IA Trial Radar
L'essai clinique NCT07098169 (iTEST R33) pour Schizophrenia Disorders, Trouble schizo-affectif, Trouble psychotique est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
Un essai clinique correspond aux filtres sélectionnés
Vue en carte
Retour à la recherche

Randomized Clinical Trial of iTEST: A Blended Intervention Targeting Introspective Accuracy (iTEST R33) 201 Randomisé

En recrutement
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT07098169 (iTEST R33) est une étude interventionnel pour Schizophrenia Disorders, Trouble schizo-affectif, Trouble psychotique. Son statut actuel est : en recrutement. L'étude a débuté le 1 septembre 2025 et vise à recruter 201 participants. Dirigée par l'Université de Californie à San Diego, l'étude devrait être terminée d'ici le 1 avril 2028. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 23 janvier 2026.
Résumé succinct
The purpose of this study is to evaluate the effectiveness of a psychosocial intervention called iTEST for people with psychotic disorders that targets introspective accuracy, or the ability to accurately gauge ones abilities. iTEST combines daily cognitive training on a mobile device with coaching that addresses recovery goals. In this trial, we will randomize people to one of two interventions conditions, iTEST or ...Afficher plus
Description détaillée
This NIH-supported clinical trial is the second phase of a two-phase program, funded by Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders, R61/R33. The overarching goal of this second R33 phase is to evaluate the replicability of R61 findings in a larger randomized control trial with iTEST, a new blended mobile intervention that is aimed at improving introspective accuracy (IA)...Afficher plus
Titre officiel

Randomized Clinical Trial of iTEST: A Blended Intervention Targeting Introspective Accuracy

Pathologies
Schizophrenia DisordersTrouble schizo-affectifTrouble psychotique
Publications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:
Autres identifiants de l'étude
Numéro NCT
NCT07098169
Date de début (réel)
2025-09-01
Dernière mise à jour publiée
2026-01-23
Date de fin (estimée)
2028-04-01
Inscription (estimée)
201
Type d'étude
Interventionnel
PHASE
N/A
Statut
En recrutement
Mots clés
Digital health
Cognitive training
Schizophrenia
Psychosis
Functional rehabilitation
Objectif principal
Traitement
Méthode d'allocation
Randomisé
Modèle d'intervention
Parallèle
Masquage
Simple aveugle
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentaliTEST
iTEST includes 6 weeks of weekly coaching sessions that last for 60 minutes each delivered by telehealth or in person per the participant's preference, followed by 3 bi-weekly 30 minute booster telephone calls. ITEST also includes daily cognitive tasks that involve task of memory for words or recognizing facial emotions. Participants guess the number correct after each task and are provided feedback on the accuracy o...Afficher plus
iTEST
iTEST is a computerized training intervention delivered on a mobile device that is coupled with individual contacts with a therapist/coach. The mobile components train in improving participant's ability to form accurate judgments about their performance and their rate of functional activities. The intervention involves coaching coupled with automated training that is delivered on a mobile device. The automated traini...Afficher plus
Comparateur actifActive Control
The control condition includes 6 weeks of weekly coaching sessions that last for 60 minutes each delivered by telehealth or in person per the participant's preference, followed by 3 bi-weekly 30 minute booster telephone calls. Participants also complete daily cognitive tasks that involve task of memory for words or recognizing facial emotions. Participants are provided feedback their performance. These tasks occur on...Afficher plus
Contrôle actif
Behavioral: Mobile cognitive tests will be administered to control subjects. Participants will receive feedback regarding their performance but not on the accuracy of their self-ratings. Coaching will also be coupled with mobile cognitive tests and will include goal-setting without specific mention of Introspective Accuracy (IA). in place of content related to IA, participants will receive psychoeducation about the b...Afficher plus
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
Informant-Rated Specific Level of Function (SLOF) Scale
Measure of participant's community functioning rated by an informant. Scale scores range from 43 to 215 with higher scores reflecting better functioning.
Change from baseline to 3 month follow up
Assistant à la participation
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
  1. Voluntary informed consent to participate and capacity to consent as measured by the UCSD Brief Assessment of Capacity to Consent (UBACC)
  2. Age 18 to 65;
  3. DSM-5 diagnosis of schizophrenia or schizoaffective disorder based on a structured diagnostic interview and available medical record review;
  4. ≥ 6th grade reading level on the Wide Range Achievement Test-4 Reading subtest (needed to read instructions on device);
  5. Stable co-treatments (no hospitalizations or medication class changes in 2 months before enrollment). The investigators will determine symptom and medication stability by best-estimate history with information from medical records;
  6. Availability of a clinician (staff member, case manager, other mental health clinician) or close associate (family member, friend) with at least monthly contact who can be their informant
  7. Minimum level of functional impairment based on milestones, excluding participants who are full-time employed and financially responsible for their household.

  1. Greater than moderate disorganization on the Positive and Negative Syndrome Scale (P2-Disorganization item >5)
  2. DSM-5 alcohol or substance dependence in past 3 months based on interview
  3. Level of care required interferes with outpatient therapy (e.g., hospitalized; severe medical illness); 4) Unable to adequately see or manually manipulate a smartphone.
University of California, San Diego logoUniversité de Californie à San Diego
Partie responsable de l'étude
Colin Depp, Investigateur principal, Professor, University of California, San Diego
Contact central de l'étude
Contact: Colin A Depp, Ph.D., 858-822-4251, [email protected]
Contact: Nikki Abaya, MA, (858) 869 0031, [email protected]
3 Centres de l'étude dans 1 pays

California

UC San Diego, San Diego, California, 92093, United States
Colin Depp, PhD, Contact, 858-822-4251, [email protected]
Nikki Abaya, MA, Contact, (858) 869 0031, [email protected]
En recrutement

Florida

University of Miami, Miami, Florida, 33146, United States
Philip Harvey, PhD, Contact, 305-243-6400, [email protected]
En recrutement

Texas

University of Texas at Dallas, Dallas, Texas, 75080, United States
Amy Pinkham, PhD, Contact, 972-883-4462, [email protected]
En recrutement