A Brief Mindfulness-Based Intervention for Suicidal Ideation

NCT04099173 | Completed

• 1 other identifier: IRB_00108786
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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).

Conditions

Suicidal Ideation; Psychiatric Disorder; Addiction

Keywords

mindfulness; suicide related behavior; Veterans; Veterans' Affairs; suicidal ideation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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 Arms (2)

Brief Mindfulness Based Intervention

EXPERIMENTAL

Some participants, as a result of random selection, will be asked to participate in four, 45-minute sessions that will occur on four separate days while on the Inpatient Psychiatric Unit (IPU). These four sessions are in addition to the standard IPU treatment and are experimental. These four sessions will include mindfulness meditation practice and education, creating a Crisis Response Plan, and a brief introduction into self-compassion. As stated above, practicing mindfulness means focusing attention on what is occurring in the present moment in a non-judgmental way. The focus may be on what one is seeing or hearing or physical sensations, such as touch, as well as thoughts and emotions. Meditation is just sitting quietly and practicing mindful awareness.

Behavioral: Brief Mindfulness Based Intervention

Treatment as Usual

NO INTERVENTION

Participants will be asked to fill out several short paper and pencil tests to assess your response to the treatment (10 to 15 minutes) pre-intervention and immediately post-intervention while on the Inpatient Psychiatric Unit (IPU), as well as a follow-up phone call or mail one month after discharge from the IPU. All participants will receive the IPU's normal standard of care treatment (for study purposes this called treatment as usual).

Interventions

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.

Also known as: MB-SI+ TAU

Brief Mindfulness Based Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• VA Salt Lake City Health Care System: lead

Study Sites (1)

VA Salt Lake City Health Care System

Salt Lake City, Utah, 84148, United States

Location

Related Publications (1)

• 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.

  PMID: 36208303 DERIVED

MeSH Terms

Conditions

Suicidal Ideation; Mental Disorders; Behavior, Addictive

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior; Compulsive Behavior; Impulsive Behavior

Study Officials

• William R Marchand, MD, LFAPA

  Salt Lake City Veterans' Administration Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: September 23, 2019
• Study Start: September 1, 2019
• Primary Completion: January 5, 2023
• Study Completion: January 5, 2023
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)