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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-24
SponsorJiangsu Medical College

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: MindBridge + Treatment as UsualExperimental treatment 1 intervention
Group B: Attention-Matched Control + Treatment as UsualActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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