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NCT Number: NCT06858540

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

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.

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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Xiangya Hospital

Changsha, Hunan, 410005, China

Location status: Recruiting

Location contact

Jianjun Ou, Professor

CONTACT

[email protected]

+86 17775861486

About this study

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.

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, 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.

Treatment and study plan

Unified protocol for transdiagnostic treatment of emotional disorders in adolescents

Behavioral

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.

Primary outcomes

  1. Adherence

    Time frame: Immediately after the intervention

    Adherence to the intervention will be measured by the number of sessions attended and the number of participants who complete at least 70% of the sessions, the timing of these sessions (within the designated week or not), the number of interactive exercises completed in each session, and the completion of home assignment tasks.

  2. Dropout rates

    Time frame: Immediately after the intervention

    Dropout rates are defined as the number of participants who dropped out from the intervention before completing it.

  3. The Feasibility and Acceptability Questionnaire (FAQ)

    Time frame: Immediately after the intervention

    The FAQ will be used to evaluate the feasibility and acceptability of the intervention. The FAQ consists of three subscales, each containing six items: (1) experience using the online platform, (2) satisfaction with the program, (3) therapeutic alliance. The higher scores indicate greater feasibility and acceptability.

  4. Participants' perspectives on the intervention

    Time frame: Immediately after the intervention

    Participants' perspectives on the intervention will be assessed through semi-structured interviews, exploring the factors that facilitate or hinder their adherence to and completion of the program.

Secondary outcomes

  1. Non-suicidal self-injury

    Time frame: baseline, immediately after the intervention, and 1-month after the intervention

    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.

  2. Emotion dysregulation

    Time frame: baseline, immediately after the intervention, and 1-month after the intervention

    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.

  3. Emotion regulation strategies

    Time frame: baseline, immediately after the intervention, and 1-month after the intervention

    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.

  4. Depression

    Time frame: baseline, immediately after the intervention, and 1-month after the intervention

    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.

  5. Anxiety

    Time frame: baseline, immediately after the intervention, and 1-month after the intervention

    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. Basic psychological need satisfaction and frustration

    Time frame: baseline, immediately after the intervention, and 1-month after the intervention

    The Basic Psychological Need Satisfaction and Frustration Scale (BPNSF) was developed by Chen in 2015. The scale consists of two subscales: basic psychological need satisfaction and basic psychological frustration. The Basic Psychological Need Satisfaction subscale includes three dimensions-autonomy satisfaction, competence satisfaction, and relatedness satisfaction-comprising 12 items in total. The Basic Psychological Need Frustration subscale includes three dimensions-autonomy frustration, competence frustration, and relatedness frustration-also comprising 12 items. Participants are asked to rate each item on a 5-point Likert scale (1 = Strongly Disagree; 5 = Strongly Agree).

  2. Neuroticism

    Time frame: baseline, immediately after the intervention, and 1-month after the intervention

    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.

  3. Distress tolerance

    Time frame: baseline, immediately after the intervention, and 1-month after the intervention

    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, Doctor

CONTACT

[email protected]

+8617775861486

Sponsors and collaborators

Lead sponsor

Jian-Jun Ou

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 5, 2025
Registry last updated
May 4, 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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