret (ungdom).
Baseline
Columbia-Suicide Severity Rating Scale (C-SSRS)-6 vare version
Tidsramme: Baseline
C -SSRS - 6 -vareversionen måler hyppigheden og sværhedsgraden af ​​selvmordstanker og adfærd. Kliniker-klassificeret.
Baseline
Columbia-Suicide Severity Rating Scale (C-SSRS)
Tidsramme: Uge 1 til 12
To poster om selvmordsadfærd fra C-SSR'erne bruges til at måle selvmord under behandlingen. Elementerne vedrører forberedende adfærd og selvmordsforsøg de sidste syv dage. Selvklassificeret (ungdom).
Uge 1 til 12
Vanskeligheder i følelsesreguleringsskala - 16 vare version (DERS -16)
Tidsramme: Uge 1 til 12
DERS-16 måler vanskeligheder i følelsesregulering. Den samlede score varierer fra 16 til 80, med højere score, der indikerer større vanskeligheder. Selvklassificeret (ungdom).
Uge 1 til 12
Erfaringer med selvrapporterede og vurderingsrapporterede ikke-selvmordsrelaterede selvskade (NSSI) rapporter
Tidsramme: Baseline, en eller tre måneder efter behandling
Unge vil blive stillet to spørgsmål om den anvendte form til rapportering af NSSI: (1) "Hvordan oplevede du at rapportere NSSI i de forskellige formater?", og i tilfælde af uoverensstemmelser mellem de to rapporteringsformater: (2) "Hvilken frekvensvurdering foretrækker du?". Begge spørgsmål vil blive administreret af en assessor under en enkelt vurderingssession.
Baseline, en eller tre måneder efter behandling
Deliberate Self-harm Inventory - Youth version (DSHI-Y)
Tidsramme: Week 1 to 12, and post-treatment (week 12)
The DSHI-Y measures the frequency of the most common NSSI behaviors. Self-rated (adolescent).
Week 1 to 12, and post-treatment (week 12)
The Swedish version of the Normalization Process Theory Measure (S-NoMAD)
Tidsramme: Through study completion for primary outcome measure and endpoint, an average of 3 years
S-NoMAD measures implementation of interventions from a normalization process theory perspective. The first section in S-NoMAD includes questions about the respondent, the second (2 items) and third (20 items) include questions about the intervention. The items in the second section are answered on a 10-point Likert scale ranging from "Not at all" to "Completely". The items in the third section are answered using a 5-point Likert scale, ranging from "Disagree Strongly" to "Agree Strongly". Participating clinicians answer the S-NoMAD once, after they have treated at least three families with the intervention (i.e., to have some experience of the intervention).
Through study completion for primary outcome measure and endpoint, an average of 3 years
Treatment benefit
Tidsramme: twelve-months post-treatment
Participants are asked to rate, using a single item, the perceived benefit of the intervention-specifically, how much of the knowledge gained continues to help them today. Self-rated (adolescent and parent).
twelve-months post-treatment
Demographical and clinical background data
Tidsramme: Baseline
Current mental health disorders, age, previous and current treatment. Clinician-rated. Gender and sexual orientation. Self-rated (adolescent). Country of birth, living situation, parental occupation, parental academic degree, and parental history of mental health disorders. Self-report (parent)
Baseline
Lifestyle behaviors
Tidsramme: Baseline
Four questions asking participants to rate how frequently they engage in the following activities: eating candy, drinking soda, playing video or computer games, and watching movies. Clinician-rated and self-rated (adolescent)
Baseline
Number of healthcare visits
Tidsramme: 1 to 10 years post-treatment
Registry data from the National Patient Register.
1 to 10 years post-treatment
Academic performance
Tidsramme: 1 to 10 years post-treatment
Grades and eligibility in primary school and upper secondary school, and highest education level. Registry data from the Swedish National Agency for Education and the Swedish longitudinal integrated database for health insurance and labour market studies (LISA).
1 to 10 years post-treatment
Mental health disorders
Tidsramme: 1 to 10 years post-treatment
Registered psychiatric disorders. Registry data from the National Patient Register.
1 to 10 years post-treatment
Occupation
Tidsramme: 1 to 10 years post-treatment
Occupation, including unemployment and sick leave. Registry data from the Swedish longitudinal integrated database for health insurance and labour market studies (LISA).
1 to 10 years post-treatment
Reasons for eventual death
Tidsramme: 1 to 10 years post-treatment
Registry data from the National Cause of Death Register.
1 to 10 years post-treatment
Prescription of psychotropics
Tidsramme: 1 to 10 years post-treatment
Registry data from the National Prescribed Drug Register.
1 to 10 years post-treatment
Suicide attempts
Tidsramme: 1 to 10 years post-treatment
Suicide attempts registered by the health care. Registry data from the National Patient Register and Regional Healthcare Registers.
1 to 10 years post-treatment
The Revised Child Anxiety and Depression Scale (RCADS)
Tidsramme: 1 to 10 years post-treatment
The RCADS measures symptoms of depression and anxiety in children and adolescents. RCADS has 47 items with a total score between 0 and 141, with higher scores indicating greater levels of symptoms. Registry data from the National Quality Register for Child and Adolescent Mental Health Services (Q-BUP).
1 to 10 years post-treatment
Kidscreen-10
Tidsramme: 1 to 10 years post-treatment
The Kidscreen-10 measures quality of life through 10 items. The summary score ranges from 10 to 50 where a higher score indicates greater quality of life. Registry data from the National Quality Register for Child and Adolescent Mental Health Services (Q-BUP).
1 to 10 years post-treatment
Children's Global Assessment Scale (CGAS)
Tidsramme: 1 to 10 years post-treatment
The CGAS measures global functioning on a single item ranging from 1 to 100, with a higher value indicating better functioning. Registry data from the National Quality Register for Child and Adolescent Mental Health Services (Q-BUP).
1 to 10 years post-treatment
Credibility/Expectancy Questionnaire (CEQ) - 1 item version
Tidsramme: Treatment week 2
CEQ measures treatment credibility and expectancy. This version of the scale has 1 item ranging from 0 to 100, with higher scores indicating greater credibility/expectancy. Self-rated (adolescent).
Treatment week 2

Samarbejdspartnere og efterforskere

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

Sponsor

Karolinska Institutet

Samarbejdspartnere

Vastra Gotaland Region
Region Skane
Region Stockholm

Efterforskere

  • Ledende efterforsker: Johan Bjureberg, PhD, Karolinska Institutet
  • Ledende efterforsker: Olivia Ojala, PhD, Karolinska Institutet

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 (Anslået)

1. maj 2026

Primær færdiggørelse (Anslået)

1. december 2029

Studieafslutning (Anslået)

1. december 2040

Datoer for studieregistrering

Først indsendt

25. april 2026

Først indsendt, der opfyldte QC-kriterier

4. maj 2026

Først opslået (Faktiske)

7. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2024-04650-01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

The data is pseudonymized in accordance with Swedish and European Union laws and cannot be anonymized and published in an open repository. Study participants have consented to sharing their data with international researchers for meta-analyses. Aggregated data can be provided upon reasonable request on a case-by-case basis in compliance with current legislation and ethical permits.

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