Non-suicidal Self-injury (NSSI)NCT06858540
Blended Unified Protocol in Chinese Adolescents With Non-Suicidal Self-Injury
A study testing Unified protocol for transdiagnostic treatment of emotional disorders in adolescents in people with Non-suicidal Self-injury (NSSI), run by Jian-Jun Ou at 1 site in China.
Trial 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. 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?
- Unified protocol for transdiagnostic treatment of emotional disorders in adolescents
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 29 Apr 2025to 30 Oct 2025
- 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, 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.
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, 1 recruiting
- Recruiting
The Second Xiangya Hospital
Changsha, Hunan, 410005
Jianjun Ou, Professor, +86 17775861486, oujianjun@csu.edu.cn
About this study
Official title: A Blended Version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Chinese Adolescents With Non-suicidal Self-injury: A Pilot Study
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.
Read the 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)
- Being tested
- Unified protocol for transdiagnostic treatment of emotional disorders in adolescents
- 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.
Unified protocol for transdiagnostic treatment of emotional disorders in adolescentsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants will receive an 8-week blended version of the Unified Protocol for Adolescents. Receives: Behavioral: Unified protocol for transdiagnostic treatment of emotional disorders in adolescents |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after the intervention
Dropout rates
Dropout rates are defined as the number of participants who dropped out from the intervention before completing it.
Measured: 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.
Measured: 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.
Measured: Immediately after the intervention
Secondary outcomes (5)
Non-suicidal self-injury
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: baseline, immediately after the intervention, and 1-month after the intervention
Emotion dysregulation
Difficulties in Emotion Regulation Scale (DERS) is used to assess the participants' emotional regulation abilities. It consists of 36 items across 6 dimensions, with higher total scores indicating a higher level of emotional dysregulation. The dimensions include: emotional awareness, emotional acceptance, impulse control, emotional understanding, goal-directed behavior, and strategy use.
Measured: baseline, immediately after the intervention, and 1-month after the intervention
Emotion regulation strategies
The Emotion Regulation Questionnaire (ERQ) is used to measure participants' emotional regulation strategies. It consists of 10 items, divided into two dimensions: cognitive reappraisal and expressive suppression. Each item is rated on a 7-point scale, with higher scores indicating a stronger tendency to use the corresponding emotional regulation strategy.
Measured: baseline, immediately after the intervention, and 1-month after the intervention
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: baseline, immediately after the intervention, and 1-month after the intervention
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: baseline, immediately after the intervention, and 1-month after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start29 Apr 2025
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2025 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT06858540
- Sponsor's protocol ID
- E2024203
- Status last verified
- Feb 2025
- First submitted
- 26 Feb 2025
- Last updated
- 4 May 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 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Blended Version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Chinese Adolescents With Non-suicidal Self-injury: A Pilot Study
- ClinicalTrials.gov ID
- NCT06858540
- Acronym / sponsor ID
- E2024203
- Conditions
- Non-suicidal Self-injury (NSSI)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Jian-Jun OuUniversity, hospital or other
- Study start
- 29 Apr 2025 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 5 Mar 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Unified protocol for transdiagnostic treatment of emotional disorders in adolescentsParticipants will receive an 8-week blended version of the Unified Protocol for Adolescents. |
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, 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;
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 |
|---|---|---|
| Unified protocol for transdiagnostic treatment of emotional disorders in adolescentsThe 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. | Behavioural | Intervention group |
Primary outcome
Adherence
Time frame: Immediately after the intervention
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.
Dropout rates
Time frame: Immediately after the intervention
Dropout rates are defined as the number of participants who dropped out from the intervention before completing it.
The Feasibility and Acceptability Questionnaire (FAQ)
Time frame: Immediately after the intervention
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.
Participants' perspectives on the intervention
Time frame: Immediately after 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.
5 secondary outcomes
Non-suicidal self-injury
Time frame: baseline, immediately after the intervention, and 1-month after the intervention
Emotion dysregulation
Time frame: baseline, immediately after the intervention, and 1-month after the intervention
Emotion regulation strategies
Time frame: baseline, immediately after the intervention, and 1-month after the intervention
Depression
Time frame: baseline, immediately after the intervention, and 1-month after the intervention
Anxiety
Time frame: baseline, immediately after the intervention, and 1-month after the intervention
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 4 May 2025.
- Individual participant dataSharing planned: No
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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 Unified protocol for transdiagnostic treatment of emotional disorders in adolescents 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: looking for participants now, as of the sponsor's last update on 4 May 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, Doctor (+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?
Adherence (time frame: Immediately after the intervention). The study lists 4 primary outcomes in all. 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 4 May 2025.