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

NCT ID: NCT07110181

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-15
• Study Completion Date: 2026-06-20

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

UP-A + Treatment as Usual

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.

Group Type: EXPERIMENTAL

a blended version of the Unified Protocol for Adolescents (UP-A)

Intervention Type: 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.

Standard psychiatric treatment

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Standard psychiatric treatment

Intervention Type: DRUG

Participants in the control group will receive treatment as usual, including pharmacotherapy and routine clinical follow-up, as determined by their treating psychiatrists.

Interventions

a blended version of the Unified Protocol for Adolescents (UP-A)

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.

Intervention Type: BEHAVIORAL

Standard psychiatric treatment

Participants in the control group will receive treatment as usual, including pharmacotherapy and routine clinical follow-up, as determined by their treating psychiatrists.

Intervention Type: DRUG

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, 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

professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

The Second Xiangya Hospital

Changsha, Hunan, China

Countries

China

Central Contacts

Jianjun Ou, PhD

Role: CONTACT

oujianjun@csu.edu.cn

+8617775861486

Facility Contacts

Jianjun Ou, PhD

Role: primary

oujianjun@csu.edu.cn

+86 17775861486

Other Identifiers

E2024193

Identifier Type: -

Identifier Source: org_study_id