- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04024488
Intervento di gruppo per migliorare la salute mentale e l'aderenza tra i giovani che vivono con l'HIV in contesti con risorse limitate
IMPAACT 2016 - Valutazione di un intervento di gruppo per migliorare la salute mentale e l'aderenza alla terapia antiretrovirale (ART) tra i giovani che vivono con l'HIV in contesti con risorse limitate
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Gaborone, Botswana
- Gaborone Prevention/Treatment Trials CRS 12701
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Molepolole, Botswana
- Molepolole Prevention/Treatment Trials CRS 12702
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Blantyre, Malawi
- College of Medicine CRS 30301
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Lilongwe, Malawi
- University of North Carolina Lilongwe CRS 12001
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Soweto, Sud Africa
- Soweto IMPAACT CRS 8052
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Chitungwiza, Zimbabwe
- St. Mary's CRS 30303
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Harare, Zimbabwe
- Harare Family Care CRS 31890
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Harare, Zimbabwe
- Seke North CRS 30306
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Descrizione
Criteri di inclusione - Per i giovani partecipanti:
- Allo screening, 15-19 anni.
- Se maggiorenne per fornire il consenso informato indipendente come determinato dalle procedure operative standard (SOP) del sito e coerente con le politiche e le procedure IRB/CE del sito: il potenziale giovane partecipante è disposto e in grado di fornire il consenso informato scritto per la partecipazione allo studio.
- Se non ha l'età legale per fornire il consenso informato indipendente: il genitore o il tutore è disposto e in grado di fornire il consenso informato scritto per la partecipazione allo studio e il potenziale giovane partecipante è disposto e in grado di fornire il consenso informato scritto per la partecipazione allo studio.
- Infezione da HIV confermata sulla base di test documentati di due campioni raccolti in momenti diversi come documentato nelle cartelle cliniche o mediante test di conferma.
- Allo screening, a conoscenza della propria infezione da HIV, come confermato dall'investigatore ufficiale o designato.
- Allo screening, è stata prescritta l'ART per un minimo di 24 settimane prima dello screening sulla base della documentazione della cartella clinica.
Allo screening, soddisfa almeno uno dei seguenti indicatori di sintomatologia di salute mentale da moderata a grave:
- Punteggio del questionario sulla salute del paziente-9 (PHQ-9) ≥ 10
- Punteggio del Disturbo d'Ansia Generale-7 (GAD-7) ≥ 10
- Punteggio UCLA Post-Traumatic Stress Disorder-Reaction Index (UCLA PTSD-RI) > 35
Criteri di inclusione - Per i partecipanti caregiver:
- Caregiver, definito come genitore biologico, tutore legale o persona che fornisce assistenza emotiva, psicologica e/o informativa a un giovane che partecipa alla sperimentazione randomizzata, come identificato dal giovane, e per il quale il giovane ha fornito il permesso scritto di partecipare nello studio.
- Di età legale per fornire il consenso indipendente e disposto e in grado di fornire il consenso informato scritto per la partecipazione allo studio.
Criteri di esclusione - Per i giovani partecipanti:
- All'ingresso, partecipazione a uno studio che fornisce un intervento di salute mentale o aderenza ART.
- Ha partecipato in precedenza a un focus group o test pilota IMPAACT 2016
- Qualsiasi altra condizione, situazione sociale avversa o compromissione cognitiva che, a giudizio del ricercatore del sito, precluderebbe il consenso informato e il consenso informato, renderebbe pericolosa la partecipazione allo studio, complicherebbe l'interpretazione dei dati sui risultati dello studio o interferirebbe in altro modo con il raggiungimento degli obiettivi dello studio.
Criteri di esclusione - Per i partecipanti caregiver:
Ha partecipato in precedenza a un focus group o test pilota IMPAACT 2016.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Youth TI-CBT Intervention Arm
For youth, the TI-CBT intervention arm consisted of six 2-hour TI-CBT group sessions led by Indigenous Youth Leaders (IYL) during weeks 1 to 8 and one 2-hour booster group session at 6-months.
The TI-CBT Intervention was delivered in a group format.
The TI-CBT Intervention arm had 15 groups with an average of 8.5 youth per group (range 6-11).
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For youth, each TI-CBT group session was led by IYL.
TI-CBT teaches techniques and ways to manage distress through psychosocial health education, cognitive restructuring, and "mastery of trauma", which refers to the process by which survivors of psychological trauma work through the traumatic experience in a meaningful way, and are able to move on with life.
TI-CBT addresses both the trauma of learning one has HIV and the trauma associated with managing a chronic and stigmatized illness.
The intervention highlights links between HIV and traditional gender roles, gender inequities, and gender-based violence.
Finally, the relaxation training teaches youth strategies to relax and these are integrated at the beginning and end of each session.
TI-CBT Youth Intervention Manuals were distributed to sites for translation, backtranslation, and cultural adaptation in preparation for the Randomized Trial.
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Comparatore attivo: Youth Discussion Control Arm
For youth, the Discussion Control arm consisted of six 2-hour discussion group sessions led by IYL during weeks 1 to 8 and one 2-hour booster discussion group session at 6 months.
The Discussion Control was delivered in a group format.
The Discussion Control arm had 15 groups with an average of 8.4 youth per group (range 5-10).
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For youth, each discussion group session was led by IYL. Discussion topics were selected by youth in the group.
Discussion Control sessions took place at a separate time from TI-CBT Intervention sessions to minimize contamination.
Youth and caregiver group sessions were also held separately.
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Sperimentale: Caregiver TI-CBT Intervention Arm
For caregivers, the TI-CBT Intervention arm consisted of two 2-hour TI-CBT group sessions on two separate weeks within 8 weeks of their youth's first group session and one 2-hour booster group session at 6-months led by adult study staff.
The TI-CBT Intervention was delivered in group format.
The TI-CBT Intervention arm had 15 groups with an average of 7.7 caregivers per group (range 5-10).
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For caregivers, each TI-CBT group session was led by adult study staff.
TI-CBT teaches techniques and ways to manage distress through psychosocial health education, cognitive restructuring, and "mastery of trauma", which refers to the process by which survivors of psychological trauma work through the traumatic experience in a meaningful way, and are able to move on with life.
TI-CBT addresses both the trauma of learning one has HIV and the trauma associated with managing a chronic and stigmatized illness.
The intervention highlights links between HIV and traditional gender roles, gender inequities, and gender-based violence.
Finally, the relaxation training teaches strategies to relax and these are integrated at the beginning and end of each session.
TI-CBT Caregiver Intervention Manuals were distributed to sites for translation, backtranslation, and cultural adaptation in preparation for the Randomized Trial.
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Comparatore attivo: Caregivers Discussion Control Arm
For caregivers, the Discussion Control arm consisted of: two 2-hour discussion group sessions on two separate weeks within 8 weeks of their youth's first group session and one 2-hour booster discussion group session at 6 months led by adult study staff.
The Discussion Control intervention was delivered in a group format.
The Discussion Control arm had 15 groups with an average of 7.6 caregivers per group (range 3-10).
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For caregivers, each discussion group session was led by adult study staff.
Discussion topics were selected by caregivers in the group.
Discussion Control sessions took place at a separate time from TI-CBT Intervention sessions to minimize contamination.
Youth and caregiver group sessions were also held separately.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Group-level Mean General Anxiety Disorder-7 (GAD-7) at 6 Months
Lasso di tempo: at 6 months
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Average (standard deviation) of the group-level mean General Anxiety Disorder-7 (GAD-7) score within arm.
The GAD-7 features 7 items assessing frequency of anxiety symptoms over the past 2 weeks on a scale from 0="Not at all" to 3="Nearly every day".
Responses to the 7 items are summed to obtain a GAD-7 score ranging from 0 (least) to 21 (most severe symptoms).
A score of 10 or more points indicates moderate to severe anxiety symptoms.
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at 6 months
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Group-level Mean UCLA Post-Traumatic Stress Disorder-Reaction Index (UCLA-PTSD-RI) at 6 Months
Lasso di tempo: at 6 months
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Average (standard deviation) of the group-level mean UCLA Post Traumatic Stress Disorder-Reaction Index (PTSD-RI) score within arm.
The UCLA PTSD-RI assesses DSM-IV criteria for PTSD in youth.
If prior trauma is endorsed, assessment asks whether 31 PTSD symptoms have occurred within the past month on a scale from 0="None" to 4="Most of the time".
A scoring algorithm is applied to the 31 items to calculate a score ranging from 0 (least) to 80 (most severe symptoms).
A score of 35 or more indicates moderate to severe PTSD symptoms.
If no trauma is endorsed, no score is calculated.
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at 6 months
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Group-level Mean Composite Mental Health Measure at 6 Months
Lasso di tempo: at 6 months
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Average (standard deviation) of the group-level mean Composite score within arm.
Composite scores are a study-specific measure of combined mental health symptoms.
A participant's PHQ-9, GAD-7, and UCLA PTSD-RI scores at the given timepoint are each standardized according to baseline to get Z scores.
The 3 Z scores are summed to obtain a Composite score.
Composite scores are not Z scores themselves and can range from -Inf to +Inf, with greater scores reflecting more severe symptoms overall.
Composite scores of 0 at baseline represent average symptom levels overall, but otherwise do not have a meaningful central value.
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at 6 months
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Group-level Mean Patient Health Questionnaire-9 (PHQ-9) at 6 Months
Lasso di tempo: at 6 months
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Average (standard deviation) of the group-level mean Patient Health Questionnaire-9 (PHQ-9) score within arm.
The PHQ-9 features 9 items assessing the frequency of depression symptoms over the past 2 weeks on a scale from 0="Not at all" to 3="Nearly every day".
Responses to the 9 items are summed to obtain a PHQ-9 score ranging from 0 (least) to 27 (most severe symptoms).
A score of 10 or more points indicates moderate to severe depression symptoms.
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at 6 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Group-level Mean General Anxiety Disorder-7 (GAD-7) at IPL (Immediately Post-Last Group Session)
Lasso di tempo: After initial treatment completion (initial treatment lasted an average of 6 weeks)
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Average (standard deviation) of the group-level mean General Anxiety Disorder-7 (GAD-7) score within arm.
The GAD-7 features 7 items assessing frequency of anxiety symptoms over the past 2 weeks on a scale from 0="Not at all" to 3="Nearly every day".
Responses to the 7 items are summed to obtain a GAD-7 score ranging from 0 (least) to 21 (most severe symptoms).
A score of 10 or more points indicates moderate to severe anxiety symptoms.
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After initial treatment completion (initial treatment lasted an average of 6 weeks)
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Group-level Mean Patient Health Questionnaire-9 (PHQ-9) at IPL (Immediately Post Last Group Session)
Lasso di tempo: After initial treatment completion (initial treatment lasted an average of 6 weeks)
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Average (standard deviation) of the group-level mean Patient Health Questionnaire-9 (PHQ-9) score within arm.
The PHQ-9 features 9 items assessing the frequency of depression symptoms over the past 2 weeks on a scale from 0="Not at all" to 3="Nearly every day".
Responses to the 9 items are summed to obtain a PHQ-9 score ranging from 0 (least) to 27 (most severe symptoms).
A score of 10 or more points indicates moderate to severe depression symptoms.
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After initial treatment completion (initial treatment lasted an average of 6 weeks)
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Group-level Mean UCLA Post-Traumatic Stress Disorder-Reaction Index (UCLA PTSD-RI) at IPL (Immediately Post-Last Group Session)
Lasso di tempo: After initial treatment completion (initial treatment lasted an average of 6 weeks)
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Average (standard deviation) of the group-level mean UCLA Post Traumatic Stress Disorder-Reaction Index (PTSD-RI) score within arm.
The UCLA PTSD-RI assesses DSM-IV criteria for PTSD in youth.
If prior trauma is endorsed, assessment asks whether 31 PTSD symptoms have occurred within the past month on a scale from 0="None" to 4="Most of the time".
A scoring algorithm is applied to the 31 items to calculate a score ranging from 0 (least) to 80 (most severe symptoms).
A score of 35 or more indicates moderate to severe PTSD symptoms.
If no trauma is endorsed, no score is calculated.
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After initial treatment completion (initial treatment lasted an average of 6 weeks)
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Group-level Mean Composite Mental Health Measure at IPL (Immediately Post-Last Group Session)
Lasso di tempo: After initial treatment completion (initial treatment lasted an average of 6 weeks)
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Average (standard deviation) of the group-level mean Composite score within arm.
Composite scores are a study-specific measure of combined mental health symptoms.
A participant's PHQ-9, GAD-7, and UCLA PTSD-RI scores at the given timepoint are each standardized according to baseline to get Z scores.
The 3 Z scores are summed to obtain a Composite score.
Composite scores are not Z scores themselves and can range from -Inf to +Inf, with greater scores reflecting more severe symptoms overall.
Composite scores of 0 at baseline represent average symptom levels overall, but otherwise do not have a meaningful central value.
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After initial treatment completion (initial treatment lasted an average of 6 weeks)
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Group-level Mean ART Adherence at 6 Months
Lasso di tempo: at 6 months
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Average (standard deviation) of the group-level mean antiretroviral therapy (ART) adherence score within arm.
The Wilson 3-Item Adherence Scale assessed self-reported ART adherence.
Within the past 30 days, the 3 items correspond to missed daily doses (0-30), adherence to medication instructions ("Very poor" to "Excellent"), and frequency of perfect use ("Never" to "Always").
Responses on the three items are transformed linearly to scores between 0 and 100 points and averaged to obtain a single score.
Scores range from 0 (worst) possible adherence to 100 (best possible adherence).
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at 6 months
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Viral Load at 6 Months
Lasso di tempo: at 6 months
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HIV-1 RNA
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at 6 months
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Group-level Mean ART Adherence at IPL (Immediately Post-Last Group Session).
Lasso di tempo: After initial treatment completion (initial treatment lasted an average of 6 weeks).
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Self-report - Wilson 3-item scale (range 0-100, higher=better)
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After initial treatment completion (initial treatment lasted an average of 6 weeks).
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Viral Load at IPL (Immediately Post-Last Group Session)
Lasso di tempo: After initial treatment completion (initial treatment lasted an average of 6 weeks)
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HIV-1 RNA
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After initial treatment completion (initial treatment lasted an average of 6 weeks)
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Collaboratori e investigatori
Collaboratori
Investigatori
- Cattedra di studio: Dorothy Dow, MD, MSc, Duke University
Pubblicazioni e link utili
Pubblicazioni generali
- Dow DE, Libous J, Ponatshego PL, Masheto G, Mvalo T, Payesa C, Buckley J, Stranix-Chibanda L, Nematadzira T, Vhembo T, Ace A, Warshaw M, Townley E, Lee S, Allison S, Donenberg G and the IMPAACT 2016 Team. High levels of mental distress among youth with HIV in Southern Africa: A description of enrollment into IMPAACT 2016, a randomized controlled trial of a peer-led, group-based mental health intervention. Presented at IAS, Kigali, Rwanda, 15 July 2025.
- Libous J, Jeffrey R, George K, Montañez N, Warshaw M, Shakes Raesi M, Ponatshego PL, Maliwichi L, Vhembo T, Mutasa T, Bere CT, Galvin L, Townley E, Varechtchouk O, Dow D, Donenberg G, and the IMPAACT 2016 Team. IMPAACT 2016: The ADAPT-ITT Framework Leveraging Youth and Supporter Voices in the Adaptation of a Trauma-Informed Cognitive Behavioral Therapy Group-Based Intervention for Youth Living with HIV and Mental Health Distress. Presented at Fast Track Cities, Paris, France, 13-15 October 2024.
- Vhemo T, Mhembere T, Mbengeranwa T, Bere TC, Mutasa T, Katsande R, Gumbo J, Mudzonga N, Nematadzira T, Maturure SJ, Mandima PF, Maonera S, Stranix-Chibanda L. High Prevalence of Common Mental Health Disorders Amongst Adolescents With HIV in Zimbabwe: IMPAACT 2016; Presented at International Workshop on Pediatrics & HIV, Munich, Germany, 19-20 July 2024.
- Libous JL, Montañez N, Donenberg G, Kapetanovic S, Dow D. IMPAACT 2016: Operationalizing the ADAPT-ITT Model to drive local adaptation of an intervention to improve mental health and medication adherence in youth living with HIV. Presented at Society for Clinical Research Associates 29th Annual Conference, Virtual, 23-26 September 2020.
- Warshaw M, Dow D, Kapetanovic S, Libous J, Reding C, Montañez , Donenberg G. IMPAACT 2016: Interdisciplinary Collaboration at Multiple Levels. Society for Clinical Trials 41st Annual Meeting, Baltimore, MD (Virtual), 2020.
- Libous JL, Montanez NA, Dow DE, Kapetanovic S, Buckley J, Kakhu TJ, Kamthunzi P, Maliwichi LA, Vhembo T, Chawana TD, Nematadzira T, Donenberg GR. IMPAACT 2016: Operationalizing HIV Intervention Adaptations to Inform the Science and Outcomes of Implementation. Front Reprod Health. 2021 May 28;3:662912. doi: 10.3389/frph.2021.662912. eCollection 2021.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IMPAACT 2016
- DAIDS ID #38506 (Altro identificatore: DAIDS/NIAID/NIH)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Periodo di condivisione IPD
Criteri di accesso alla condivisione IPD
I dati saranno condivisi con i ricercatori che forniscono una proposta metodologicamente valida per l'utilizzo dei dati approvata dalla rete IMPAACT.
Tipi di analisi: in particolare per i tipi di analisi necessari per raggiungere gli obiettivi della proposta approvata dalla rete IMPAACT.
Meccanismo: i ricercatori possono presentare una richiesta di accesso ai dati utilizzando il modulo IMPAACT "Data Request" all'indirizzo: https://www.impaactnetwork.org/resources/study-proposals.htm. I ricercatori delle proposte approvate dovranno firmare un IMPAACT Data Use Agreement prima di ricevere i dati.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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University of North Carolina, Chapel HillNon ancora reclutamento
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Craig Cohen, MD, MPHNational Institute of Allergy and Infectious Diseases (NIAID); Duke University; Osel, Inc... e altri collaboratoriReclutamento
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Prove cliniche su Youth TI-CBT Intervention Arm
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China Medical University HospitalCompletatoGli sport | Percezione visiva | Movimenti oculari | Prestazioni psicomotorieTaiwan