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Набор скоро начнётся NCT07337473

Evidence-based Digital CBT for Nonsuicidal Self-Injury

Без фазы С лечением Non Suicidal Self Injury Cognitive Behavior Therapy

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: Evidence-based digital cognitive behaviour therapy, Health Education.
Кому может быть актуально
Состояния в реестре: Non Suicidal Self Injury, Cognitive Behavior Therapy. Базовые параметры: 12 лет — 25 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
Список центров уточняется — проверьте первичный протокол.
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

Effect of Evidence-based Digital Cognitive Behavior Therapy for Adolescents With Nonsuicidal Self-Injury Disorder: A Randomized Clinical Trial

Обзор

To evaluate if evidence-based digital cognitive behaviour therapy for adolescents is an efficacious treatment when delivered as an adjunctive treatment to treatment as usual, compared to a control group consisting of treatment as usual.

Вмешательства

  • Поведенческое Evidence-based digital cognitive behaviour therapy
    The Evidence-based digital cognitive behaviour therapy is delivered via an internet platform during the intervention period via the platform.
  • Поведенческое Health Education
    The Health Education therapy is delivered via an internet platform during the intervention period via the platform.

Первичные конечные точки

  • Ottawa Self-injury Inventory（OSI） [Срок оценки: From the date of baseline assessment (enrollment) until the date of 12-month follow-up, assessed at baseline, post-treatment (Day 1 of the week following treatment completion), and 1 month, 6 months, and 12 months after post-treatment.]
Вторичные конечные точки (5)
  • General Anxiety Disorder-7 [Срок оценки: Change from baseline (Day 1 of study enrollment), assessed every 2 weeks during the 6-week treatment period, at post-treatment (Day 1 of the week following treatment completion), and at 1 month, 6 months, and 12 months after post-treatment.]
  • Patient Health Questionnaire-9 [Срок оценки: Change from baseline (Day 1 of study enrollment), assessed every 2 weeks during the 6-week treatment period, at post-treatment (Day 1 of the week following treatment completion), and at 1 month, 6 months, and 12 months after post-treatment.]
  • Beck's Suicide Intent Scale [Срок оценки: Change from baseline (Day 1 of study enrollment), assessed every week during the 6-week treatment period, at post-treatment (Day 1 of the week following treatment completion), and at 1 month, 6 months, and 12 months after post-treatment.]
  • Self-harm behaviour craving visual analog scale [Срок оценки: Change from baseline (Day 1 of study enrollment), assessed every week during the 6-week treatment period, at post-treatment (Day 1 of the week following treatment completion), and at 1 month, 6 months, and 12 months after post-treatment.]
  • Difficulties in Emotion Regulation Scale - 16-item version (DERS) [Срок оценки: Change from baseline (Day 1 of study enrollment), assessed at post-treatment (Day 1 of the week following treatment completion), and at 1 month, 6 months, and 12 months after post-treatment.]

Критерии участия

Критерии включения

  • 5 nonsuicidal self-injury episodes past year
  • 1 nonsuicidal self-injury episodes past month having at least one parent who committed to participate in the program

Критерии исключения

Severe suicidal ideation a diagnosis of psychotic or ongoing (past month) substance dependence the presence of co-occurring psychological disorders that required immediate treatment (i.e., severe anorexia nervosa)

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
Двойное слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Bjureberg J, Ojala O, Hesser H, Habel H, Sahlin H, Gratz KL, Tull MT, Claesdotter Knutsson E, Hedman-Lagerlof E, Ljotsson B, Hellner C. Effect of Internet-Delivered Emotion Regulation Individual Therapy for Adolescents With Nonsuicidal Self-Injury Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jul 3;6(7):e2322069. doi: 10.1001/jamanetworkopen.2023.22069. PMID 37440232
  • Morthorst B, Olsen MH, Jakobsen JC, Lindschou J, Gluud C, Heinrichsen M, Mohl B, Rubaek L, Ojala O, Hellner C, Bjureberg J, Pagsberg AK. Internet based intervention (Emotion Regulation Individual Therapy for Adolescents) as add-on to treatment as usual versus treatment as usual for non-suicidal self-injury in adolescent outpatients: The TEENS randomised feasibility trial. JCPP Adv. 2022 Dec 3;2(4) PMID 37431416
  • Kaess M, Edinger A, Fischer-Waldschmidt G, Parzer P, Brunner R, Resch F. Effectiveness of a brief psychotherapeutic intervention compared with treatment as usual for adolescent nonsuicidal self-injury: a single-centre, randomised controlled trial. Eur Child Adolesc Psychiatry. 2020 Jun;29(6):881-891. doi: 10.1007/s00787-019-01399-1. Epub 2019 Sep 11. PMID 31512050
  • Franklin JC, Fox KR, Franklin CR, Kleiman EM, Ribeiro JD, Jaroszewski AC, Hooley JM, Nock MK. A brief mobile app reduces nonsuicidal and suicidal self-injury: Evidence from three randomized controlled trials. J Consult Clin Psychol. 2016 Jun;84(6):544-57. doi: 10.1037/ccp0000093. Epub 2016 Mar 28. PMID 27018530

Идентификаторы

NCT: NCT07337473 · PekingUSH 20251020

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗