Non-suicidal Self-injury (NSSI)NCT07110181
Blended Unified Protocol for Chinese Adolescents With Non-Suicidal Self-Injury: A Randomized Controlled Trial
A study testing a blended version of the Unified Protocol for Adolescents (UP-A) and Standard psychiatric treatment in people with Non-suicidal Self-injury (NSSI), run by Jian-Jun Ou at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Non-suicidal Self-injury (NSSI)
- What is being tested?
- a blended version of the Unified Protocol for Adolescents (UP-A) and Standard psychiatric treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2025to 20 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Xiangya Hospital
Changsha, Hunan, 410005
Jianjun Ou, PhD, +86 17775861486, oujianjun@csu.edu.cn
About this study
Official title: A Randomized Controlled Trial Evaluating the Efficacy of a Blended Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Chinese Adolescents With Non-Suicidal Self-Injury
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)
- Being tested
- a blended version of the Unified Protocol for Adolescents (UP-A), Standard psychiatric treatment
- Keywords
- non-suicidal self-injury, adolescent
- Medical subject headings
- Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a blended version of the Unified Protocol for Adolescents (UP-A)Behavioural
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 treatmentDrug
Participants in the control group will receive treatment as usual, including pharmacotherapy and routine clinical follow-up, as determined by their treating psychiatrists.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Standard psychiatric treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 months post-baseline (measured at baseline, 1, 2, and 3 months)
Secondary outcomes (2)
Depression
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.
Measured: Up to 3 months post-baseline (measured at baseline, 1, 2, and 3 months)
Anxiety
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.
Measured: Up to 3 months post-baseline (measured at baseline, 1, 2, and 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start15 Aug 2025 (estimated)
- Primary completion20 Mar 2026 (estimated)
- Study completion20 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-suicidal Self-injury (NSSI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jian-Jun Ou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jian-Jun Ou, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07110181
- Sponsor's protocol ID
- E2024193
- Status last verified
- Jul 2025
- First submitted
- 31 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluating the Efficacy of a Blended Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Chinese Adolescents With Non-Suicidal Self-Injury
- ClinicalTrials.gov ID
- NCT07110181
- Acronym / sponsor ID
- E2024193
- Conditions
- Non-suicidal Self-injury (NSSI)
- Keywords
- non-suicidal self-injury, adolescent
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jian-Jun OuUniversity, hospital or other
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 20 Mar 2026 (estimated)
- Study completion
- 20 Jun 2026 (estimated)
- First posted
- 7 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UP-A + Treatment as Usual | Experimental | Behavioral: a blended version of the Unified Protocol for Adolescents (UP-A), Drug: Standard psychiatric treatmentParticipants 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 | Active comparator | Drug: Standard psychiatric treatmentParticipants 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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | UP-A + Treatment as Usual |
| Standard psychiatric treatmentParticipants in the control group will receive treatment as usual, including pharmacotherapy and routine clinical follow-up, as determined by their treating psychiatrists. | Drug | Treatment as Usual, UP-A + Treatment as Usual |
Primary outcome
Non-suicidal self-injury behavior
Time frame: 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.
2 secondary outcomes
Depression
Time frame: Up to 3 months post-baseline (measured at baseline, 1, 2, and 3 months)
Anxiety
Time frame: Up to 3 months post-baseline (measured at baseline, 1, 2, and 3 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Non-suicidal Self-injury (NSSI)
Recruiting
Neurobiological Markers of Non-suicidal Self-injury and Treatment Mechanisms of Adolescent Self-injury Intervention Skills Training
Non-suicidal Self-injury (NSSI), Adolescent
Recruiting
Efficacy of Triple-daily 15mA tACS on Adolescent NSSI
Non-suicidal Self-injury (NSSI)
RecruitingObservational study
Evaluation of National Highly Specialized Care for Children and Adolescents With Severe Self-Harm or Eating Disorders
Self-harm Behavior, Eating Disorders
RecruitingObservational study
Evaluation of National Highly Specialized Care for Adults With Treatment-Resistant Self-Harm and Eating Disorders: Substudy 1
Self-harm Behavior, Eating Disorders
Not yet recruiting
Acceptance and Commitment Therapy-Based Chatbot for Non-suicidal Self-Injury in Adolescents
Non-suicidal Self-injury (NSSI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a blended version of the Unified Protocol for Adolescents (UP-A) and Standard psychiatric treatment in people with Non-suicidal Self-injury (NSSI), run by Jian-Jun Ou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianjun Ou, PhD (+8617775861486, oujianjun@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-suicidal self-injury behavior (time frame: Up to 3 months post-baseline (measured at baseline, 1, 2, and 3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.