Suicide Prevention
Conditions
Keywords
Mental health education, Clinical Trial, Suicidal ideation, Suicide, attempted
Brief summary
The VA is committed to reducing suicide in the U.S. Veteran population. Over 6,000 Veterans die from suicide each year, and this risk is particularly high following a psychiatric hospitalization. This may be due to problems with engagement in care and poor social connectedness. Although the VA has implemented tools to address Veteran suicide risk, suicide after psychiatric discharge remains an ongoing problem. This has highlighted the need to develop new interventions and approaches to post-discharge mental health care within the VA. In response, this project is a randomized control trial of an intervention an intervention called Prevention of suicide: Education, Awareness, Connection, and Engagement (PEACE). This intervention is comprised of two synergistic and promising components to prevent suicide: 1) a mobile mental health app, which aims to improve social connectedness after discharge; and 2) a manual-based intervention called the Veterans Affairs Brief Intervention and Contact Program (VA-BIC), which promotes engagement in care. The overall goal of this study is to determine if the PEACE intervention combined with standard discharge care reduces suicidal ideation as compared to a control group receiving only standard discharge care.
Detailed description
Background: Suicide is a major public health concern in the U.S., and even more so in the Veteran population. Furthermore, the period following psychiatric hospitalization is one of the highest risk periods for suicide. Based on current evidence, some of the most important contributing factors to post-hospitalization suicide risk include problems with engagement in care, fragmented care, and lack of social connectedness. Other studies in civilian populations have also raised similar concerns, highlighting the need to identify novel and effective interventions or approaches to post-discharge mental health care. Objectives: This project aims to 1) Identify the effect of PEACE on suicidal ideation after psychiatric hospitalization, compared to standard care alone; 2) Identify the effect of PEACE on social connectedness and engagement in care after psychiatric hospitalization, compared to standard care alone; and 3) Compare the effect of PEACE on suicide attempts and suicide deaths after psychiatric hospitalization, compared to standard care alone. Methods: This is a single-site, assessor-blinded, randomized control trial of PEACE plus standard psychiatric hospital discharge care compared to standard psychiatric hospital discharge care alone. The trial will enroll up to 160 participants aged 18 years and older who are being discharged from the White River Junction VA Medical Center inpatient mental health unit. Participants will be randomized to either the PEACE intervention plus standard psychiatric discharge care or standard psychiatric discharge care alone. Suicidal ideation, hopelessness, social connectedness, engagement in care, suicide attempts, and app engagement (only those randomized to PEACE) will be measured at baseline and one, three, and six months post-discharge. Participants randomized to PEACE will also receive eight additional intervention contacts as part of the VA-BIC protocol. Hypothesis: Veterans receiving the PEACE intervention will report greater improvements in suicidal thoughts and behaviors, hopelessness, social connectedness, and engagement in care at follow-up contact visits compared to Veterans receiving standard care alone.
Interventions
BEHAVIORALPEACE
The intervention consists of three synergistic components that work to support the patient after inpatient psychiatric discharge: 1) Brief educational component, where the patient receives a one-hour, one-on-one, personalized educational session on suicide prevention; 2) Seven regular contacts after discharge, where the study psychologist who delivered the brief educational visit will contact the patient to monitor the patient's symptoms, assess treatment adherence, review their safety plan, and assist the patient with engaging in care, if needed; and 3) Mobile app, which aims to improve the patient's social connectedness and provide additional educational materials on suicide.
OTHERStandard Psychiatric Hospital Discharge Care
Current VA standard discharge care includes five core elements. First, patients and their outpatient providers are required to be involved in discharge planning. Second, patients should be offered evidence-based treatments to address their mental health symptoms. Third, the inpatient team should work with the patient to complete a safety plan prior to discharge. Fourth, the inpatient team should arrange two follow-up care visits within 30 days of discharge. Fifth, the inpatient team in conjunction with the SPC assess whether patients are appropriate to be placed on the High Risk for Suicide List. Patients who are placed on the High Risk for Suicide List receive enhanced oversight as outlined in VA policy.
Sponsors
VA Office of Research and Development
White River Junction Veterans Affairs Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcomes assessor will be blinded to treatment allocation and will remind the participant at each contact to not disclose their treatment status.
Intervention model description
Participants are assigned to one of two groups in parallel: PEACE plus standard psychiatric discharge care vs. standard psychiatric discharge care alone
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Per the unit psychiatrist, hospitalization was due to concerns about acute risk for self-harm including suicidal ideation, suicide attempt, and/or admitting provider deemed the patient was at imminent risk for self-harm; * Be a Veteran eligible to receive VA services; * Be 18 years or older; * Be able to speak English; * Have access to a smart phone and express willingness to download a mobile app.
Exclusion criteria
* Unable to provide informed consent; * The investigators do not plan to enroll any potentially vulnerable populations including prisoners, or involuntarily committed patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Beck Scale for Suicide Ideation (BSS) | 1-month, 3-month, and 6- month post-discharge | The BSS is a self-reported questionnaire that assesses severity of suicidal ideation. The BSS measures attitudes, behaviors, and plans to die by suicide. Each item on the BSS is scored on a scale from 0 to 2 and the first 19 of the 21 items are used to calculate a total score ranging from 0 - 38. The BSS has high reliability and is a valid measure of suicidal ideation. There is also evidence that the BSS is measurement invariant across time. The BSS is widely used in clinical trials, is sensitive to clinical change, and unlike most other measures of suicidal ideation, higher scores on the BSS are associated with death by suicide. While there is no established BSS cutoff score to classify suicide risk as high, low, or none, there is evidence that higher scores on the BSS correspond to more severe suicidal ideation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Suicide-Related Coping Scale (SRCS) | 1-month, 3-month, and 6- month post-discharge | This scale includes 17 questions related to a patient's perception of their ability to cope with suicidal thoughts. Each item is assessed using a 5-point Likert scale and the measure has been developed based on two studies of suicide prevention strategies conducted within Veteran populations. The scale includes two subscales including an External Coping subscale and an Internal Coping Subscale. Both subscales have shown good acceptable internal consistency. The two factors are also sensitive to change over time. The score range for the entire scale is 0-68. Higher scores on the scale suggest better coping. |
| The Partners in Health Scale (PIH): Self-Management | 1-month, 3-months, and 6-months post discharge | The Partners in Health Scale measures self-management of chronic health conditions. It is a valid scale that includes 12 items. Each question is measured on a Likert scale of 0-8. Scores range from 0-96. Higher scores reflect improved engagement and self-management of chronic health conditions. |
| Beck Hopelessness Scale (BHS) | 1-month, 3-months and 6- months post-discharge | The BHS is a 20-item self-report scale that assesses hopelessness over the past seven days. Patients comment on feelings about the future, loss of motivation, and future expectations. Total scores range from 0 to 20, with higher scores suggesting more hopelessness. Higher scores on the BHS are associated with increased suicide risk. The BHS has good reliability and validity and is sensitive to change. |
| Interpersonal Needs Questionnaire-15 (INQ-15): Thwarted Belongingness | 1 month, 3-months, and 6-months post discharge | The INQ-15 is a 15 item scale that measures thwarted belongingness and perceived burdensomeness. Each item is measured on a 7-point Likert scale. Items 7, 8, 10, 13, 14, and 15 are reverse coded. Scores on the total scale range from 15-105. The thwarted belongingness subscale includes 9 items and scores range from 9-63 with higher scores indicating worse thwarted belongingness. |
| Interpersonal Needs Questionnaire-15 (INQ-15): Perceived Burdensomeness | 1-month, 3-months, and 6-months post discharge | The INQ-15 is a 15 item scale that measures thwarted belongingness and perceived burdensomeness. Each item is measured on a 7-point Likert scale. Items 7, 8, 10, 13, 14, and 15 are reverse coded. Scores on the total scale range from 15-105. The perceived burdensomeness subscale includes 6 items and scores range from 6-42 with higher scores indicating worse perceived burdensomeness. |
| The Multidimensional Scale of Perceived Social Support (MSPSS) | 1-month, 3-months and 6- months post-discharge | The multidimensional scale of perceived social support is a valid scale that includes 12 items that measure several perceived sources of social support including family, friends, and significant others. The score range is 1-7 with higher scores suggesting greater perceived support. |
| App Engagement Scale (AES) for Mobile Applications | 6- month post-discharge | The App Engagement Scale (AES) is adapted from the Mobile Application Rating Scale (uMARS) and is a valid scale. All items are rated on a 5-point scale. Scores range from 0-40 and higher scores indicate greater perceived quality of the mobile application. |
| Continuity of Care | 3-months post discharge | There is some evidence that improved continuity of care may lead to better mental health outcomes. However, a single valid standardized measure of continuity of care for mental health has not been described in the literature. Continuity of care was measured by assessing the total number of VA outpatient mental health visits attended within the three months after discharge. |
| Suicide Attempts: Columbia Suicide Severity Rating Scale (C-SSRS) | Baseline to 6- months post-discharge | The C-SSRS includes a 7-item subscale that assesses for actual and interrupted suicide attempts. It is a valid and reliable scale that includes a seven-item subscale that asks patients to self-report on actual attempts, interrupted attempts, aborted attempts, and preparatory acts or behaviors. The C-SSRS subscale was used specifically to assess the number of participants who had an actual fatal or non-fatal suicide attempt within the first 6 months post discharge. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNatalie Riblet, MD MPH
White River Junction VA Medical Center, White River Junction, VT
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 50.33 years STANDARD_DEVIATION 15.66 |
| Beck Scale for Suicide Ideation (BSS) | 13.59 units on a scale STANDARD_DEVIATION 9.44 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 87 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Interpersonal Needs Questionnaire-15 (INQ-15), perceived burdensomeness | 20.61 units on a scale STANDARD_DEVIATION 10.58 |
| Interpersonal Needs Questionnaire-15 (INQ-15), thwarted belongingness | 38.04 units on a scale STANDARD_DEVIATION 12.42 |
| MINI International Neuropsychiatric Interview: Current mental health conditions | 2.6 sum of mental health conditions STANDARD_DEVIATION 0.9 |
| Partners in Health Scale (PIH): Self-Management | 60.36 units on a scale STANDARD_DEVIATION 14.31 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 40 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 42 Participants |
| Suicide Related Coping Scale (SRCS) | 44.30 units on a scale STANDARD_DEVIATION 12.62 |
| The Beck Scale for Hopelessness (BHS) | 10.88 units on a scale STANDARD_DEVIATION 6.02 |
| The Multidimensional Scale of Perceived Social Support (MSPSS) | 4.51 units on a scale STANDARD_DEVIATION 1.52 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 46 | 0 / 46 |
| other Total, other adverse events | 18 / 46 | 15 / 46 |
| serious Total, serious adverse events | 1 / 46 | 0 / 46 |
Outcome results
None listed