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

Primary Purpose

NSSI

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Dialectical behavior therapy
Social support group therapy
Sponsored by
Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NSSI

Eligibility Criteria

10 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nanjing Brain Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NSSI-DBT

NSSI-SSGT

Arm Description

Dialectical behavior therapy, 2 hours every week for 13 weeks.

Social support group therapy, 2 hours every week for 13 weeks.

Outcomes

Primary Outcome Measures

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. )

Secondary Outcome Measures

Full Information

First Posted
September 4, 2019
Last Updated
April 23, 2020
Sponsor
Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04094623
Brief Title
The Muti-centered Investigation，Pathogenesis and Intervention Study of Non-suicidal Self-injury Behavior in China
Official Title
The Muti-centered Investigation，Pathogenesis and Intervention Study of Non-suicidal Self-injury Behavior in China
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 10, 2019 (Actual)
Primary Completion Date
January 31, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NSSI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NSSI-DBT
Arm Type
Experimental
Arm Description
Dialectical behavior therapy, 2 hours every week for 13 weeks.
Arm Title
NSSI-SSGT
Arm Type
Active Comparator
Arm Description
Social support group therapy, 2 hours every week for 13 weeks.
Intervention Type
Other
Intervention Name(s)
Dialectical behavior therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Social support group therapy
Intervention Description
15 patients in a group are treated by 2 psychotherapist by SSGT.(Giving support to each other.)
Primary Outcome Measure Information:
Title
Self-made Behavior Report Scale
Description
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. )
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 10-40 years old; Voluntary participation, signing informed consent and obtaining the consent of family members of patients under 18 years old; Exclusion Criteria: 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
Facility Information:
Facility Name
Nanjing Brain Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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