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PEACE App Intervention for Suicide Prevention in Veterans (VA-BIC RCT Trial)

N/A
Recruiting
Led By Natalie Riblet, MD MPH
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month to 6 months post-discharge
Awards & highlights

VA-BIC RCT Trial Summary

This trial is testing a new intervention called PEACE, which is a mobile mental health app combined with a manual-based intervention, to see if it reduces suicidal ideation in veterans.

Who is the study for?
This trial is for U.S. Veterans eligible for VA services who were hospitalized due to acute self-harm risk, can speak English, and are willing to use a smartphone app. It excludes those unable to consent or considered vulnerable such as prisoners or involuntarily committed patients.Check my eligibility
What is being tested?
The study tests the PEACE intervention, which includes a mental health app and the VA-BIC program aimed at improving social connections and care engagement post-discharge, against standard psychiatric discharge care in preventing suicide.See study design
What are the potential side effects?
Since this trial involves non-pharmacological interventions like an app and manual-based program, typical drug side effects are not expected; however, participants may experience emotional discomfort while discussing sensitive topics.

VA-BIC RCT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month to 6 months post-discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month to 6 months post-discharge for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Beck Scale for Suicidal Ideation (BSS)
Secondary outcome measures
App Engagement Scale (AES)
Beck Hopelessness Scale (BHS)
Columbia Suicide Severity Rating Scale (C-SSRS)
+3 more
Other outcome measures
MINI International Neuropsychiatric Interview

VA-BIC RCT Trial Design

2Treatment groups
Experimental Treatment
Group I: PEACEExperimental Treatment2 Interventions
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.
Group II: ControlExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,610 Previous Clinical Trials
3,305,092 Total Patients Enrolled
7 Trials studying Suicide Prevention
1,554 Patients Enrolled for Suicide Prevention
White River Junction Veterans Affairs Medical CenterFED
28 Previous Clinical Trials
16,789 Total Patients Enrolled
2 Trials studying Suicide Prevention
85 Patients Enrolled for Suicide Prevention
Natalie Riblet, MD MPHPrincipal InvestigatorWhite River Junction VA Medical Center, White River Junction, VT

Media Library

PEACE Clinical Trial Eligibility Overview. Trial Name: NCT04446468 — N/A
Suicide Prevention Research Study Groups: Control, PEACE
Suicide Prevention Clinical Trial 2023: PEACE Highlights & Side Effects. Trial Name: NCT04446468 — N/A
PEACE 2023 Treatment Timeline for Medical Study. Trial Name: NCT04446468 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for volunteers to join this research project?

"Affirmative. Clinicaltrials.gov data reveals that this research is actively seeking participants, having been initiated on March 19th 2021 with an update posted October 19th 2022. For the duration of the study, 92 patients will be enrolled from one primary location."

Answered by AI

What is the population size of this research endeavor?

"Affirmative. The clinical trial's information hosted on clinicaltrials.gov affirms that it is in the process of accepting patients, with a commencement date of March 19th 2021 and an update as recently as October 19th 2022. 92 individuals are being sought out from 1 medical centre."

Answered by AI
Recent research and studies
~11 spots leftby Sep 2024