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Набор скоро начнётся NCT06928935

Digital Dialectical Behavioural Therapy (d-DBT) for Youth at Clinical High Risk (CHR) for Psychosis

Без фазы С лечением Clinical High Risk for Psychosis (CHR)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: d-DBT.
Кому может быть актуально
Состояния в реестре: Clinical High Risk for Psychosis (CHR). Базовые параметры: 16 лет — 29 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Digital Dialectical Behavioural Therapy (d-DBT) for Youth at Clinical High Risk (CHR) for Psychosis: An Exploratory Multi-Methods Study

Обзор

This study examines the feasibility and acceptability of a digital dialectical behavior therapy (d-DBT) intervention for youth at clinical high risk (CHR) for psychosis. The study aims to assess the acceptability of the intervention to the CHR population, the feasibility of conducting a larger-scale clinical efficacy trial and the potential benefits in improving emotional regulation, reducing psychiatric symptoms, and enhancing overall functioning. Participants will be randomized to receive either the d-DBT intervention or treatment as usual over eight weeks.

Подробное описание

This study evaluates the feasibility, acceptability, and preliminary efficacy of digital Dialectical Behavior Therapy (d-DBT) for youth at Clinical High Risk (CHR) for psychosis. Given the limited availability of evidence-based digital interventions tailored to this group, this trial explores whether a digital DBT approach can address emotion dysregulation, mood symptoms, and functional impairments, which are common in CHR populations and may contribute to distress and progression of disease.

Participants will be randomized to receive either d-DBT or treatment-as-usual (TAU). The intervention is designed to be self-directed, incorporating, interactive exercises, and skill-building modules targeting emotional regulation, distress tolerance, mindfulness, and substance use. Primary outcomes include measuring feasibility, acceptability, and usability. Secondary measures will evaluate preliminary clinical outcomes related to psychiatric symptoms, substance use, and functioning. Results will inform future adaptations, larger trials, and clinical applications.

Вмешательства

  • Поведенческое d-DBT
    d-DBT is an 8-week self-led online intervention that teaches mindfulness, emotional regulation, distress tolerance, and interpersonal effectiveness skills. Participants receive weekly digital navigator check-ins.

Первичные конечные точки

  • Recruitment [Срок оценки: 8 weeks]
  • Retention [Срок оценки: 8 weeks]
  • Adherence [Срок оценки: 8 weeks]
  • Client Satisfaction Questionnaire [Срок оценки: 8 weeks]
  • System Usability Scale [Срок оценки: 8 weeks]
Вторичные конечные точки (12)
  • Structured Interview for Psychosis-risk Syndromes (SIPS) [Срок оценки: Baseline and 8 weeks]
  • PRIME-Revised (PRIME-R) [Срок оценки: Baseline and 8 weeks]
  • Borderline Symptom List (BSL-23) [Срок оценки: Baseline and 8 weeks]
  • Brief Difficulties in Emotion Regulation Scale (DERS-16) [Срок оценки: Baseline and 8 weeks]
  • State-Trait Anxiety Inventory (STAI) [Срок оценки: Baseline and 8 weeks]
  • Calgary Depression Scale for Schizophrenia (CDSS) [Срок оценки: Baseline and 8 weeks]
  • Global Functioning: Social and Role Scales [Срок оценки: Baseline and 8 weeks]
  • Connor-Davidson Resilience Scale (CD-RISC) [Срок оценки: Baseline and 8 weeks]
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [Срок оценки: Baseline and 8 weeks]
  • MATRICS Consensus Cognitive Battery (MCCB) [Срок оценки: Baseline and 8 weeks]
  • Timeline Follow Back (TLFB) [Срок оценки: Baseline and 8 weeks]
  • Cannabis Use Disorders Identification Test-Revised (CUDIT-R) [Срок оценки: Baseline and 8 weeks]

Критерии участия

Критерии включения

  • Be 16-29 years old.
  • Being competent and willing to consent to study participation.
  • Meets CHR criteria for a psychosis risk syndrome based on the Structured Interview for Psychosis Risk Syndromes (SIPS) within the past 3 years.

Критерии исключения

  • Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of psychotic disorder (e.g., schizophrenia spectrum disorder, mood disorder with psychotic features)
  • Diagnosis of intellectual disability
  • Severe developmental disorder
  • Acute suicidality requiring immediate life-saving intervention (i.e., inpatient psychiatric care).
  • Receiving any additional psychotherapy interventions or structured digital mental health support during the study period.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Канада · 1 центр
  • Centre for Addiction and Mental Health — Toronto

Публикации

  • Lawlor C, Vitoratou S, Hepworth C, Jolley S. Self-reported emotion regulation difficulties in psychosis: Psychometric properties of the Difficulties in Emotion Regulation Scale (DERS-16). J Clin Psychol. 2021 Oct;77(10):2323-2340. doi: 10.1002/jclp.23164. Epub 2021 May 10. PMID 33971018
  • Adamson SJ, Kay-Lambkin FJ, Baker AL, Lewin TJ, Thornton L, Kelly BJ, Sellman JD. An improved brief measure of cannabis misuse: the Cannabis Use Disorders Identification Test-Revised (CUDIT-R). Drug Alcohol Depend. 2010 Jul 1;110(1-2):137-43. doi: 10.1016/j.drugalcdep.2010.02.017. Epub 2010 Mar 26. PMID 20347232
  • Robinson SM, Sobell LC, Sobell MB, Leo GI. Reliability of the Timeline Followback for cocaine, cannabis, and cigarette use. Psychol Addict Behav. 2014 Mar;28(1):154-62. doi: 10.1037/a0030992. Epub 2012 Dec 31. PMID 23276315
  • Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin GA, Greenhill L, Shen S, Mann JJ. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011 Dec;168(12):1266-77. doi: 10.1176/appi.ajp.2011.10111704. PMID 22193671
  • Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113. PMID 12964174
  • Miller TJ, McGlashan TH, Rosen JL, Cadenhead K, Cannon T, Ventura J, McFarlane W, Perkins DO, Pearlson GD, Woods SW. Prodromal assessment with the structured interview for prodromal syndromes and the scale of prodromal symptoms: predictive validity, interrater reliability, and training to reliability. Schizophr Bull. 2003;29(4):703-15. doi: 10.1093/oxfordjournals.schbul.a007040. PMID 14989408
  • Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. doi: 10.1016/0149-7189(82)90074-x. PMID 10259963
  • Neacsiu AD, Eberle JW, Kramer R, Wiesmann T, Linehan MM. Dialectical behavior therapy skills for transdiagnostic emotion dysregulation: a pilot randomized controlled trial. Behav Res Ther. 2014 Aug;59:40-51. doi: 10.1016/j.brat.2014.05.005. Epub 2014 May 27. PMID 24974307

Идентификаторы

NCT: NCT06928935 · 2025/007

Первоисточники (государственные реестры)

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