Depression, AnxietyIOS ToolkitNCT06981598
Prevention of Psychological Health Problems Via Integrated Operational Support
A study testing Cognitive Behavioral Coaching Training in people with Depression, Anxiety and Grief, run by New York University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, Grief, Leadership
- What is being tested?
- Cognitive Behavioral Coaching Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,586 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2025to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Service members seeing a behavioral health (BH) technician.
- Currently embedded BH technicians.
Who cannot join
- Service members who are not currently seeing a BH technician.
- BH technicians who are not embedded or have taken a clinic role.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
New York University
New York, New York, 10016
Amy S Slep, PhD, amy.slep@nyu.edu
Ana Ivic, LMSW, 9143195245, ai679@nyu.edu
About this study
Official title: Optimizing Psychological Health and Preventing Clinical Problems: Testing the Effectiveness of an Evidence-Based Toolkit for Integrated Operational Support
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.
Read the 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.
- Conditions
- Depression, Anxiety, Grief, Leadership, Dissatisfaction
- Being tested
- Cognitive Behavioral Coaching Training
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Coaching TrainingBehavioural
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 provide individualized guidance throughout the training. During the weekly coaching sessions, participants will review session notes, engage in structured practice exercises, and work toward mastering the skills and competencies necessary for effective intervention delivery. Weekly homework assignments will allow participants to practice each tool as though they were working with an SM client, followed by self-reflections that will be discussed in coaching sessions.
| Study group | Role | What they receive |
|---|---|---|
| BH Technician Training | Experimental | BH Technician Training; active deliberate practice training Receives: Behavioral: Cognitive Behavioral Coaching Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Satisfaction of Service Members (SM) with Embedded Behavioral Health Technician (BHT) Services
We will ask participating SMs questions about their session with their embedded BHT to gauge their satisfaction with the experience. The questions are prompts such as "How much do you think your meeting today will help you deal with your current difficulties?" and How much do you think working with a MHT/BHT/psych/4C will help you improve the things you would like to change?"
Measured: 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
The PHQ-9 (Patient Health Questionnaire-9) measures physical, emotional, and cognitive symptoms of Major Depression such as "feeling down, depressed, or hopeless," "trouble falling or staying asleep, or sleeping too much," or "trouble concentrating on things, such as reading the newspaper or watching television." Service members (SM) will fill out this measure.
Measured: 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
The WHO-5 Well-being Index measures general well-being with prompts such as "I have felt cheerful and in good spirits" and "I woke up feeling fresh and rested." Service members (SM) will fill out this measure.
Measured: 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
The PSS-10 (Perceived Stress Scale - 10 item version) measures the SM's stress with prompts such as: "In the last month, how often have you felt that you were unable to control the important things in your life?" and "In the last month, how often have you felt that you were on top of things?" Service members (SM) will fill out this measure.
Measured: 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
The STAI (State-Trait Anxiety Inventory) measures anxiety by asking participants about their current emotions with prompts such as "I feel calm," "I feel frightened," and "I feel nervous." Service members (SM) will fill out this measure.
Measured: 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 (1)
Frequency of evidence based intervention (EBI) use among behavioral health technicians (BHT) following IOS Toolkit Cognitive Behavioral Coaching training
The percentage of all interventions offered by BHTs while treating service members that are evidence based will be compared to the percentage that are not evidence based from pre-training (10-week period) to post-training (10-week period).
Measured: Pre-training (10-week period) to post-training (10-week period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start10 Mar 2025
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- More trials run by New York UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Modified stepped wedge design training behavioral health technicians
- Masking
- None (open label)
- Enrolment
- 5,586 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy S Slep, PhD, Principal investigator, NYU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981598
- Sponsor's protocol ID
- IRB-FY2023-7921
- Acronym
- IOS Toolkit
- Status last verified
- May 2026
- First submitted
- 17 Mar 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Psychological Health and Preventing Clinical Problems: Testing the Effectiveness of an Evidence-Based Toolkit for Integrated Operational Support
- ClinicalTrials.gov ID
- NCT06981598
- Acronym / sponsor ID
- IOS Toolkit / IRB-FY2023-7921
- Conditions
- Depression, Anxiety, Grief, Leadership, Dissatisfaction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5,586 participants (estimated)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Modified stepped wedge design training behavioral health technicians
| Arm | Type | Receives |
|---|---|---|
| BH Technician Training | Experimental | Behavioral: Cognitive Behavioral Coaching TrainingBH Technician Training; active deliberate practice training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Service members seeing a behavioral health (BH) technician.
- Currently embedded BH technicians.
Key exclusion criteria (2 listed)
- Service members who are not currently seeing a BH technician.
- BH technicians who are not embedded or have taken a clinic role.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Coaching TrainingBehavioral 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 provide individualized guidance throughout the training. During the weekly coaching sessions, participants will review session notes, engage in structured practice exercises, and work toward mastering the skills and competencies necessary for effective intervention delivery. Weekly homework assignments will allow participants to practice each tool as though they were working with an SM client, followed by self-reflections that will be discussed in coaching sessions. | Behavioural | BH Technician Training |
Primary outcome
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)
We will ask participating SMs questions about their session with their embedded BHT to gauge their satisfaction with the experience. The questions are prompts such as "How much do you think your meeting today will help you deal with your current difficulties?" and How much do you think working with a MHT/BHT/psych/4C will help you improve the things you would like to change?"
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)
The PHQ-9 (Patient Health Questionnaire-9) measures physical, emotional, and cognitive symptoms of Major Depression such as "feeling down, depressed, or hopeless," "trouble falling or staying asleep, or sleeping too much," or "trouble concentrating on things, such as reading the newspaper or watching television." Service members (SM) will fill out this measure.
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)
The WHO-5 Well-being Index measures general well-being with prompts such as "I have felt cheerful and in good spirits" and "I woke up feeling fresh and rested." Service members (SM) will fill out this measure.
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)
The PSS-10 (Perceived Stress Scale - 10 item version) measures the SM's stress with prompts such as: "In the last month, how often have you felt that you were unable to control the important things in your life?" and "In the last month, how often have you felt that you were on top of things?" Service members (SM) will fill out this measure.
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)
The STAI (State-Trait Anxiety Inventory) measures anxiety by asking participants about their current emotions with prompts such as "I feel calm," "I feel frightened," and "I feel nervous." Service members (SM) will fill out this measure.
1 secondary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amy S Slep, PhD principal investigator
NYU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Coaching Training in people with Depression, Anxiety and Grief, run by New York University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelly Daly, PhD (914-806-5093, kd2691@nyu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.