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Clinical Trials/NCT04099173
NCT04099173
Completed
Not Applicable

A Randomized Pilot Study of a Brief Mindfulness-Based Intervention for Suicidal Ideation

VA Salt Lake City Health Care System1 site in 1 country25 target enrollmentSeptember 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Suicidal Ideation
Sponsor
VA Salt Lake City Health Care System
Enrollment
25
Locations
1
Primary Endpoint
Measure P1: Change in Columbia Suicide Severity Rating Scale among the MB-SI + TAU cohort compared to the TAU only cohort
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The primary aim of this study is to determine whether a Brief Mindfulness-Based Intervention for Suicidal Ideation (MB-SI) is feasible and safe to implement. The secondary aims are short and longer-term reduction in suicidal ideation (SI) and/or suicide-related behaviors (SRBs) as well as improvements in mindfulness and emotional regulation measures compared to Treatment as Usual (TAU).

Detailed Description

The study feasibility will be assessed through participant enrollment and retention numbers. The safety be monitored by the study personnel and include reporting any adverse effects. The intervention fidelity will be aided by standardizing the intervention and ensuring study personnel has the appropriate trainings. Participants will completed questionnaires assessing their SI and SRB as well as mindfulness and emotional regulation measures at three time points (preintervention, immediately postintervention, and 1-month postintervention) and their results will be compared between MB-SI and TAU groups. Additionally, the comparisons will also be conducted for the Emergency Department (ED) admissions, Inpatient Psychiatric Unit (IPU) admissions, and psychiatric ED admissions.

Registry
clinicaltrials.gov
Start Date
September 1, 2019
End Date
January 5, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
VA Salt Lake City Health Care System
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Admitted with suicidal ideation and any active psychiatric or addictive disorder diagnosis.

Exclusion Criteria

  • Diagnosis of psychotic spectrum illness and current psychotic symptoms or significant cognitive impairment.

Outcomes

Primary Outcomes

Measure P1: Change in Columbia Suicide Severity Rating Scale among the MB-SI + TAU cohort compared to the TAU only cohort

Time Frame: pre-intervention and one month post-intervention

Determine if there is a significant difference in the Columbia Suicide Severity Rating Scale, among the MB-SI + TAU cohort compared to the TAU only cohort. The total Columbia Suicide Severity Rating Scale score can range from 0 to 25, with higher values indicating greater intensity. Longitudinal generalized linear mixed models will be used for the primary analyses. We estimate a total of two time points (baseline and one month follow-up) for the primary outcome.

Secondary Outcomes

  • Measure S1: Number or category of patient and intervention characteristics(throughout the study)
  • Measure S2: Change in psychiatric hospitalizations, emergency room visits for psychiatric illness, and emergency room visits(before the Inpatient Psychiatric Unit (IPU) admission, one-month before the IPU admission, and one-month after the discharge from the IPU)
  • Measure S3: Change in TMS among the MB-SI + TAU cohort compared to the TAU only cohort(Pre-intervention, immediately post-intervention, and one month post-intervention)
  • Measure S4: Change in ERQ among the MB-SI + TAU cohort compared to the TAU only cohort(Pre-intervention and immediately post-intervention)
  • Measure S5: Change in Five Facet Mindfulness among the MB-SI + TAU cohort compared to the TAU only cohort(Pre-intervention, immediately post-intervention, and one month post-intervention)

Study Sites (1)

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