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Completed

NCT Number: NCT04481425

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

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.

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Key information

Conditions

Non-suicidal Self-injury Behavior Behavioral Symptoms Self-Injurious Behavior

Age range

10 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry, Xiangya Second Hospital, Central South University

Changsha, Hunan, 410000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SMS intervention

Other

SMS intervention

Primary outcomes

  1. 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.

Secondary outcomes

  1. The change of anxiety level.

    Time frame: At baseline, the fourth week, the eighth week

    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.

  2. The change of depression level.

    Time frame: At baseline, the fourth week, the eighth week

    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.

  3. The change of hopelessness.

    Time frame: At baseline, the fourth week, the eighth week

    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.

  4. The change of emotion regulation strategies.

    Time frame: At baseline, the fourth week, the eighth week

    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.

  5. The change of coping styles.

    Time frame: At baseline, the fourth week, the eighth week

    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.

  6. The change of life events stress.

    Time frame: At baseline, the fourth week, the eighth week

    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.

Sponsors and collaborators

Lead sponsor

Central South University

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 22, 2020
Registry last updated
Nov 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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