Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-24 @ 5:53 PM
Study NCT ID:
NCT04446468
Status:
COMPLETED
Last Update Posted:
2025-09-30
First Post:
2020-06-22
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Suicide Prevention Study of VA-BIC in the Veteran Population
Sponsor:
Organization:
Raw JSON
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This scale has been validated against the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM). It is a short, structured diagnostic interview that, on average, takes about 15 minutes to administer. This will be administered at Baseline. There is no score range for this measure.'}], 'primaryOutcomes': [{'measure': 'Beck Scale for Suicidal Ideation (BSS)', 'timeFrame': 'Baseline to 6 Months Post-Discharge', 'description': '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. This will be assessed at Baseline and one, three, and six months post-discharge.'}], 'secondaryOutcomes': [{'measure': 'Suicide-Related Coping Scale', 'timeFrame': 'Baseline to 6 Months Post-Discharge', 'description': "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 with the External Coping being 0-28 and the Internal Coping being 0-28. Higher scores on the scale suggest better coping. This will be assessed at Baseline and one, three, and six months post-discharge."}, {'measure': 'Continuity of Care', 'timeFrame': 'Baseline to 3 Months Post-Discharge', 'description': '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. Current literature on Veterans who were discharged from a VA inpatient mental health unit provides sufficient evidence that three aspects of continuity of care after psychiatric hospitalization (regularity of care, continuity of treatment across organizational boundaries, and intensity of treatment) are associated with improvements in overall mental health. This will be assessed at study completion and will include any care received between Baseline and three months post-discharge. There is no score range for this measure.'}, {'measure': 'Beck Hopelessness Scale (BHS)', 'timeFrame': 'Baseline to 6 Months Post-Discharge', 'description': '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. This will be assessed at Baseline and one, three, and six months post-discharge.'}, {'measure': 'Interpersonal Needs Questionnaire-15 (INQ-15)', 'timeFrame': 'Baseline to 6 Months Post-Discharge', 'description': 'This is a 15-item self-report scale that measures thwarted belongingness and perceived burdensomeness. The score range for the scale is 15-105. Each item is measured on a 7-point Likert scale, with higher scores suggesting lower perceived connectedness. The INQ-15 has good reliability and validity in the Veteran population. Higher scores on the INQ-15 have been associated with suicide risk. This will be assessed at Baseline and one, three, and six months post-discharge.'}, {'measure': 'Columbia Suicide Severity Rating Scale (C-SSRS)', 'timeFrame': 'Baseline to 6 Months Post-Discharge', 'description': '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. There are two subscales within the C-SSRS: suicidal ideation (range: 0-5, with higher scores suggesting increased suicidal ideation) and intensity of ideation (range: 0-25, with higher scores suggesting increased intensity). This will be assessed at Baseline and one, three, and six months post-discharge.'}, {'measure': 'App Engagement Scale (AES)', 'timeFrame': '1 Month to 6 Months Post-Discharge', 'description': 'The AES is adapted from the end-user version of the Mobile Application Rating Scale (uMARS). It has been studied in patients with mental health conditions, has been shown to have good internal reliability, and is strongly related to app engagement. The scale assess four key analytic indicators of app engagement: amount, duration, breadth, and depth. All items are rated on a 5-point scale from "1.Inadequate" to "5.Excellent" with scores ranging from 0 - 40. Higher scores are associated with increased perceived quality of the mobile application. This will be assessed at one, three, and six months post-discharge.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mental health education', 'Clinical Trial', 'Suicidal ideation', 'Suicide, attempted'], 'conditions': ['Suicide Prevention']}, 'referencesModule': {'references': [{'pmid': '34360101', 'type': 'BACKGROUND', 'citation': 'Cornelius SL, Berry T, Goodrich AJ, Shiner B, Riblet NB. The Effect of Meteorological, Pollution, and Geographic Exposures on Death by Suicide: A Scoping Review. Int J Environ Res Public Health. 2021 Jul 23;18(15):7809. doi: 10.3390/ijerph18157809.'}, {'pmid': '34214935', 'type': 'BACKGROUND', 'citation': 'Riblet NB, Gottlieb DJ, Watts BV, Levis M, Shiner B. Irregular hospital discharge from acute inpatient and residential mental health treatment settings in a large integrated healthcare system. Gen Hosp Psychiatry. 2021 Sep-Oct;72:7-14. doi: 10.1016/j.genhosppsych.2021.06.009. Epub 2021 Jun 26.'}, {'pmid': '35199662', 'type': 'BACKGROUND', 'citation': 'Riblet NB, Gottlieb DJ, Watts BV, Levis M, Scott R, Shiner B. Is It Time for the Mental Health Field to Consider Unplanned Discharge a Key Metric of Patient Safety? J Nerv Ment Dis. 2022 Mar 1;210(3):227-230. doi: 10.1097/NMD.0000000000001425.'}, {'pmid': '35202942', 'type': 'BACKGROUND', 'citation': 'Riblet NB, Kenneally L, Stevens S, Watts BV, Gui J, Forehand J, Cornelius S, Rousseau GS, Schwartz JC, Shiner B. A virtual, pilot randomized trial of a brief intervention to prevent suicide in an integrated healthcare setting. Gen Hosp Psychiatry. 2022 Mar-Apr;75:68-74. doi: 10.1016/j.genhosppsych.2022.02.002. Epub 2022 Feb 18.'}, {'pmid': '35382976', 'type': 'BACKGROUND', 'citation': 'Riblet NB, Varela M, Ashby W, Zubkoff L, Shiner B, Pogue J, Stevens SP, Wasserman D, Watts BV. Spreading a Strategy to Prevent Suicide After Psychiatric Hospitalization: Results of a Quality Improvement Spread Initiative. Jt Comm J Qual Patient Saf. 2022 Oct;48(10):503-512. doi: 10.1016/j.jcjq.2022.02.009. Epub 2022 Mar 6.'}, {'pmid': '35958652', 'type': 'BACKGROUND', 'citation': 'Britton PC, Berrouiguet S, Riblet NB, Zhong BL. Editorial: Brief interventions in suicide prevention across the continuum of care. Front Psychiatry. 2022 Jul 26;13:976855. doi: 10.3389/fpsyt.2022.976855. eCollection 2022. No abstract available.'}, {'pmid': '36383739', 'type': 'BACKGROUND', 'citation': 'Riblet NB, Matsunaga S, Lee Y, Young-Xu Y, Shiner B, Schnurr PP, Levis M, Watts BV. Tools to Detect Risk of Death by Suicide: A Systematic Review and Meta-Analysis. J Clin Psychiatry. 2022 Nov 16;84(1):21r14385. doi: 10.4088/JCP.21r14385.'}, {'pmid': '36384820', 'type': 'BACKGROUND', 'citation': 'Riblet NB, Shiner B, Young-Xu Y, Watts BV. Lithium in the prevention of suicide in adults: systematic review and meta-analysis of clinical trials. BJPsych Open. 2022 Nov 17;8(6):e199. doi: 10.1192/bjo.2022.605.'}, {'pmid': '36931135', 'type': 'BACKGROUND', 'citation': 'Riblet NB, Matsunaga S, Shiner B, Schnurr PP, Watts BV. Are suicide risk scales sensitive to change? A scoping review. J Psychiatr Res. 2023 May;161:170-178. doi: 10.1016/j.jpsychires.2023.03.007. Epub 2023 Mar 9.'}, {'pmid': '36759108', 'type': 'BACKGROUND', 'citation': 'Riblet NBV, Watts BV. Another Reason to Quit Smoking: Results of a Prospective Study Examining Smoking, COPD, and Suicide. Chest. 2023 Feb;163(2):259-261. doi: 10.1016/j.chest.2022.10.016. No abstract available.'}, {'pmid': '37019069', 'type': 'BACKGROUND', 'citation': 'Riblet NB, Young-Xu Y, Shiner B, Schnurr PP, Watts BV. The efficacy and safety of buprenorphine for the treatment of depression: A systematic review and meta-analysis. J Psychiatr Res. 2023 May;161:393-401. doi: 10.1016/j.jpsychires.2023.03.037. Epub 2023 Mar 30.'}, {'pmid': '37002596', 'type': 'BACKGROUND', 'citation': 'Riblet NB, Soncrant C, Mills P, Yackel EE. Analysis of Reported Suicide Safety Events Among Veterans Who Received Treatment Through Department of Veterans Affairs-Contracted Community Care. Mil Med. 2023 Aug 29;188(9-10):e3173-e3181. doi: 10.1093/milmed/usad088.'}, {'pmid': '37167031', 'type': 'BACKGROUND', 'citation': 'Riblet NB, Gottlieb DJ, Shiner B, Zubkoff L, Rice K, Watts BV, Rusch B. An Analysis of Irregular Discharges From Residential Treatment Programs in the Department of Veterans Affairs Health Care System. Mil Med. 2023 Nov 3;188(11-12):e3657-e3666. doi: 10.1093/milmed/usad131.'}, {'pmid': '37652208', 'type': 'BACKGROUND', 'citation': 'Kenneally L, Stevens S, Cornelius S, Shiner B, Rice K, Park J, Watts BV, Teja N, Riblet N. Pilot randomized controlled trial of a brief strategy to prevent suicide after discharge from residential addiction treatment. J Subst Use Addict Treat. 2023 Nov;154:209156. doi: 10.1016/j.josat.2023.209156. Epub 2023 Aug 29.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nObjectives: 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.\n\nMethods: 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.\n\nHypothesis: 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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;\n* Be a Veteran eligible to receive VA services;\n* Be 18 years or older;\n* Be able to speak English;\n* Have access to a smart phone and express willingness to download a mobile app.\n\nExclusion Criteria:\n\n* Unable to provide informed consent;\n* The investigators do not plan to enroll any potentially vulnerable populations including prisoners, or involuntarily committed patients.'}, 'identificationModule': {'nctId': 'NCT04446468', 'acronym': 'VA-BIC RCT', 'briefTitle': 'Suicide Prevention Study of VA-BIC in the Veteran Population', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Prevention of Suicide in Veterans Through Brief Intervention and Contact (VA-BIC)', 'orgStudyIdInfo': {'id': 'MHBC-007-19F'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PEACE', 'description': "The PEACE intervention will be delivered by a trained mental health staff member, such as a study psychologist, mental health nurse, social worker, or psychiatrist. 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. Patients in this arm will also continue to receive standard post-discharge psychiatric care.", 'interventionNames': ['Behavioral: PEACE', 'Other: Standard Psychiatric Hospital Discharge Care']}, {'type': 'EXPERIMENTAL', 'label': 'Control', 'description': 'Those randomized to the control arm will receive standard psychiatric hospital discharge care alone. 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.', 'interventionNames': ['Other: Standard Psychiatric Hospital Discharge Care']}], 'interventions': [{'name': 'PEACE', 'type': 'BEHAVIORAL', 'description': "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.", 'armGroupLabels': ['PEACE']}, {'name': 'Standard Psychiatric Hospital Discharge Care', 'type': 'OTHER', 'otherNames': ['Standard Care'], 'description': '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.', 'armGroupLabels': ['Control', 'PEACE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05001-3833', 'city': 'White River Junction', 'state': 'Vermont', 'country': 'United States', 'facility': 'White River Junction VA Medical Center, White River Junction, VT', 'geoPoint': {'lat': 43.64896, 'lon': -72.31926}}], 'overallOfficials': [{'name': 'Natalie Riblet, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'White River Junction VA Medical Center, White River Junction, VT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'collaborators': [{'name': 'White River Junction Veterans Affairs Medical Center', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}