Suicidal IdeationMindBridgeNCT07767604
Effectiveness of the MindBridge Mobile Health Module for Young Adults at Risk of Suicide
A study testing MindBridge Mobile Health Intervention and Attention-Matched General Well-Being Program in people with Suicidal Ideation, run by Jiangsu Medical College at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Suicidal Ideation
- What is being tested?
- MindBridge Mobile Health Intervention and Attention-Matched General Well-Being Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- Mar 2027to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Jiangsu Medical College
Yancheng, Jiangsu, 224005
Jin Chen, +8615061630375, P160643@siswa.ukm.edu.my
About this study
Official title: Development and Effectiveness of the MindBridge Mobile Health Module for Chinese Young Adults at Risk of Suicide: A Sequential Mixed Methods Study
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
- Being tested
- MindBridge Mobile Health Intervention, Attention-Matched General Well-Being Program
- Keywords
- Suicide Prevention, Mobile Health, Dialectical Behavior Therapy, Digital Mental Health, Young Adults
- Medical subject headings
- Suicidal Ideation, Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindBridge Mobile Health InterventionBehavioural
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 ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Attention-Matched General Well-Being Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 8 weeks
Secondary outcomes (7)
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.
Measured: Baseline, week 4, week 8, and 1-month follow-up
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.
Measured: Baseline, week 4, week 8, and 1-month follow-up
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).
Measured: Baseline, week 4, week 8, and 1-month follow-up
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.
Measured: Baseline, week 4, week 8, and 1-month follow-up
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.
Measured: Baseline, week 4, week 8, and 1-month follow-up
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.
Measured: Baseline, week 4, week 8, and 1-month follow-up
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.
Measured: Baseline, week 4, week 8, and 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study startMar 2027 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nor Afifi Razaob, Doctor, Study chair, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07767604
- Sponsor's protocol ID
- 202603-PJ-025
- Acronym
- MindBridge
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to the sensitive nature of the data and participant privacy and confidentiality considerations.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Effectiveness of the MindBridge Mobile Health Module for Chinese Young Adults at Risk of Suicide: A Sequential Mixed Methods Study
- ClinicalTrials.gov ID
- NCT07767604
- Acronym / sponsor ID
- MindBridge / 202603-PJ-025
- Conditions
- Suicidal Ideation
- Keywords
- Suicide Prevention, Mobile Health, Dialectical Behavior Therapy, Digital Mental Health, Young Adults
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Jiangsu Medical CollegeUniversity, hospital or other
- Study start
- Mar 2027 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MindBridge + Treatment as Usual | Experimental | Behavioral: MindBridge Mobile Health InterventionParticipants assigned to this arm will receive the MindBridge mobile health intervention in addition to treatment as usual (TAU) for 8 weeks. |
| Attention-Matched Control + Treatment as Usual | Active comparator | Behavioral: Attention-Matched General Well-Being ProgramParticipants assigned to this arm will receive an attention-matched general well-being program in addition to treatment as usual (TAU) for 8 weeks. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MindBridge Mobile Health InterventionMindBridge 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). | Behavioural | MindBridge + Treatment as Usual |
| Attention-Matched General Well-Being ProgramParticipants 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. | Behavioural | Attention-Matched Control + Treatment as Usual |
Primary outcome
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.
7 secondary outcomes
Change in Depressive Symptoms Measured by the PHQ-9
Time frame: Baseline, week 4, week 8, and 1-month follow-up
Change in Anxiety Symptoms Measured by the GAD-7
Time frame: Baseline, week 4, week 8, and 1-month follow-up
Change in Emotion Regulation Difficulties Measured by the DERS-16
Time frame: Baseline, week 4, week 8, and 1-month follow-up
Change in Sleep Quality Measured by the PSQI
Time frame: Baseline, week 4, week 8, and 1-month follow-up
Change in Perceived Social Support Measured by the MSPSS
Time frame: Baseline, week 4, week 8, and 1-month follow-up
Change in Academic Self-Efficacy Measured by the ASES
Time frame: Baseline, week 4, week 8, and 1-month follow-up
Change in Problematic Internet Use Measured by the IAT
Time frame: Baseline, week 4, week 8, and 1-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to the sensitive nature of the data and participant privacy and confidentiality considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nor Afifi Razaob, Doctor study chair
National University of Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MindBridge Mobile Health Intervention and Attention-Matched General Well-Being Program in people with Suicidal Ideation, run by Jiangsu Medical College at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JIN CHEN (+8615061630375, P160643@siswa.ukm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Suicide-Related Thoughts and Behaviors Measured by the SSBI (time frame: Baseline to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.