What side effects are associated with this type of intervention?

Motivational Interviewing (MI) and similar psychotherapeutic interventions for suicidal thoughts generally have minimal physical side effects. Patients may experience emotional discomfort as they confront difficult feelings and thoughts during therapy. The effectiveness of MI can vary, and some individuals may not respond as well, potentially leading to frustration or a sense of hopelessness if progress is slow.

What prior FDA approvals exist?

The FDA has approved several treatments for suicidal thoughts, primarily focusing on pharmacotherapy and psychotherapy. Notably, esketamine (Spravato) nasal spray has been approved for treatment-resistant depression and acute suicidal ideation or behavior. While Motivational Interviewing (MI) itself is a therapeutic approach rather than a drug, it is often used in conjunction with other treatments to enhance motivation and commitment to change. MI techniques are designed to address ambivalence and promote self-efficacy, making them a valuable component of comprehensive treatment plans for individuals experiencing suicidal thoughts.

What other types of research exist?

Promising alternatives to MI-SI-R for treating suicidal thoughts include: 1) Dialectical Behavior Therapy (DBT), which focuses on building skills in mindfulness, distress tolerance, emotion regulation, and interpersonal effectiveness; 2) Cognitive Behavioral Therapy for Suicide Prevention (CBT-SP), which targets suicidal thoughts and behaviors through cognitive restructuring and behavioral strategies; 3) Collaborative Assessment and Management of Suicidality (CAMS), which involves a collaborative approach between the patient and therapist to understand and address the drivers of suicidal ideation; and 4) Pharmacotherapy options such as ketamine or esketamine, which have shown rapid reduction in suicidal ideation in clinical trials.

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Motivational Interviewing for Suicidal Thoughts (MI-SI Trial)

N/A

Recruiting

Led By Peter C. Britton, PhD MS

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 and over

English speaking and reading

Must not have

Impaired decision making capacity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-month

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a special type of counseling called MI-SI-R, which helps Veterans who are thinking about suicide find reasons to live. The study involves 470 high-risk Veterans who have had suicidal thoughts or attempts. The goal is to see if this counseling, combined with usual care, reduces suicide attempts and suicidal thoughts more effectively than usual care alone. Motivational interviewing to address suicidal ideation (MI-SI) has been previously tested for its acceptability and effectiveness in reducing suicidal thoughts among hospitalized veterans.

Who is the study for?

This trial is for Veterans over 18 who've recently attempted suicide or have severe suicidal thoughts. They must be English-speaking, able to understand the study, and give informed consent. It's not for those with active mania, current psychosis, dementia, or impaired decision-making capacity.

What is being tested?

The trial tests a revised motivational interviewing technique (MI-SI-R) against enhanced usual care in reducing suicide risk among Veterans. Participants are randomly assigned to one of these two approaches to compare effectiveness.

What are the potential side effects?

Since this trial involves psychological interventions rather than medications, traditional side effects are not expected. However, discussing sensitive topics like suicidal ideation may cause emotional discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I can speak and read English.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have difficulty making decisions due to my health condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12-month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Beck Scale for Suicidal Ideation

Columbia-Suicide Severity Rating Scale

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Motivational Interviewing to Address Suicidal Ideation- Revised (MI-SI-R)Experimental Treatment2 Interventions

Motivational Interviewing to Address Suicidal Ideation (MI-SI-R) was developed to help Veterans resolve ambivalence about living by increasing the motivation to live, and is delivered in three sessions in person, virtually, or by telephone.

Group II: Enhanced usual care (EUC)Active Control1 Intervention

Enhanced usual care (EUC) includes safety plans administered or reviewed by research therapists, care coordination, and access to a 24-hour crisis hotline.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Motivational Interviewing (MI) enhances motivation and commitment to change by addressing ambivalence and promoting self-efficacy. It involves expressing empathy, developing discrepancy between current behaviors and broader goals, rolling with resistance, and supporting the patient's belief in their ability to change. These mechanisms are crucial for patients with suicidal thoughts as they help build a therapeutic alliance, increase motivation to engage in life-saving behaviors, and reduce feelings of hopelessness and helplessness.