Modified Interactive Screening Program Plus MINDBODYSTRONG: A Mental Health Resiliency Intervention for Nurses

NCT05582343 | Completed DMC

• 2 other identifiers: 2021B0417TBT-2-007-21
• Study Type: interventional
• Target: 849
• Locations: 1 country
• Sites: 1

Brief Summary

The overall purpose of this study is to evaluate the efficacy of an intervention designed to prevent nurse suicide. This randomized controlled trial will test the modified Interactive Screening Program (mISP) alone and the mISP combined with a program called MINDBODYSTRONG. The mISP is a method of screening to detect clinicians at moderate to high risk for suicide and referring them for treatment through an encrypted anonymous on-line platform. MINDBODYSTRONG© is an adaptation of a well-tested cognitive-behavioral skills building intervention (also known as COPE in the literature) that provides a cognitive-behavior theory-based approach to decrease depression, anxiety and suicidal ideation and improve healthy lifestyle beliefs and behaviors in at-risk populations. MINDBODYSTRONG© will involve eight self-paced computerized sessions designed specifically for nurses and clinicians. Nurses will be recruited nationally through the professional nursing organizations and health systems.

Conditions

Suicide Threat; Burnout, Professional; Depression

Keywords

nurse; suicide; depression; burnout; trauma; computerized; CBT; intervention; depression screening

Outcome Measures

Primary Outcomes (2)

• Change is being assessed for an increase or decrease in self-reported suicidal intent

  The valid and reliable Columbia Suicide Severity Rating Scale assesses the severity of suicidal ideation and behavior through a semi-structured list of yes or no questions divided into four constructs: (1) suicidal ideation; (2) intensity of ideation; (3) suicidal behavior; and (4) suicidal lethality subscale (actual or potential).

  Baseline (Timepoint 0), 8 weeks after baseline (Timepoint 1), 3 months after screening (Timepoint 2), 6 months after screening (Timepoint 3), 12 months after screening (Timepoint 4)

• Change in is being assessed for an increase or decrease in self-reported depressive symptoms

  The 9-item valid and reliable Personal Health Questionnaire-9 will be used to measure depressive symptoms. Participants are asked to respond to nine items (e.g., little interest or pleasure in doing things; feeling down, depressed or hopeless) regarding how they have felt over the previous 2-week period. Scores are based on a 4-point Likert scale ranging from 0 "not at all" to 3 "nearly every day."

  Baseline (Timepoint 0), 8 weeks after baseline (Timepoint 1), 3 months after screening (Timepoint 2), 6 months after screening (Timepoint 3), 12 months after screening (Timepoint 4)

Secondary Outcomes (8)

• Change in being assessed for an increase or decrease in self-reported anxiety symptoms

  Baseline (Timepoint 0), 8 weeks after baseline (Timepoint 1), 3 months after screening (Timepoint 2), 6 months after screening (Timepoint 3), 12 months after screening (Timepoint 4)

• Change is being assessed for an increase or decrease in self-reported burnout level

  Baseline (Timepoint 0), 8 weeks after baseline (Timepoint 1), 3 months after screening (Timepoint 2), 6 months after screening (Timepoint 3), 12 months after screening (Timepoint 4)

• Change is being assessed for an increase or decrease in self-reported post-traumatic stress levels

  Baseline (Timepoint 0), 8 weeks after baseline (Timepoint 1), 3 months after screening (Timepoint 2), 6 months after screening (Timepoint 3), 12 months after screening (Timepoint 4)

• Change is being assessed for an increase or decrease in self-reported job satisfaction

  Baseline (Timepoint 0), 8 weeks after baseline (Timepoint 1), 3 months after screening (Timepoint 2), 6 months after screening (Timepoint 3), 12 months after screening (Timepoint 4)

• Change is being assessed for an increase or decrease in self-reported healthy lifestyle beliefs

  Baseline (Timepoint 0), 8 weeks after baseline (Timepoint 1), 3 months after screening (Timepoint 2), 6 months after screening (Timepoint 3), 12 months after screening (Timepoint 4)

Study Arms (2)

mISP

NO INTERVENTION

Participants who are identified as having moderate to high risk of suicide, as identified by suicide risk on the ISP, will be contacted by a mental health counselor who will engage them through the mISP encrypted interface online. The mental health counselor will offer counseling online through encryption or on the phone. Where indicated, the mental health counselor will provide the crisis hotline, and encourage participants to use their insurance provider and/or Employee Assistance Program to obtain treatment. The mental health counselor will offer to help with referrals and will bridge high-risk participants into treatment. Participants who are not identified as having moderate to high risk of suicide will be thanked for their time.

mISP plus MINDSTRONG

ACTIVE COMPARATOR

Participants identified as having a moderate to high risk of suicide based on ISP screening will then be randomized. Participants randomized to the MINDBODYSTRONG© program (intervention) will receive the 8-session online interactive program. Reminders will be sent weekly to complete the next MINDBODYSTRONG© session and a MINDBODYSTRONG© trained coach will check in with participants by phone at baseline, weeks 3 and 5 of the on-line program to reinforce key program concepts and assess whether participants are completing the weekly skills building activities. Nurses assigned to the control group will only receive the mISP alone (aforementioned) and will be contacted for follow-up surveys.

Behavioral: MINDBODYSTRONG™

Interventions

MINDBODYSTRONG™ BEHAVIORAL

Digitalized MINDBODYSTRONG™ is designed for self-paced weekly use via an online platform. MINDBODYSTRONG© Session Content 1. Thinking, feeling, \& behaving, The ABCs of CBT, Mindfulness Skills Building: Positive self-talk/The ABCs 2. Self-esteem \& positive self-talk, Intentional gratitude, Managing change Skills building: Self-esteem \& positive self-talk 3. Stress, Healthy coping, Abdominal breathing Skills Building: Managing stress 4. Problem solving, Setting goals, Steps to problem solving Skills building: Strategies to overcoming barriers 5. Dealing w/ emotions in healthy ways, Using guided imagery, Coping strategies, Effective communication Skills building: Dealing with emotions 6. Coping w/ stressful situations/valuable sleep Skills building: Coping w/ stressful situations 7. Distress tolerance \& added emotional regulation skills Skills bulding: RAIN practice, Self-love skill, Distracting using ACCEPTS 8. Putting it all together for a healthy YOU!

Also known as: COPE

mISP plus MINDSTRONG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• self-identify as a registered nurse
• identified as moderate to high risk of suicide by the mISP-specific interactive screening program assignment

You may not qualify if:

• low risk of suicide by the mISP-specific interactive screening program assignment
• under the age of 18 years
• prior participation in MINDBODYSTRONG
• prior participation in this study

Sponsors & Collaborators

• Ohio State University: lead
• American Foundation for Suicide Prevention: collaborator
• University of San Diego: collaborator

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• Melnyk BM, Davidson JE, Mayfield C, Zisook S, Tucker S, Hsieh AP, Cooper A, Gray-Bauer R, Hoying J, Cuccia AF, Tan A. A study protocol for the modified interactive screening program plus MINDBODYSTRONG(c) RCT: A mental health resiliency intervention for nurses. PLoS One. 2024 Jun 6;19(6):e0303425. doi: 10.1371/journal.pone.0303425. eCollection 2024.

  PMID: 38843149 DERIVED

MeSH Terms

Conditions

Burnout, Professional; Depression; Suicide; Burnout, Psychological; Wounds and Injuries

Condition Hierarchy (Ancestors)

Occupational Stress; Occupational Diseases; Stress, Psychological; Behavioral Symptoms; Behavior; Self-Injurious Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean and Helene Fuld Health Trust Professor of Evidence-Based Practice, College of Nursing Professor of Pediatrics & Psychiatry, College of Medicine Executive Director, the Helene Fuld Health Trust National Institute for EBP

Model Details: Longitudinal, randomized RCT with repeated measures

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 17, 2022
• Study Start: April 17, 2023
• Primary Completion: April 10, 2026
• Study Completion: April 10, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)