Evaluation of the effect of hospital-based assertive case management for patient with major depressive disorder and suicidal ideation

Evaluation of the effect of hospital-based assertive case management for patient with major depressive disorder and suicidal ideation: a prospective, multicentre, randomised controlled trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0008123

Enrollment

314

Registered

2023-01-13

Start date

2021-01-18

Completion date

Unknown

Last updated

2026-01-05

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

Conditions

None listed

Interventions

Others(Assertive Case Management (ACM) ) : The medical intervention in this study is a hospital-based intensive case management service for patients with major depression with suicide attempts. Intens

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Adult men and women aged 18 or older. 2) Participants must have either suicidal ideation with intent within 1 month or a history of suicide attempt within 2 months before study registration, and must meet the DSM-5 diagnostic criteria for Major Depressive Disorder (MDD). Clinical evaluation and the Mini-International Neuropsychiatric Interview (MINI) must confirm the absence of psychotic features. 3) Participants must have the capacity to provide consent and voluntarily decide to join the study. They must also be able to use a smartphone app or website to receive the assertive case management service.

Exclusion criteria

Exclusion criteria: 1) Cases where the investigator determines that acute psychiatric hospitalization is clinically necessary, owing to the participant's imminent suicide risk at the time of enrolment. 2) Cases that currently meet co-occurring Axis II diagnostic criteria (such as Borderline Personality Disorder) according to DSM-5 criteria. 3) Cases with a current clinical diagnosis of Autism Spectrum Disorder, Dementia, or Intellectual Disability. 4) History of moderate or severe Substance or Alcohol Use Disorder, according to DSM-5 criteria, within 6 months before screening, excluding nicotine or caffeine. 5) Other cases where the investigator deems participation in the study inappropriate.

Design outcomes

Primary

Measure	Time frame
The change from baseline to 6 months in the overall severity of suicidal thoughts and behaviours, as assessed by the total score of the Columbia–Suicide Severity Rating Scale (C-SSRS)	—

Secondary

Measure	Time frame
Change from baseline in depressive symptoms measured by the Hamilton Depression Rating Scale (HAM-D);Economic evaluation measured by the EQ-5D and CSRI scales;Change from baseline in SIS and BSSI;Patient satisfaction with the assertive case management service;Change from baseline in GAD-7;Change from baseline in loneliness	—

Countries

Korea, Republic of

Contacts

Public ContactSangmin Lee

Kyung Hee University Hospital

leesangmin@khu.ac.kr+82-2-958-8543

Outcome results