A.02 Request for Information RISE UP KO Review 8-26-25.docx

Request for Information (RFI)

Requiring Activity Name: The United States Army Medical Research Division - West (USAMRD-W).

Subject: Research and development support to develop the framework and iterations of the Reconnecting to Internal Sensations and Experiences for Uniformed Personnel (RISE UP) intervention.

This Request for Information (RFI)/Sources Sought (SS) Notice is for market research information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of USAMRD-W or the US Army Medical Research Acquisition Activity (USAMRAA).

This market research is seeking sources only that have knowledge and capabilities to provide Research and Development to support the RISE UP intervention and develop the software required to run the intervention study on the Qualtrics platform.

The NAICS code for this requirement 541720 – Research and Development in the Social Sciences and Humanities. Only capability statements and/or fact sheet will be accepted.

RFI AVAILABILITY: In accordance with FAR Part 10 Market Research, this RFI is to ensure responsible and constructive exchanges with industry while complying with existing law and regulation that does not provide an unfair competitive advantage to particular firms or violate the procurement integrity requirements.

This RFI is being made available through the following platforms to maximize market research to target Prime Contractors to perform military specific research:

DISCLAIMER: This RFI is NOT a Request for Proposals (RFP) or a Request for Quotations (RFQ); This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Responses to the RFI will not be returned. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. No Contract will be awarded from this announcement. No reimbursement will be made of any costs to provide information in response to this announcement or any follow up information requests. Responders are solely responsible for all expense associated with responding to this RFI. Availability of any formal solicitation will be announced under a separate announcement.

All information received in response to this RFI will be treated as business confidential information. Submitters should properly mark their responses if the information is confidential. All information received in response to this RFI that is marked Proprietary will be handled accordingly.

At this time, questions concerning the composition and requirements for a future solicitation will not be entertained.

RFI Response and due date: 08 SEPT 2025 10am Eastern Standard Time (EST)

Background: The purpose of this requirement is to provide research and development support to assist with a study using RISE to circumvent many of the current limitations to existing treatments for behavioral health problems in the military.

The overall objective of the two-phase research and development support is to further develop an evidence-based interoception training program by adapting RISE specifically for Active-duty service members (ADSM) (i.e., RISE-UP) and subsequently evaluating the effectiveness of RISE-UP on improved interoceptive sensibility, key aspects of psychological readiness (i.e., stress management, resilience), and military outcomes via a waitlist randomized controlled trial (RCT).

Instructions to Responders: Responses from Small Businesses capable and qualified sources are encouraged to respond to this request.

Review the attached DRAFT Statement of Work (SOW). Respondents should address how they best can fulfil the requirements set forth in the SOW in their capabilities statement. Capability Statements or any other proprietary information relative to this RFI should adhere to the following formatting and outline instructions:

1. All submissions shall be made electronically and be in one of the following formats: Microsoft Word or Adobe PDF and shall not exceed 3 pages (Cover page excluded from page count).

2. Cover Page

• Responders technical and administrative points of contact (names, addresses, phone, fax number and email addresses)

Address whether the respondent is offering similar or like services in the commercial market to the general public.

3. Please note that the response shall provide sufficient technical data to determine how you fully meet the requirements as specified in the DRAFT SOW.

Please note that responses are due no later than 08 SEPT 2025 10am Eastern Standard Time (EST). The requested information shall be submitted via email. The point of contact for this action is Herbert Caj Keen, Contract Specialist herbert.e.keen.civ@health.mil. Only electronic responses are requested. No evaluation letters and/or results will be issued to the respondents. At this time no solicitation exists; therefore, please do not request a copy of the solicitation. NO PHONE CALLS PLEASE.

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A01-SOW- RISE_Up DRAFT.pdf

STATEMENT OF WORK (SOW)

Contents

1. INTRODUCTION

2. PURPOSE AND BACKGROUND

3. SCOPE

4. PERIOD OF PERFORMANCE (PoP)

5. WORK SCHEDULE AND LOCATION

6. PERFORMANCE REQUIREMENTS

7. DELIVERABLES

8. CONTRACT MANAGEMENT ............................... Error! Bookmark not defined.

9. COMPLIANCE DOCUMENTS

10. OTHER TERMS, CONDITIONS, AND PROVISIONS

11. ATTACHMENTS

STATEMENT OF WORK (SOW)

Title: RISE-UP Study

Requiring Activity Name: Walter Reed Army Institute of Research (WRAIR), United States Army Medical Research Directorate – West (USAMRD-W).

1. INTRODUCTION

The Walter Reed Army Institute of Research (WRAIR) provides unique research capabilities and innovative medical solutions to a range of Force Health Protection and Readiness challenges currently facing U.S. Service Members, along with threats anticipated during future operations.

Through both times of peace and war, infectious diseases have killed, sickened, and disabled far more Service Members than bombs and bullets. WRAIR has created a model of vaccine and therapeutic development that is unique, nimble, and responsive to dynamically evolving infectious disease threats of military importance. WRAIR, with its unparalleled expertise, facilities, and international network, has developed many vaccines and drugs in use today by military and civilian medicine around the globe.

In addition to protecting against infectious disease threats, WRAIR conducts basic and applied research that promotes psychological resilience, enhances neurological functioning, and improves operational readiness among U.S. Service Members. By using a continuum of research from basic science to applied field studies, WRAIR creates innovative solutions to enhance Service Members’ resilience and recovery.

Research in military psychiatry and neuroscience has been an integral part of WRAIR's portfolio for more than 70 years. WRAIR researchers are recognized leaders in operational medical research for the military in a number of fields, including brain trauma, blast exposure, deployment stressors, and sleep management.

2. PURPOSE AND BACKGROUND

U.S. Army Medical Research Directorate – West (USAMRD-W) conducts research and delivers solutions to optimize brain health to increase resilience and mitigate operational stress for maximizing Soldier health and performance. We are strategically located at Joint Base Lewis-McChord (JBLM) to support readiness across the Indo-Pacific Combatant Command (INDOPACOM). USAMRD-W's capabilities include the ability to conduct large, randomized controlled trials to assess the efficacy of interventions, validation of screening and assessment measures, deliver training, evaluation of behavioral health programs, field/training assessments for identifying risk factors and health readiness surveillance, and research consultation. As subject matter experts in the field of behavioral health and applied psychology, USAMRD-W offers leading expertise in military performance, health and readiness, and operational stress management.

Active-duty service members (ADSM) experience unique occupational stressors inherent to their roles in the military, such as deployment, service commitments, potential for exposure to combat trauma, and physical fitness requirements that impact career opportunities (e.g., promotion). An extensive literature indicates that elevated occupational stress among ADSM is associated with a host of negative physiological (e.g., increased injury risk) and psychological consequences (e.g., burnout, suicidality) that have a substantive impact on key operational factors (e.g., profiles/chaptering, job turnover) that undermine military readiness. Given these impacts, it is imperative that the military develops and evaluates easily accessible, evidence-based interventions that will help ADSM develop the skills to effectively manage stress, improve resilience, and ultimately, strengthen psychological readiness. The primary aim of the proposed waitlist randomized controlled trial (RCT) is to develop and test an online intervention specifically designed for ADSM to improve interoception and key military relevant outcomes.

Interoception is linked to behavioral health and military readiness. Interoception is a broad construct that refers to the ability to recognize, interpret, and respond to one’s internal body sensations, including hunger, fullness, pain, thirst, temperature, and emotions. Behavioral models indicate that interoception is critical to homeostasis and consequently, has been linked to a variety of adaptive psychological traits, including the development and maintenance of resilience defined as the ability to adaptively respond to stressors. For example, a resilient response after experiencing a work-related stressor would involve an individual understanding how the stressor is affecting them (e.g., reduced sleep, increased eating, increased anxiety) and responding adaptively (e.g., practice sleep hygiene and intuitive eating and engage in anxiety reduction techniques like progressive muscle relaxation). This may be particularly important for ADSM, given occupation demands and the potentially life-threatening consequences of failing to meet those demands that require ADSM to be highly attuned to internal states (e.g., fatigue, breathing, heart rate, heightened emotional states, blood-glucose level) and to respond efficiently and appropriately. Interoception allows one to be aware of internal sensations and respond to perturbations adaptively. Extant research supports these assertions, indicating individuals with low resilience have worse interoception and less bodily responsiveness. Conversely, individuals with greater interoceptive sensitivity were more resilient after experiencing a stressor. Specifically, across two studies, individuals with greater interoceptive sensitivity responded more adaptively to stressors than individuals with lower interoceptive sensitivity. Collectively, there is robust theoretical and empirical support that interoception is strongly, positively linked with improved stress management and resilience.

Reconnecting to Internal Sensations and Experiences (RISE) has been introduced as an interoceptive intervention for treatment of interoceptive deficits. Notably, interoception is malleable and can be manipulated through relatively simple and straightforward training procedures. To this aim, our novel interoceptive intervention Reconnecting to Internal Sensations and Experiences (RISE) promotes connection with one’s body through psychoeducation (e.g., noticing emotions) and skill development training (e.g., diaphragmatic breathing, self-care, improved emotional awareness, enhanced communication). Pilot studies, including an RCT, conducted by our team indicate that RISE not only improves interoception (e.g., +15-26% relative to active control) and improves key behavioral health outcomes (e.g., d = 0.50-0.80 on suicidal ideation), but also demonstrates high compliance (e.g., >94% completed three or more modules). Specifically, relative to an active comparator, participation in RISE led to greater noticing of body sensations, not worrying about sensations of pain or discomfort, emotional awareness, self-regulation, body listening, and body trust following treatment and generally were maintained at a three-month follow-up.

Importantly, RISE was developed to circumvent many of the current limitations to existing treatments for behavioral health problems in the military. First, RISE was designed to circumvent barriers associated with more traditional face-to-face treatment, as individuals can access RISE materials at any time from the privacy of a clinic, or a location of their choosing. Further, the electronic medium for administration means that RISE can be widely disseminated, including in remote and/or low-resource environments, as well as in deployed environments. Second, given that the intervention is self-guided, RISE addresses one of the primary barriers to access to care (i.e., lack of qualified providers) by not requiring licensed and/or trained clinicians for administration.

Third, because our intervention does not require talking about past negative experiences, it may be more attractive than traditional psychotherapy, particularly in military populations. In fact, our intervention is contextualized in terms of improving ‘mental fitness’ and ‘physical performance’.

3. SCOPE

The USAMRD-W requires an online RISE for Uniformed Personnel (UP) intervention tool to be developed and evaluated for effectiveness to improve resilience and reduce suicidality among Service Members. The overall objective of the two-phase research proposal is to further develop an evidence-based interoception training program by adapting RISE specifically for ADSM (i.e., RISE-UP) and subsequently evaluating the effectiveness of RISE-UP on improved interoceptive sensibility, key aspects of psychological readiness (i.e., stress management, resilience), and military outcomes via a waitlist RCT. Based conservatively on previous enrollment efforts, the proposed study shall recruit a total of 230 ADSM participants from JBLM due to anticipated completion failures (i.e., 15% attrition).

4. PERIOD OF PERFORMANCE (PoP)

The PoP for this contract shall be January 5, 2026 to January 4, 2029.

Base Period January 5, 2026 – January 4, Option Year 1 January 5, 2027 – January 4, Option Year 2 January 5, 2028 – January 4,

5. WORK SCHEDULE AND LOCATION

5.1. Place of Performance: The work to be performed under this contract shall be performed off-site at Contractor facilities.

5.2. The deliverables shall be provided to the USAMRD-W located at 9933A Johnson St., Joint Base Lewis-McChord, WA 98433-9500.

6. PERFORMANCE REQUIREMENTS

6.1. Objectives: The Contractor shall develop the framework and iterations of the RISE UP intervention and develop the software required to run the intervention study on the Qualtrics platform. The contractor shall provide the facilities, equipment, and labor to modify the software code to run the intervention study. The Contractor shall provide the software code to the Government via the Qualtrics platform.

6.1.1. The following milestones and their expected completion dates are in the table below:

Milestone Estimated Start Date

Completion Date

Fiscal Year

Solicit Feedback from Military Service Community Advisory Panel (MSCAP) on original RISE content

01/05/2026 03/31/2026 FY26

Validation of methods and measures 01/05/2026 09/30/2026 FY26 Obtain primary letter(s) of support 01/05/2026 09/30/2026 FY26 Submit Institutional Review Board (IRB) protocol 01/05/2026 09/30/2026 FY26 Finalize online training platform 01/05/2026 09/30/2026 FY26 Establish tentative data collection and intervention timeline

01/05/2026 09/30/2026 FY26

Analyze quantitative study data 01/05/2027 01/04/2029 FY29

6.2. Key Personnel: The following personnel are considered key personnel by the Government:

Key Personnel Position

Minimum Requirements

Lead Investigator

Licensed Clinical Psychologist 10 years of experience conducting intervention development and/or randomized controlled trials related to interoception 5 years of experience conducting Community Based Participatory Research in the military community 5 years of experience conducting interoception-based interventions

6.2.1. The Contractor shall provide key personnel in accordance with the minimum requirements listed within the Key Personnel table above.

6.2.2. Substitutions of proposed key personnel shall not be allowed for a period of six months after award, except under extreme circumstances. Any substitution or replacement key personnel shall have the necessary experience and knowledge required to perform the duties defined herein. For temporary and/or permanent replacement of key personnel, the Contractor shall provide a resume for each individual to the COR. Resumes shall be provided at least two weeks (or as mutually agreed upon) prior to making any personnel changes. The Government reserves the right to pre-approve any replacement or substitution of key personnel. Substitution or replacement personnel shall be replaced within 30 days. (A.001)

6.3. Tasks:

6.3.1. Perform remote analysis and support while the study is conducted on JBLM for a total of eight weeks, including: a baseline assessment prior to treatment (Week 1), four weeks of intervention, one assessment following intervention completion (Week 4), and one follow-up at one-month (Week 8). Participation for those assigned to RISE-UP shall involve completing one treatment module per week (30 minutes each) for four consecutive weeks, with optional out-of-session practice worksheets. A one-month follow-up assessment shall be completed within ± 7 days of the post-intervention date and shall take participants 30-40 minutes to complete. The initial intervention materials are due within 90 days of contract start. (A.002)

6.3.1.1. Obtain primary letter(s) of support from relevant military leadership and stakeholders and JBLM to endorse the implementation of the RISE-UP study. This task involves coordinating with key personnel to secure written commitments affirming support for the study’s objectives, recruitment efforts, and logistical requirements. The Contractor shall ensure that the letter(s) address the study’s alignment with military priorities, such as the People First Strategy, and confirm command approval for participant access and study execution. The letter(s) of support shall be finalized and submitted to the COR NLT September 30, 2026 (A.003).

6.3.2. Provide an intellectual contribution to overseeing the community advisory board, the study design, method, analytics, and interpretation of findings. The MSCAP shall be comprised of up to 10 members, including (but not limited to) the following: enlisted ADSM of various rank, including both junior enlisted and non-commissioned officers (NCO), behavioral health officers (e.g., Embedded Behavioral Health), Veterans’ Administration (VA) clinicians, and Industrial/Organizational (I/O) psychologists.

6.3.3. Provide an intuitive and specific online RISE-UP intervention based on community feedback to be assessed/evaluated. Panel members shall provide feedback on each of the four original RISE modules (e.g., module content, activities), as well as general feedback on any missing components that may be uniquely relevant to ADSM.

Generally, feedback is anticipated to target three primary domains: (1) Military Suitability

(e.g., extent to which intervention guidance aligns with the realities of the military); (2) Language and Terminology (e.g., correct acronyms, appropriate phrasing that aligns with military objectives); and (3) Structural and Logistic Factors (e.g., format consistency with other military document, reasonable time to completion, practicing skills in different military settings). However, all feedback shall be considered. WRAIR-W shall use this information to develop the initial draft of RISE-UP. This iterative process shall culminate in the final RISE-UP intervention to be tested during the subsequent RCT. (A.004)

6.3.3.1. Develop and provide the HSPB and IRB protocols for the RISE-UP study, ensuring compliance with all applicable federal, Department of Defense (DoD), Defense Health Agency (DHA), and USAMRDC regulations governing human subjects research.

The Contractor shall draft comprehensive protocols that outline the study’s objectives, methodology, participant recruitment, informed consent procedures, data collection, and ethical considerations to safeguard participant safety and privacy. These protocols shall be submitted to WRAIR for review and approval by September 20, 2026 (A.004).

6.3.4. Develop an intervention manual to aid in the transfer of information throughout the military and the greater scientific community. The manual shall describe in detail the protocols and assumptions used throughout the tool. Draft of the manual shall be due within 120 days of contract start and final version shall be due within 90 days of contract end. (A.005, A.006)

6.3.5. Collect and store data from the study in the Qualtrics platform for viewing and analysis at offsite locations. Additionally, provide capability to share and export raw and summated data to authorized individuals for analysis to assess effectiveness of intervention. Final datasets shall be provided to WRAIR no later than 90 days prior to contract completion. (A.007)

6.3.6. Provide study data via Qualtrics that is compatible with various devices for online delivery (e.g., iPad Pro, iPhone, Android, etc.). (A.007)

6.3.7. Recruit 230 ADSM. Participants shall be compensated $50 for completing the baseline, post-intervention, and the follow-up surveys; total compensation for completion is $150. Participants shall be compensated for all parts of the study that were completed.

6.3.8. Participants shall be randomly assigned to one of two conditions: RISE-UP (n = 100) or waitlist control (n = 100) using stratified block randomization techniques.

Given the intent of RISE-UP to serve as a tool for the prevention of downstream behavioral health outcomes (i.e., through the development of adaptive skills), eligibility criteria were purposefully chosen to balance internal validity, ecological validity, and generalizability. All participants shall meet the following inclusionary criteria: current ADSM, are at least 18 years of age, have English fluency, are available and willing to meet scheduling requirements (e.g., no anticipated deployment, permanent change of station [PCS]/separation in next eight months), and are willing to comply with study procedures. Conversely, participants shall not be eligible if they meet any of the following exclusionary criteria: gross cognitive impairment that would interfere with the ability to consent or complete study procedures, acutely suicidal, have any current/recent participation in any behavioral health intervention study, or are currently seeking or undergoing treatment for behavioral health concerns.

6.3.9. Schedule participants for baseline assessment. During this baseline assessment, all participants shall complete the full online assessment battery (see

6.3.11 below) via Qualtrics, as well as an intervention history assessment providing a detailed list of informal and formal behavioral health intervention options engaged in prior to enrollment (e.g., Behavioral Health Officer (BHO) referral). Participants in the RISE-UP condition shall receive an additional information packet providing a detailed overview and instructions on completing the RISE modules and homework, troubleshooting instructions, and a reminder sheet for anticipated RISE-UP intervention session dates (i.e., Sessions 2-4). To reduce burden on participants, the first RISE-UP session shall be scheduled on the same day as the baseline assessment. Following the baseline assessment, participants in the intervention condition shall complete one session of RISE-UP once per week for four weeks. Scheduling reminders and instructions (including a hyperlink to the intervention session) shall be sent via email and/or text, depending on the participants’ documented preference for contact.

6.3.10. Send participants reminders for weekly intervention modules and follow-up assessments. Participants shall be asked to provide permission to contact in a variety of ways (e.g., text, voice call, email, combination) and their preference for initial reminders. For the weekly intervention modules, participants shall be sent up to two reminders via their documented preference for contact; for the follow-up assessment, participants shall receive up to three reminders. If the participant does not respond to these reminders, a research coordinator shall attempt to reach them by trying their other contact options. Participants shall be informed about the longitudinal component of the study, as well as specific tracking procedures, as part of the informed consent procedure.

6.3.11. The study shall measure the following variables and/or others as determined by the MSCAP:

6.3.11.1. Interoceptive Sensibility shall be assessed via the Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2) which includes 32-items and generates eight different subscales assessing various aspects of interoceptive sensibility, including noticing internal sensations, being worried and/or distracted by sensations of pain and discomfort, attending to body sensations, awareness of emotion sensations, and listening to and trusting one’s body.

6.3.11.2. Resilience shall be assessed via the Connor-Davidson Resilience Scale (CD- RISC). The CD-RISC is a 25-item, self-report measure of resilience. Responses range on a five-point Likert-type scale from 1 (“not at all”) to 4 (“true nearly all of the time”).

Responses are summed to generate an overall resilience score, with higher scores indicative of greater resilience. Notably, the CD-RISC has been shown to reliably distinguish between those with higher and lower resilience, has been validated within active-duty military populations, and has been regularly used in I/O psychology research to delineate associations between resilience and psychological (e.g., perceived stress, coping ability) and occupational outcomes (e.g., job satisfaction, job competency).

6.3.11.3. Perceived Ability to Cope shall be assessed via a modified military-relevant stressful impacts measure developed by the WRAIR. The modified measure shall evaluate individuals’ self-reported ability to cope with each of 21 face-valid occupational/operational stressors. Examples include unpredictable schedule, lack of meaningful work, maintaining physical fitness, time away from home (e.g., training, deployment), conflicts with others, progressing in one’s military career, and small annoyances with military life. Responses are scored on a five-point, Likert-type scale from 1 (“not at all able to cope”) to 4 (“completely able to cope”). Responses are summed to generate a singular total score, with higher scores indicating a greater perceived ability to cope with military occupational/operational stressors.

6.3.11.4. Military Readiness shall be assessed across two domains: individual readiness and combat readiness. Perceived individual readiness shall be assessed with a seven-item scale informed by the Army’s Health and Holistic Fitness (H2F) initiative.

Participants rate seven items on a four-point, Likert-type scale from 1 (“not at all ready”) to 5 (“extremely ready”). Perceived combat readiness shall be assessed via a 20-item self-report scale measuring respondents’ self-perceived combat effectiveness based on ratings across three subscales: general combat readiness, combat-related emotional readiness, and Military Occupational Specialty (MOS)-specific readiness. Both measures were developed and evaluated by the WRAIR and have been successfully used in previous longitudinal research studies with military populations.

6.3.12. Utilize descriptive statistics and bivariate correlations among study measures to determine adherence of variables to normal distributions, potential outliers, and interrelations among multiple methods of constructs. Additionally, descriptive statistics, such as mean and standard deviation for continuous variables and frequency and proportion for categorical variables, shall be used to depict the sociodemographic and mental health characteristics for the study sample. The RISE and waitlist control groups shall be compared to determine if imbalances occur in demographics and other baseline measures, by conducting t-test/Wilcoxon rank sum test or chi- square tests, depending on the nature of the scale. Any potential confounders shall be included in all subsequent analytic models. When deciding on what, if any, variables shall be used as covariates in models, follow the recommendations by only including covariates with significant associations with key predictor variables (i.e., any pre-existing differences between conditions).

6.3.13. Assess the efficacy of RISE-UP, general or generalized through linear mixed effects models, based on the distribution of the outcome. These models shall include fixed effects for group (RISE-UP vs waitlist), time (baseline, post-intervention, and one-month follow-up), and a group by time interaction. To account for the correlation among repeated measurements, a random patient effect shall be included in the model. The covariance structure (ex: unstructured, compound symmetry, autoregressive) of the random effect shall be determined by fitting each to the model and determining the most appropriate using model fit criteria, such as Akaike Information Criterion and Bayesian Information Criterion. Additionally, the models shall control for sociodemographic and clinical variables that were not balanced through randomization, as well as for any behavioral health treatment options engaged in since the prior assessment point (confirmed by medical chart history, as appropriate). To determine if there is a significant difference in the way groups respond over the course of the study, the group by time interaction shall be assessed. If this interaction is significant, the slope (beta) and 95% confidence intervals of change between baseline, post-intervention, and the follow-up time by group shall be evaluated to determine if it is significantly different from

0. If the interaction is not significant, it shall be removed from the model, and the slope of the change over time shall be assessed across all groups combined to evaluate trajectories of change over the course of the treatment and follow-up.

6.3.14. Evaluate group equivalence at designated annual time points and adjust stratification procedures, as needed, to ensure equal and adequate representation across conditions. Consideration is given to alternatives to the waitlist control comparator group. Given the intent of RISE-UP as a prevention tool to be administered prior to the development of any formal, documented behavioral health concerns, a waitlist control comparator is the most consistent with the expected levels of intervention that a ‘healthy’ ADSM would naturally receive as part of their duties. As such, a waitlist control shall serve to improve the ecological validity of findings, while not placing ADSM at any additional risk or harm.

6.3.15. Complete a scientific report of the study and outcomes that adheres to community norms. White papers with preliminary study findings shall be provided on a semi-annual basis. The final report shall be delivered to WRAIR within 90 days of contract end. (A.008, A.009)

6.3.16. Utilize the following hypotheses for the RISE-UP Study:

6.3.16.1. Hypothesis 1 (Preliminary): RISE-UP will evidence greater improvement in interoceptive sensibility relative to waitlist control, and these improvements will remain significant at one-month follow-up.

6.3.16.2. Hypothesis 2 (Primary): RISE-UP will evidence greater improvement in perceived occupational stress management and resilience relative to waitlist control and remain significant at one-month follow-up.

6.3.16.3. Hypothesis 3 (Secondary): RISE-UP will evidence greater improvement in perceived military readiness outcomes (i.e., individual readiness and combat readiness) relative to waitlist control and remain significant at one-month follow-up.

7. DELIVERABLES

The Contractor shall complete and submit deliverables in accordance with the table below.

DELIVERABLES TABLE

SOW

Ref.

Numbe r Title/Description Due

6.2.2 A.001 Key Personnel Resumes

Within 2 weeks (or as mutually agreed upon) prior to any key personnel changes

6.3.1 A.003 Completed finalized RISE-UP

intervention materials, including updating the online intervention materials and out-of-session worksheets

Within 90 days of initial contract acceptance

6.3.3, 6.3.3.1

A.004 Approved Human Subjects Protection Branch (HSPB) protocol (regulatory) and IRB protocol through WRAIR

Within 270 days of

6.3.4. A.005 Draft electronic manual for RISE-

UP for providers

Within 120 days of

6.3.4. A.006 Complete electronic manual for

providers, including but not limited to: treatment overview, procedural guidelines, instructions for administration, and troubleshooting software

Within 90 days of the conclusion of the study

6.3.5, 6.3.6

A.007 De-identified datasets to WRAIR via the Qualtrics platform

Within 90 days of the conclusion of the study

6.3.15 A.008 Information paper with preliminary

findings reported.

Semi-annually, throughout period of performance

6.3.15 A.009 Final project report delivered to

WRAIR

At conclusion of the study within 90 days of contract end.

8.3 A.010 Monthly Status Report Monthly or as

determined by COR

10.1 A.011 WAWF Invoices Monthly

7.1. Inspection and Acceptance

The Contracting Officer’s Representative (COR) is delegated with oversight of specific technical and functional responsiblities to include inspection and acceptance of all products, incoming shipments, documents, deliverables, and services.

Certification by the Government of satisfactory performance provided is contingent upon the Contractor adhering to the performance standards contained in the SOW and all terms and conditions of this order, including all modifications.

7.2. RESERVED

8. CONTRACT MANAGEMENT

8.1. Government Management

The COR for this contract will be appointed by the Contracting Officer (KO). The COR will serve as the primary point of contact for all activities and issues that occur under this contract. Only the KO has the authority to enact changes to this award.

8.2. Contractor Organization

The Contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of the resources assigned to the requirement. The Contractor shall ensure that all Contractor personnel are advised of their chain of command and who they should contact if they have questions.

8.3. Monthly Status Report (MSR): The MSR shall provide a detailed status for each milestone within the SOW as well as capture an overall status of the contract. The contractor shall deliver the MSR no later than five days after the final day of the reported month. Specific MSR format, and any additional content not specified in this section, shall be mutually agreed upon by the contractor and COR. The MSR reports cost, schedule, and performance against the SOW baseline and identifies planned versus actual expenditures per project and per Contract Line Item Number (CLIN); details all hours worked and workload accomplished; total monthly and cumulative Other Direct Cost (ODC) expenditures and projections; status of known risks and risk mitigation efforts; deliverable(s) completed; technical progress made; meetings attended and outcomes; conference and event status and log; CONUS and OCONUS trip reports if applicable; schedule status; and updated staff contact roster. The MSR shall report all funding received and shall detail the projects supported by such funding. (A.010)

9. COMPLIANCE DOCUMENTS

9.1. General Compliance

9.1.1 Federal Law

The products and services provided under this contract must be provided in accordance with all Federal, DoD, Defense Health Agency (DHA), and United States Army Medical Research and Development Command (USAMRDC) laws, as well as command laws, regulations, policies, and procedures that govern the conduct of regulated research.

9.1.2 Department of Defense (DoD) Compliance Documents

A complete list of DoD compliance documents providing specifications, standards, or guidelines can be found at https://www.defense.gov/Resources/Forms-Directives- Instructions/. Where applicable, the contractor’s attention is called to the availability of commercial, industry, federal, and military guides, instructions, and standards for many of the topics addressed in this SOW and under this contract.

10. OTHER TERMS, CONDITIONS, AND PROVISIONS

10.1. Invoices

The Contractor shall submit invoices monthly to Wide Area Work Flow (WAWF) with sufficient documentation to provide certification of invoice (A.011).

The Contractor is responsible for properly preparing and forwarding to the appropriate Government official the invoice and receiving report for payment. Invoices submitted for payment which do not contain Contract Line Item Number (CLIN) and Accounting Classification Reference Number (ACRN) information will be rejected. The WAWF – Receipt and Acceptance application is the required method of submission.

10.1.1 Other Direct Costs (ODCs)

ODCs are anticipated during the performance of this contract for facility usage and travel. Cost type CLINs under this contract will be invoiced as ODCs. The Contractor shall manage and account for all costs associated with requirements labeled as ODCs, not to exceed the price ceiling listed in this contract.

10.2. Anti-Terrorism (AT) and Operational Security (OPSEC) – Reserved.

10.3. Compliance with Relevant DoD, Service, and Institutional Policy Regulations

The Contractor shall comply with Health Insurance Portability and Accountability Act (HIPAA) and all relevant DoD/USG regulations for collection, storage, and transfer of sensitive data and protected health information (PHI). In addition, the Contractor will comply with all requirements for communication of findings and publication in the scientific peer reviewed literature (e.g., Public Affairs clearance and Operational Security clearance for dissemination).

10.4. Personally Identifiable Information (PII) and Protected Health Information

(PHI)

The contractor shall comply with the DHA Procedures and Governmental Information (PGI) 224 – Protection of Privacy and Freedom of Information, revised 17 May 2015.

The contractor may access PII during task response to the requirements of this contract, as such the contractor shall comply with the document titled “Personally https://www.defense.gov/Resources/Forms-Directives-Instructions/ https://www.defense.gov/Resources/Forms-Directives-Instructions/

Identifiable Information (PII), Protected Health Information (PHI) and Federal Information Requirements”.

The Contractor shall establish appropriate administrative, technical, and physical safeguards to protect all Government data. The Contractor shall also ensure the confidentiality, integrity, and availability of Government data in compliance with all applicable laws and regulations, including data breach reporting and response requirements, in accordance with Defense Federal Acquisition Regulation (DFAR Subpart 224.1 (Protection of Individual Privacy), which incorporates by reference DoDD 5400.11, “DoD Privacy Program,” May 8, 2007, and DoD 5400.11-R, “DoD Privacy Program,” May 14, 2007. The contractor shall also comply with federal laws relating to freedom of information and records management. The Contractor shall comply with all requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) (Pub. L. 104-191), as implemented by the HIPAA Privacy and Security Rules codified at 45 CFR Parts 160 and 164, and as further implemented within the Military Health System (MHS) by DoD 6025.18-R, "DoD Health Information Privacy Regulation," January 24, 2003, and DoD 8580.02-R, “DoD Health Information Security Regulation, July 12, 2007.

Information technology (IT) services that collect, maintain, use, or disseminate personally identifiable information must be managed in a manner that protects privacy, in accordance with section 552a of Title 5, U.S.C., DoD 5400.11 and DoD 5400.11-R.

DoDI 5400.16 established the guidance for development, review, and approval of Privacy Impact Assessments, in accordance with chapter 36 of Title 44, U.S.C.

11. ATTACHMENTS

Attachment 1 - Acronyms List

ATTACHMENT 1 – ACRONYMS LIST

Acronym Definition ACRN Accounting Classification Reference Number ADSM Active Duty Service Member AT Antiterrorism BHO Behavioral Health Officer CAB Community Advisory Board CD-RISC Connor-Davidson Resilience Scale CLIN Contract Line Item Number CONUS Continental United States COR Contracting Officer’s Representative DFAR Defense Federal Acquisition Regulation DHA Defense Health Agency DoD Department of Defense FHP Force Health Protection FIM Feasibility of Intervention Measure H2F Health and Holistic Fitness HIPAA Health Insurance Portability and Accountability Act HSPB Human Subjects Protection Branch INDOPACOM Indo-Pacific Combatant Command I/O Industrial/Organizational IRB Institutional Review Board IT Information Technology JBLM Joint Base Lewis-McChord KO Contracting Officer MAIA-2 Multidimensional Assessment of Interoceptive Awareness-2 MOS Military Occupational Specialty MSCAP Military Service Community Advisory Panel NCO Non-Commissioned Officer OPSEC Operational Security PCS Permanent Change of Station PGI Procedures and Governmental Information PHI Protected Health Information PII Personally Identifiable Information PoP Period of Performance R&D Research and Development RCT Randomized Control Trial RISE Reconnecting to Internal Sensations and Experiences SOW Statement of Work UP Uniformed Personnel U.S. United States USAMRDC United States Army Medical Research and Development Command USAMRD-W United States Army Medical Research Directorate – West VA Veterans’ Administration

WAWF Wide Area Work Flow WRAIR Walter Reed Army Institute of Research

1. INTRODUCTION

2. PURPOSE AND BACKGROUND

3. SCOPE

The USAMRD-W requires an online RISE for Uniformed Personnel (UP) intervention tool to be developed and evaluated for effectiveness to improve resilience and reduce suicidality among Service Members. The overall objective of the two-phase research pro...

4. PERIOD OF PERFORMANCE (PoP)

5. WORK SCHEDULE AND LOCATION

6. PERFORMANCE REQUIREMENTS

7. DELIVERABLES

8. CONTRACT MANAGEMENT

8.1. Government Management

8.2. Contractor Organization

The Contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of the resources assigned to the requirement. The Contractor shall ensure that all Contractor personnel are advised of their chain...

8.3. Monthly Status Report (MSR): The MSR shall provide a detailed status for each milestone within the SOW as well as capture an overall status of the contract. The contractor shall deliver the MSR no later than five days after the final day of the r...

9. COMPLIANCE DOCUMENTS

10. OTHER TERMS, CONDITIONS, AND PROVISIONS

11. ATTACHMENTS

Attachment 1 - Acronyms List