Evaluation of the Efficacy of Non-drug Therapy (SMS Intervention) for Adolescents With NSSI

NCT ID: NCT04481425

Last Updated: 2022-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-23
• Study Completion Date: 2022-01-30

Brief Summary

In this proposed study, Text messages are used to intervene in the NSSI behavior of adolescents, and the efficacy of this intervention method is evaluated, as well as the internal mechanism of adolescents' NSSI behavior is discussed.

Detailed Description

In this proposed study, the investigators will evaluate the effect of text message intervention on Nonsuicidal self-injury behavior in adolescents. The study will recruit 110 adolescents with Nonsuicidal self-injury behavior in outpatient and ward, then all the participants will be randomized to the intervention group (55 cases) or the control group 55 cases) for an 8-week clinic trial. Clinical efficacy and safety assessment will be done at baseline, the fourth week, and the eighth week. The specific aims are to evaluate the effect of text message intervention on NSSI in adolescents are on 1) Tendency and frequency of Nonsuicidal self-injury behavior; 2) Level of negative emotion such as depression, anxiety, and hopelessness 3) The use of emotion regulation strategies and coping styles. A semi-structured quantitative interview will be conducted among adolescents from the SMS group to get the attitude and experiences feedback about the text message.

Conditions

Non-suicidal Self-injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

intervention group

Text messages will be sent to the subjects through the investigator, including giving popularization of psychiatric knowledge, coping skills, emotional regulation strategies, and brief care. Two or three times a week for two months.

Group Type: OTHER

SMS intervention

Intervention Type: OTHER

SMS intervention

control group

Subjects both collected in the outpatient department and the ward were randomly divided into the control group and regularly followed up.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

SMS intervention

SMS intervention

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Adolescents aged 10-19 years old.

2. Meet the diagnostic criteria of NSSI behavior recommended by DSM-5.

3. The adolescents who have mobile phone, and have the ability to send or receive text messages.

4. Adolescents and guardians agreed to participate and signed the informed consent form

Exclusion Criteria

1. Adolescents with severe somatic diseases who cannot complete the study.

2. Adolescents with cognitive impairment, neurodevelopmental disorder, mental retardation, visual impairment who cannot complete the study.

3. The adolescents who do not have a mobile phone.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central South University

OTHER

Sponsor Role: lead

Responsible Party

Jian-Jun Ou

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jianjun Ou, doctor

Role: STUDY_CHAIR

Central South University

Runsen Chen, doctor

Role: STUDY_DIRECTOR

Central South University

Locations

Department of Psychiatry, Xiangya Second Hospital, Central South University

Changsha, Hunan, China

Countries

China

Other Identifiers

MD20200309

Identifier Type: -

Identifier Source: org_study_id