Clinical trial NCT04099173: A Brief Mindfulness-Based Intervention for Suicidal Ideation
Official title: A Randomized Pilot Study of a Brief Mindfulness-Based Intervention for Suicidal Ideation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicidal Ideation
Psychiatric Disorder
Addiction
Keywords: mindfulness
suicide related behavior
Veterans
Veterans' Affairs
suicidal ideation
Lead sponsor: VA Salt Lake City Health Care System
Sponsor class: FED
First posted: 2019-09-23
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Measure P1: Change in Columbia Suicide Severity Rating Scale among the MB-SI + TAU cohort compared to the TAU only cohort
timeFrame: pre-intervention and one month post-intervention
Secondary outcomes:
measure: Measure S1: Number or category of patient and intervention characteristics
timeFrame: throughout the study
measure: Measure S2: Change in psychiatric hospitalizations, emergency room visits for psychiatric illness, and emergency room visits
timeFrame: before the Inpatient Psychiatric Unit (IPU) admission, one-month before the IPU admission, and one-month after the discharge from the IPU
measure: Measure S3: Change in TMS among the MB-SI + TAU cohort compared to the TAU only cohort
timeFrame: Pre-intervention, immediately post-intervention, and one month post-intervention
measure: Measure S4: Change in ERQ among the MB-SI + TAU cohort compared to the TAU only cohort
timeFrame: Pre-intervention and immediately post-intervention
measure: Measure S5: Change in Five Facet Mindfulness among the MB-SI + TAU cohort compared to the TAU only cohort
timeFrame: Pre-intervention, immediately post-intervention, and one month post-intervention
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: VA Salt Lake City Health Care System
state: Utah
Study officials:
affiliation: Salt Lake City Veterans' Administration Medical Center
name: William R Marchand, MD, LFAPA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Herrmann TS, Nazarenko E, Marchand W, Day A, Merrill J, Neil M, Thatcher J, Garland E, Bryan C. Randomized Controlled Trial of a Brief Mindfulness-Based Intervention for Suicidal Ideation Among Veterans. Mil Med. 2024 Feb 27;189(3-4):732-741. doi: 10.1093/milmed/usac291.