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

Not Applicable

Not yet recruiting

• Conditions: Non-suicidal Self-injury (NSSI)
• Interventions: Behavioral: a blended version of the Unified Protocol for Adolescents (UP-A); Drug: Standard psychiatric treatment

• Registration Number: NCT07110181
• Lead Sponsor: Jian-Jun Ou

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-31
• Study First Submitted QC: 2025-07-31
• Last Update Submitted: 2025-07-31
• Study First Posted: 2025-08-07
• Last Update Posted: 2025-08-07
• Study Start: 2025-08-15
• Primary Completion: 2026-03-20
• Study Completion: 2026-06-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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, 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UP-A + Treatment as Usual	a blended version of the Unified Protocol for Adolescents (UP-A)	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.
UP-A + Treatment as Usual	Standard psychiatric treatment	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.
Treatment as Usual	Standard psychiatric treatment	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.

Primary Outcome Measures

Name	Time	Method
Non-suicidal self-injury behavior	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 Outcome Measures

Name	Time	Method
Depression	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.
Anxiety	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.

Trial Locations

Locations (1)

The Second Xiangya Hospital; 🇨🇳 Changsha, Hunan, China