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

NCT ID: NCT06858540

Last Updated: 2025-05-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-29
• Study Completion Date: 2025-10-30

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.

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.

Conditions

Non-suicidal Self-injury (NSSI)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

Participants will receive an 8-week blended version of the Unified Protocol for Adolescents.

Group Type: EXPERIMENTAL

Unified protocol for transdiagnostic treatment of emotional disorders in adolescents

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jian-Jun Ou

OTHER

Sponsor Role: lead

Responsible Party

Jian-Jun Ou

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

The Second Xiangya Hospital

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jianjun Ou, Doctor

Role: CONTACT

oujianjun@csu.edu.cn

+8617775861486

Facility Contacts

Jianjun Ou, Professor

Role: primary

oujianjun@csu.edu.cn

+86 17775861486

Other Identifiers

E2024203

Identifier Type: -

Identifier Source: org_study_id