NCT04094623

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

September 10, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 19, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

April 27, 2020

Status Verified

April 1, 2020

Enrollment Period

2.4 years

First QC Date

September 4, 2019

Last Update Submit

April 23, 2020

Conditions

Outcome Measures

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. )

    2 weeks

Study Arms (2)

NSSI-DBT

EXPERIMENTAL

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

Other: Dialectical behavior therapy

NSSI-SSGT

ACTIVE COMPARATOR

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

Other: Social support group therapy

Interventions

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.

NSSI-DBT

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

NSSI-SSGT

Eligibility Criteria

Age10 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Brain Hospital

Nanjing, Jiangsu, 210029, China

Location

Related Publications (1)

  • Lang 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.

MeSH Terms

Interventions

Dialectical Behavior Therapy

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate chief physician

Study Record Dates

First Submitted

September 4, 2019

First Posted

September 19, 2019

Study Start

September 10, 2019

Primary Completion

January 31, 2022

Study Completion

June 30, 2022

Last Updated

April 27, 2020

Record last verified: 2020-04

Locations