Preliminary study for organizing and developing evidence for PRO indicators for depression, anxiety, and premenstrual syndrome used in healthcare

Preliminary study for organizing and developing evidence for PRO indicators for depression, anxiety, and premenstrual syndrome used in healthcare - Preliminary study for organizing and developing evidence for PRO indicators for depression, anxiety, and premenstrual syndrome used in healthcare

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000054001

Enrollment

400

Registered

2024-03-30

Start date

2024-02-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

sub threshold depression, sub threshold anxiety, premenstrual syndrome

Interventions

We provide psychoeducation based on cognitive behavioral therapy and stories (reading materials) that encourage behavior change, reading one a day.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Persons who work more than 32 hours a week -You have never been seen or diagnosed with depression, anxiety, or premenstrual syndrome. -Persons who do not have suicidal thoughts (score for suicidal thoughts in question 9 of the depression scale PHQ-9 is 0 or 1) -Person who has an Internet environment (PC, smartphone, or tablet) -Persons who have Japanese nationality, can understand explanations in Japanese, and can consent online of their own free will. *Registration conditions for premenstrual syndrome 1) Women aged 18 to 45 2) Regular menstrual cycle (25 to 38 day cycle)

Exclusion criteria

Exclusion criteria: 1) Depression is defined by a PHQ-9 score of 15 points or higher, anxiety is defined by a GAD-7 score of 15 points or higher, and premenstrual syndrome is defined by a score of 15 points or higher on the PHQ-9. People who fall under PMDD according to the PMDD rating scale 2) People with gynecological diseases (fibroids, endometriosis, etc.)

Design outcomes

Primary

Measure	Time frame
Minimally Important Difference, MID	—

Countries

Japan

Contacts

Public ContactNoriko Numata

Chiba University Graduate School of Medicine, Cognitive Behavioral Physiology

n_numata@chiba-u.jp043-226-2027

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026