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Suicidal ideation Assessment: Fluctuation monitoring with Ecological momentary assessment

Suicidal ideation Assessment: Fluctuation monitoring with Ecological momentary assessment - SAFE

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON52614
Enrollment
80
Registered
2020-04-24
Start date
2020-08-13
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

suicide

Interventions

None listed

Sponsors

Universiteit Leiden
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. A history of a suicide attempt or severe ideation in the past 12 months (>=3 Columbia-Suicide Severity Rating Scale, or >=2 if symptoms present in the past 2 months). 2. Aged 18 years or older. 3. Adequate proficiency of both written and spoken Dutch or English. 4. Possession/use of an Android or iOS compatible mobile phone. 5. Willingness to participate in a 1-year longitudinal study.

Exclusion criteria

Exclusion criteria: 1. Current diagnosis of Bipolar disorder, a Psychotic disorder, or (severe) Substance dependence (DSM-5 criteria). 2. Intellectual impairment, dementia or a physical impairment that may prevent the participant from adequately following the study procedures. Participants in need of immediate support or treatment will be referred before enrolment in the study.

Design outcomes

Primary

MeasureTime frame
The primary outcome measure is self-reported suicidal ideation, as measured with EMA. The primary predictors include self-reported sleep parameters (sleep quality/quantity), mood (positive/negative), cognitions (hopelessness, burdensomeness, loneliness, optimism), stressful events, social interaction (/isolation), and substance use/coping strategies, as measured with EMA; and objective sleep parameters (incl. total sleep time, sleep onset latency, sleep efficiency, wake after sleep onset), as measured with actigraphy.

Secondary

MeasureTime frame
The following self report measures will be assessed at the beginning and at the end of the cohort study. 1. suicidal ideation 2. depressive symptoms 3. anxiety symptoms 4. quality of life 5. sleep problems 6. cognitive reactivity 7. anger expression 8. borderline personality traits Acceptability of EMA will also be tested: agreement to participate, compliance rates, and attrition (operationalized as the number and percentage of individuals who agree to participate in the study/ valid EMA observations/ individuals who complete the study) and study burden questions (self-report).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)