- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07733596
Development of a Digital Acceptance and Commitment Therapy Intervention for Suicide Prevention in Adults Through Co-design
July 23, 2026 updated by: The Hong Kong Polytechnic University
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tao Zhang
- Phone Number: +85294233827
- Email: tao-t.zhang@connect.polyu.hk
Study Locations
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-
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Hong Kong, China
- The Hong Kong Polytechnic University
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Contact:
- Bryant Hui
- Phone Number: +85227667744
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria Lived experience participants
- Aged 18 years or older;
- Have experienced suicidal thoughts and/or behaviors;
- Able to read and communicate in Chinese; Professionals
- Aged 18 years or older;
- Professionals with experience relevant to suicide prevention, Acceptance and Commitment Therapy (ACT), digital mental health, or related fields;
Exclusion Criteria
- Unable to provide informed consent or participate in study activities;
- Currently experiencing acute suicide risk requiring immediate intervention;
- Severe cognitive impairment or active psychotic symptoms that would prevent participation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
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A co-designed digital Acceptance and Commitment Therapy (ACT) intervention for suicide prevention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intervention completion rate
Time Frame: 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.
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End of the intervention (approximately 2 weeks)
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Retention rate
Time Frame: End of the 1-month follow-up
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The participant retention rate will be assessed as the percentage of participants who complete the post-intervention assessment and the follow-up assessment.
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End of the 1-month follow-up
|
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Acceptability outcome
Time Frame: End of the intervention (approximately 2 weeks)
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Acceptability of the intervention will be assessed using participant-reported ratings and feedback regarding satisfaction and overall experience with the intervention.
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End of the intervention (approximately 2 weeks)
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Usability outcome
Time Frame: End of the intervention (approximately 2 weeks)
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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.
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End of the intervention (approximately 2 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Suicide ideation
Time Frame: 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.
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Baseline, end of the 2-week intervention, and 1-month follow-up
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Psychological flexibility and inflexibility
Time Frame: Baseline, end of the 2-week intervention, and 1-month follow-up
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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.
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Baseline, end of the 2-week intervention, and 1-month follow-up
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Psychological Distress
Time Frame: Baseline, end of the 2-week intervention, and 1-month follow-up
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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.
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Baseline, end of the 2-week intervention, and 1-month follow-up
|
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Mental well-being
Time Frame: Baseline, end of the 2-week intervention, and 1-month follow-up
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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.
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Baseline, end of the 2-week intervention, and 1-month follow-up
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Qualitative Feedback and Design Recommendations
Time Frame: Through study completion, an average of 6 months
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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.
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Through study completion, an average of 6 months
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Cultural Relevance
Time Frame: Through study completion, an average of 6 months
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Cultural relevance of the intervention will be assessed through participant feedback regarding the appropriateness, relevance, and cultural fit of the intervention content and delivery.
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Through study completion, an average of 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Tao Zhang, The Hong Kong Polytechnic University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 15, 2026
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
December 30, 2026
Study Registration Dates
First Submitted
July 9, 2026
First Submitted That Met QC Criteria
July 23, 2026
First Posted (Actual)
July 29, 2026
Study Record Updates
Last Update Posted (Actual)
July 29, 2026
Last Update Submitted That Met QC Criteria
July 23, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSEARS20260122008-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.