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Fostering Optimal Regulation of Emotion for Prevention of Secondary Trauma (FOREST) (FOREST)

Primary Purpose

Burnout, Burnout, Professional, Positive Affect

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FOREST
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Burnout focused on measuring Burnout, Anxiety, Depression, Positive Emotion, Coping, Job Stress

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age 18 and over Currently employed by Heartland Alliance/READI Chicago Has internet access Speaks and reads English Exclusion Criteria: None

Sites / Locations

  • Northwestern University Feinberg School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FOREST + Assessments

Arm Description

READI staff will participate in Monthly Skill Sessions and complete FOREST content modules in the Learning Management System (LMS). Staff will also be invited to complete annual assessments for primary and secondary outcome measures, as well as annual interviews and focus groups to gather feedback on progress, implementation, and content.

Outcomes

Primary Outcome Measures

Decrease in turnover intentions measured by Turnover Intentions Scale.
Turnover Intentions Scale (TIS) measures the extent to which an employee intends to leave their place of employment. Higher scores indicate a higher response for participants' turnover intention.
Decrease in burnout measured by the Maslach Burnout Inventory (MBI).
The MBI evaluates burnout severity based on three aspects: emotional exhaustion, depersonalization, and lack of personal accomplishment, with higher scores on the emotional exhaustion and depersonalization subscales, and lower scores on the personal accomplishments subscale, indicating increased levels of burnout. Responses on the scale range from "never" to "every day."
Increase in positive affect measured by PROMIS Short Form v1.0- Positive Affect 15a.
PROMIS Positive Affect assesses momentary positive or rewarding affective experiences, such as feelings and mood associated with pleasure, joy, elation, contentment, pride, affection, happiness, engagement, and excitement. Higher scores indicate higher levels of positive affect.
Decrease in depression measured by PROMIS Short Form v1.0- Depression 4a.
PROMIS Depression Bank assesses self-reported negative mood (sadness, guilt), views of self (self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose). Higher scores indicate higher levels of depression.
Decrease in anxiety measured by PROMIS Short Form v1.0- Anxiety 4a.
PROMIS Anxiety Bank assesses self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). Higher scores indicate higher levels of anxiety.
Measure of trauma exposure using the Lifetime Events Checklist (LEC).
The LEC measures trauma exposure, including the ability to differentiate direct experience vs work-related or other secondary exposure through a series of questions about stressful events, with responses including "happened to me," "witnessed it," "learned about it," "not sure," and "doesn't apply," followed up by a question asking if the experience happened as part of one's job. There is no formal scoring protocol or interpretation per se, other than identifying whether a person has experienced one or more of the events listed.
Measure of PTSD symptoms using the the PTSD Checklist for DSM-5 (PCL-5).
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Responses range from "not at all" to "extremely," with higher scores indicating higher occurrence of PTSD symptoms.
Increase in meaning and purpose measured by PROMIS Short Form v1.0- Meaning and Purpose 4a.
PROMIS Meaning and Purpose Bank assesses one's sense of life having purpose and that there are good reasons for living. Higher scores indicate hopefulness, optimism, goal-directedness, and feelings that one's life is worthy.
Improvement in professional quality of life/well-being measured by Eudaimonic Workplace Well-being Scale (EWWS).
EWWS measures workplace well-being on both interpersonal and intrapersonal dimensions through a series of eight statements where respondents indicate how strongly they relate to those statements. Values range from "strongly disagree" to "strongly agree," with higher scores reflecting higher workplace well-being/quality of life.

Secondary Outcome Measures

Decrease in staff turnover.
Measured by number of READI staff who have left their job after <1 year of employment based on employee records
Increase in staff retention
Measured by number of staff who have stayed employed for >1 year based on employee records
Increase in staff promotion
Measured by number of staff who have been promoted into a new role based on employee records
Decrease in use of sick days
Measured by average number of sick days used per staff member based on employee records

Full Information

First Posted
June 26, 2023
Last Updated
September 29, 2023
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT05942469
Brief Title
Fostering Optimal Regulation of Emotion for Prevention of Secondary Trauma (FOREST)
Acronym
FOREST
Official Title
Fostering Optimal Regulation of Emotion for Prevention of Secondary Trauma (FOREST): Implementation and Evaluation of a Burnout Prevention Program for Staff in Gun Violence Prevention Programs
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
October 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
FOREST is a positive emotion skills program designed to target mental health and coping needs for frontline violence prevention workers at READI Chicago. Ten skills are taught over a period of nine months during existing meetings and wellness activities, as well as in online modules in READI's Learning Management System (LMS). Through infusing the FOREST skills throughout READI, we hope to inspire organizational culture change that will emphasize the importance of wellbeing and enhance resilience, therefore reducing burnout and turnover.
Detailed Description
All READI personnel will receive the FOREST program, including coaches, crew chiefs, outreach workers, managers, and supervisors at all sites and partner organizations delivering the READI program. Each month for 9 months there will be a focus on one to two positive emotion skills. The skill(s) of the month will be taught to the staff at each of the three READI sties (Austin, Englewood, and North Lawndale) separately on the first three Fridays of the month. These sessions will take place during existing one-hour wellness meetings/activities, and will be co-facilitated by Positive Emotion Ambassadors (PEAs; READI Staff members nominated to infuse the skills into READI culture) and Northwestern University. The skill sessions will include didactic content defining the skill and explaining the rationale for inclusion, as well as examples of existing research demonstrating the skills benefits. During the session the group will practice the skill together and discuss ways to use the skill in both work and personal situations. Throughout the month, PEAs will implement the FOREST skill of the month in other existing meetings, check-ins, and team outings Each of the 3 monthly site sessions will be observed by a member of the Implementation Resource Team (IRT) who will use a checklist to track that all core pieces of the skill training were delivered. Additionally, a PEA from a different site will observe each skill session to assess content alignment, engagement, and practice. The fourth Friday of the month the IRT will meet with the PEAs for additional training and support. These sessions will be audio recorded for qualitative data on facilitators and barriers to the skill. Each month a module in READI's learning management system (LMS) that covers that month's skill(s) will also become available. The LMS modules will contain skill-related content similar to what is taught in the skill sessions, including a thorough definition of the skill, examples of ways to utilize the skill, a review or summary of the skill, and several knowledge questions to check for comprehension. The LMS content may include text, audio, images, and video components. All READI staff will be required to complete the LMS FOREST skill module of the month, like any other required training rolled out at READI. Percentage of staff completing each LMS training will be tracked. Annual assessments to assess primary and secondary outcomes will be administered via REDCap. Annual interviews and focus groups will ask for feedback on implementation and content.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burnout, Burnout, Professional, Positive Affect, Depression, Anxiety, Compassion Fatigue, Job Stress
Keywords
Burnout, Anxiety, Depression, Positive Emotion, Coping, Job Stress

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FOREST + Assessments
Arm Type
Experimental
Arm Description
READI staff will participate in Monthly Skill Sessions and complete FOREST content modules in the Learning Management System (LMS). Staff will also be invited to complete annual assessments for primary and secondary outcome measures, as well as annual interviews and focus groups to gather feedback on progress, implementation, and content.
Intervention Type
Behavioral
Intervention Name(s)
FOREST
Intervention Description
The skill sessions will include didactic content defining the skill, rationale for including the skill in FOREST, and research demonstrating that practice of the skill increases positive emotion. In addition, the group will practice the skill together and will discuss ways to practice the skill at work as well as outside of work. Throughout the month, PEAs will implement the FOREST skill of the month in other existing meetings, check-ins, and team outings. Concurrently, a module in READI's learning management system (LMS) will become available. The LMS modules will contain skill-related content similar to what is taught in the skill sessions, including a thorough definition of the skill, examples of ways to utilize the skill, a review or summary of the skill, and several knowledge questions to check for comprehension. The LMS content may include text, audio, images, and video components.
Primary Outcome Measure Information:
Title
Decrease in turnover intentions measured by Turnover Intentions Scale.
Description
Turnover Intentions Scale (TIS) measures the extent to which an employee intends to leave their place of employment. Higher scores indicate a higher response for participants' turnover intention.
Time Frame
12 months
Title
Decrease in burnout measured by the Maslach Burnout Inventory (MBI).
Description
The MBI evaluates burnout severity based on three aspects: emotional exhaustion, depersonalization, and lack of personal accomplishment, with higher scores on the emotional exhaustion and depersonalization subscales, and lower scores on the personal accomplishments subscale, indicating increased levels of burnout. Responses on the scale range from "never" to "every day."
Time Frame
12 months
Title
Increase in positive affect measured by PROMIS Short Form v1.0- Positive Affect 15a.
Description
PROMIS Positive Affect assesses momentary positive or rewarding affective experiences, such as feelings and mood associated with pleasure, joy, elation, contentment, pride, affection, happiness, engagement, and excitement. Higher scores indicate higher levels of positive affect.
Time Frame
12 months
Title
Decrease in depression measured by PROMIS Short Form v1.0- Depression 4a.
Description
PROMIS Depression Bank assesses self-reported negative mood (sadness, guilt), views of self (self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose). Higher scores indicate higher levels of depression.
Time Frame
12 months
Title
Decrease in anxiety measured by PROMIS Short Form v1.0- Anxiety 4a.
Description
PROMIS Anxiety Bank assesses self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). Higher scores indicate higher levels of anxiety.
Time Frame
12 months
Title
Measure of trauma exposure using the Lifetime Events Checklist (LEC).
Description
The LEC measures trauma exposure, including the ability to differentiate direct experience vs work-related or other secondary exposure through a series of questions about stressful events, with responses including "happened to me," "witnessed it," "learned about it," "not sure," and "doesn't apply," followed up by a question asking if the experience happened as part of one's job. There is no formal scoring protocol or interpretation per se, other than identifying whether a person has experienced one or more of the events listed.
Time Frame
12 months
Title
Measure of PTSD symptoms using the the PTSD Checklist for DSM-5 (PCL-5).
Description
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Responses range from "not at all" to "extremely," with higher scores indicating higher occurrence of PTSD symptoms.
Time Frame
12 months
Title
Increase in meaning and purpose measured by PROMIS Short Form v1.0- Meaning and Purpose 4a.
Description
PROMIS Meaning and Purpose Bank assesses one's sense of life having purpose and that there are good reasons for living. Higher scores indicate hopefulness, optimism, goal-directedness, and feelings that one's life is worthy.
Time Frame
12 months
Title
Improvement in professional quality of life/well-being measured by Eudaimonic Workplace Well-being Scale (EWWS).
Description
EWWS measures workplace well-being on both interpersonal and intrapersonal dimensions through a series of eight statements where respondents indicate how strongly they relate to those statements. Values range from "strongly disagree" to "strongly agree," with higher scores reflecting higher workplace well-being/quality of life.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Decrease in staff turnover.
Description
Measured by number of READI staff who have left their job after <1 year of employment based on employee records
Time Frame
12 months
Title
Increase in staff retention
Description
Measured by number of staff who have stayed employed for >1 year based on employee records
Time Frame
12 months
Title
Increase in staff promotion
Description
Measured by number of staff who have been promoted into a new role based on employee records
Time Frame
12 months
Title
Decrease in use of sick days
Description
Measured by average number of sick days used per staff member based on employee records
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18 and over Currently employed by Heartland Alliance/READI Chicago Has internet access Speaks and reads English Exclusion Criteria: None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amanda Summers, MA
Phone
3125035247
Email
amanda.summers@northwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline Leong, BA
Email
caroline.leong1@northwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith Moskowitz, PhD, MPH
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Summers, MA
Phone
312-503-5247
Email
amanda.summers@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Caroline Leong, BA
Email
caroline.leong1@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Judith Moskowitz, PhD, MPH

12. IPD Sharing Statement

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Fostering Optimal Regulation of Emotion for Prevention of Secondary Trauma (FOREST)

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