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Not yet recruitingNCT07767604MindBridgeUpdated Aug 17, 2026

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

An interventional study of MindBridge Mobile Health Intervention and Attention-Matched General Well-Being Program in Suicidal Ideation, sponsored by Jiangsu Medical College. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 24 Years. Per ClinicalTrials.gov, last updated 2026-08-17.

Sponsored by Jiangsu Medical College · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
18 Years to 24 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Suicidal Ideation

Keywords

  • Suicide Prevention
  • Mobile Health
  • Dialectical Behavior Therapy
  • Digital Mental Health
  • Young Adults
03

Who can participate

Ages eligible
18 Years to 24 Years
Sexes eligible
All
Accepts 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

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.

04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
84 participants (estimated)

Study arms

  • Experimental
    MindBridge + Treatment as Usual

    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

  • Active comparator
    Attention-Matched Control + Treatment as Usual

    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

  • 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.

05

What researchers measure

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.

    Time frame: Baseline to 8 weeks

Secondary outcomes

  1. 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.

    Time frame: Baseline, week 4, week 8, and 1-month follow-up

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

    Anxiety symptoms will be assessed using the Generalized Anxiety Disorder-7 (GAD-7). Higher scores indicate more severe anxiety symptoms.

    Time frame: Baseline, week 4, week 8, and 1-month follow-up

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

    Emotion regulation difficulties will be assessed using the 16-item Difficulties in Emotion Regulation Scale (DERS-16).

    Time frame: Baseline, week 4, week 8, and 1-month follow-up

  4. Change in Sleep Quality Measured by the PSQI

    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.

    Time frame: Baseline, week 4, week 8, and 1-month follow-up

  5. Change in Perceived Social Support Measured by the MSPSS

    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.

    Time frame: Baseline, week 4, week 8, and 1-month follow-up

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

    Academic self-efficacy will be assessed using the Chinese Academic Self-Efficacy Scale (ASES), which assesses learning ability and learning behavior.

    Time frame: Baseline, week 4, week 8, and 1-month follow-up

  7. Change in Problematic Internet Use Measured by the IAT

    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.

    Time frame: Baseline, week 4, week 8, and 1-month follow-up

06

Study locations

1 site
07

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared due to the sensitive nature of the data and participant privacy and confidentiality considerations.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07767604
Lead sponsor
Jiangsu Medical College
Responsible party
Sponsor
First posted
Aug 17, 2026
Start date
Mar 2027 (estimated)
Primary completion
Oct 2027 (estimated)
Completion
Nov 2027 (estimated)
Last update
Aug 17, 2026

Study contacts

JIN CHEN
Contact
P160643@siswa.ukm.edu.my
+8615061630375
Nor Afifi Razaob, Doctor
study chair · National University of Malaysia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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