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

NCT ID: NCT05582343

Last Updated: 2025-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

849 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-17

Study Completion Date

2026-04-30

Brief Summary

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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.

Detailed Description

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The study will be the first to test the combination of the mISP with a new on-line digitalized version of the previously tested manualized version of the CBSB program (i.e., MINDBODYSTRONG©) for nurses. If found to be effective, the combined program will be able to be easily scaled to prevent suicide in nurses and potentially other high-risk populations of clinicians. Although CBT is gold standard evidence-based treatment for depression, only a small percentage of affected individuals receive it due to a shortage of mental health providers, which contributes to high depression relapse rates of 50 to 70%. A scalable digitalized intervention could be one key solution to bringing CBT skills to nurses at risk for suicide who could so benefit from them. This randomized controlled trial (RCT) will determine the effects of the mISP, this adaptation of the American Foundation for Suicide Prevention's (AFSP) Interactive Screening program (ISP), combined with the on-line version of the MINDBODYSTRONG© program versus the HEAR program alone on depression, suicidal ideation, burnout, anxiety, post-traumatic stress, healthy lifestyle beliefs, healthy lifestyle behaviors, and job satisfaction in U.S. nurses.

Conditions

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Suicide Threat Burnout, Professional Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Longitudinal, randomized RCT with repeated measures
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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mISP

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

mISP plus MINDSTRONG

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.

Group Type ACTIVE_COMPARATOR

MINDBODYSTRONG™

Intervention Type 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!

Interventions

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MINDBODYSTRONG™

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!

Intervention Type BEHAVIORAL

Other Intervention Names

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COPE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American Foundation for Suicide Prevention

OTHER

Sponsor Role collaborator

University of San Diego

OTHER

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role lead

Responsible Party

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Bernadette Melnyk

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38843149 (View on PubMed)

Other Identifiers

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TBT-2-007-21

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2021B0417

Identifier Type: -

Identifier Source: org_study_id

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