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.
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
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
- In the overall patient group considered together, suicide ideation (degree and endurance) will fluctuate markedly within a day and over the assessment period
- 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
- 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
- Associations with relational and contextual measures during EMA assessment:
- 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
- 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
- Explore differences in suicide ideation and related cognitions/ other EMA measures in the group with and without a suicide attempt
- 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.
- Conditions
- Suicide Risk, Suicide Ideation, Suicide Prevention, Ecological Momentary Assessment, Suicide Attempt
- 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 group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Suicidal behaviors
The Suicide Attempt Self-injury Count (SASIC-interview)
Measured: Baseline, 3 weeks after discharge, and then again 3 months after discharge
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
Depression
Patient Health Questionnaire-9 (Likert scare 0-3. 9 questions, where high scores indicate higher symptom severity)
Measured: baseline
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
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
Suicide ideation
Suicide Status Form-IV (1-5, where higher scores indicate more symptoms)
Measured: Baseline, 3 weeks, 3 months
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.
- First posted21 Jul 2023
- Study start15 Aug 2022
- Primary completion8 Jun 2024 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide RiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Vestre Viken Hospital Trust
- Sponsor type
- University, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05955807
- Acronym / sponsor ID
- Vestreviken
- Conditions
- Suicide Risk, Suicide Ideation, Suicide Prevention, Ecological Momentary Assessment, Suicide Attempt
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Vestre Viken Hospital TrustUniversity, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 8 Jun 2024 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 21 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- In the overall patient group considered together, suicide ideation (degree and endurance) will fluctuate markedly within a day and over the assessment period
- 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
- 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
- Associations with relational and contextual measures during EMA assessment:
- 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
- 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
- Explore differences in suicide ideation and related cognitions/ other EMA measures in the group with and without a suicide attempt
- 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in psychiatric care in Norway are characterized by high symptom severity and comorbid conditions.
Key inclusion criteria (2 listed)
- Patients hospitalized with a recent suicide attempt or
- Patient hospitalized due to severe risk of suicide
Key exclusion criteria (4 listed)
- Active psychosis
- Developmental disorders
- Intellectual disability
- Poor norwegian acquisition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fluctuations in suicide ideation
Time frame: 10 day Ecological Momentary Assessment-registrations
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.
7 secondary outcomes
Suicidal behaviors
Time frame: Baseline, 3 weeks after discharge, and then again 3 months after discharge
General symptom severity
Time frame: Baseline and 3 months
Depression
Time frame: baseline
Experience with using the EMA app
Time frame: 3 weeks
Suicide Ideation
Time frame: Baseline, 3 weeks, 3 months
Suicide ideation
Time frame: Baseline, 3 weeks, 3 months
EMA questionnaire protocol
Time frame: 10 day intensive tracking og experiences
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.