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

NCT07110181 | Not Yet Recruiting

• 1 other identifier: E2024193
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-suicidal Self-injury (NSSI)

Keywords

non-suicidal self-injury; adolescent

Outcome Measures

Primary Outcomes (1)

• Non-suicidal self-injury behavior

  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.

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

Secondary Outcomes (2)

• Depression

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

• Anxiety

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

Other Outcomes (4)

• Neuroticism

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

• Emotion regulation strategies

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

• Emotion dysregulation

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

Study Arms (2)

UP-A + Treatment as Usual

EXPERIMENTAL

Participants receive standard psychiatric care (e.g., pharmacotherapy) plus a blended version of the Unified Protocol for Adolescents (UP-A), which includes both face-to-face and online sessions over 8 weeks.

Behavioral: a blended version of the Unified Protocol for Adolescents (UP-A); Drug: Standard psychiatric treatment

Treatment as Usual

ACTIVE COMPARATOR

Participants in the control group will receive standard psychiatric care as provided by their treating clinicians, including pharmacotherapy as appropriate. No additional psychological intervention will be provided during the study period.

Drug: Standard psychiatric treatment

Interventions

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.

UP-A + Treatment as Usual

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.

Treatment as Usual; UP-A + Treatment as Usual

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jian-Jun Ou: lead

Study Sites (1)

The Second Xiangya Hospital

Changsha, Hunan, 410005, China

Location

MeSH Terms

Conditions

Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Jianjun Ou, PhD

CONTACT

+8617775861486; oujianjun@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 7, 2025
• Study Start: August 15, 2025
• Primary Completion: March 20, 2026
• Study Completion (Estimated): June 20, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)