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NCT Number: NCT07110181

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

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.

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Key information

Conditions

Non-suicidal Self-injury (NSSI) Behavior Behavioral Symptoms Self-Injurious Behavior

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

a blended version of the Unified Protocol for Adolescents (UP-A)

Behavioral

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.

Standard psychiatric treatment

Drug

Participants in the control group will receive treatment as usual, including pharmacotherapy and routine clinical follow-up, as determined by their treating psychiatrists.

Primary outcomes

  1. Non-suicidal self-injury behavior

    Time frame: Up to 3 months post-baseline (measured at baseline, 1, 2, and 3 months)

    The Adolescent Self-Harm Behavior Scale includes 18 items describing forms of self-harm. The scale is divided into two dimensions: frequency and severity of self-harm. Self-harm frequency is scored on a 4-point scale (0-3), with the following categories: 0 times, 1 time, 2-4 times, and more than 5 times. The severity of physical injury is scored on a 5-point scale (0-4), with the following categories: none, mild, moderate, severe, and extremely severe. The product of frequency and injury severity for each item is used as the overall score for NSSI, with higher scores indicating more severe NSSI behavior.

Secondary outcomes

  1. Depression

    Time frame: Up to 3 months post-baseline (measured at baseline, 1, 2, and 3 months)

    The Patient Health Questionnaire-9 (PHQ-9) was used to measure depression levels. This nine-item scale rates each item on a four-point scale from 0 ("not at all") to 3 ("nearly every day"), with total scores ranging from 0 to 27. Higher scores indicate greater depression severity.

  2. Anxiety

    Time frame: Up to 3 months post-baseline (measured at baseline, 1, 2, and 3 months)

    The Generalized Anxiety Disorder-7 (GAD-7) was used to assess anxiety levels of participants. This seven-item scale also employs a four-point scoring system from 0 ("not at all") to 3 ("nearly every day"), with higher scores reflecting greater anxiety severity.

Other outcomes

  1. Neuroticism

    Time frame: Up to 3 months post-baseline (measured at baseline, 1, 2, and 3 months)

    The Neuroticism subscale from the Neuroticism-Extraversion-Openness Five-Factor Inventory was selected to measure neuroticism. The Neuroticism subscale consists of 12 items, rated on a 5-point Likert scale. Higher scores indicate a stronger tendency toward neuroticism in the individual.

  2. Emotion regulation strategies

    Time frame: Up to 3 months post-baseline (measured at baseline, 1, 2, and 3 months)

    The Emotion Regulation Questionnaire (ERQ) is used to measure participants' emotional regulation strategies. It consists of 10 items, divided into two dimensions: cognitive reappraisal and expressive suppression. Each item is rated on a 7-point scale, with higher scores indicating a stronger tendency to use the corresponding emotional regulation strategy.

  3. Emotion dysregulation

    Time frame: Up to 3 months post-baseline (measured at baseline, 1, 2, and 3 months)

    Difficulties in Emotion Regulation Scale (DERS) is used to assess the participants' emotional regulation abilities. It consists of 36 items across 6 dimensions, with higher total scores indicating a higher level of emotional dysregulation. The dimensions include: emotional awareness, emotional acceptance, impulse control, emotional understanding, goal-directed behavior, and strategy use.

  4. Distress tolerance

    Time frame: Up to 3 months post-baseline (measured at baseline, 1, 2, and 3 months)

    The Distress Tolerance Scale (DTS) is a 15-item measure of an individual's perceived ability to withstand negative emotions. Items are answered on a five-point Likert scale ranging from 1 = strongly agree to 5 = strongly disagree. Traditionally, high DTS-global distress intolerance scores reflect a heightened ability to tolerate distress, whereas low total scores represent distress intolerance.

Study contacts

Contact information is provided by the study sponsor or research team.

Jianjun Ou, PhD

CONTACT

[email protected]

+8617775861486

Sponsors and collaborators

Lead sponsor

Jian-Jun Ou

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 7, 2025
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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