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

NCT06858540 | Recruiting

• 1 other identifier: E2024203
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-suicidal Self-injury (NSSI)

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Non-suicidal self-injury

  baseline, immediately after the intervention, and 1-month after the intervention

• Emotion dysregulation

  baseline, immediately after the intervention, and 1-month after the intervention

• Emotion regulation strategies

  baseline, immediately after the intervention, and 1-month after the intervention

• Depression

  baseline, immediately after the intervention, and 1-month after the intervention

• Anxiety

  baseline, immediately after the intervention, and 1-month after the intervention

Other Outcomes (3)

• Basic psychological need satisfaction and frustration

  baseline, immediately after the intervention, and 1-month after the intervention

• Neuroticism

  baseline, immediately after the intervention, and 1-month after the intervention

• Distress tolerance

  baseline, immediately after the intervention, and 1-month after the intervention

Study Arms (1)

Intervention group

EXPERIMENTAL

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

Interventions

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.

Intervention group

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, 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.

Sponsors & Collaborators

• Jian-Jun Ou: lead

Study Sites (1)

The Second Xiangya Hospital

Changsha, Hunan, 410005, China

RECRUITING

MeSH Terms

Conditions

Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Jianjun Ou, Doctor

CONTACT

+8617775861486; oujianjun@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 5, 2025
• Study Start: April 29, 2025
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: May 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)