NCT04067401

Brief Summary

A study evaluating a training program to decrease risk for suicidal thoughts and behaviors among early career trainees in the United States Air Force.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,485

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 3, 2017

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 26, 2019

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2019

Completed
10 months until next milestone

Results Posted

Study results publicly available

July 8, 2020

Completed
Last Updated

July 8, 2020

Status Verified

June 1, 2020

Enrollment Period

1.9 years

First QC Date

August 21, 2019

Results QC Date

June 2, 2020

Last Update Submit

June 23, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Mean Computerized Adaptive Testing for Suicide Severity

    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.

    6 months

  • Mean Computerized Adaptive Testing for Suicide Severity

    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.

    1 month

Secondary Outcomes (6)

  • Mean Computerized Adaptive Testing for Depression

    6 months

  • Computerized Adaptive Testing for Depression

    1 month

  • Mean Behavioral Occupational Performance Outcomes

    6 months

  • Mean Behavioral Occupational Performance Outcomes

    1 month

  • Mean Class Cohesion

    1 month

  • +1 more secondary outcomes

Study Arms (2)

Wingman Connect

EXPERIMENTAL

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).

Behavioral: Wingman Connect

Stress Management

ACTIVE COMPARATOR

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. The training will be delivered through lecture format using PowerPoint, supplemented by brief videos and interactive discussion.

Behavioral: Stress Management

Interventions

Wingman ConnectBEHAVIORAL

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.

Wingman Connect

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.

Stress Management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Airmen-in-Training (AiT) in Technical Training classes in the 365 or 363 Training Squadrons of the 82 Training Wing (82 TRW)
  • Eligible classes must be between 37-91 class days in length

You may not qualify if:

  • Airmen from other countries receiving training in US
  • Airmen who are not in their first year of enlistment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheppard Air Force Base

Wichita Falls, Texas, 76311-9999, United States

Location

Related Publications (7)

  • 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.

    PMID: 28493655BACKGROUND
  • 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.

    PMID: 20634440BACKGROUND
  • 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.

    PMID: 25692382BACKGROUND
  • 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.

    PMID: 23117634BACKGROUND
  • 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.

    PMID: 25068298BACKGROUND
  • 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

    BACKGROUND
  • 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.

MeSH Terms

Conditions

Suicidal Ideation

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

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.

Results Point of Contact

Title
Dr. Peter Wyman
Organization
University of Rochester Medical Center, Psychiatry Dept

Study Officials

  • Peter A Wyman, PhD

    University of Rochester Medical Center, Psychiatry Dept

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The study design will involve randomizing approximately 1440 Airman-in-Training (AiT) within 160 Technical Training classes to one of two conditions: Wingman-Connect or a brief Stress Management training. Randomization will occur at the class level, since Wingman-Connect is designed to train AiTs within a class together as a group (those who voluntarily enroll).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 21, 2019

First Posted

August 26, 2019

Study Start

October 3, 2017

Primary Completion

September 2, 2019

Study Completion

September 2, 2019

Last Updated

July 8, 2020

Results First Posted

July 8, 2020

Record last verified: 2020-06

Locations