| Registry | NCT07733596 |
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, prevention |
| Enrollment | 80 (Estimated) |
| Sponsor | The Hong Kong Polytechnic University (Other) |
| Conditions | Suicide, Co-design, Suicide Prevention |
| Interventions | Digital ACT Intervention (Behavioral) |
| Dates | start 2026-07-15 (estimated), primary completion 2026-10-31 (estimated), completion 2026-12-30 (estimated), first posted 2026-07-29, last updated 2026-07-29 |
| Locations | 1 site in China |
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All trials for Suicide All trials for Co-design All trials of Digital ACT Intervention
-Summary
Suicide is a major public health concern and there is a need for accessible and scalable interventions to support individuals experiencing suicidal thoughts. The aim of this study is to develop a digital Acceptance and Commitment Therapy (ACT) intervention for suicide prevention in Chinese adults through co-design. The study will involve literature review, interviews, and co-design activities to identify user needs, preferences, and contextual factors, and to develop the intervention. Following intervention development, a pilot study will be conducted to evaluate the feasibility, usability, acceptability, and user engagement of the intervention. Findings from this study will inform further refinement of the intervention and future evaluation studies.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Digital ACT Intervention | Experimental | Behavioral: Digital ACT Intervention | The Digital ACT Intervention will be co-designed with stakeholders and informed by co-design activities. The intervention aims to support adults experiencing suicidal thoughts through a digital platform. |
- Digital ACT Intervention (Behavioral): A co-designed digital Acceptance and Commitment Therapy (ACT) intervention for suicide prevention
+Outcome measures
Primary outcomes
- Intervention completion rate [End of the intervention (approximately 2 weeks)]: The intervention completion rate will be assessed as the percentage of participants who complete the digital intervention, based on intervention usage records.
- Retention rate [End of the 1-month follow-up]: The participant retention rate will be assessed as the percentage of participants who complete the post-intervention assessment and the follow-up assessment.
- Acceptability outcome [End of the intervention (approximately 2 weeks)]: Acceptability of the intervention will be assessed using participant-reported ratings and feedback regarding satisfaction and overall experience with the intervention.
- Usability outcome [End of the intervention (approximately 2 weeks)]: Usability will be assessed using the System Usability Scale (SUS), a 10-item self-report questionnaire. Total scores range from 0 to 100, with higher scores indicating better usability of the intervention.
Secondary outcomes
- Suicide ideation [Baseline, end of the 2-week intervention, and 1-month follow-up]: Suicidal ideation will be assessed using the Beck Scale for Suicide Ideation (BSSI). Each item is rated on a 3-point scale ranging from 0 to 2, with higher scores indicating greater suicidal ideation.
- Psychological flexibility and inflexibility [Baseline, end of the 2-week intervention, and 1-month follow-up]: Psychological flexibility and inflexibility will be assessed using the Multidimensional Psychological Flexibility Inventory-24 (MPFI-24). Each item is rated on a 6-point scale ranging from 1 to 6. Higher scores on the flexibility and inflexibility subscales indicate greater psychological flexibility and psychological inflexibility, respectively.
- Psychological Distress [Baseline, end of the 2-week intervention, and 1-month follow-up]: Psychological distress will be assessed using the Depression Anxiety Stress Scales (DASS). Each item is rated on a 4-point scale ranging from 0 to 3, with higher scores indicating greater psychological distress.
- Mental well-being [Baseline, end of the 2-week intervention, and 1-month follow-up]: Mental well-being will be assessed using the Mental Health Continuum-Short Form (MHC-SF). Each item is rated on a 6-point scale ranging from 0 to 5, with higher scores indicating greater mental well-being.
Other outcomes
- Qualitative Feedback and Design Recommendations [Through study completion, an average of 6 months]: Qualitative feedback related to user needs, preferences, barriers, facilitators, cultural considerations, and recommendations for intervention refinement will be identified from co-design activities and feedback sessions.
- Cultural Relevance [Through study completion, an average of 6 months]: Cultural relevance of the intervention will be assessed through participant feedback regarding the appropriateness, relevance, and cultural fit of the intervention content and delivery.
+Eligibility
Sex: All, ages: 18 Years to any
* Inclusion Criteria Lived experience participants
1. Aged 18 years or older;
2. Have experienced suicidal thoughts and/or behaviors;
3. Able to read and communicate in Chinese; Professionals
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1. Aged 18 years or older;
2. Professionals with experience relevant to suicide prevention, Acceptance and Commitment Therapy (ACT), digital mental health, or related fields;
* Exclusion Criteria
1. Unable to provide informed consent or participate in study activities;
2. Currently experiencing acute suicide risk requiring immediate intervention;
3. Severe cognitive impairment or active psychotic symptoms that would prevent participation.
+Locations (1)
| Facility | City | Country | Status |
|---|
| The Hong Kong Polytechnic University | Hong Kong | China | |
+Investigators
- Tao Zhang, Principal investigator, The Hong Kong Polytechnic University