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

Last updated: May 2, 2025
Sponsor: Jian-Jun Ou
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Unified protocol for transdiagnostic treatment of emotional disorders in adolescents

Clinical Study ID

NCT06858540
E2024203
  • Ages 12-17
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Aged between 12 and 17 years;

  2. 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;

  3. Minimum education level of primary school or above;

  4. Participant and guardian fully understand the research content and agree toparticipate, with signed informed consent provided.

Exclusion

Exclusion Criteria:

  1. Suicide attempts in the past month or a score of ≥17 on the MINI NationalNeuropsychiatric Interview for Children (MINI KID 5.0), indicating a high risk ofsuicide;

  2. Diagnosis of a psychotic disorder, manic or hypomanic episode, autism spectrumdisorder, or other serious neurodevelopmental disorders according to the DSM-5;

  3. Presence of severe physical illness or other medical conditions that may affect thecompletion of treatment and evaluation;

  4. Currently receiving other professional psychotherapy or participating in anotherNSSI intervention study;

  5. Received 5 or more sessions of cognitive behavioral therapy (CBT) in the past 5years;

  6. Having received electroconvulsive therapy (ECT) within the past 6 months.

Study Design

Total Participants: 12
Treatment Group(s): 1
Primary Treatment: Unified protocol for transdiagnostic treatment of emotional disorders in adolescents
Phase:
Study Start date:
April 29, 2025
Estimated Completion Date:
October 30, 2025

Study Description

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.

Connect with a study center

  • The Second Xiangya Hospital

    Changsha, Hunan 410005
    China

    Active - Recruiting

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