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Randomized Clinical Trial of the AvecMom Digital Therapeutic to Improve Anxiety in Perinatal Women

Prospective, Multicenter, randomized, Superior, open-label pivotal clinical trial to evaluate the safety and efficacy of the AvecMom digital therapeutic device to quantitatively improve anxiety in perinatal women.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0010978
Enrollment
102
Registered
2025-09-04
Start date
2025-09-22
Completion date
Unknown
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others(Mobile app-based Intervention) : Participants are randomized into either the intervention group or the control group. Participants in the intervention group are asked to download and use the m

Sponsors

Digitalmedic Co.
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) Pregnant women aged =19 years. 2) Currently pregnant at the time of screening. 3) State-Trait Anxiety Inventory-State (STAI-S) score =40. 4) Provided informed consent and able to communicate with the investigator. 5) Able to install and use a smartphone or tablet application, receive text messages, and respond to electronic questionnaires.

Exclusion criteria

Exclusion criteria: 1) Gestational age >36 weeks at screening. 2) Diagnosis of bipolar disorder or psychotic disorder. 3) Judged unsuitable for participation by the investigator.

Design outcomes

Primary

MeasureTime frame
State-Trait Anxiety Inventory (STAI-S)

Secondary

MeasureTime frame
Depression, Anxiety and Stress Scale, 21-question version (DASS-21);Edinburgh Postnatal Depression Scale (EPDS);Cognitive and Affective Mindfulness Scale-revised (CAMS-r);WHOQOL-BREF;Mental Health Continuum-short form (MHC-SF);Maternal-Fetal Attachment scale (MFAS)

Countries

Korea, Republic of

Contacts

Public ContactHee Young Cho

Seoul National University Hospital

hycho.md@snu.ac.kr+82-2-2072-4033

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026