Career Enhancement Training Study (USAF) (CETS)

• ClinicalTrials.gov Identifier: NCT04067401
• Recruitment Status: Completed
• First Posted: August 26, 2019
• Results First Posted: July 8, 2020
• Last Update Posted: July 8, 2020
• Sponsor: University of Rochester
• Collaborator: United States Department of Defense
• Information provided by (Responsible Party): Peter Wyman, University of Rochester

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Suicidal Ideation
• Interventions: Behavioral: Wingman Connect; Behavioral: Stress Management
• Enrollment: 1485

Participant Flow

Recruitment Details	Recruitment of classes was staggered over 16 months-Oct 2017 - Jan 2019-with classes matched. Clusters of class units within training squadron were formed over time as they became available, selected to maximize balance (e.g., AFSC), and randomized to one of two training conditions.
Pre-assignment Details

Arm/Group Title	Wingman Connect	Stress Management
Arm/Group Description	Wingman-Connect total training time is 5 hours, typically spread over three consecutive training 'blocks'(or days), plus 1-hour of booster training (one month later). Wingman Connect: Wingman-Connect combines group and individual skill training. Group exercises build cohesion, belonging and shared purpose, and promote value of healthy unit, giving and receiving support. Individual skills promote the ability to thrive during transitions, manage stressors and meet career goals, and decrease barriers to utilizing organizational resources (family, health). The training has a total of 22 modules comprised of specific learning objectives and activities. Six months of text messages (1-2 per week) to reinforce and extend program concepts and skills.	The control training condition will consist of a 2 hr. informational training that provides an overview of the human stress response system and strategies to manage stress. Stress Management: training reviews the basics of the hypothalamic-pituitary-adrenal axis stress-response system; common experiences of stress (physiological, cognitive, emotional); the impact of chronic stress on the brain and other domains of health; how exercise reduces harmful effects of stress; and relaxation techniques that have been shown to reduce stress and adverse effects of stress on health. Additional modules review the physiological stress response and effects of stress on health; how cognition influences stress responses; common cognitive distortions/attributions that affect stress including strategies to strengthen protective cognitive responses. Six months of text messages (1-2 per week) to reinforce and extend program concepts and skills.
Period Title: Overall Study
Started	748	737
Baseline Survey Completion	746	735
1 Month Survey Completion	697	694
6 Month Survey Completion	629	618
Completed	740	737
Not Completed	8	0
Reason Not Completed
Withdrawal by Subject	7	0
no data provided	1	0

Baseline Characteristics

Arm/Group Title		Wingman Connect	Stress Management	Total
Arm/Group Description		Wingman-Connect total training time is 5 hours, typically spread over three consecutive training 'blocks'(or days), plus 1-hour of booster training (one month later). Wingman Connect: Wingman-Connect combines group and individual skill training. Group exercises build cohesion, belonging and shared purpose, and promote value of healthy unit, giving and receiving support. Individual skills promote the ability to thrive during transitions, manage stressors and meet career goals, and decrease barriers to utilizing organizational resources (family, health). The training has a total of 22 modules comprised of specific learning objectives and activities. Six months of text messages (1-2 per week) to reinforce and extend program concepts and skills.	The control training condition will consist of a 2 hr. informational training that provides an overview of the human stress response system and strategies to manage stress. Stress Management: Stress management training reviews the basics of the hypothalamic-pituitary-adrenal axis stress-response system; common experiences of stress (physiological, cognitive, emotional); the impact of chronic stress on the brain and other domains of health; how exercise reduces harmful effects of stress; and relaxation techniques that have been shown to reduce stress and adverse effects of stress on health. Additional modules review the physiological stress response and effects of stress on health; introduces how cognition influences stress responses; common cognitive distortions/attributions are reviewed that affect stress including strategies to strengthen protective cognitive responses. Six months of text messages (1-2 per week) to reinforce and extend program concepts and skills.	Total of all reporting groups
Overall Number of Baseline Participants		746	735	1481
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	746 participants	735 participants	1481 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	746 100.0%	735 100.0%	1481 100.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	746 participants	735 participants	1481 participants
		20.96 (3.255)	20.87 (3.019)	20.92 (3.140)
Sex: Female, Male [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	744 participants	731 participants	1475 participants
	Female	128 17.2%	125 17.1%	253 17.2%
	Male	616 82.8%	606 82.9%	1222 82.8%
		[1] Measure Analysis Population Description: 2 participants in Wingman Connect and 4 participants in Stress Management did not report Sex in baseline survey
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	746 participants	735 participants	1481 participants
	Hispanic or Latino	137 18.4%	154 21.0%	291 19.6%
	Not Hispanic or Latino	608 81.5%	581 79.0%	1189 80.3%
	Unknown or Not Reported	1 0.1%	0 0.0%	1 0.1%
Race (NIH/OMB) [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	746 participants	735 participants	1481 participants
	American Indian or Alaska Native	6 0.8%	5 0.7%	11 0.7%
	Asian	31 4.2%	31 4.2%	62 4.2%
	Native Hawaiian or Other Pacific Islander	9 1.2%	10 1.4%	19 1.3%
	Black or African American	91 12.2%	83 11.3%	174 11.7%
	White	498 66.8%	483 65.7%	981 66.2%
	More than one race	59 7.9%	72 9.8%	131 8.8%
	Unknown or Not Reported	52 7.0%	51 6.9%	103 7.0%
		[1] Measure Description: 47 in Wingman Connect and 46 in Stress Management reported 'Other' in race - these are included in the 'Not reported' category.
Educational Background; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	746 participants	735 participants	1481 participants
	GED	30 4.0%	23 3.1%	53 3.6%
	High School Diploma	597 80.0%	571 77.7%	1168 78.9%
	Associates Degree	72 9.7%	87 11.8%	159 10.7%
	Bachelor's Degree or higher	47 6.3%	54 7.3%	101 6.8%
Military Component; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	746 participants	735 participants	1481 participants
	Active Duty	617 82.7%	596 81.1%	1213 81.9%
	National Guard	92 12.3%	90 12.2%	182 12.3%
	Reserves	37 5.0%	49 6.7%	86 5.8%

Outcome Measures

1. Primary Outcome

Title	Mean Computerized Adaptive Testing for Suicide Severity
Description	Participants will complete a computerized adaptive test for suicide severity. Participants will answer questions about their mental health. Participant scores will range from 0-100 with 100 indicating higher likelihood of current suicidal ideation and higher risk for suicide attempt.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Some participants completed the main survey, but not the computerized adaptive test section.

Arm/Group Title	Wingman Connect	Stress Management
Arm/Group Description:	Wingman-Connect total training time is 5 hours, typically spread over three consecutive training 'blocks'(or days), plus 1-hour of booster training (one month later). Wingman Connect: Wingman-Connect combines group and individual skill training. Group exercises build cohesion, belonging and shared purpose, and promote value of healthy unit, giving and receiving support. Individual skills promote the ability to thrive during transitions, manage stressors and meet career goals, and decrease barriers to utilizing organizational resources (family, health). The training has a total of 22 modules comprised of specific learning objectives and activities. Six months of text messages (1-2 per week) to reinforce and extend program concepts and skills.	The control training condition will consist of a 2 hr. informational training that provides an overview of the human stress response system and strategies to manage stress. Stress Management: Stress management training reviews the basics of the hypothalamic-pituitary-adrenal axis stress-response system; common experiences of stress (physiological, cognitive, emotional); the impact of chronic stress on the brain and other domains of health; how exercise reduces harmful effects of stress; and relaxation techniques that have been shown to reduce stress and adverse effects of stress on health. Additional modules review the physiological stress response and effects of stress on health; introduces how cognition influences stress responses; common cognitive distortions/attributions are reviewed that affect stress including strategies to strengthen protective cognitive responses. Six months of text messages (1-2 per week) to reinforce and extend program concepts and skills.
Overall Number of Participants Analyzed	577	571
Mean (Standard Deviation); Unit of Measure: units on a scale
	10.76 (13.87)	12.12 (13.50)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stress Management
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	.062
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component
Method of Estimation	Estimation Parameter	Effect size
	Estimated Value	-0.13
	Confidence Interval	(2-Sided) 95%; -.29 to .01
	Estimation Comments	[Not Specified]

2. Primary Outcome

Title	Mean Computerized Adaptive Testing for Suicide Severity
Description	Participants will complete a computerized adaptive test for suicide severity. Participants will answer questions about their mental health. Participant scores will range from 0-100 with 100 indicating higher likelihood of current suicidal ideation and higher risk for suicide attempt.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

Some participants completed the main survey, but not the computerized adaptive test section.

Arm/Group Title	Wingman Connect	Stress Management
Arm/Group Description:	Wingman-Connect total training time is 5 hours, typically spread over three consecutive training 'blocks'(or days), plus 1-hour of booster training (one month later). Wingman Connect: Wingman-Connect combines group and individual skill training. Group exercises build cohesion, belonging and shared purpose, and promote value of healthy unit, giving and receiving support. Individual skills promote the ability to thrive during transitions, manage stressors and meet career goals, and decrease barriers to utilizing organizational resources (family, health). The training has a total of 22 modules comprised of specific learning objectives and activities. Six months of text messages (1-2 per week) to reinforce and extend program concepts and skills.	The control training condition will consist of a 2 hr. informational training that provides an overview of the human stress response system and strategies to manage stress. Stress Management: Stress management training reviews the basics of the hypothalamic-pituitary-adrenal axis stress-response system; common experiences of stress (physiological, cognitive, emotional); the impact of chronic stress on the brain and other domains of health; how exercise reduces harmful effects of stress; and relaxation techniques that have been shown to reduce stress and adverse effects of stress on health. Additional modules review the physiological stress response and effects of stress on health; introduces how cognition influences stress responses; common cognitive distortions/attributions are reviewed that affect stress including strategies to strengthen protective cognitive responses. Six months of text messages (1-2 per week) to reinforce and extend program concepts and skills.
Overall Number of Participants Analyzed	657	661
Mean (Standard Deviation); Unit of Measure: units on a scale
	11.05 (13.25)	13.43 (13.94)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stress Management
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component
Method of Estimation	Estimation Parameter	Effect size
	Estimated Value	-0.23
	Confidence Interval	(2-Sided) 95%; -.39 to -.09
	Estimation Comments	[Not Specified]

3. Secondary Outcome

Title	Mean Computerized Adaptive Testing for Depression
Description	Participants will complete a computerized adaptive test for depression. Participants will answer questions about their mental health. Participant scores will range from 0-100 with 100 indicating higher risk for clinical depression.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Some participants completed the main survey, but not the computerized adaptive test section.

Arm/Group Title	Wingman Connect	Stress Management
Arm/Group Description:	Wingman-Connect total training time is 5 hours, typically spread over three consecutive training 'blocks'(or days), plus 1-hour of booster training (one month later). Wingman Connect: Wingman-Connect combines group and individual skill training. Group exercises build cohesion, belonging and shared purpose, and promote value of healthy unit, giving and receiving support. Individual skills promote the ability to thrive during transitions, manage stressors and meet career goals, and decrease barriers to utilizing organizational resources (family, health). The training has a total of 22 modules comprised of specific learning objectives and activities. Six months of text messages (1-2 per week) to reinforce and extend program concepts and skills.	The control training condition will consist of a 2 hr. informational training that provides an overview of the human stress response system and strategies to manage stress. Stress Management: Stress management training reviews the basics of the hypothalamic-pituitary-adrenal axis stress-response system; common experiences of stress (physiological, cognitive, emotional); the impact of chronic stress on the brain and other domains of health; how exercise reduces harmful effects of stress; and relaxation techniques that have been shown to reduce stress and adverse effects of stress on health. Additional modules review the physiological stress response and effects of stress on health; introduces how cognition influences stress responses; common cognitive distortions/attributions are reviewed that affect stress including strategies to strengthen protective cognitive responses. Six months of text messages (1-2 per week) to reinforce and extend program concepts and skills.
Overall Number of Participants Analyzed	577	571
Mean (Standard Deviation); Unit of Measure: units on a scale
	13.36 (17.18)	15.64 (15.21)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stress Management
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	.027
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component
Method of Estimation	Estimation Parameter	Effect size
	Estimated Value	-0.16
	Confidence Interval	(2-Sided) 95%; -.34 to -.02
	Estimation Comments	[Not Specified]

4. Secondary Outcome

Title	Computerized Adaptive Testing for Depression
Description	Participants will complete a computerized adaptive test for depression. Participants will answer questions about their mental health. Participant scores will range from 0-100 with 100 indicating higher risk for clinical depression.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

Some participants completed the main survey, but not the computerized adaptive test section.

Arm/Group Title	Wingman Connect	Stress Management
Arm/Group Description:	Wingman-Connect total training time is 5 hours, typically spread over three consecutive training 'blocks'(or days), plus 1-hour of booster training (one month later). Wingman Connect: Wingman-Connect combines group and individual skill training. Group exercises build cohesion, belonging and shared purpose, and promote value of healthy unit, giving and receiving support. Individual skills promote the ability to thrive during transitions, manage stressors and meet career goals, and decrease barriers to utilizing organizational resources (family, health). The training has a total of 22 modules comprised of specific learning objectives and activities. Six months of text messages (1-2 per week) to reinforce and extend program concepts and skills.	The control training condition will consist of a 2 hr. informational training that provides an overview of the human stress response system and strategies to manage stress. Stress Management: Stress management training reviews the basics of the hypothalamic-pituitary-adrenal axis stress-response system; common experiences of stress (physiological, cognitive, emotional); the impact of chronic stress on the brain and other domains of health; how exercise reduces harmful effects of stress; and relaxation techniques that have been shown to reduce stress and adverse effects of stress on health. Additional modules review the physiological stress response and effects of stress on health; introduces how cognition influences stress responses; common cognitive distortions/attributions are reviewed that affect stress including strategies to strengthen protective cognitive responses. Six months of text messages (1-2 per week) to reinforce and extend program concepts and skills.
Overall Number of Participants Analyzed	657	661
Mean (Standard Deviation); Unit of Measure: units on a scale
	15.42 (16.93)	18.38 (16.87)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stress Management
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	.002
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component
Method of Estimation	Estimation Parameter	Effect size
	Estimated Value	-0.24
	Confidence Interval	(2-Sided) 95%; -.41 to -.08
	Estimation Comments	[Not Specified]

5. Secondary Outcome

Title	Mean Behavioral Occupational Performance Outcomes
Description	Participants will complete 5 yes/no questions about job performance, including if superior has expressed concerns about work performance, if Airman has received corrective training for substandard performance, received a negative counseling statement, received a Letter of Reprimand. The sum of affirmative responses will be calculated. Scores will range from 0-5 with 5 indicating greater work impairment.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Wingman Connect	Stress Management
Arm/Group Description:	Wingman-Connect total training time is 5 hours, typically spread over three consecutive training 'blocks'(or days), plus 1-hour of booster training (one month later). Wingman Connect: Wingman-Connect combines group and individual skill training. Group exercises build cohesion, belonging and shared purpose, and promote value of healthy unit, giving and receiving support. Individual skills promote the ability to thrive during transitions, manage stressors and meet career goals, and decrease barriers to utilizing organizational resources (family, health). The training has a total of 22 modules comprised of specific learning objectives and activities. Six months of text messages (1-2 per week) to reinforce and extend program concepts and skills.	The control training condition will consist of a 2 hr. informational training that provides an overview of the human stress response system and strategies to manage stress. Stress Management: Stress management training reviews the basics of the hypothalamic-pituitary-adrenal axis stress-response system; common experiences of stress (physiological, cognitive, emotional); the impact of chronic stress on the brain and other domains of health; how exercise reduces harmful effects of stress; and relaxation techniques that have been shown to reduce stress and adverse effects of stress on health. Additional modules review the physiological stress response and effects of stress on health; introduces how cognition influences stress responses; common cognitive distortions/attributions are reviewed that affect stress including strategies to strengthen protective cognitive responses. Six months of text messages (1-2 per week) to reinforce and extend program concepts and skills.
Overall Number of Participants Analyzed	629	618
Mean (Standard Deviation); Unit of Measure: units on a scale
	0.29 (0.93)	0.28 (0.94)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stress Management
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	.821
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component
Method of Estimation	Estimation Parameter	Effect size
	Estimated Value	0.01
	Confidence Interval	(2-Sided) 95%; -.12 to .11
	Estimation Comments	[Not Specified]

6. Secondary Outcome

Title	Mean Behavioral Occupational Performance Outcomes
Description	Participants will complete 5 yes/no questions about job performance, including if superior has expressed concerns about work performance, if Airman has received corrective training for substandard performance, received a negative counseling statement, received a Letter of Reprimand. The sum of affirmative responses will be calculated. Scores will range from 0-5 with 5 indicating greater work impairment.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Wingman Connect	Stress Management
Arm/Group Description:	Wingman-Connect total training time is 5 hours, typically spread over three consecutive training 'blocks'(or days), plus 1-hour of booster training (one month later). Wingman Connect: Wingman-Connect combines group and individual skill training. Group exercises build cohesion, belonging and shared purpose, and promote value of healthy unit, giving and receiving support. Individual skills promote the ability to thrive during transitions, manage stressors and meet career goals, and decrease barriers to utilizing organizational resources (family, health). The training has a total of 22 modules comprised of specific learning objectives and activities. Six months of text messages (1-2 per week) to reinforce and extend program concepts and skills.	The control training condition will consist of a 2 hr. informational training that provides an overview of the human stress response system and strategies to manage stress. Stress Management: Stress management training reviews the basics of the hypothalamic-pituitary-adrenal axis stress-response system; common experiences of stress (physiological, cognitive, emotional); the impact of chronic stress on the brain and other domains of health; how exercise reduces harmful effects of stress; and relaxation techniques that have been shown to reduce stress and adverse effects of stress on health. Additional modules review the physiological stress response and effects of stress on health; introduces how cognition influences stress responses; common cognitive distortions/attributions are reviewed that affect stress including strategies to strengthen protective cognitive responses. Six months of text messages (1-2 per week) to reinforce and extend program concepts and skills.
Overall Number of Participants Analyzed	685	681
Mean (Standard Deviation); Unit of Measure: units on a scale
	0.17 (0.62)	0.25 (0.73)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stress Management
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	.024
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component
Method of Estimation	Estimation Parameter	Effect size
	Estimated Value	-0.14
	Confidence Interval	(2-Sided) 95%; -.31 to -.02
	Estimation Comments	[Not Specified]

7. Secondary Outcome

Title	Mean Class Cohesion
Description	Participants will complete a 3-item scale on how well members of their class cooperate, can depend on each other and stand up for each other. Scores range from 0 to 4 with higher scores indicating higher class cohesion.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Wingman Connect	Stress Management
Arm/Group Description:	Wingman-Connect total training time is 5 hours, typically spread over three consecutive training 'blocks'(or days), plus 1-hour of booster training (one month later). Wingman Connect: Wingman-Connect combines group and individual skill training. Group exercises build cohesion, belonging and shared purpose, and promote value of healthy unit, giving and receiving support. Individual skills promote the ability to thrive during transitions, manage stressors and meet career goals, and decrease barriers to utilizing organizational resources (family, health). The training has a total of 22 modules comprised of specific learning objectives and activities. Six months of text messages (1-2 per week) to reinforce and extend program concepts and skills.	The control training condition will consist of a 2 hr. informational training that provides an overview of the human stress response system and strategies to manage stress. Stress Management: Stress management training reviews the basics of the hypothalamic-pituitary-adrenal axis stress-response system; common experiences of stress (physiological, cognitive, emotional); the impact of chronic stress on the brain and other domains of health; how exercise reduces harmful effects of stress; and relaxation techniques that have been shown to reduce stress and adverse effects of stress on health. Additional modules review the physiological stress response and effects of stress on health; introduces how cognition influences stress responses; common cognitive distortions/attributions are reviewed that affect stress including strategies to strengthen protective cognitive responses. Six months of text messages (1-2 per week) to reinforce and extend program concepts and skills.
Overall Number of Participants Analyzed	687	698
Mean (Standard Deviation); Unit of Measure: units on a scale
	3.16 (0.72)	3.05 (0.75)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stress Management
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	.012
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component
Method of Estimation	Estimation Parameter	Effect size
	Estimated Value	0.18
	Confidence Interval	(2-Sided) 95%; .04 to .29
	Estimation Comments	[Not Specified]

8. Secondary Outcome

Title	Mean Number of Positive Connections to Classmates
Description	Participants will be asked to name up to 5 other students in their class who they respect and would choose to spend time with. Participants can name 0-5 classmates.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Wingman Connect	Stress Management
Arm/Group Description:	Wingman-Connect total training time is 5 hours, typically spread over three consecutive training 'blocks'(or days), plus 1-hour of booster training (one month later). Wingman Connect: Wingman-Connect combines group and individual skill training. Group exercises build cohesion, belonging and shared purpose, and promote value of healthy unit, giving and receiving support. Individual skills promote the ability to thrive during transitions, manage stressors and meet career goals, and decrease barriers to utilizing organizational resources (family, health). The training has a total of 22 modules comprised of specific learning objectives and activities. Six months of text messages (1-2 per week) to reinforce and extend program concepts and skills.	The control training condition will consist of a 2 hr. informational training that provides an overview of the human stress response system and strategies to manage stress. Stress Management: Stress management training reviews the basics of the hypothalamic-pituitary-adrenal axis stress-response system; common experiences of stress (physiological, cognitive, emotional); the impact of chronic stress on the brain and other domains of health; how exercise reduces harmful effects of stress; and relaxation techniques that have been shown to reduce stress and adverse effects of stress on health. Additional modules review the physiological stress response and effects of stress on health; introduces how cognition influences stress responses; common cognitive distortions/attributions are reviewed that affect stress including strategies to strengthen protective cognitive responses. Six months of text messages (1-2 per week) to reinforce and extend program concepts and skills.
Overall Number of Participants Analyzed	687	698
Mean (Standard Deviation); Unit of Measure: classmates
	2.08 (1.61)	1.83 (1.56)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stress Management
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	.010
	Comments	Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Effect size
	Estimated Value	0.21
	Confidence Interval	(2-Sided) 95%; .05 to .35
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	6 months
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Wingman Connect	Stress Management
Arm/Group Description	Wingman-Connect total training time is 5 hours, typically spread over three consecutive training 'blocks'(or days), plus 1-hour of booster training (one month later). Wingman Connect: Wingman-Connect combines group and individual skill training. Group exercises build cohesion, belonging and shared purpose, and promote value of healthy unit, giving and receiving support. Individual skills promote the ability to thrive during transitions, manage stressors and meet career goals, and decrease barriers to utilizing organizational resources (family, health). The training has a total of 22 modules comprised of specific learning objectives and activities. Six months of text messages (1-2 per week) to reinforce and extend program concepts and skills.	The control training condition will consist of a 2 hr. informational training that provides an overview of the human stress response system and strategies to manage stress. Stress Management: Stress management training reviews the basics of the hypothalamic-pituitary-adrenal axis stress-response system; common experiences of stress (physiological, cognitive, emotional); the impact of chronic stress on the brain and other domains of health; how exercise reduces harmful effects of stress; and relaxation techniques that have been shown to reduce stress and adverse effects of stress on health. Additional modules review the physiological stress response and effects of stress on health; introduces how cognition influences stress responses; common cognitive distortions/attributions are reviewed that affect stress including strategies to strengthen protective cogn
All-Cause Mortality
	Wingman Connect	Stress Management
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/748 (0.00%)	0/737 (0.00%)
Serious Adverse Events
	Wingman Connect	Stress Management
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/748 (0.00%)	0/737 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Wingman Connect	Stress Management
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/748 (0.00%)	0/737 (0.00%)

Limitations and Caveats

AiTs and training school leadership were not blinded to intervention condition. Second, outcomes relied on self-report. Third, trainers were research staff, and findings may not generalize to training by military personnel.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Dr. Peter Wyman
• Organization: University of Rochester Medical Center, Psychiatry Dept
• Phone: 5852733372
• EMail: peter_wyman@urmc.rochester.edu

Publications:

Gibbons RD, Kupfer D, Frank E, Moore T, Beiser DG, Boudreaux ED. Development of a Computerized Adaptive Test Suicide Scale-The CAT-SS. J Clin Psychiatry. 2017 Nov/Dec;78(9):1376-1382. doi: 10.4088/JCP.16m10922.

Wyman PA, Brown CH, LoMurray M, Schmeelk-Cone K, Petrova M, Yu Q, Walsh E, Tu X, Wang W. An outcome evaluation of the Sources of Strength suicide prevention program delivered by adolescent peer leaders in high schools. Am J Public Health. 2010 Sep;100(9):1653-61. doi: 10.2105/AJPH.2009.190025. Epub 2010 Jul 15.

Petrova M, Wyman PA, Schmeelk-Cone K, Pisani AR. Positive-Themed Suicide Prevention Messages Delivered by Adolescent Peer Leaders: Proximal Impact on Classmates' Coping Attitudes and Perceptions of Adult Support. Suicide Life Threat Behav. 2015 Dec;45(6):651-63. doi: 10.1111/sltb.12156. Epub 2015 Feb 18.

Gibbons RD, Weiss DJ, Pilkonis PA, Frank E, Moore T, Kim JB, Kupfer DJ. Development of a computerized adaptive test for depression. Arch Gen Psychiatry. 2012 Nov;69(11):1104-12. doi: 10.1001/archgenpsychiatry.2012.14. Erratum in: Arch Gen Psychiatry. 2013 Jan;70(1):30.

Herrell RK, Edens EN, Riviere LA, Thomas JL, Bliese PD, Hoge CW. Assessing functional impairment in a working military population: the Walter Reed functional impairment scale. Psychol Serv. 2014 Aug;11(3):254-64. doi: 10.1037/a0037347.

Williams, J, Brown, JM, Bray, RM, Anderson Goodell, EM, Olmsted, KR, Adler, AB. (2016) Unit Cohesion, Resilience, and Mental Health of Soldiers in Basic Combat Training, Military Psychology, 28:4, 241-250, DOI: 10.1037/mil0000120

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wyman PA, Pisani AR, Brown CH, Yates B, Morgan-DeVelder L, Schmeelk-Cone K, Gibbons RD, Caine ED, Petrova M, Neal-Walden T, Linkh DJ, Matteson A, Simonson J, Pflanz SE. Effect of the Wingman-Connect Upstream Suicide Prevention Program for Air Force Personnel in Training: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2022532. doi: 10.1001/jamanetworkopen.2020.22532.

• Responsible Party: Peter Wyman, University of Rochester
• ClinicalTrials.gov Identifier: NCT04067401
• Other Study ID Numbers: 1337
• First Submitted: August 21, 2019
• First Posted: August 26, 2019
• Results First Submitted: June 2, 2020
• Results First Posted: July 8, 2020
• Last Update Posted: July 8, 2020