- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07733596
Development of a Digital Acceptance and Commitment Therapy Intervention for Suicide Prevention in Adults Through Co-design
23. juli 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
80
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Tao Zhang
- Telefonnummer: +85294233827
- E-post: tao-t.zhang@connect.polyu.hk
Studiesteder
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-
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Hong Kong, Kina
- The Hong Kong Polytechnic University
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Ta kontakt med:
- Bryant Hui
- Telefonnummer: +85227667744
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Intervention completion rate
Tidsramme: End of the intervention (approximately 2 weeks)
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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
Tidsramme: 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.
|
End of the 1-month follow-up
|
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Acceptability outcome
Tidsramme: 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.
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End of the intervention (approximately 2 weeks)
|
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Usability outcome
Tidsramme: 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)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Suicide ideation
Tidsramme: Baseline, end of the 2-week intervention, and 1-month follow-up
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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
Tidsramme: 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.
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Baseline, end of the 2-week intervention, and 1-month follow-up
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Psychological Distress
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Qualitative Feedback and Design Recommendations
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Tao Zhang, The Hong Kong Polytechnic University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
15. juli 2026
Primær fullføring (Antatt)
31. oktober 2026
Studiet fullført (Antatt)
30. desember 2026
Datoer for studieregistrering
Først innsendt
9. juli 2026
Først innsendt som oppfylte QC-kriteriene
23. juli 2026
Først lagt ut (Faktiske)
29. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
29. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. juli 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HSEARS20260122008-1
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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