Evaluation of the Efficacy of Non-drug Therapy (SMS Intervention) for Adolescents With NSSI
Primary Purpose
Non-suicidal Self-injury
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
SMS intervention
Sponsored by
About this trial
This is an interventional treatment trial for Non-suicidal Self-injury
Eligibility Criteria
Inclusion Criteria:
- Adolescents aged 10-19 years old.
- Meet the diagnostic criteria of NSSI behavior recommended by DSM-5.
- The adolescents who have mobile phone, and have the ability to send or receive text messages.
- Adolescents and guardians agreed to participate and signed the informed consent form
Exclusion Criteria:
- Adolescents with severe somatic diseases who cannot complete the study.
- Adolescents with cognitive impairment, neurodevelopmental disorder, mental retardation, visual impairment who cannot complete the study.
- The adolescents who do not have a mobile phone.
Sites / Locations
- Department of Psychiatry, Xiangya Second Hospital, Central South University
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
intervention group
control group
Arm Description
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.
Subjects both collected in the outpatient department and the ward were randomly divided into the control group and regularly followed up.
Outcomes
Primary Outcome Measures
The change of NSSI behavior of the participants.
NSSI behavior will be measured by Nonsuicidal self-injury Questionnaire which contains several items designed by investigators. The questionnaire is mainly used to measure the frequency of NSSI among adolescents.
Secondary Outcome Measures
The change of anxiety level.
The Generalized Anxiety Disorder 7-item Scale will be used to measure the change of anxiety. GAD-7 scale consists of 7 items. Each item ranging from 0 to 3, and the total score ranging from 0 to 21. The higher score indicates severe anxiety symptoms.
The change of depression level.
The Patient Health Questionnaire 9-item will be used to measure the change of depression. PHQ-9 scale consists of 9 items. Each item raging from 0 to 3, and the total score ranging from 0 to 27. The higher score indicates severe depression symptoms.
The change of hopelessness.
The Beck Hopelessness Scale will be used to measure the change of hopelessness. BHS scale consists of 20 items. Each item can be answered "yes" or "no" for 1 or 0 points respectively. The total score ranging from 0 to 20. A higher total score indicates a higher degree of hopelessness.
The change of emotion regulation strategies.
The Emotion Regulation Questionnaire will be used to measure the change of emotion regulation styles. ERQ scale consists of 10 items which can be divided into cognitive reappraisal and expression suppression two emotion-regulating strategy subscales. Each item ranging from 1 to 7 points. The higher the score, the more often the respondent used this emotion-regulating strategy.
The change of coping styles.
The Simplified Coping Style Questionnaire will be used to measure the change of coping styles. SCSQ scale consists of 20 items which can be divide into positive coping styles and negative coping styles in two dimensions. Each item raging from 0 to 3, and the total score ranging from 0 to 60. The higher the score, the more likely the respondents are to use this coping style.
The change of life events stress.
The Adolescent Self-Rating Life Events Check-list will be used to measure the frequency and intensity of life events that may trigger a stressful psychological response in adolescents. There are 27 items in the scale, which can be divided into 6 dimensions. The scale scores ranged from 27 to 135. The higher the score means the higher the degree of negative life event stress. The scale is widely used in China and has good reliability and validity.
Full Information
NCT ID
NCT04481425
First Posted
July 13, 2020
Last Updated
November 17, 2022
Sponsor
Central South University
1. Study Identification
Unique Protocol Identification Number
NCT04481425
Brief Title
Evaluation of the Efficacy of Non-drug Therapy (SMS Intervention) for Adolescents With NSSI
Official Title
Evaluation of the Efficacy of Non-drug Therapy (SMS Intervention) for Adolescents With NSSI
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
December 23, 2020 (Actual)
Primary Completion Date
January 30, 2022 (Actual)
Study Completion Date
January 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central South University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-suicidal Self-injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Other
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
Subjects both collected in the outpatient department and the ward were randomly divided into the control group and regularly followed up.
Intervention Type
Other
Intervention Name(s)
SMS intervention
Intervention Description
SMS intervention
Primary Outcome Measure Information:
Title
The change of NSSI behavior of the participants.
Description
NSSI behavior will be measured by Nonsuicidal self-injury Questionnaire which contains several items designed by investigators. The questionnaire is mainly used to measure the frequency of NSSI among adolescents.
Time Frame
At baseline, the fourth week, the eighth week
Secondary Outcome Measure Information:
Title
The change of anxiety level.
Description
The Generalized Anxiety Disorder 7-item Scale will be used to measure the change of anxiety. GAD-7 scale consists of 7 items. Each item ranging from 0 to 3, and the total score ranging from 0 to 21. The higher score indicates severe anxiety symptoms.
Time Frame
At baseline, the fourth week, the eighth week
Title
The change of depression level.
Description
The Patient Health Questionnaire 9-item will be used to measure the change of depression. PHQ-9 scale consists of 9 items. Each item raging from 0 to 3, and the total score ranging from 0 to 27. The higher score indicates severe depression symptoms.
Time Frame
At baseline, the fourth week, the eighth week
Title
The change of hopelessness.
Description
The Beck Hopelessness Scale will be used to measure the change of hopelessness. BHS scale consists of 20 items. Each item can be answered "yes" or "no" for 1 or 0 points respectively. The total score ranging from 0 to 20. A higher total score indicates a higher degree of hopelessness.
Time Frame
At baseline, the fourth week, the eighth week
Title
The change of emotion regulation strategies.
Description
The Emotion Regulation Questionnaire will be used to measure the change of emotion regulation styles. ERQ scale consists of 10 items which can be divided into cognitive reappraisal and expression suppression two emotion-regulating strategy subscales. Each item ranging from 1 to 7 points. The higher the score, the more often the respondent used this emotion-regulating strategy.
Time Frame
At baseline, the fourth week, the eighth week
Title
The change of coping styles.
Description
The Simplified Coping Style Questionnaire will be used to measure the change of coping styles. SCSQ scale consists of 20 items which can be divide into positive coping styles and negative coping styles in two dimensions. Each item raging from 0 to 3, and the total score ranging from 0 to 60. The higher the score, the more likely the respondents are to use this coping style.
Time Frame
At baseline, the fourth week, the eighth week
Title
The change of life events stress.
Description
The Adolescent Self-Rating Life Events Check-list will be used to measure the frequency and intensity of life events that may trigger a stressful psychological response in adolescents. There are 27 items in the scale, which can be divided into 6 dimensions. The scale scores ranged from 27 to 135. The higher the score means the higher the degree of negative life event stress. The scale is widely used in China and has good reliability and validity.
Time Frame
At baseline, the fourth week, the eighth week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adolescents aged 10-19 years old.
Meet the diagnostic criteria of NSSI behavior recommended by DSM-5.
The adolescents who have mobile phone, and have the ability to send or receive text messages.
Adolescents and guardians agreed to participate and signed the informed consent form
Exclusion Criteria:
Adolescents with severe somatic diseases who cannot complete the study.
Adolescents with cognitive impairment, neurodevelopmental disorder, mental retardation, visual impairment who cannot complete the study.
The adolescents who do not have a mobile phone.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianjun Ou, doctor
Organizational Affiliation
Central South University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Runsen Chen, doctor
Organizational Affiliation
Central South University
Official's Role
Study Director
Facility Information:
Facility Name
Department of Psychiatry, Xiangya Second Hospital, Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Efficacy of Non-drug Therapy (SMS Intervention) for Adolescents With NSSI
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