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

N/ANot Yet RecruitingNCT07767604

Jiangsu Medical College84 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Suicidal Ideation

Interventions

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 ProgramBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 24 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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.

Time frame: Baseline to 8 weeks

Secondary Outcomes

Change in Depressive Symptoms Measured by the PHQ-9

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.