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NCT Number: NCT07767604

Effectiveness of the MindBridge Mobile Health Module for Young Adults at Risk of Suicide

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.

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Key information

Conditions

Suicidal Ideation Behavior Behavioral Symptoms Self-Injurious Behavior Suicide Suicide Prevention

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

MindBridge Mobile Health Intervention

Behavioral

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).

Attention-Matched General Well-Being Program

Behavioral

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.

Primary outcomes

  1. Change in Suicide-Related Thoughts and Behaviors Measured by the SSBI

    Time frame: 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 outcomes

  1. Change in Depressive Symptoms Measured by the PHQ-9

    Time frame: 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.

  2. Change in Anxiety Symptoms Measured by the GAD-7

    Time frame: 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.

  3. Change in Emotion Regulation Difficulties Measured by the DERS-16

    Time frame: 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).

  4. Change in Sleep Quality Measured by the PSQI

    Time frame: 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.

  5. Change in Perceived Social Support Measured by the MSPSS

    Time frame: 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.

  6. Change in Academic Self-Efficacy Measured by the ASES

    Time frame: 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.

  7. Change in Problematic Internet Use Measured by the IAT

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

JIN CHEN

CONTACT

[email protected]

+8615061630375

Sponsors and collaborators

Lead sponsor

Jiangsu Medical College

Other

Registry information

Official study title

Development and Effectiveness of the MindBridge Mobile Health Module for Chinese Young Adults at Risk of Suicide: A Sequential Mixed Methods Study

Acronym: MindBridge

Important dates

Study start
2027
Primary completion
2027
Study completion
2027
First posted
Aug 17, 2026
Registry last updated
Aug 17, 2026

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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