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NCT Number: NCT04099173

A Brief Mindfulness-Based Intervention for Suicidal Ideation

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).

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Key information

Conditions

Suicidal Ideation Addiction Behavior Behavior, Addictive Behavioral Symptoms Compulsive Behavior Impulsive Behavior Mental Disorders Psychiatric Disorder Self-Injurious Behavior Suicide

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Salt Lake City Health Care System

Salt Lake City, Utah, 84148, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brief Mindfulness Based Intervention

Behavioral

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.

Other names: MB-SI+ TAU

Primary outcomes

  1. 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

  1. Measure S1: Number or category of patient and intervention characteristics

    Time frame: throughout the study

    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.

  2. Measure S2: Change in psychiatric hospitalizations, emergency room visits for psychiatric illness, and emergency room visits

    Time frame: before the Inpatient Psychiatric Unit (IPU) admission, one-month before the IPU admission, and one-month after the discharge from the IPU

    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.

  3. Measure S3: Change in TMS among the MB-SI + TAU cohort compared to the TAU only cohort

    Time frame: Pre-intervention, immediately post-intervention, and one month post-intervention

    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.

  4. Measure S4: Change in ERQ among the MB-SI + TAU cohort compared to the TAU only cohort

    Time frame: Pre-intervention and immediately post-intervention

    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.

  5. Measure S5: Change in Five Facet Mindfulness among the MB-SI + TAU cohort compared to the TAU only cohort

    Time frame: Pre-intervention, immediately post-intervention, and one month post-intervention

    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.

Sponsors and collaborators

Lead sponsor

VA Salt Lake City Health Care System

Fed

Registry information

Official study title

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

Acronym: MB-SI

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Sep 23, 2019
Registry last updated
May 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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