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

NCT07767604 | Not Yet Recruiting

• 1 other identifier: 202603-PJ-025
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicidal Ideation

Keywords

Suicide Prevention; Mobile Health; Dialectical Behavior Therapy; Digital Mental Health; Young Adults

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 8 weeks

Secondary Outcomes (7)

• Change in Depressive Symptoms Measured by the PHQ-9

  Baseline, week 4, week 8, and 1-month follow-up

• Change in Anxiety Symptoms Measured by the GAD-7

  Baseline, week 4, week 8, and 1-month follow-up

• Change in Emotion Regulation Difficulties Measured by the DERS-16

  Baseline, week 4, week 8, and 1-month follow-up

• Change in Sleep Quality Measured by the PSQI

  Baseline, week 4, week 8, and 1-month follow-up

• Change in Perceived Social Support Measured by the MSPSS

  Baseline, week 4, week 8, and 1-month follow-up

Study Arms (2)

MindBridge + Treatment as Usual

EXPERIMENTAL

Participants assigned to this arm will receive the MindBridge mobile health intervention in addition to treatment as usual (TAU) for 8 weeks.

Behavioral: MindBridge Mobile Health Intervention

Attention-Matched Control + Treatment as Usual

ACTIVE COMPARATOR

Participants assigned to this arm will receive an attention-matched general well-being program in addition to treatment as usual (TAU) for 8 weeks.

Behavioral: Attention-Matched General Well-Being Program

Interventions

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).

MindBridge + Treatment as Usual

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.

Attention-Matched Control + Treatment as Usual

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu Medical College: lead

Study Sites (1)

Jiangsu Medical College

Yancheng, Jiangsu, 224005, China

Location

MeSH Terms

Conditions

Suicidal Ideation; Suicide Prevention

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Nor Afifi Razaob, Doctor

  National University of Malaysia

  STUDY CHAIR

Central Study Contacts

JIN CHEN

CONTACT

+8615061630375; P160643@siswa.ukm.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to participants' treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 17, 2026
• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)