Blended Unified Protocol for Chinese Adolescents With Non-Suicidal Self-Injury: A Randomized Controlled Trial

Официальное название

A Randomized Controlled Trial Evaluating the Efficacy of a Blended Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Chinese Adolescents With Non-Suicidal Self-Injury

Обзор

This study is an open-label, randomized controlled trial evaluating the efficacy of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) in reducing non-suicidal self-injury (NSSI) among Chinese adolescents. This program is an annualized cognitive-behavioral therapy designed for adolescents aged 12-17 years who engage in non-suicidal self-injury behavior. Its primary goal is to reduce the intensity and frequency of distressing emotional experiences by teaching adolescents how to confront and respond to these emotions in more adaptive ways. In turn, this helps reduce self-injury impulses and behaviors. The UP-A is adapted to the Chinese cultural context and delivered as a blended treatment, combining face-to-face and online sessions.

Вмешательства

• Поведенческое a blended version of the Unified Protocol for Adolescents (UP-A)
  The blended UP-A includes 8 weekly modules, 6 of which (Modules 2 - 7)are online self-guided sessions. The online self-guided sessions will last approximately 45 minutes each. Over the course of these 6 weeks, participants will also have 6 therapist-guided online sessions via videoconference, each lasting 30 minutes. Two face-to-face individual sessions are scheduled, one at the beginning of each (Module 1) and one at the end (Module 8), each with an expected duration of 90 minutes.
• Препарат Standard psychiatric treatment
  Participants in the control group will receive treatment as usual, including pharmacotherapy and routine clinical follow-up, as determined by their treating psychiatrists.

Первичные конечные точки

• Non-suicidal self-injury behavior [Срок оценки: Up to 3 months post-baseline (measured at baseline, 1, 2, and 3 months)]

Вторичные конечные точки (2)

• Depression [Срок оценки: Up to 3 months post-baseline (measured at baseline, 1, 2, and 3 months)]
• Anxiety [Срок оценки: Up to 3 months post-baseline (measured at baseline, 1, 2, and 3 months)]

Критерии участия

Критерии включения

• Aged between 12 and 17 years;
• Engaged in non-suicidal self-injury (NSSI) at least 5 times in the past 12 months, with at least 1 episode in the past month;
• Minimum education level of primary school or above;
• Participant and guardian fully understand the research content and agree to participate, with signed informed consent provided.

Критерии исключения

• Suicide attempts in the past month or a score of ≥17 on the MINI National Neuropsychiatric Interview for Children (MINI KID 5.0), indicating a high risk of suicide;
• Diagnosis of a psychotic disorder, autism spectrum disorder, or other serious neurodevelopmental disorders according to the DSM-5;
• Presence of severe physical illness or other medical conditions that may affect the completion of treatment and evaluation;
• Currently receiving other professional psychotherapy or participating in another NSSI intervention study;
• Received 5 or more sessions of cognitive behavioral therapy (CBT) in the past 5 years;
• Having received electroconvulsive therapy (ECT) within the past 6 months.

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

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Second Xiangya Hospital — Чанша

Идентификаторы

NCT: NCT07110181 · E2024193

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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