Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06378541
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-04-15
Brief Title:
Smartphone App Enhanced Facilitation Among Veterans in a Mental Health Inpatient Setting Project HOPE
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Virtual Hope Box Enhanced Facilitation in High-Risk Suicidal Veterans
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Project HOPE
Brief Summary:
This study will test whether a new intervention Virtual Hope Box Enhanced Facilitation VHB-EF reduces suicide risk in Veterans after discharge from inpatient psychiatric hospitalization Additionally this study will also conduct interviews with Veterans and healthcare providers to explore barriers and facilitators to future adoption of the VHB-EF intervention in healthcare settings
Detailed Description:
Background Veteran suicide prevention is a top national priority with Veterans experiencing suicide rates 15 times higher than the general population Suicide rates are especially high among Veterans recently discharged from inpatient mental health units The Virtual Hope Box VHB app developed by the Department of Defense DoD aims to improve access to an intervention used in evidence-based suicide prevention treatments The VHB app provides users with instant access to suicide prevention resources and coping tools and is routinely cited as a top evidence-based mental health app and has been nationally disseminated in the Veterans Health Administration VHA and DoD Despite this its efficacy in suicide prevention remains under-evidenced and its reach among high-risk Veterans is limited
To address these concerns the investigators developed the VHB-EF intervention VHB-EF has two phases 1 the in-person inpatient phase involves a single session that assists the Veteran with downloading and using the VHB app provides personalization and behavioral practice for each component of the app and addresses strategies to enhance app use 2 the remote-delivery phase includes two follow-up phone contacts following hospital discharge to monitor suicide risk review andor revise VHB content and support app use and outpatient treatment engagement The investigators hypothesize that VHB-EF will bolster reasons for living and increase self-efficacy to cope and refrain from suicide attempts which will in turn reduce suicide attempts
The specific aims of this study are
Aim 1 To evaluate the effects of VHB-EF for reducing suicide attempts primary outcome
H1 Suicidal Veterans in the VHB-EF arm will be less likely to have a suicide attempt over the 6 months following enrollment compared to those in the EUC condition The investigators will also examine the effects of VHB-EF on severity of suicidal ideation secondary outcome
Aim 2 Examine intervention mechanisms by measuring the effects of VHB-EF on potential mediators 1 reasons for living and 2 self-efficacy to a cope and b refrain from suicide attempts
H2 VHB-EF Veterans will report higher levels of reasons for living and self-efficacy compared to EUC Exploratory sub-aim The investigators will test the hypothesis that higher levels of reasons for living and self-efficacy will partially mediate the effect of VHB-EF on suicide attempts over 6-months Furthermore the investigators will measure the effects of VHB-EF vs EUC on depressive symptoms and healthcare utilization and their potential role as mediators of outcomes
Aim 3 To examine the determinants barriers and facilitators of VHB-EF adoption to inform future implementation and sustainability of VHB-EF across the VA The investigators will conduct qualitative interviews with providers and Veterans to determine the feasibility and acceptability of VHB-EF This will be used to refine the intervention to maximize the impact of future implementation
Methods This is a 2-site randomized effectiveness-implementation hybrid type I trial that will recruit Veterans N928 hospitalized for suicidal crises test this intervention and gather data to support future implementation Outcomes will be assessed at 6 weeks 3 months and 6 months post-baseline The study will also include qualitative interviews with providers and Veterans to assess the feasibility and acceptability of VHB-EF
Significance This innovative study is the first to test the VHBs impact on suicidal behavior in Veterans during high-risk periods following acute care addressing a key gap in suicide prevention for this vulnerable group
To address these concerns the investigators developed the VHB-EF intervention VHB-EF has two phases 1 the in-person inpatient phase involves a single session that assists the Veteran with downloading and using the VHB app provides personalization and behavioral practice for each component of the app and addresses strategies to enhance app use 2 the remote-delivery phase includes two follow-up phone contacts following hospital discharge to monitor suicide risk review andor revise VHB content and support app use and outpatient treatment engagement The investigators hypothesize that VHB-EF will bolster reasons for living and increase self-efficacy to cope and refrain from suicide attempts which will in turn reduce suicide attempts
The specific aims of this study are
Aim 1 To evaluate the effects of VHB-EF for reducing suicide attempts primary outcome
H1 Suicidal Veterans in the VHB-EF arm will be less likely to have a suicide attempt over the 6 months following enrollment compared to those in the EUC condition The investigators will also examine the effects of VHB-EF on severity of suicidal ideation secondary outcome
Aim 2 Examine intervention mechanisms by measuring the effects of VHB-EF on potential mediators 1 reasons for living and 2 self-efficacy to a cope and b refrain from suicide attempts
H2 VHB-EF Veterans will report higher levels of reasons for living and self-efficacy compared to EUC Exploratory sub-aim The investigators will test the hypothesis that higher levels of reasons for living and self-efficacy will partially mediate the effect of VHB-EF on suicide attempts over 6-months Furthermore the investigators will measure the effects of VHB-EF vs EUC on depressive symptoms and healthcare utilization and their potential role as mediators of outcomes
Aim 3 To examine the determinants barriers and facilitators of VHB-EF adoption to inform future implementation and sustainability of VHB-EF across the VA The investigators will conduct qualitative interviews with providers and Veterans to determine the feasibility and acceptability of VHB-EF This will be used to refine the intervention to maximize the impact of future implementation
Methods This is a 2-site randomized effectiveness-implementation hybrid type I trial that will recruit Veterans N928 hospitalized for suicidal crises test this intervention and gather data to support future implementation Outcomes will be assessed at 6 weeks 3 months and 6 months post-baseline The study will also include qualitative interviews with providers and Veterans to assess the feasibility and acceptability of VHB-EF
Significance This innovative study is the first to test the VHBs impact on suicidal behavior in Veterans during high-risk periods following acute care addressing a key gap in suicide prevention for this vulnerable group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None