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Recruiting NCT06981598

Prevention of Psychological Health Problems Via Integrated Operational Support

No phase Interventional Depression, Anxiety Grief Leadership Dissatisfaction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cognitive Behavioral Coaching Training.
Who it may be relevant to
Registry conditions: Depression, Anxiety, Grief, Leadership, Dissatisfaction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Optimizing Psychological Health and Preventing Clinical Problems: Testing the Effectiveness of an Evidence-Based Toolkit for Integrated Operational Support

Overview

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.

Interventions

  • Behavioral Cognitive Behavioral Coaching Training
    Behavioral technicians will engage in a structured, deliberate-practice-based training program designed to enhance competence in evidence-based interventions (EBIs) over a 10-week period. The program begins with an initial seminar that provides an overview of the training framework, key research supporting deliberate practice, and specific intervention techniques. Each participant is assigned a coach-either a clinical psychologist or a licensed MSW with expertise in the EBI Toolkit-who will prov

Primary outcome measures

  • Average Satisfaction of Service Members (SM) with Embedded Behavioral Health Technician (BHT) Services [Time frame: From the SM's first session with their embedded BHT to their last session (up to 10 weeks)]
  • Change in Service Member PHQ-9 (Patient Health Questionnaire-9) Score [Time frame: 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)]
  • Change in Service Member WHO-5 Well-being Index Score [Time frame: 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)]
  • Change in Service Member PSS-10 (Perceived Stress Scale - 10 item version) Score [Time frame: 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)]
  • Change in Service Member STAI (State-Trait Anxiety Inventory) Score [Time frame: 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 outcome measures (1)
  • Frequency of evidence based intervention (EBI) use among behavioral health technicians (BHT) following IOS Toolkit Cognitive Behavioral Coaching training [Time frame: Pre-training (10-week period) to post-training (10-week period)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • New York University — New York

Identifiers

NCT: NCT06981598 · IRB-FY2023-7921

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗