Clinical trial NCT05582343: Modified Interactive Screening Program Plus MINDBODYSTRONG: A Mental Health Resiliency Intervention for Nurses
Official title: Modified Interactive Screening Program Plus MINDBODYSTRONG: A Mental Health Resiliency Intervention for Nurses
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Suicide Threat
Burnout, Professional
Depression
Keywords: nurse
suicide
depression
burnout
trauma
computerized
CBT
intervention
depression screening
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: American Foundation for Suicide Prevention
name: University of San Diego
First posted: 2022-10-17
Enrollment: 849
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Longitudinal, randomized RCT with repeated measures
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change is being assessed for an increase or decrease in self-reported suicidal intent
timeFrame: 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)
measure: Change in is being assessed for an increase or decrease in self-reported depressive symptoms
timeFrame: 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:
measure: Change in being assessed for an increase or decrease in self-reported anxiety symptoms
timeFrame: 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)
measure: Change is being assessed for an increase or decrease in self-reported burnout level
timeFrame: 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)
measure: Change is being assessed for an increase or decrease in self-reported post-traumatic stress levels
timeFrame: 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)
measure: Change is being assessed for an increase or decrease in self-reported job satisfaction
timeFrame: 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)
measure: Change is being assessed for an increase or decrease in self-reported healthy lifestyle beliefs
timeFrame: 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)
measure: Change is being assessed for an increase or decrease in self-reported healthy lifestyle behaviors
timeFrame: 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)
measure: Open-ended stressors question
timeFrame: 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)
measure: Evaluation Questionnaire
timeFrame: 3 months after screening (Timepoint 2), 6 months after screening (Timepoint 3), 12 months after screening (Timepoint 4)
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
References: