NCT05955807

Brief Summary

The goal of this observational study is to increase the knowledge base about fluctuations in suicide ideation and its association with relational and contextual factors after hospital discharge in patients with high risk of suicide. Patients hospitalized due to severe risk of suicide (recent suicide attempt or due to acute suicidality) are invited to participate in the study. Researchers will investigate how psychological, relational and contextual factors trigger as well as protect against escalating suicide ideation in this period in the post discharge period. Information will be retrieved from multiple sources (eg. by Ecological Momentary Assessment Method (EMA), regular patient interviews and questionnaires in addition to information from Electronic Patient Registry) to; a) delineate fluctuations in suicide ideation, b) identify factors that are associated with/ influence suicide ideation in the EMA assessment period, c) explore associations with relational and contextual measures during EMA assessment, d) generate profiles for subgroups and investigate how participants experience and evaluate their participation and completion of the EMA assessment protocol.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 21, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2024

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

May 8, 2024

Status Verified

August 1, 2023

Enrollment Period

1.8 years

First QC Date

April 21, 2023

Last Update Submit

May 7, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Fluctuations in suicide ideation

    Fluctuations in Suicide Ideation and related variables (eg. "I wish to live", "I wish to die" "I think about taking my own life", "I feel hopeless". Questions are rated on a Likert scale (1-5). Participant will answer questions on their mobile-phone 5 times each day for 10 days.

    10 day Ecological Momentary Assessment-registrations

Secondary Outcomes (7)

  • Suicidal behaviors

    Baseline, 3 weeks after discharge, and then again 3 months after discharge

  • General symptom severity

    Baseline and 3 months

  • Depression

    baseline

  • Experience with using the EMA app

    3 weeks

  • Suicide Ideation

    Baseline, 3 weeks, 3 months

  • +2 more secondary outcomes

Other Outcomes (3)

  • Baseline characteristics/ descriptive variable/ diagnostic group

    baseline

  • Psychological diagnostic group

    3 weeks

  • general patient demographics

    baseline and 3 months

Study Arms (1)

Patients hospitalized due to severe risk of suicide

This is an observational study that focus on patients wellbeing and life-experience in the discharge period after a stay in psychiatric care due to severe risk of suicide. Patients will be treated according to usual pratice in clinical care

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients hospitalized in psychiatric care in Norway are characterized by high symptom severity and comorbid conditions.

You may qualify if:

  • Patients hospitalized with a recent suicide attempt or
  • Patient hospitalized due to severe risk of suicide

You may not qualify if:

  • Active psychosis
  • Developmental disorders
  • Intellectual disability
  • Poor norwegian acquisition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Research and Delvelopment, Mental health and Addiction, Vestre Viken Hospital Trust

Drammen, 3004, Norway

Location

MeSH Terms

Conditions

Suicide PreventionSuicide, Attempted

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2023

First Posted

July 21, 2023

Study Start

August 15, 2022

Primary Completion

June 8, 2024

Study Completion

August 1, 2025

Last Updated

May 8, 2024

Record last verified: 2023-08

Locations