CClinicalTrials.gg
Status unknownNCT04094623Updated Apr 27, 2020

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

An interventional study of Dialectical behavior therapy and Social support group therapy in NSSI, sponsored by Nanjing Medical University. Status unknown at 1 site in China. Open to participants aged 10 Years to 40 Years. Per ClinicalTrials.gov, last updated 2020-04-27.

Sponsored by Nanjing Medical University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2020), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
10 Years to 40 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • NSSI
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In context

Self-Injurious Behavior

249 studies on the registry are indexed under Self-Injurious Behavior; 92 are open to participants now.

This study's planned enrollment of 100 is above the median of 66 across 212 interventional studies indexed under Self-Injurious Behavior.

Browse Self-Injurious Behavior studies →

Lead sponsor

Nanjing Medical University is the lead sponsor of 169 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    NSSI-DBT

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

    Other: Dialectical behavior therapy

  • Active comparator
    NSSI-SSGT

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

    Other: Social support group therapy

Interventions

  • OtherDialectical 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.

  • OtherSocial support group therapy

    15 patients in a group are treated by 2 psychotherapist by SSGT.(Giving support to each other.)

06

What researchers measure

Primary outcomes

  1. 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. )

    Time frame: 2 weeks

07

Study locations

1 site
  • Nanjing Brain Hospital
    Nanjing, Jiangsu 210029, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04094623
Lead sponsor
Nanjing Medical University
Responsible party
Chun Wang (Associate chief physician, Nanjing Medical University) — Principal investigator
First posted
Sep 19, 2019
Start date
Sep 10, 2019
Primary completion
Jan 31, 2022 (estimated)
Completion
Jun 30, 2022 (estimated)
Last update
Apr 27, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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