The Muti-centered Investigation，Pathogenesis and Intervention Study of Non-suicidal Self-injury Behavior in China

NSSI Clinical Trial

Official title:

The Muti-centered Investigation，Pathogenesis and Intervention Study of Non-suicidal Self-injury Behavior in China

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04094623
• Other study ID #: 2019-KY043-01
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 10, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: April 2020
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: June 30, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 40 Years

Eligibility

Inclusion Criteria:

1. 10-40 years old;

2. Voluntary participation, signing informed consent and obtaining the consent of family members of patients under 18 years old;

Exclusion Criteria:

1. history and family of neurological or psychiatric disorders;

2. history of psychiatric disorders and family history;

3. severe somatic diseases;

4. taking psychotropic drugs within three months;

5. pregnancy and lactation

Related Conditions & MeSH terms

• NSSI
• Self-Injurious Behavior

Intervention

Other:
• Dialectical behavior therapy
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 therapy
15 patients in a group are treated by 2 psychotherapist by SSGT.(Giving support to each other.)

Locations

Country	Name	City	State
China	Nanjing Brain Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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. )	2 weeks