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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05582343
• Other study ID #: 2021B0417
• Secondary ID: TBT-2-007-21
• Status: Recruiting
• Phase: N/A
• Start date: April 17, 2023
• Est. completion date: October 15, 2025

Study information

• Verified date: May 2024
• Source: Ohio State University
• Contact: Bernadette Melnyk, PhD
• Phone: 614-292-4844
• Email: melnyk.15[@]osu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5200
• Est. completion date: October 15, 2025
• Est. primary completion date: October 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burnout, Professional
• Burnout, Psychological
• Depression
• Suicide
• Suicide Threat

Intervention

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

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Ohio State University	American Foundation for Suicide Prevention, University of San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Change in being assessed for an increase or decrease in self-reported anxiety symptoms	The valid and reliable Generalized Anxiety Disorder Scale (GAD-7) will be used to measure anxiety. The GAD-7 measures feelings and actions associated with anxiety within the prior 2-week period. Responses are based on a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly everyday).	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	Change is being assessed for an increase or decrease in self-reported burnout level	The following non-proprietary single-item question from the Maslach Burnout Inventory will be used to measure burnout: "Overall, based on your definition of burnout, how would you rate your level of burnout?" Responses are scored on a five-category ordinal scale, where 1 = "I enjoy my work. I have no symptoms of burnout;" 2 = "Occasionally I am under stress, and I don't always have as much energy as I once did, but I don't feel burned out;" 3 = "I am definitely burning out and have one or more symptoms of burnout, such as physical and emotional exhaustion;" 4 = "The symptoms of burnout that I'm experiencing won't go away. I think about frustration at work a lot;" and 5 = "I feel completely burned out and often wonder if I can go on. I am at the point where I may need some changes or may need to seek some sort of help."	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	Change is being assessed for an increase or decrease in self-reported post-traumatic stress levels	The Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) will be used to screening for post-trauma symptoms. This 5-item screening tool was developed to identify individuals with probable PTSD in a primary care setting.	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	Change is being assessed for an increase or decrease in self-reported job satisfaction	Job Satisfaction will be measured using the Job Satisfaction Scale (JSS). This 7-item scale queries responses such as "I find real enjoyment in my job" and are measured on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree).	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	Change is being assessed for an increase or decrease in self-reported healthy lifestyle beliefs	The Healthy Lifestyle Beliefs Scale is a 10-item scale that will be used to tap cognitive beliefs about dealing with stress/problems and engaging in healthy lifestyle behaviors, the proposed mediator in this study. Participants respond to each of the items on a 10-point Likert scale ranging from (1) strongly disagree to (5) strongly agree.	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	Change is being assessed for an increase or decrease in self-reported healthy lifestyle behaviors	The Healthy Lifestyle Behaviors scale is a 16-item scale that asks for responses on statements such as "I make healthy food choices" and "I set goals I can accomplish." It us scored on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree).	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	Open-ended stressors question	One previously tested question on self-reported stressors (risk factors) will be used. The question is: Please take a minute to let us know about anything that has been particularly stressful for you lately - death of a loved one, relationship break-up, academic stressors, family or money problems, difficulty with your living situation - or anything else that might be contributing to how you are feeling.	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	Evaluation Questionnaire	. A questionnaire also will be administered to yield open ended feedback on the interventions in terms of their helpfulness as well as collect data on whether the nurses have received any treatment since beginning the study (e.g., therapy, medication).	3 months after screening (Timepoint 2), 6 months after screening (Timepoint 3), 12 months after screening (Timepoint 4)