NSSINCT04094623
The Muti-centered Investigation，Pathogenesis and Intervention Study of Non-suicidal Self-injury Behavior in China
A study testing Dialectical behavior therapy and Social support group therapy in people with NSSI, run by Nanjing Medical University at 1 site in China.
Trial summary
Non-suicidal self-injury (NSSINSSINSSI) refers to a series of direct and consequently repeated injuries to one's body without suicidal intent. At present, it has become an important issue of mental disorders. Read more about this study
- Who is it for?
- Ages 10 to 40 years
- Conditions the study is for
- NSSI
- What is being tested?
- Dialectical behavior therapy and Social support group therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2019to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 10-40 years old;
- Voluntary participation, signing informed consent and obtaining the consent of family members of patients under 18 years old;
Who cannot join
- history and family of neurological or psychiatric disorders;
- history of psychiatric disorders and family history;
- severe somatic diseases;
- taking psychotropic drugs within three months;
- pregnancy and lactation
Trial locations and contacts
1 site in 1 country.
About this study
Non-suicidal self-injury (NSSINSSINSSI) refers to a series of direct and consequently repeated injuries to one's body without suicidal intent. At present, it has become an important issue of mental disorders. This study is expected to complete a multi-center epidemiological survey of non-suicidal self-injury in China, and to study its pathogenesis and intervention methods.
Read the detailed description
(1) NSSI NSSI epidemiological survey. For example, epidemiological investigation. For example, in the period of 2020.1.1-2020.6.30 half a year, the psychiatric departments of fourteen hospitals of different regions, regions and nature (psychiatric specialist hospitals/general hospitals), hospitals of different types in Jiangsu Province, and hospitals of different types in Jiangsu Province were selected by stratification. In outpatient and inpatient departments, a certain proportion of young people were selected from outpatients and inpatients. Guided by the recommended diagnostic criteria of DSM-5 and guided by semi-structured interviews, the patients with NSSI behavior were screened out by semi-structured interviews. The incidence, comorbidity, incidence, comorbidity and basic psychosocial factors were investigated.(2) Exploring the pathogenesis of NSSI. Exploration of pathogenesis. A case-control study was designed on the basis of flow survey. The NSSI NSSI group and the normal control group were set up. The data of symptomatology, genetic factors of social factors of psychological cognitive function and brain imaging were collected. The data of brain imaging, brain imaging and other data were collected, and the data of social-psychological-biological data collection and mechanism exploration were carried out.(3) Clinical intervention study of NSSI. NSSI patients were randomly divided into structured DBT group intervention group (DBT-ST) and support group discussion group (SGT). The experimental group was given structured DBT group therapy intervention, while the control group was given the same frequency of support group discussion. To explore the therapeutic effect and mechanism of structured DBT group therapy intervention on NSSI behavior. In order to provide a scientific and effective treatment for NSSI behavior.
- Conditions
- NSSI
- Being tested
- Dialectical behavior therapy, Social support group therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialectical behavior therapyOther
15 patients in a group are treated by 2 psychotherapist by DBT including mindfulness skills, distress tolerance skills, emotional regulation skills and interpersonal effectiveness skills.
Social support group therapyOther
15 patients in a group are treated by 2 psychotherapist by SSGT.(Giving support to each other.)
| Study group | Role | What they receive |
|---|---|---|
| NSSI-DBT | Experimental | Dialectical behavior therapy, 2 hours every week for 13 weeks. Receives: Other: Dialectical behavior therapy |
| NSSI-SSGT | Active comparator | Social support group therapy, 2 hours every week for 13 weeks. Receives: Other: Social support group therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-made Behavior Report Scale
Self reported non-suicidal self-injury behaviors over the past 2 weeks. Each item is scored 0-3(0=never; 3=every day), yielding a total between 0 and 6, also need choose locations of injury(such as hand, arm and so on. )
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start10 Sep 2019
- Primary completion31 Jan 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for NSSIStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun Wang, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094623
- Sponsor's protocol ID
- 2019-KY043-01
- Status last verified
- Apr 2020
- First submitted
- 4 Sep 2019
- Last updated
- 27 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lei M, Wu S, Hang Y, Liang M, Zhang P, Yang K, Long J, Wang C. Insular spontaneous activity changes after dialectical behavior therapy skills training for depressed patients with non-suicidal self-injury: a randomized controlled trial. BMC Psychiatry. 2026 Jun 4. doi: 10.1186/s12888-026-08254-z. Online ahead of print.
PubMed 42243789Lang AN, Zhong Y, Lei W, Xiao Y, Hang Y, Xie Y, Lv Z, Zhang Y, Liu X, Liang M, Zhang C, Zhang P, Yang H, Wu Y, Wang Q, Yang K, Long J, Liu Y, Wang S, Tang Y, Lei M, Zhang D, Ouyang L, Zhang L, Wang C. Neural mechanism of non-adaptive cognitive emotion regulation in patients with non-suicidal self-injury. Compr Psychiatry. 2024 Aug;133:152487. doi: 10.1016/j.comppsych.2024.152487. Epub 2024 May 1.
PubMed 38714144
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Muti-centered Investigation，Pathogenesis and Intervention Study of Non-suicidal Self-injury Behavior in China
- ClinicalTrials.gov ID
- NCT04094623
- Acronym / sponsor ID
- 2019-KY043-01
- Conditions
- NSSI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 19 Sep 2019 (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.
Non-suicidal self-injury (NSSINSSINSSI) refers to a series of direct and consequently repeated injuries to one's body without suicidal intent. At present, it has become an important issue of mental disorders. This study is expected to complete a multi-center epidemiological survey of non-suicidal self-injury in China, and to study its pathogenesis and intervention methods.
Detailed description
(1) NSSI NSSI epidemiological survey. For example, epidemiological investigation. For example, in the period of 2020.1.1-2020.6.30 half a year, the psychiatric departments of fourteen hospitals of different regions, regions and nature (psychiatric specialist hospitals/general hospitals), hospitals of different types in Jiangsu Province, and hospitals of different types in Jiangsu Province were selected by stratification. In outpatient and inpatient departments, a certain proportion of young people were selected from outpatients and inpatients. Guided by the recommended diagnostic criteria of DSM-5 and guided by semi-structured interviews, the patients with NSSI behavior were screened out by semi-structured interviews. The incidence, comorbidity, incidence, comorbidity and basic psychosocial factors were investigated.(2) Exploring the pathogenesis of NSSI. Exploration of pathogenesis. A case-control study was designed on the basis of flow survey. The NSSI NSSI group and the normal control group were set up. The data of symptomatology, genetic factors of social factors of psychological cognitive function and brain imaging were collected. The data of brain imaging, brain imaging and other data were collected, and the data of social-psychological-biological data collection and mechanism exploration were carried out.(3) Clinical intervention study of NSSI. NSSI patients were randomly divided into structured DBT group intervention group (DBT-ST) and support group discussion group (SGT). The experimental group was given structured DBT group therapy intervention, while the control group was given the same frequency of support group discussion. To explore the therapeutic effect and mechanism of structured DBT group therapy intervention on NSSI behavior. In order to provide a scientific and effective treatment for NSSI behavior.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NSSI-DBT | Experimental | Other: Dialectical behavior therapyDialectical behavior therapy, 2 hours every week for 13 weeks. |
| NSSI-SSGT | Active comparator | Other: Social support group therapySocial support group therapy, 2 hours every week for 13 weeks. |
Who may qualify
- Ages
- 10 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 10-40 years old;
- Voluntary participation, signing informed consent and obtaining the consent of family members of patients under 18 years old;
Key exclusion criteria (5 listed)
- history and family of neurological or psychiatric disorders;
- history of psychiatric disorders and family history;
- severe somatic diseases;
- taking psychotropic drugs within three months;
- pregnancy and lactation
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 |
|---|---|---|
| Dialectical behavior therapy15 patients in a group are treated by 2 psychotherapist by DBT including mindfulness skills, distress tolerance skills, emotional regulation skills and interpersonal effectiveness skills. | Other | NSSI-DBT |
| Social support group therapy15 patients in a group are treated by 2 psychotherapist by SSGT.(Giving support to each other.) | Other | NSSI-SSGT |
Primary outcome
Self-made Behavior Report Scale
Time frame: 2 weeks
Self reported non-suicidal self-injury behaviors over the past 2 weeks. Each item is scored 0-3(0=never; 3=every day), yielding a total between 0 and 6, also need choose locations of injury(such as hand, arm and so on. )
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2020.
- Derived from this study: PubMed 42243789Lei M, Wu S, Hang Y, Liang M, Zhang P, Yang K, Long J, Wang C. Insular spontaneous activity changes after dialectical behavior therapy skills training for depressed patients with non-suicidal self-injury: a randomized controlled trial. BMC Psychiatry. 2026 Jun 4. doi: 10.1186/s12888-026-08254-z. Online ahead of print.
- Derived from this study: PubMed 38714144Lang AN, Zhong Y, Lei W, Xiao Y, Hang Y, Xie Y, Lv Z, Zhang Y, Liu X, Liang M, Zhang C, Zhang P, Yang H, Wu Y, Wang Q, Yang K, Long J, Liu Y, Wang S, Tang Y, Lei M, Zhang D, Ouyang L, Zhang L, Wang C. Neural mechanism of non-adaptive cognitive emotion regulation in patients with non-suicidal self-injury. Compr Psychiatry. 2024 Aug;133:152487. doi: 10.1016/j.comppsych.2024.152487. Epub 2024 May 1.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialectical behavior therapy and Social support group therapy in people with NSSI, run by Nanjing Medical University 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 27 Apr 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-made Behavior Report Scale (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04094623, which also lists 2 linked publications.
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 27 Apr 2020.