Suicidal Ideation
Conditions
Keywords
Suicide Prevention, Mobile Health, Dialectical Behavior Therapy, Digital Mental Health, Young Adults
Brief summary
This study will evaluate the effectiveness of MindBridge, a dialectical behavior therapy (DBT)-informed mobile health module delivered through a WeChat mini-program, among Chinese young adults aged 18 to 24 years with mild-to-moderate suicide risk. In the randomized controlled trial, 84 participants will be randomized 1:1 to receive MindBridge plus treatment as usual or an attention-matched general well-being program plus treatment as usual for 8 weeks. Assessments will be conducted at baseline, week 4, week 8, and 1-month follow-up. The primary outcome is suicide-related thoughts and behaviors. Secondary outcomes include depression, anxiety, emotion regulation, sleep quality, perceived social support, academic self-efficacy, and problematic internet use. This randomized controlled trial is the effectiveness-evaluation component of a broader sequential mixed methods study involving the development and evaluation of MindBridge.
Interventions
BEHAVIORALMindBridge Mobile Health Intervention
MindBridge is an 8-week mobile health intervention delivered through a WeChat mini-program. The intervention is informed by dialectical behavior therapy (DBT) and is designed to reduce suicide-related thoughts and behaviors among young adults at mild-to-moderate suicide risk. Participants assigned to the intervention arm will receive MindBridge in addition to treatment as usual (TAU).
BEHAVIORALAttention-Matched General Well-Being Program
Participants assigned to the control arm will receive an attention-matched general well-being program for 8 weeks in addition to treatment as usual (TAU). The program is designed to provide a comparable level of participant attention without delivering the specific therapeutic components of the MindBridge intervention.
Sponsors
Jiangsu Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors will be blinded to participants' treatment allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to 24 Years
Healthy volunteers
No
Inclusion criteria
Aged 18-24 years. Mild-to-moderate suicide risk, defined as a Suicide and Self-Injury Behavior Inventory (SSBI) past-year or recent suicide-related or self-harm composite score of 17-51. Able to understand the study procedures and complete questionnaires independently. Own a smartphone and are able to use WeChat and the relevant study application. Able and willing to provide voluntary informed consent. Have not participated in earlier phases of this research.
Exclusion criteria
Current acute suicide crisis requiring immediate clinical intervention, operationally defined as a Columbia-Suicide Severity Rating Scale (C-SSRS) ideation level of 4-5 and/or recent suicidal behavior (any actual, aborted, or interrupted attempt or preparatory act within the past month), assessed at screening/baseline. Serious physical illness or other condition that, in the judgment of the research or clinical safety team, makes participation inappropriate. Currently receiving intensive psychiatric crisis intervention that would make trial participation unsafe. Expected to be unable to complete the 8-week intervention or 1-month follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Suicide-Related Thoughts and Behaviors Measured by the SSBI | Baseline to 8 weeks | Suicide-related thoughts and behaviors will be assessed using the Suicide and Self-Injury Behavior Inventory (SSBI). The primary effectiveness endpoint is the between-group difference in change in the prespecified SSBI past-30-day suicide-related/self-harm composite from baseline to the end of the 8-week intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depressive Symptoms Measured by the PHQ-9 | Baseline, week 4, week 8, and 1-month follow-up | Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 total score ranges from 0 to 27, with higher scores indicating more severe depressive symptoms. |
| Change in Anxiety Symptoms Measured by the GAD-7 | Baseline, week 4, week 8, and 1-month follow-up | Anxiety symptoms will be assessed using the Generalized Anxiety Disorder-7 (GAD-7). Higher scores indicate more severe anxiety symptoms. |
| Change in Emotion Regulation Difficulties Measured by the DERS-16 | Baseline, week 4, week 8, and 1-month follow-up | Emotion regulation difficulties will be assessed using the 16-item Difficulties in Emotion Regulation Scale (DERS-16). |
| Change in Sleep Quality Measured by the PSQI | Baseline, week 4, week 8, and 1-month follow-up | Sleep quality will be assessed using the Chinese version of the Pittsburgh Sleep Quality Index (PSQI). The PSQI total score ranges from 0 to 21, with higher scores indicating poorer sleep quality. |
| Change in Perceived Social Support Measured by the MSPSS | Baseline, week 4, week 8, and 1-month follow-up | Perceived social support will be assessed using the 12-item Multidimensional Scale of Perceived Social Support (MSPSS), covering perceived support from family, friends, and significant others. |
| Change in Academic Self-Efficacy Measured by the ASES | Baseline, week 4, week 8, and 1-month follow-up | Academic self-efficacy will be assessed using the Chinese Academic Self-Efficacy Scale (ASES), which assesses learning ability and learning behavior. |
| Change in Problematic Internet Use Measured by the IAT | Baseline, week 4, week 8, and 1-month follow-up | Problematic internet use will be assessed using the 20-item Internet Addiction Test (IAT), with a cutoff score of 50 used to identify problematic internet use. |
Countries
China
Contacts
CONTACTJIN CHEN
STUDY_CHAIRNor Afifi Razaob, Doctor
National University of Malaysia
Outcome results
None listed