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Development and Clinical Usability Study of a Safety Plan Handbook for Patients with Depressive Disorders and Suicide Risk

Development and Clinical Usability Study of a Safety Plan Handbook for Patients with Depressive Disorders and Suicide Risk

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600120028
Enrollment
Unknown
Registered
2026-03-09
Start date
2026-03-09
Completion date
Unknown
Last updated
2026-03-16

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

Conditions

Depressive Disorder

Interventions

Investigation Group:None

Sponsors

Beijing Chao-Yang Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Diagnosis: Meets DSM-5 diagnostic criteria for any depressive disorder. 2.Suicide Risk: Assessed by the attending physician as having suicide risk, and the MINI "Suicide Behavior Module" indicates the presence of suicidal ideation, suicide plan, or history of suicide attempts. 3.Age and Language: Aged >=18 years, able to read and understand Simplified Chinese. 4.Informed Consent: Capable of providing informed consent and participating voluntarily. 5.Safety Conditions: Able to independently complete the manual reading and questionnaire in a safe outpatient environment.

Exclusion criteria

Exclusion criteria: 1.Psychotic Symptoms: Presence of significant active psychotic symptoms (e.g., delusions, hallucinations, disorganized thinking) affecting understanding or compliance. 2.Substance-Related States: Current acute intoxication, severe withdrawal, or other states resulting in impaired judgment due to alcohol or drugs. 3.Behavioral/Emotional Instability: Inability to maintain basic safety in the outpatient setting (e.g., extreme agitation, impulsive behavior, need for immediate referral). 4.Legal or Custodial Restrictions: Under judicial supervision, forced medical treatment, or unable to complete the routine informed consent process. 5.Investigator Judgment: Deemed unsuitable for participation by the investigator based on overall risk assessment.

Design outcomes

Primary

MeasureTime frame
Comprehension Accuracy;

Secondary

MeasureTime frame
Subjective Usability Score;Immediate Subjective Sense of Safety Score;

Countries

China

Contacts

Public ContactLiu Huifeng

Beijing Chao-Yang Hospital, Capital Medical University

miksa@qq.com+86 10 85231441

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 20, 2026