A Brief Mindfulness-Based Intervention for Suicidal Ideation

Suicidal Ideation Clinical Trial

— MB-SI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04099173
• Other study ID #: IRB_00108786
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: January 5, 2023

Study information

• Verified date: May 2023
• Source: VA Salt Lake City Health Care System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 5, 2023
• Est. primary completion date: January 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Addiction
• Mental Disorders
• Problem Behavior
• Psychiatric Disorder
• Suicidal Ideation

Intervention

Behavioral:
• Brief Mindfulness Based Intervention
This intervention will consist of four, 45 minute individual mindfulness training sessions (one session per day, over a range of 12 subsequent days) provided by a trained mindfulness facilitator.

Locations

Country	Name	City	State
United States	VA Salt Lake City Health Care System	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
VA Salt Lake City Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure P1: Change in Columbia Suicide Severity Rating Scale among the MB-SI + TAU cohort compared to the TAU only cohort	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.	pre-intervention and one month post-intervention
Secondary	Measure S1: Number or category of patient and intervention characteristics	Demographic data extraction will include gender, age, race, ethnicity, religious preferences, service branch, service connection, percent of service connection, diagnosis of psychiatric disorders, substance abuse disorder (SUD) diagnosis, medical diagnosis, and medical diagnosis. In addition, the following factors will also be tracked: the group the participant has been placed in, admission date, consent date, the four intervention dates ( if participant is placed in the treatment group), post-intervention date, and one-month post-intervention date.	throughout the study
Secondary	Measure S2: Change in psychiatric hospitalizations, emergency room visits for psychiatric illness, and emergency room visits	The change in psychiatric hospitalizations, emergency room visits for psychiatric illness, and emergency room visits, as measured by retrospective review of the electronic medical record, among the MB-SI + TAU cohort will be compared to the TAU only cohort.	before the Inpatient Psychiatric Unit (IPU) admission, one-month before the IPU admission, and one-month after the discharge from the IPU
Secondary	Measure S3: Change in TMS among the MB-SI + TAU cohort compared to the TAU only cohort	Determine if there is a significant difference in state or trait mindfulness, as measured by the Toronto Mindfulness Scale (TMS), among the MB-SI + TAU cohort compared to the TAU only cohort. The TMS consists of 2 subscales: curiosity and decentering. Altogether, the TMS includes 13 statements rated on a scale from 0 = not at all, to 4 = very much. Higher values represent higher state of mindfulness.	Pre-intervention, immediately post-intervention, and one month post-intervention
Secondary	Measure S4: Change in ERQ among the MB-SI + TAU cohort compared to the TAU only cohort	Determine if there is a significant difference in the Emotional Regulation Questionnaire (ERQ), among the MB-SI + TAU cohort compared to the TAU only cohort. ERQ is a 10-likert-type items designed to measure respondents' tendency to regulate emotions in two ways: cognitive reappraisal and expressive suppression. Scoring is kept continuous and each facet's scoring is kept separate. Higher scores indicate greater capacity for emotional regulation.	Pre-intervention and immediately post-intervention
Secondary	Measure S5: Change in Five Facet Mindfulness among the MB-SI + TAU cohort compared to the TAU only cohort	Determine if there is a significant difference in Five Facet Mindfulness among the MB-SI + TAU cohort compared to the TAU only cohort. Five Facet Mindfulness is a scale of 15 items, scores can range from 15 - 75, and higher scores indicate a greater capacity for mindfulness.	Pre-intervention, immediately post-intervention, and one month post-intervention