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Not yet recruiting NCT07110181

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

No phase Interventional Non-suicidal Self-injury (NSSI)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: a blended version of the Unified Protocol for Adolescents (UP-A), Standard psychiatric treatment.
Who it may be relevant to
Registry conditions: Non-suicidal Self-injury (NSSI). Basic parameters: 12 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Behavioral 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.
  • Drug 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.

Primary outcome measures

  • Non-suicidal self-injury behavior [Time frame: Up to 3 months post-baseline (measured at baseline, 1, 2, and 3 months)]
Secondary outcome measures (2)
  • Depression [Time frame: Up to 3 months post-baseline (measured at baseline, 1, 2, and 3 months)]
  • Anxiety [Time frame: Up to 3 months post-baseline (measured at baseline, 1, 2, and 3 months)]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The Second Xiangya Hospital — Changsha

Identifiers

NCT: NCT07110181 · E2024193

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗