Clinical trial NCT06981598: Prevention of Psychological Health Problems Via Integrated Operational Support
Official title: Optimizing Psychological Health and Preventing Clinical Problems: Testing the Effectiveness of an Evidence-Based Toolkit for Integrated Operational Support
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression, Anxiety
Grief
Leadership
Dissatisfaction
Lead sponsor: New York University
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 5586
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Modified stepped wedge design training behavioral health technicians
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Sub-clinical behavioral health services in the military are performed by BH technicians, who receive minimal training. Due to this, embedding more technicians in military units is unlikely to benefit service members. Giving technicians training in, and access to, evidence-based interventions (EBI) could make their work more effective. The proposed study is a training trial examining the efficacy of the full integrated operational support (IOS) toolkit (evidence-based interventions for behavioral health), relative to routine care using standard resources, as a prevention resource for active-duty airmen.

Detailed description: This study is conducted in collaboration with the Department of the Air Force (DAF) Medical Service to enhance the effectiveness of embedded behavioral health (BH) technicians in operational units. The initiative aligns with military health goals by embedding paraprofessional BH technicians within line units to improve service member (SM) access to mental health care, reduce stigma, and address risk factors such as sleep disorders, stress, trauma, and suicide prevention. However, variability in training and intervention delivery has limited their effectiveness. This research aims to test evidence-based training (EBT) approaches for BH technicians, equipping them with validated intervention tools and engagement techniques to improve SM psychological well-being, stress management, and service satisfaction.

The research builds on previous findings showing that embedded BH technicians increase accessibility and reduce stigma but often lack standardized training and structured intervention tools. The study will use a randomized controlled trial (RCT) design to compare trained vs. untrained BH technicians, assessing their adoption of evidence-based interventions (EBIs) and the resulting impact on SM well-being. The CBPR advisory board, which has guided the development of the IOS EBI Toolkit, will continue its role in refining training methods and implementation. Additionally, a patient advocate consultant, who has experienced suicidality, PTSD, and sleep disorders, will contribute to recruitment strategies and intervention refinement. This approach ensures that training is optimized for real-world military settings, increasing adoption and effectiveness.

The study's objectives are to evaluate whether EBI training improves BH technicians' adoption of intervention tools and SM outcomes, test whether BH technician competency mediates SM improvement, and deliver empirically supported training protocols to the DAF. The research aims to enhance the quality and impact of BH services in operational units, ultimately improving SM resilience, recovery, and mission readiness. By formalizing structured training programs and evidence-based engagement strategies, this initiative seeks to standardize and optimize the role of embedded BH technicians, ensuring they effectively support service members' mental health needs. If successful, these training protocols will be scaled for military-wide implementation, contributing to long-term mental health improvements across the DAF and broader military community.

Eligibility criteria: Inclusion Criteria:

* Service members seeing a behavioral health (BH) technician.
* Currently embedded BH technicians.

Exclusion Criteria:

* Service members who are not currently seeing a BH technician.
* BH technicians who are not embedded or have taken a clinic role.

Primary outcomes:
measure: Average Satisfaction of Service Members (SM) with Embedded Behavioral Health Technician (BHT) Services
timeFrame: From the SM's first session with their embedded BHT to their last session (up to 10 weeks)
measure: Change in Service Member PHQ-9 (Patient Health Questionnaire-9) Score
timeFrame: From the SM's first session with their embedded BHT to one month after their last session with their embedded BHT (up to 14 months after the completion of the baseline survey after the first appointment with their embedded BHT)
measure: Change in Service Member WHO-5 Well-being Index Score
timeFrame: From the SM's first session with their embedded BHT to one month after their last session with their embedded BHT (up to 14 months after the completion of the baseline survey after the first appointment with their embedded BHT)
measure: Change in Service Member PSS-10 (Perceived Stress Scale - 10 item version) Score
timeFrame: From the SM's first session with their embedded BHT to one month after their last session with their embedded BHT (up to 14 months after the completion of the baseline survey after the first appointment with their embedded BHT)
measure: Change in Service Member STAI (State-Trait Anxiety Inventory) Score
timeFrame: From the SM's first session with their embedded BHT to one month after their last session with their embedded BHT (up to 14 months after the completion of the baseline survey after the first appointment with their embedded BHT)
Secondary outcomes:
measure: Frequency of evidence based intervention (EBI) use among behavioral health technicians (BHT) following IOS Toolkit Cognitive Behavioral Coaching training
timeFrame: Pre-training (10-week period) to post-training (10-week period)
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University
state: New York
Study officials:
affiliation: NYU
name: Amy S Slep, PhD
role: PRINCIPAL_INVESTIGATOR
References: