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Suicide RiskNCT05955807

Momentary Assessment.Tracking Suicidal Ideation

An observational study of Suicide Risk and Suicide Ideation, run by Vestre Viken Hospital Trust at 1 site in Norway.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Suicide Risk, Suicide Ideation, Suicide Prevention
How many people
50 participants
Where
1 siteNorway
Study dates
15 Aug 2022to 1 Aug 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Norway1 site
  • Department of Research and Delvelopment, Mental health and Addiction, Vestre Viken Hospital Trust

    Drammen, 3004

Other trials in Norway

About this study

Official title: Tracking Suicidal Ideation and Factors That Influence it in High-risk Patients After Discharge From Psychiatric Acute Wards. An Ambulatory Momentary Experience-sampling Study

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.

Read the detailed description

Suicide risk is high amongst patients in mental health services in the postdischarge period (Large \& Kapur, 2018; Chung et al 2019). However, our current knowledge and understanding does not help us in preventing suicide as an outcome. It is not possible to predict suicide in high risk populations, and- more importantly- we also are not able in any efficient way to discriminate between those who are at higher risk for suicide and those who are in less high risk of suicide in this population (Franklin et al 2017, Large, 2018).

The most limiting feature of current procedures for suicide risk assessment is their very broad based, coarse characteristics, with a notable lack of incorporated knowledge of how ongoing daily life experiences influence suicide risk. If clinical judgments on suicide risk are to reach a higher level of certainty, this can only be achieved by addressing the specific, proximal factors that maximally relevant to the patients and their situation (Nock et al, 2009).

The field of suicidology needs to determine how, when and for whom continued life suffering after discharge are accompanied by increased suicidal risk. Further important tasks are to identify the post-discharge factors that protect these patients. In this context, the aim is to increase the knowledge base about fluctuations in suicide ideation and its association with relational and contextual factors after hospital discharge in suicide attempters and patients hospitalized to psychiatric institutions due to severe suicide risk. Moreover, the researchers aim to determine "profiles" of such associations for different patient subgroups. These profiles of associations will be regressed against the presence vs absence of novel suicide risk behavior including possible self-harm and suicide episodes as a subsequent follow up point months later. Hence, the core data from the project will be seen in relation to both suicidal thoughts and subsequent suicidal behavior.

Below, four Research Questions (RQ) including specific hypotheses are described.

RQ1: Delineate fluctuations in suicide ideation

  1. In the overall patient group considered together, suicide ideation (degree and endurance) will fluctuate markedly within a day and over the assessment period
  2. Patient characteristics and patient subgroups can be identified, with different fluctuations in suicide ideation, including absence of suicide ideation at most time points, stable levels of suicide ideation, highly fluctuating levels, and duration of suicide ideation

RQ2: Identify factors that are associated with/ influence suicide ideation in the EMA assessment period

  1. Associations with patient characteristics at baseline: Overall, suicide ideation will be at higher levels and fluctuate more profoundly, in individuals with high baseline scores on the following: i) psychological pain, stress, agitation or inner turmoil, hopelessness and self-hate, ii) high severity of their recent suicide attempt, and iii) high levels of depression and general symptom severity, in addition to (iv) in individuals who live socially isolated/ alone versus those who live together with a partner or family
  2. Associations with relational and contextual measures during EMA assessment:
  3. Suicide ideation will be relatively high as well as enduring in times of i) psychological pain, stress, agitation or inner turmoil, hopelessness and self-hate, ii) interpersonal conflict, iii) when they are alone or with friends and negative feelings dominate over positive feelings, and iv) when perceived control over thoughts is low ii. Suicide ideation will be absent when i) patients are in relations with other people and (ii) when they experience positive feelings

RQ3: Generate profiles for subgroups

  1. Based on findings for RQ1-RQ3, different profiles of associations between suicide ideation and other EMA measures can be delineated for different subgroups of patients, and that can be reliably linked to patient characteristics at baseline
  2. Explore differences in suicide ideation and related cognitions/ other EMA measures in the group with and without a suicide attempt
  3. High risk profiles can be identified by linking associations between suicide ideation and other EMA measures to subsequent suicide ideation, symptom severity, self-harm, and/ or suicide attempts at 3 weeks and 3 months follow-up

RQ4: How do participants experience and evaluate their participation and completion of the EMA assessment protocol?

This is a longitudinal observational study. The researchers will adopt the method of Ecological Momentary Assessment to assess how participants cope in the postdischarge period. Participants will receive 5 surveys daily in the first 10 days after leaving the hospital. Additionally, participants will meet to three research interviews; baseline interview before discharge from the hospital, after three weeks and after three months

Measures (see section for outcome measures)

The multi-level EMA data (assessments nested within days and participants) will be analyzed in mixed effect regression models, focusing on linear changes in suicidal ideation over time and on how this is associated with independent variables. To estimate within-subject and between-subject variation, the patient identifier and time will be the random variables in the mixed effect model. In the random part of the mixed model, the residual is the estimate for within-subject variation. In prospective analyses (from T to T+1), time-lagged variables will be used as predictors. Data will be centered prior to analysis, with centering model based on the hypothesis to be tested.

Statistical power in multilevel data depends on number of both individuals and assessments.

With 5 daily assessments over 10 days in 50 participants, power is 100% to detect large effect sizes and 80% to detect medium effect sizes (as modeled by Power Curves for Multi-level Studies (shinyapps.io).

References- Chung, D., et al., Meta-analysis of suicide rates in the first week and the first month after psychiatric hospitalisation. BMJ Open, 2019. 9(3): p. e023883.

Franklin, J.C., et al., Risk factors for suicidal thoughts and behaviors: A meta-analysis of 50 years of research. Psychol Bull, 2017. 143(2): p. 187-232.

Large, M. and N. Kapur, Psychiatric hospitalisation and the risk of suicide. Br J Psychiatry, 2018. 212(5): p. 269-273.

Large, M., The role of prediction in suicide prevention. Dialogues Clin Neurosci, 2018. 20(3): p. 197-205.

Nock, M.K., M.J. Prinstein, and S.K. Sterba, Revealing the form and function of self-injurious thoughts and behaviors: A real-time ecological assessment study among adolescents and young adults. J Abnorm Psychol, 2009. 118(4): p. 816-27.

Medical subject headings
Suicide Prevention, Suicide, Attempted

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05955807
Study groupRoleWhat they receive
Patients hospitalized due to severe risk of suicideThis 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 10 day Ecological Momentary Assessment-registrations

Secondary outcomes (7)
  1. Suicidal behaviors

    The Suicide Attempt Self-injury Count (SASIC-interview)

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

  2. General symptom severity

    Outcome Questionnaire 45 (Likert scale 0-4, 45 questions, where high scores refers to high symptom severity)

    Measured: Baseline and 3 months

  3. Depression

    Patient Health Questionnaire-9 (Likert scare 0-3. 9 questions, where high scores indicate higher symptom severity)

    Measured: baseline

  4. Experience with using the EMA app

    User Satisfaction Survey on patient experience with EMA-assessment (1-5, 6 questions where higher scores indicate that the participant agrees more to the statement)

    Measured: 3 weeks

  5. Suicide Ideation

    Beck Scale for Suicide Ideation- Current (0-2, 19 questions. Higher scores indicate more severe suicide ideation)

    Measured: Baseline, 3 weeks, 3 months

  6. Suicide ideation

    Suicide Status Form-IV (1-5, where higher scores indicate more symptoms)

    Measured: Baseline, 3 weeks, 3 months

  7. EMA questionnaire protocol

    26- 28 questions covering; mood, suicide ideation, significant recent events, context and actions. Likers scale questions are scaled from 1-5 or 1-7, where higher scores indicate higher intensity.

    Measured: 10 day intensive tracking og experiences

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2023
  2. Study start15 Aug 2022
  3. Primary completion8 Jun 2024 (estimated)
  4. Study completion1 Aug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05955807
Sponsor's protocol ID
Vestreviken
Status last verified
Aug 2023
First submitted
21 Apr 2023
Last updated
8 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Suicide Risk and Suicide Ideation, run by Vestre Viken Hospital Trust at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fluctuations in suicide ideation (time frame: 10 day Ecological Momentary Assessment-registrations). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.

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