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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH115111-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This is a single-blind, randomized controlled trial to test the effectiveness of a peer mentorship intervention (PREVAIL) for reducing suicide risk compared to enhanced usual care among participants (N=455) at high-risk for suicide recruited from inpatient psychiatric units.
Amid consistently worsening suicide rates, in 2012 the U.S. Surgeon General's National Strategy for Suicide Prevention proposed to "change the narrative" about suicide prevention to include a focus on promoting hope and belongingness. Despite hopelessness and thwarted belongingness being among the most replicated risk factors for suicide, many widely implemented suicide prevention efforts instead emphasize the identification of acute suicide risk and referral to mental health treatment services. However, there are very few health service interventions known to reduce suicides among those identified as high risk. Those interventions shown to be effective have not achieved the wide scale implementation necessary to alter the trend of increasing suicide deaths. New interventions are needed, and one promising, scalable intervention with a novel approach to addressing the risk factors advocated by the Surgeon General is peer mentorship. A peer mentorship intervention, PREVAIL, has been piloted in a two-site randomized controlled trial (N=70) and is acceptable and feasible with enrollment of nearly half of eligible high-risk patients, mean completion of over 6 mentorship sessions, and 85% of sessions meeting fidelity standards for addressing the intended targets of hope and belongingness.
The aims of this hybrid effectiveness-implementation study are:
Specific Aim 1: Determine the effectiveness of the PREVAIL peer mentorship intervention for reducing suicide attempts and suicidal ideation among recently hospitalized adult psychiatric patients at high risk for suicide.
Specific Aim 2: Examine the mechanisms of peer mentorship by measuring the effects of PREVAIL on potential mediators,including hope and belongingness.
Specific Aim 3: Identify barriers and facilitators to implementation of PREVAIL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peer Mentorship intervention (PREVAIL) | Experimental | PREVAIL peer mentorship |
|
| Enhanced Usual Care (EUC) | Active Comparator | Enhanced Usual Care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer mentorship | Behavioral | The PREVAIL intervention will be delivered by a Certified Peer Support Specialist (CPSS) or Peer Recovery Coach. Participants will select a Peer to work with based on brief personal descriptions. Sessions may occur in-person (public place, the participant's home, or a research clinic space) or remotely (phone or video call). The first meeting will occur while the participant is hospitalized, and subsequent sessions will be scheduled per the participant's preferences, with a suggested frequency of twice weekly for weeks 1-2, weekly for weeks 3-8, and every other week for the last month. Sessions will last 1 hour on average and will consist of semi-structured conversations focused on protective factors such as hope, safety planning, and coping skills. Session structure and content are intentionally flexible to allow for general supportive listening, validation, sharing, and genuineness in the relationship, thereby increasing acceptability and implicit belongingness. |
| Measure | Description | Time Frame |
|---|---|---|
| Suicide Attempts, as Measured by the Columbia Suicide Severity Rating Scale (CSSRS) | Number of participants reporting any suicide attempt, as reported on the Columbia Suicide Severity Rating Scale (CSSRS). The definition of suicide attempt for the primary outcome will consist of any actual suicide attempt, aborted suicide attempt, or interrupted suicide attempt reported on the CSSR-S. | 3 months, 6 months |
| Suicidal Ideation (Current), as Measured by the Beck Suicide Scale (BSS) | Patient's current suicidal ideation as measured by the Beck Scale for Suicidal Ideation (BSS). The BSS is a 19-item (5 screening items are first administered to determine whether the remaining items are administered) self-report scale that assesses thoughts, plans and intent to commit suicide. All 19 items are rated on a three-point scale (0 to 2). Total scores could range from 0 to 38. No specific cut-off scores exist to classify severity. Higher scores mean a worse outcome (greater suicide risk). | 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Suicide Attempts (Measured by the Medical Record) | Count of participants with any suicide attempt as notated in the patient's electronic medical record. The definition of suicide attempt for the primary outcome will consist of any actual suicide attempt, aborted suicide attempt, or interrupted suicide attempt. | 6-months |
| Measure | Description | Time Frame |
|---|---|---|
| Depression, as Measured by the Patient Health Questionnaire (PHQ-9) | The Patient Health Questionnaire (PHQ-9) is a 9-item, self-report survey which assesses frequency of depression symptoms over the past 2 weeks on a 4-item response scale (where 0 = "Not at all" and 3 = "Nearly every day"). Scores range between 0 and 27, with high scores indicating worse outcomes (more severe depression) | 3 months, 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Pfeiffer, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Inpatient Psychiatry Unit | Ann Arbor | Michigan | 48109 | United States | ||
| Henry Ford Kingswood Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40434775 | Derived | Pfeiffer PN, Abraham KM, Lapidos A, Vega E, Jagusch J, Garlick J, Pasiak S, Ganoczy D, Kim HM, Ahmedani B, Ilgen M, King C. Peer Support Intervention for Suicide Prevention Among High-Risk Adults in Michigan: A Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e2510808. doi: 10.1001/jamanetworkopen.2025.10808. | |
| 33884617 | Derived | Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Peer Mentorship Intervention (PREVAIL) | A Peer Specialist will be making regular follow-up contact with study participants in the community or by telephone for 3 months following hospital discharge. Peer mentorship interactions will include a series of manualized, semi-structured conversations developed by the study team and will address protective factors such as hope and belongingness. PREVAIL arm participants will also receive Enhanced Usual Care (EUC). Peer mentorship: The PREVAIL intervention will be delivered by a Certified Peer Support Specialist (CPSS) or Peer Recovery Coach. Participants will select a Peer to work with based on brief personal descriptions. Sessions may occur in-person (public place, the participant's home, or a research clinic space) or remotely (phone or video call). The first meeting will occur while the participant is hospitalized, and subsequent sessions will be scheduled per the participant's preferences, with a suggested frequency of twice weekly for weeks 1-2, weekly for weeks 3-8, and every other week for the last month. Sessions will last 1 hour on average and will consist of semi-structured conversations focused on protective factors such as hope, safety planning, and coping skills. Session structure and content are intentionally flexible to allow for general supportive listening, validation, sharing, and genuineness in the relationship, thereby increasing acceptability and implicit belongingness. |
| FG001 | Enhanced Usual Care (EUC) | The EUC condition will consist of a "caring message" from the study team via e-mail or text message (based on the participant's preference) 24-72 hours after discharge. An example message is, "We hope things are going well for you since you left the hospital. If you wish to reply, we'd be glad to hear from you." A list of local mental health resources will be available if participants reply and during the 3 and 6-month follow-up assessments. The EUC condition is modeled on prior studies of caring letters and brief contacts by health professionals after suicidal crisis and national recommendations to provide post-crisis follow-up contacts. Enhanced Usual Care: The EUC condition will consist of a "caring message" from the study team via e-mail or text message (based on the participant's preference) 24-72 hours after discharge. An example message is, "We hope things are going well for you since you left the hospital. If you wish to reply, we'd be glad to hear from you". A list of local mental health resources will be available if participants reply and during the 3 and 6-month follow-up assessments. The EUC condition is modeled on prior studies of caring letters and brief contacts by health professionals after suicidal crisis and national recommendations to provide post-crisis follow-up contacts. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Peer Mentorship Intervention (PREVAIL) | A Peer Specialist will be making regular follow-up contact with study participants in the community or by telephone for 3 months following hospital discharge. Peer mentorship interactions will include a series of manualized, semi-structured conversations developed by the study team and will address protective factors such as hope and belongingness. PREVAIL arm participants will also receive Enhanced Usual Care (EUC). Peer mentorship: The PREVAIL intervention will be delivered by a Certified Peer Support Specialist (CPSS) or Peer Recovery Coach. Participants will select a Peer to work with based on brief personal descriptions. Sessions may occur in-person (public place, the participant's home, or a research clinic space) or remotely (phone or video call). The first meeting will occur while the participant is hospitalized, and subsequent sessions will be scheduled per the participant's preferences, with a suggested frequency of twice weekly for weeks 1-2, weekly for weeks 3-8, and every other week for the last month. Sessions will last 1 hour on average and will consist of semi-structured conversations focused on protective factors such as hope, safety planning, and coping skills. Session structure and content are intentionally flexible to allow for general supportive listening, validation, sharing, and genuineness in the relationship, thereby increasing acceptability and implicit belongingness. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Suicide Attempts, as Measured by the Columbia Suicide Severity Rating Scale (CSSRS) | Number of participants reporting any suicide attempt, as reported on the Columbia Suicide Severity Rating Scale (CSSRS). The definition of suicide attempt for the primary outcome will consist of any actual suicide attempt, aborted suicide attempt, or interrupted suicide attempt reported on the CSSR-S. | The number of participant analyzed decreases at the 3- and 6-month time points due to attrition. | Posted | Count of Participants | Participants | 3 months, 6 months |
|
24 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Peer Mentorship Intervention (PREVAIL) | A Peer Specialist will be making regular follow-up contact with study participants in the community or by telephone for 3 months following hospital discharge. Peer mentorship interactions will include a series of manualized, semi-structured conversations developed by the study team and will address protective factors such as hope and belongingness. PREVAIL arm participants will also receive Enhanced Usual Care (EUC). Peer mentorship: The PREVAIL intervention will be delivered by a Certified Peer Support Specialist (CPSS) or Peer Recovery Coach. Participants will select a Peer to work with based on brief personal descriptions. Sessions may occur in-person (public place, the participant's home, or a research clinic space) or remotely (phone or video call). The first meeting will occur while the participant is hospitalized, and subsequent sessions will be scheduled per the participant's preferences, with a suggested frequency of twice weekly for weeks 1-2, weekly for weeks 3-8, and every other week for the last month. Sessions will last 1 hour on average and will consist of semi-structured conversations focused on protective factors such as hope, safety planning, and coping skills. Session structure and content are intentionally flexible to allow for general supportive listening, validation, sharing, and genuineness in the relationship, thereby increasing acceptability and implicit belongingness. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Medically serious suicide attempt | Psychiatric disorders | Systematic Assessment | Suicide attempt requiring medical hospitalization. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Pfeiffer, MD | University of Michigan | 734-845-3645 | ppfeiffe@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 25, 2024 | Sep 26, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 20, 2022 | Sep 26, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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|
|
| Enhanced Usual Care | Behavioral | The EUC condition will consist of a "caring message" from the study team via e-mail or text message (based on the participant's preference) 24-72 hours after discharge. An example message is, "We hope things are going well for you since you left the hospital. If you wish to reply, we'd be glad to hear from you." A list of local mental health resources will be available if participants reply and during the 3 and 6-month follow-up assessments. The EUC condition is modeled on prior studies of caring letters and brief contacts by health professionals after suicidal crisis and national recommendations to provide post-crisis follow-up contacts. |
|
|
| Self Efficacy to Avoid Suicidal Action (Measured by the Self Efficacy to Avoid Suicidal Action Scale) |
Participants' sense of self-efficacy to avoid suicidal action, as measured by the 6-item Self Efficacy to Avoid Suicidal Action Scale (SEASA). To indicate level of confidence, respondents rate each item on a 9-point scale (where 0=very uncertain and 9=very certain). Scores range between 0 and 54; lower scores are associated with worse outcomes (a higher incidence and greater severity of suicide attempts). |
| 3 months, 6 months |
| Suicidal Ideation (Worst-point), as Measured by the Beck Scale for Suicidal Ideation (BSS) | Patient's worst-point suicidal ideation as measured by the Beck Scale for Suicidal Ideation (BSS). The BSS is a 19-item (5 screening items are first administered to determine whether the remaining items are administered) self-report scale that assesses thoughts, plans and intent to commit suicide. All 19 items are rated on a three-point scale (0 to 2). Total scores could range from 0 to 38. No specific cut-off scores exist to classify severity. Higher scores mean a worse outcome (greater suicide risk). | 3 months, 6 months |
| Hope, as Measured by the State Hope Scale (SHS) | The State Hope Scale (SHS) is a 6-item, self-report measure that assesses hopeful thinking along two sub-scales reflecting respondents' personal capacity for change (agency) and knowledge regarding how to achieve change (pathways). Total scores range from 6 to 48. Higher scores indicated better outcomes (greater hope). | 3-months |
| Burdensomeness, as Measured by the Perceived Burdensomeness Subscale of the Interpersonal Needs Questionnaire (INQ-10) | The Interpersonal Needs Questionnaire (INQ-10) is a 10-item, self-report measure of perceived burdensomeness and thwarted belongingness. The perceived burdensomeness subscale of the INQ-10 consists of 4 items; scores range from 4 to 28, with higher scores indicating worse outcomes (greater perceived burdensomeness). | 3-months |
| Perceived Emotional Support (Measured by the NIH Toolbox Adult Social Relationship Scales (ASRS)) | The Adult Toolbox Social Relationship Scales measures social relationship concepts including social support, companionship, and social distress. The Emotional Support subscale consists of 8 items rated on a 5-point Likert scale. Scores range from 8 to 40; higher scores indicate better outcomes (greater perceived emotional support). | 3-months |
| Perceived Instrumental Support (Measured by the NIH Toolbox Adult Social Relationship Scales (ASRS)) | The Adult Toolbox Social Relationship Scales measures social relationship concepts including social support, companionship, and social distress. The Instrumental Support subscale consists of 8 items rated on a 5-point Likert scale. Scores range from 8 to 40; higher scores indicate better outcomes (greater perceived instrumental support). | 3-months |
| Perceived Friendship (Measured by the NIH Toolbox Adult Social Relationship Scales (ASRS)) | The Adult Toolbox Social Relationship Scales measures social relationship concepts including social support, companionship, and social distress. The Friendship subscale consists of 8 items rated on a 5-point Likert scale. Scores range from 8 to 40; higher scores indicate better outcomes (greater perceived friendship). | 3-months |
| Loneliness (Measured by the NIH Toolbox Adult Social Relationship Scales (ASRS)) | The Adult Toolbox Social Relationship Scales measures social relationship concepts including social support, companionship, and social distress. The Loneliness subscale consists of 5 items rated on a 5-point Likert scale. Scores range from 5 to 25; higher scores indicate worse outcomes (greater loneliness). | 3-months |
| Perceived Rejection (Measured by the NIH Toolbox Adult Social Relationship Scales (ASRS)) | The Adult Toolbox Social Relationship Scales measures social relationship concepts including social support, companionship, and social distress. The perceived rejection subscale consists of 8 items rated on a 5-point Likert scale. Scores range from 8 to 40; higher scores indicate worse outcomes (greater loneliness). | 3-months |
| Quality of Life (Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF)) | Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) consists of 14 items, assesses satisfaction with a variety of life domains such as physical health, work, and social relationships. The scoring of the Q-LES-Q-SF involves summing only the first 14 items to yield a raw total score. The last two items are not included in the total score but are standalone items. The raw total score ranges from 14 to 70. Higher level of enjoyment and satisfaction with life are reflected in higher scores. | 3 months, 6 months |
| Functional Status (Measured by the SF-12) | The SF-12 covers domains including: (1) physical functioning; (2) role-physical; (3) bodily pain; (4) general health; (5) vitality; (6) social functioning; (7) role emotional; and (8) mental health. Summary scores are calculated by summing factor-weighted scores across all 8 subscales, with factor weights derived from a US-based general population sample. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | 3 months, 6 months |
| Hopelessness (Measured by the Beck Hopelessness Scale (BHS)) | Measure of patients' negative attitudes about the future and will be the primary measure of hopelessness. The BHS consists of 20 true-false statements that measure the degree of pessimism and negativity about the future. Summed scores range from 0 to 20. Scores provide a measure of the severity of self-reported hopelessness: 0-3 minimal, 4-8 mild, 9-14 moderate, and 15-20 severe. | 3-months |
| Perceived Social Support (Measured by the Multidimensional Scale of Perceived Social Support (MDPSS)) | The Multidimensional Scale of Perceived Social Support (MDPSS) contains 12 Likert scale items with three subscales to address different sources of support: family, friends, and significant other. Total scores are an average (mean) of the subscale scores. Mean scores under 2.9 are considered low support, mean scores 3-5 are considered moderate, and 5.1-7 are considered high. Scores range from 1-7, with 1 representing lowest support and 7 representing highest support. | 3-months |
| Self-reported Utilization of Health Care Services, as Measured by the Adapted Health Services Inventory | Count of participants who self-reported utilizing any mental health care services. | 3 months, 6 months |
| Medication Adherence, as Measured by the Single-Item Self Rating (SISR) Scale for Medication Adherence | Single item that ask patients' ability to take their medications as their doctor prescribed them, rated on a 6-point scale from 1 = "Excellent" to 6 = "Very Poor," such that higher scores indicate worse outcomes (poorer adherence with taking medications as prescribed). | 3 months, 6 months |
| Perceived Meaning in Life, as Measured by the Meaning in Life Questionnaire (MLQ) | The Meaning in Life Questionnaire (MLQ) consists of 10 items measured on a 7-point likert scale ranging from absolutely true to absolutely not true. The measure consists of two subscales: presence of meaning and search for meaning. Subscale scores range from 5 to 35; higher scores indicated better outcomes (greater meaning). | 3 months, 6 months |
| Worst Suicidal Ideation in Past 3 Months (Measured by the Beck Suicide Scale (BSS)) | Patient's worst suicidal ideation in the previous 3-month time period as measured by the Beck Suicide Scale (BSS). The BSS is a self-report 19-item scale preceded by five screening items. The BSS and its screening items assess thoughts, plans and intent to commit suicide. All 24 items are rated on a three-point scale (0 to 2). Total scores could range from 0 to 38 (if the screening items are included). No specific cut-off scores exist to classify severity. Increasing scores reflect greater suicide risk. | 3-months |
| Worst Suicidal Ideation in Past 3 Months (Measured by the Beck Suicide Scale (BSS)) | Patient's worst suicidal ideation in the previous 3-month time period as measured by the Beck Suicide Scale (BSS). The BSS is a self-report 19-item scale preceded by five screening items. The BSS and its screening items assess thoughts, plans and intent to commit suicide. All 24 items are rated on a three-point scale (0 to 2). Total scores could range from 0 to 38 (if the screening items are included). No specific cut-off scores exist to classify severity. Increasing scores reflect greater suicide risk. | 6-months |
| Thwarted Belongingness, as Measured by the Thwarted Belongingness Subscale of the Interpersonal Needs Questionnaire (INQ-10) | The Interpersonal Needs Questionnaire (INQ-10) is a 10-item, self-report measure of perceived burdensomeness and thwarted belongingness. The thwarted belongingness subscale of the INQ-10 consists of 6 items; scores range from 5 to 35, with higher scores indicating worse outcomes (greater thwarted belongingness). | 3-months |
| Ferndale |
| Michigan |
| 48220 |
| United States |
| Henry Ford Macomb Hospital | Mount Clemens | Michigan | 48043 | United States |
| BG001 | Enhanced Usual Care (EUC) | The EUC condition will consist of a "caring message" from the study team via e-mail or text message (based on the participant's preference) 24-72 hours after discharge. An example message is, "We hope things are going well for you since you left the hospital. If you wish to reply, we'd be glad to hear from you." A list of local mental health resources will be available if participants reply and during the 3 and 6-month follow-up assessments. The EUC condition is modeled on prior studies of caring letters and brief contacts by health professionals after suicidal crisis and national recommendations to provide post-crisis follow-up contacts. Enhanced Usual Care: The EUC condition will consist of a "caring message" from the study team via e-mail or text message (based on the participant's preference) 24-72 hours after discharge. An example message is, "We hope things are going well for you since you left the hospital. If you wish to reply, we'd be glad to hear from you". A list of local mental health resources will be available if participants reply and during the 3 and 6-month follow-up assessments. The EUC condition is modeled on prior studies of caring letters and brief contacts by health professionals after suicidal crisis and national recommendations to provide post-crisis follow-up contacts. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Suicide attempts, as measured by the Columbia Suicide Severity Rating Scale (CSSRS) | Number of participants reporting any suicide attempt, as reported on the Columbia Suicide Severity Rating Scale (CSSRS). The definition of suicide attempt for the primary outcome will consist of any actual suicide attempt, aborted suicide attempt, or interrupted suicide attempt reported on the CSSR-S. | Count of Participants | Participants |
|
| Suicidal ideation (past week), as measured by the Beck Suicide Scale (BSS) | Patient's suicidal ideation during the week prior to inpatient psychiatric admission, as measured by the Beck Scale for Suicidal Ideation (BSS). The BSS is a 19-item (5 screening items are first administered to determine whether the remaining items are administered) self-report scale that assesses thoughts, plans and intent to commit suicide. All 19 items are rated on a three-point scale (0 to 2). Total scores could range from 0 to 38. No specific cut-off scores exist to classify severity. Higher scores mean a worse outcome (greater suicide risk). | Mean | Standard Deviation | units on a scale |
|
| Self efficacy to avoid suicidal action (measured by the Self Efficacy to Avoid Suicidal Action Scale | Participants' sense of self-efficacy to avoid suicidal action, as measured by the 6-item Self Efficacy to Avoid Suicidal Action Scale (SEASA). To indicate level of confidence, respondents rate each item on a 9-point scale (where 0=very uncertain and 9=very certain). Scores range between 0 and 54; lower scores are associated with worse outcomes (a higher incidence and greater severity of suicide attempts). | Mean | Standard Deviation | units on a scale |
|
| Depression, as measured by the Patient Health Questionnaire (PHQ-9) | The Patient Health Questionnaire (PHQ-9) is a 9-item, self-report survey which assesses frequency of depression symptoms over the past 2 weeks on a 4-item response scale (where 0 = "Not at all" and 3 = "Nearly every day"). Scores range between 0 and 27, with high scores indicating worse outcomes (more severe depression) | Counts of participants analyzed differ from the overall number of participants because some participants did not answer all survey questions. | Mean | Standard Deviation | units on a scale |
|
| Hope, as measured by the State Hope Scale (SHS) | The State Hope Scale (SHS) is a 6-item, self-report measure that assesses hopeful thinking along two sub-scales reflecting respondents' personal capacity for change (agency) and knowledge regarding how to achieve change (pathways). Total scores range from 6 to 48. Higher scores indicated better outcomes (greater hope). | The number analyzed differs from the overall number of participants because some participants did not respond to all survey questions. | Mean | Standard Deviation | units on a scale |
|
| Burdensomeness, as measured by the perceived burdensomeness subscale of the Interpersonal Needs Ques | The Interpersonal Needs Questionnaire (INQ-10) is a 10-item, self-report measure of perceived burdensomeness and thwarted belongingness. The perceived burdensomeness subscale of the INQ-10 consists of 4 items; scores range from 4 to 28, with higher scores indicating worse outcomes (lower perceived belongingness). | The number analyzed differs from the overall number of participants because some participants did not respond to all survey questions. | Mean | Standard Deviation | units on a scale |
|
| Thwarted Belongingness, as Measured by the Thwarted Belongingness Subscale of the INQ-10 | The Interpersonal Needs Questionnaire (INQ-10) is a 10-item, self-report measure of perceived burdensomeness and thwarted belongingness. The thwarted belongingness subscale of the INQ-10 consists of 6 items; scores range from 5 to 35, with higher scores indicating worse outcomes (greater thwarted belongingness). | The number analyzed differs from the overall number of participants because some participants did not respond to all survey questions. | Mean | Standard Deviation | units on a scale |
|
| Utilization of Health Care Services (Measured by the Adapted Health Services Inventory) | Count of participants who self-reported utilizing any mental health care services on an adapted version of the Health Services Inventory. | Count of Participants | Participants |
|
| Hopelessness (Measured by the Beck Hopelessness Scale (BHS)) | Measure of patients' negative attitudes about the future and will be the primary measure of hopelessness. The BHS consists of 20 true-false statements that measure the degree of pessimism and negativity about the future. Summed scores range from 0 to 20. Scores provide a measure of the severity of self-reported hopelessness: 0-3 minimal, 4-8 mild, 9-14 moderate, and 15-20 severe. | The number analyzed differs from the overall number of participants because some participants did not respond to all survey questions. | Mean | Standard Deviation | units on a scale |
|
| Perceived Rejection (Measured by the NIH Toolbox Adult Social Relationship Scales (ASRS)) | The Adult Toolbox Social Relationship Scales measures social relationship concepts including social support, companionship, and social distress. The perceived rejection subscale consists of 8 items rated on a 5-point Likert scale. Scores range from 8 to 40; higher scores indicate worse outcomes (greater loneliness). | The number analyzed differs from the overall number of participants because some participants did not respond to all survey questions. | Mean | Standard Deviation | units on a scale |
|
| Perceived Emotional Support (measured by the NIH Toolbox Adult Social Relationship Scales (ASRS)) | The Adult Toolbox Social Relationship Scales measures social relationship concepts including social support, companionship, and social distress. The Emotional Support subscale consists of 8 items rated on a 5-point Likert scale. Scores range from 8 to 40; higher scores indicate better outcomes (greater perceived emotional support). | The number analyzed differs from the overall number of participants because some participants did not respond to all survey questions. | Mean | Standard Deviation | units on a scale |
|
| Perceived Instrumental Support (measured by the NIH Toolbox Adult Social Relationship Scales (ASRS)) | The Adult Toolbox Social Relationship Scales measures social relationship concepts including social support, companionship, and social distress. The Instrumental Support subscale consists of 8 items rated on a 5-point Likert scale. Scores range from 8 to 40; higher scores indicate better outcomes (greater perceived instrumental support). | The number analyzed differs from the overall number of participants because some participants did not respond to all survey questions. | Mean | Standard Deviation | units on a scale |
|
| Perceived Friendship (Measured by the NIH Toolbox Adult Social Relationship Scales (ASRS)) | The Adult Toolbox Social Relationship Scales measures social relationship concepts including social support, companionship, and social distress. The Friendship subscale consists of 8 items rated on a 5-point Likert scale. Scores range from 8 to 40; higher scores indicate better outcomes (greater perceived friendship). | The number analyzed differs from the overall number of participants because some participants did not respond to all survey questions. | Mean | Standard Deviation | units on a scale |
|
| Loneliness (measured by the NIH Toolbox Adult Social Relationship Scales (ASRS)) | The Adult Toolbox Social Relationship Scales measures social relationship concepts including social support, companionship, and social distress. The Loneliness subscale consists of 5 items rated on a 5-point Likert scale. Scores range from 5 to 25; higher scores indicate worse outcomes (greater loneliness). | Mean | Standard Deviation | units on a scale |
|
| Highest level of education | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Occupation | Participants could select more than one occupation if applicable. | Count of Participants | Participants |
|
| Income (annual) | Count of Participants | Participants |
|
| Living Situation | Participants could select more than one option if applicable. | Count of Participants | Participants |
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| Quality of Life (Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form | Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) consists of 14 items, assesses satisfaction with a variety of life domains such as physical health, work, and social relationships. The scoring of the Q-LES-Q-SF involves summing only the first 14 items to yield a raw total score. The last two items are not included in the total score but are standalone items. The raw total score ranges from 14 to 70. Higher level of enjoyment and satisfaction with life are reflected in higher scores. | Counts of participants analyzed differ from the overall number of participants because some participants did not answer all survey questions. | Mean | Standard Deviation | units on a scale |
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| Physical Health (Measured by the SF-12) | The SF-12 covers domains including: (1) physical functioning; (2) role-physical; (3) bodily pain; (4) general health; (5) vitality; (6) social functioning; (7) role emotional; and (8) mental health. Physical Health Composite Score (PCS) is computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | Counts of participants analyzed differ from the overall number of participants because some participants did not answer all survey questions. | Mean | Standard Deviation | units on a scale |
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| Mental Health (measured by the SF-12) | The SF-12 covers domains including: (1) physical functioning; (2) role-physical; (3) bodily pain; (4) general health; (5) vitality; (6) social functioning; (7) role emotional; and (8) mental health. Mental Health Composite Score (MCS) is computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | Counts of participants analyzed differ from the overall number of participants because some participants did not answer all survey questions. | Mean | Standard Deviation | units on a scale |
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| Perceived Social Support (Measured by the Multidimensional Scale of Perceived Social Support (MDPSS) | The Multidimensional Scale of Perceived Social Support (MDPSS) contains 12 Likert scale items with three subscales to address different sources of support: family, friends, and significant other. Mean scores under 2.9 are considered low support, mean scores 3-5 are considered moderate, and 5.1-7 are considered high. The family and friend support subscales score ranges from 1-7. Total item mean is the mean of all single item means and ranges from 1-7. Higher scores indicate greater social support. | Counts of participants analyzed differ from the overall number of participants because some participants did not answer all survey questions. | Mean | Standard Deviation | units on a scale |
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| Perceived Meaning in Life, as Measured by the Meaning in Life Questionnaire (MLQ) | The Meaning in Life Questionnaire (MLQ) consists of 10 items measured on a 7-point likert scale ranging from absolutely true to absolutely not true. The measure consists of two subscales - presence of meaning and search for meaning. Subscale scores range from 5 to 35; higher scores indicate better outcomes (greater meaning). | Counts of participants analyzed differ from the overall number of participants because some participants did not answer all survey questions. | Mean | Standard Deviation | units on a scale |
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| OG001 | Enhanced Usual Care (EUC) | The EUC condition will consist of a "caring message" from the study team via e-mail or text message (based on the participant's preference) 24-72 hours after discharge. An example message is, "We hope things are going well for you since you left the hospital. If you wish to reply, we'd be glad to hear from you." A list of local mental health resources will be available if participants reply and during the 3 and 6-month follow-up assessments. The EUC condition is modeled on prior studies of caring letters and brief contacts by health professionals after suicidal crisis and national recommendations to provide post-crisis follow-up contacts. Enhanced Usual Care: The EUC condition will consist of a "caring message" from the study team via e-mail or text message (based on the participant's preference) 24-72 hours after discharge. An example message is, "We hope things are going well for you since you left the hospital. If you wish to reply, we'd be glad to hear from you". A list of local mental health resources will be available if participants reply and during the 3 and 6-month follow-up assessments. The EUC condition is modeled on prior studies of caring letters and brief contacts by health professionals after suicidal crisis and national recommendations to provide post-crisis follow-up contacts. |
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| Primary | Suicidal Ideation (Current), as Measured by the Beck Suicide Scale (BSS) | Patient's current suicidal ideation as measured by the Beck Scale for Suicidal Ideation (BSS). The BSS is a 19-item (5 screening items are first administered to determine whether the remaining items are administered) self-report scale that assesses thoughts, plans and intent to commit suicide. All 19 items are rated on a three-point scale (0 to 2). Total scores could range from 0 to 38. No specific cut-off scores exist to classify severity. Higher scores mean a worse outcome (greater suicide risk). | The number of participant analyzed decreases at the 3- and 6-month time points due to attrition. | Posted | Mean | Standard Deviation | units on a scale | 3 months, 6 months |
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| Secondary | Suicide Attempts (Measured by the Medical Record) | Count of participants with any suicide attempt as notated in the patient's electronic medical record. The definition of suicide attempt for the primary outcome will consist of any actual suicide attempt, aborted suicide attempt, or interrupted suicide attempt. | Posted | Count of Participants | Participants | 6-months |
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| Secondary | Self Efficacy to Avoid Suicidal Action (Measured by the Self Efficacy to Avoid Suicidal Action Scale) | Participants' sense of self-efficacy to avoid suicidal action, as measured by the 6-item Self Efficacy to Avoid Suicidal Action Scale (SEASA). To indicate level of confidence, respondents rate each item on a 9-point scale (where 0=very uncertain and 9=very certain). Scores range between 0 and 54; lower scores are associated with worse outcomes (a higher incidence and greater severity of suicide attempts). | Number of participants analyzed decreases at 3- and 6-month time points due to attrition. | Posted | Mean | Standard Deviation | score on a scale | 3 months, 6 months |
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| Secondary | Suicidal Ideation (Worst-point), as Measured by the Beck Scale for Suicidal Ideation (BSS) | Patient's worst-point suicidal ideation as measured by the Beck Scale for Suicidal Ideation (BSS). The BSS is a 19-item (5 screening items are first administered to determine whether the remaining items are administered) self-report scale that assesses thoughts, plans and intent to commit suicide. All 19 items are rated on a three-point scale (0 to 2). Total scores could range from 0 to 38. No specific cut-off scores exist to classify severity. Higher scores mean a worse outcome (greater suicide risk). | Number of participants analyzed decreases at 3- and 6-month time points due to attrition. | Posted | Mean | Standard Deviation | score on a scale | 3 months, 6 months |
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| Other Pre-specified | Depression, as Measured by the Patient Health Questionnaire (PHQ-9) | The Patient Health Questionnaire (PHQ-9) is a 9-item, self-report survey which assesses frequency of depression symptoms over the past 2 weeks on a 4-item response scale (where 0 = "Not at all" and 3 = "Nearly every day"). Scores range between 0 and 27, with high scores indicating worse outcomes (more severe depression) | Number of participants analyzed decreases at 3- and 6-month time points due to attrition. | Posted | Mean | Standard Deviation | score on a scale | 3 months, 6 months |
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| Other Pre-specified | Hope, as Measured by the State Hope Scale (SHS) | The State Hope Scale (SHS) is a 6-item, self-report measure that assesses hopeful thinking along two sub-scales reflecting respondents' personal capacity for change (agency) and knowledge regarding how to achieve change (pathways). Total scores range from 6 to 48. Higher scores indicated better outcomes (greater hope). | Number of participants analyzed decreases at 3- and 6-month time points due to attrition. | Posted | Mean | Standard Deviation | score on a scale | 3-months |
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| Other Pre-specified | Burdensomeness, as Measured by the Perceived Burdensomeness Subscale of the Interpersonal Needs Questionnaire (INQ-10) | The Interpersonal Needs Questionnaire (INQ-10) is a 10-item, self-report measure of perceived burdensomeness and thwarted belongingness. The perceived burdensomeness subscale of the INQ-10 consists of 4 items; scores range from 4 to 28, with higher scores indicating worse outcomes (greater perceived burdensomeness). | Posted | Mean | Standard Deviation | units on a scale | 3-months |
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| Other Pre-specified | Perceived Emotional Support (Measured by the NIH Toolbox Adult Social Relationship Scales (ASRS)) | The Adult Toolbox Social Relationship Scales measures social relationship concepts including social support, companionship, and social distress. The Emotional Support subscale consists of 8 items rated on a 5-point Likert scale. Scores range from 8 to 40; higher scores indicate better outcomes (greater perceived emotional support). | Posted | Mean | Standard Deviation | units on a scale | 3-months |
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| Other Pre-specified | Perceived Instrumental Support (Measured by the NIH Toolbox Adult Social Relationship Scales (ASRS)) | The Adult Toolbox Social Relationship Scales measures social relationship concepts including social support, companionship, and social distress. The Instrumental Support subscale consists of 8 items rated on a 5-point Likert scale. Scores range from 8 to 40; higher scores indicate better outcomes (greater perceived instrumental support). | Posted | Mean | Standard Deviation | units on a scale | 3-months |
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| Other Pre-specified | Perceived Friendship (Measured by the NIH Toolbox Adult Social Relationship Scales (ASRS)) | The Adult Toolbox Social Relationship Scales measures social relationship concepts including social support, companionship, and social distress. The Friendship subscale consists of 8 items rated on a 5-point Likert scale. Scores range from 8 to 40; higher scores indicate better outcomes (greater perceived friendship). | Posted | Mean | Standard Deviation | units on a scale | 3-months |
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| Other Pre-specified | Loneliness (Measured by the NIH Toolbox Adult Social Relationship Scales (ASRS)) | The Adult Toolbox Social Relationship Scales measures social relationship concepts including social support, companionship, and social distress. The Loneliness subscale consists of 5 items rated on a 5-point Likert scale. Scores range from 5 to 25; higher scores indicate worse outcomes (greater loneliness). | Posted | Mean | Standard Deviation | units on a scale | 3-months |
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| Other Pre-specified | Perceived Rejection (Measured by the NIH Toolbox Adult Social Relationship Scales (ASRS)) | The Adult Toolbox Social Relationship Scales measures social relationship concepts including social support, companionship, and social distress. The perceived rejection subscale consists of 8 items rated on a 5-point Likert scale. Scores range from 8 to 40; higher scores indicate worse outcomes (greater loneliness). | Posted | Mean | Standard Deviation | units on a scale | 3-months |
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| Other Pre-specified | Quality of Life (Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF)) | Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) consists of 14 items, assesses satisfaction with a variety of life domains such as physical health, work, and social relationships. The scoring of the Q-LES-Q-SF involves summing only the first 14 items to yield a raw total score. The last two items are not included in the total score but are standalone items. The raw total score ranges from 14 to 70. Higher level of enjoyment and satisfaction with life are reflected in higher scores. | The number of participants analyzed decreases at 6-months due to attrition. | Posted | Mean | Standard Deviation | units on a scale | 3 months, 6 months |
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| Other Pre-specified | Functional Status (Measured by the SF-12) | The SF-12 covers domains including: (1) physical functioning; (2) role-physical; (3) bodily pain; (4) general health; (5) vitality; (6) social functioning; (7) role emotional; and (8) mental health. Summary scores are calculated by summing factor-weighted scores across all 8 subscales, with factor weights derived from a US-based general population sample. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | Number of participants analyzed decreases at 6-months due to attrition. | Posted | Mean | Standard Deviation | units on a scale | 3 months, 6 months |
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| Other Pre-specified | Hopelessness (Measured by the Beck Hopelessness Scale (BHS)) | Measure of patients' negative attitudes about the future and will be the primary measure of hopelessness. The BHS consists of 20 true-false statements that measure the degree of pessimism and negativity about the future. Summed scores range from 0 to 20. Scores provide a measure of the severity of self-reported hopelessness: 0-3 minimal, 4-8 mild, 9-14 moderate, and 15-20 severe. | Posted | Mean | Standard Deviation | units on a scale | 3-months |
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| Other Pre-specified | Perceived Social Support (Measured by the Multidimensional Scale of Perceived Social Support (MDPSS)) | The Multidimensional Scale of Perceived Social Support (MDPSS) contains 12 Likert scale items with three subscales to address different sources of support: family, friends, and significant other. Total scores are an average (mean) of the subscale scores. Mean scores under 2.9 are considered low support, mean scores 3-5 are considered moderate, and 5.1-7 are considered high. Scores range from 1-7, with 1 representing lowest support and 7 representing highest support. | Posted | Mean | Standard Deviation | units on a scale | 3-months |
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| Other Pre-specified | Self-reported Utilization of Health Care Services, as Measured by the Adapted Health Services Inventory | Count of participants who self-reported utilizing any mental health care services. | Number of participants analyzed decreases at 6-months due to attrition. | Posted | Count of Participants | Participants | 3 months, 6 months |
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| Other Pre-specified | Medication Adherence, as Measured by the Single-Item Self Rating (SISR) Scale for Medication Adherence | Single item that ask patients' ability to take their medications as their doctor prescribed them, rated on a 6-point scale from 1 = "Excellent" to 6 = "Very Poor," such that higher scores indicate worse outcomes (poorer adherence with taking medications as prescribed). | Number of participants analyzed is lower at 6-months due to attrition. | Posted | Mean | Standard Deviation | units on a scale | 3 months, 6 months |
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| Other Pre-specified | Perceived Meaning in Life, as Measured by the Meaning in Life Questionnaire (MLQ) | The Meaning in Life Questionnaire (MLQ) consists of 10 items measured on a 7-point likert scale ranging from absolutely true to absolutely not true. The measure consists of two subscales: presence of meaning and search for meaning. Subscale scores range from 5 to 35; higher scores indicated better outcomes (greater meaning). | Number of participants analyzed decreases at 6-months due to attrition. | Posted | Mean | Standard Deviation | units on a scale | 3 months, 6 months |
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| Other Pre-specified | Worst Suicidal Ideation in Past 3 Months (Measured by the Beck Suicide Scale (BSS)) | Patient's worst suicidal ideation in the previous 3-month time period as measured by the Beck Suicide Scale (BSS). The BSS is a self-report 19-item scale preceded by five screening items. The BSS and its screening items assess thoughts, plans and intent to commit suicide. All 24 items are rated on a three-point scale (0 to 2). Total scores could range from 0 to 38 (if the screening items are included). No specific cut-off scores exist to classify severity. Increasing scores reflect greater suicide risk. | Posted | Mean | Standard Deviation | units on a scale | 3-months |
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| Other Pre-specified | Worst Suicidal Ideation in Past 3 Months (Measured by the Beck Suicide Scale (BSS)) | Patient's worst suicidal ideation in the previous 3-month time period as measured by the Beck Suicide Scale (BSS). The BSS is a self-report 19-item scale preceded by five screening items. The BSS and its screening items assess thoughts, plans and intent to commit suicide. All 24 items are rated on a three-point scale (0 to 2). Total scores could range from 0 to 38 (if the screening items are included). No specific cut-off scores exist to classify severity. Increasing scores reflect greater suicide risk. | Posted | Mean | Standard Deviation | units on a scale | 6-months |
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| Other Pre-specified | Thwarted Belongingness, as Measured by the Thwarted Belongingness Subscale of the Interpersonal Needs Questionnaire (INQ-10) | The Interpersonal Needs Questionnaire (INQ-10) is a 10-item, self-report measure of perceived burdensomeness and thwarted belongingness. The thwarted belongingness subscale of the INQ-10 consists of 6 items; scores range from 5 to 35, with higher scores indicating worse outcomes (greater thwarted belongingness). | Posted | Mean | Standard Deviation | units on a scale | 3-months |
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| 2 |
| 229 |
| 51 |
| 229 |
| 0 |
| 229 |
| EG001 | Enhanced Usual Care (EUC) | The EUC condition will consist of a "caring message" from the study team via e-mail or text message (based on the participant's preference) 24-72 hours after discharge. An example message is, "We hope things are going well for you since you left the hospital. If you wish to reply, we'd be glad to hear from you." A list of local mental health resources will be available if participants reply and during the 3 and 6-month follow-up assessments. The EUC condition is modeled on prior studies of caring letters and brief contacts by health professionals after suicidal crisis and national recommendations to provide post-crisis follow-up contacts. Enhanced Usual Care: The EUC condition will consist of a "caring message" from the study team via e-mail or text message (based on the participant's preference) 24-72 hours after discharge. An example message is, "We hope things are going well for you since you left the hospital. If you wish to reply, we'd be glad to hear from you". A list of local mental health resources will be available if participants reply and during the 3 and 6-month follow-up assessments. The EUC condition is modeled on prior studies of caring letters and brief contacts by health professionals after suicidal crisis and national recommendations to provide post-crisis follow-up contacts. | 2 | 226 | 55 | 226 | 0 | 226 |
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| Psychiatric hospitalization due to suicidal intent or behavior | Psychiatric disorders | Systematic Assessment |
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| Psychiatric hospitalization for a reason other than suicide risk | Psychiatric disorders | Systematic Assessment |
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| Psychiatric Emergency Department visit without hospitalization | Psychiatric disorders | Systematic Assessment |
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| Homicidal behavior | Psychiatric disorders | Systematic Assessment |
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| Suicide attempt without medical attention | Psychiatric disorders | Systematic Assessment |
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Not provided
Not provided
| Other |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 6 Months |
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| 6 months |
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| 6-Months |
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| 6-Months |
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| 6-Months |
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| 6-Months |
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| 6-Months |
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| 6-Months |
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| Presence subscale: 6-Months |
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| Searching subscale: 3-Months |
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| Searching subscale: 6-Months |
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