A Brief Mindfulness-Based Intervention for Suicidal Ideation

NCT ID: NCT04099173

Last Updated: 2023-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2023-01-05

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.

Conditions

Suicidal Ideation; Psychiatric Disorder; Addiction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Brief Mindfulness Based Intervention

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.

Group Type: EXPERIMENTAL

Brief Mindfulness Based Intervention

Intervention Type: 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.

Treatment as Usual

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

MB-SI+ TAU

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Salt Lake City Health Care System

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William R Marchand, MD, LFAPA

Role: PRINCIPAL_INVESTIGATOR

Salt Lake City Veterans' Administration Medical Center

Locations

VA Salt Lake City Health Care System

Salt Lake City, Utah, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36208303 (View on PubMed)

Other Identifiers

IRB_00108786

Identifier Type: -

Identifier Source: org_study_id