Blended Unified Protocol in Chinese Adolescents With Non-Suicidal Self-Injury

Официальное название

A Blended Version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Chinese Adolescents With Non-suicidal Self-injury: A Pilot Study

Обзор

This study utilizes the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) to address non-suicidal self-injury 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. The study will assess the feasibility, acceptability, and preliminary efficacy of this intervention through a single-arm design, which includes pretest, posttest, and follow-up assessments.

Подробное описание

The blended UP-A includes 8 weekly modules, 6 of which (Module 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.

Вмешательства

• Поведенческое Unified protocol for transdiagnostic treatment of emotional disorders in adolescents
  The blended UP-A includes 8 weekly modules, 6 of which (Module 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.

Первичные конечные точки

• Adherence [Срок оценки: Immediately after the intervention]
• Dropout rates [Срок оценки: Immediately after the intervention]
• The Feasibility and Acceptability Questionnaire (FAQ) [Срок оценки: Immediately after the intervention]
• Participants' perspectives on the intervention [Срок оценки: Immediately after the intervention]

Вторичные конечные точки (5)

• Non-suicidal self-injury [Срок оценки: baseline, immediately after the intervention, and 1-month after the intervention]
• Emotion dysregulation [Срок оценки: baseline, immediately after the intervention, and 1-month after the intervention]
• Emotion regulation strategies [Срок оценки: baseline, immediately after the intervention, and 1-month after the intervention]
• Depression [Срок оценки: baseline, immediately after the intervention, and 1-month after the intervention]
• Anxiety [Срок оценки: baseline, immediately after the intervention, and 1-month after the intervention]

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, manic or hypomanic episode, 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

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Second Xiangya Hospital — Чанша

Идентификаторы

NCT: NCT06858540 · E2024203

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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