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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Non-suicidal Self-injury (NSSI)
• Intervention / Treatment: Behavioral: Unified protocol for transdiagnostic treatment of emotional disorders in adolescents

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jianjun Ou, Doctor; Phone Number: +8617775861486; Email: oujianjun@csu.edu.cn

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410005
      • Recruiting
      • The Second Xiangya Hospital
      • Contact: Jianjun Ou, Professor; Phone Number: +86 17775861486; Email: oujianjun@csu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 to participate, with signed informed consent provided.

Exclusion Criteria:

1. 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;
2. Diagnosis of a psychotic disorder, manic or hypomanic episode, autism spectrum disorder, or other serious neurodevelopmental disorders according to the DSM-5;
3. Presence of severe physical illness or other medical conditions that may affect the completion of treatment and evaluation;
4. Currently receiving other professional psychotherapy or participating in another NSSI intervention study;
5. Received 5 or more sessions of cognitive behavioral therapy (CBT) in the past 5 years;
6. Having received electroconvulsive therapy (ECT) within the past 6 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention group; Participants will receive an 8-week blended version of the Unified Protocol for Adolescents.

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence	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.	Immediately after the intervention
Dropout rates	Dropout rates are defined as the number of participants who dropped out from the intervention before completing it.	Immediately after the intervention
The Feasibility and Acceptability Questionnaire (FAQ)	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.	Immediately after the intervention
Participants' perspectives on 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.	Immediately after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-suicidal self-injury	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.	baseline, immediately after the intervention, and 1-month after the intervention
Emotion dysregulation	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.	baseline, immediately after the intervention, and 1-month after the intervention
Emotion regulation strategies	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.	baseline, immediately after the intervention, and 1-month after the intervention
Depression	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.	baseline, immediately after the intervention, and 1-month after the intervention
Anxiety	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.	baseline, immediately after the intervention, and 1-month after the intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Basic psychological need satisfaction and frustration	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).	baseline, immediately after the intervention, and 1-month after the intervention
Neuroticism	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.	baseline, immediately after the intervention, and 1-month after the intervention
Distress tolerance	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.	baseline, immediately after the intervention, and 1-month after the intervention

Collaborators and Investigators

• Sponsor: Jian-Jun Ou

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2025
• Primary Completion (Estimated): October 30, 2025
• Study Completion (Estimated): October 30, 2025

Study Registration Dates

• First Submitted: February 26, 2025
• First Submitted That Met QC Criteria: February 27, 2025
• First Posted (Actual): March 5, 2025

Study Record Updates

• Last Update Posted (Actual): May 4, 2025
• Last Update Submitted That Met QC Criteria: May 2, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Wounds and Injuries; Self-Injurious Behavior
• Other Study ID Numbers: E2024203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No