Non-suicidal Self-injuryNCT04481425
Evaluation of the Efficacy of Non-drug Therapy (SMS Intervention) for Adolescents With NSSI
A study testing SMS intervention in people with Non-suicidal Self-injury, run by Central South University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- Non-suicidal Self-injury
- What is being tested?
- SMS intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 23 Dec 2020to 30 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Psychiatry, Xiangya Second Hospital, Central South University
Changsha, Hunan, 410000
About this study
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.
Read the 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
- Being tested
- SMS intervention
- Medical subject headings
- Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS interventionOther
SMS intervention
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Other | 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. Receives: Other: SMS intervention |
| control group | No intervention | Subjects both collected in the outpatient department and the ward were randomly divided into the control group and regularly followed up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline, the fourth week, the eighth week
Secondary outcomes (6)
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.
Measured: At baseline, the fourth week, the eighth week
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.
Measured: At baseline, the fourth week, the eighth week
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.
Measured: At baseline, the fourth week, the eighth week
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.
Measured: At baseline, the fourth week, the eighth week
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.
Measured: At baseline, the fourth week, the eighth week
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.
Measured: At baseline, the fourth week, the eighth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start23 Dec 2020
- Primary completion30 Jan 2022
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-suicidal Self-injuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-Jun Ou, Central South University
- Investigators
- Jianjun Ou, doctor, Study chair, Central South UniversityRunsen Chen, doctor, Study director, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481425
- Sponsor's protocol ID
- MD20200309
- Status last verified
- Nov 2022
- First submitted
- 13 Jul 2020
- Last updated
- 18 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang C, Qu D, Chong D, Lei C, Shen Y, Cui X, He Y, Li Y, Ou J, Chen R. Brief digital psychological intervention to prevent relapse of non-suicidal self-injury behavior in adolescents: A randomized controlled trial. J Child Psychol Psychiatry. 2026 Mar;67(3):380-389. doi: 10.1111/jcpp.70054. Epub 2025 Sep 26.
PubMed 40999958
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Non-drug Therapy (SMS Intervention) for Adolescents With NSSI
- ClinicalTrials.gov ID
- NCT04481425
- Acronym / sponsor ID
- MD20200309
- Conditions
- Non-suicidal Self-injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 23 Dec 2020 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 22 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Other | Other: SMS interventionText 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. |
| control group | No intervention | –Subjects both collected in the outpatient department and the ward were randomly divided into the control group and regularly followed up. |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMS interventionSMS intervention | Other | intervention group |
Primary outcome
The change of NSSI behavior of the participants.
Time frame: At baseline, the fourth week, the eighth week
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.
6 secondary outcomes
The change of anxiety level.
Time frame: At baseline, the fourth week, the eighth week
The change of depression level.
Time frame: At baseline, the fourth week, the eighth week
The change of hopelessness.
Time frame: At baseline, the fourth week, the eighth week
The change of emotion regulation strategies.
Time frame: At baseline, the fourth week, the eighth week
The change of coping styles.
Time frame: At baseline, the fourth week, the eighth week
The change of life events stress.
Time frame: At baseline, the fourth week, the eighth week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2022.
- Derived from this study: PubMed 40999958Zhang C, Qu D, Chong D, Lei C, Shen Y, Cui X, He Y, Li Y, Ou J, Chen R. Brief digital psychological intervention to prevent relapse of non-suicidal self-injury behavior in adolescents: A randomized controlled trial. J Child Psychol Psychiatry. 2026 Mar;67(3):380-389. doi: 10.1111/jcpp.70054. Epub 2025 Sep 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianjun Ou, doctor study chair
Central South University
Runsen Chen, doctor study director
Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS intervention in people with Non-suicidal Self-injury, run by Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of NSSI behavior of the participants. (time frame: At baseline, the fourth week, the eighth week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04481425, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2022.