Justice and equity in pragmatic clinical trials: Considerations for pain research within integrated health systems.

Introduction: Pragmatic clinical trials (PCTs) can overcome implementation challenges for bringing evidence-based therapies to people living with pain and co-occurring conditions, providing actionable information for patients, providers, health systems, and policy makers. All studies, including those conducted within health systems that have a history of advancing equitable care, should make efforts to address justice and equity. Methods: Drawing from collective experience within pragmatic pain clinical trials networks, and synthesizing relevant literature, our multidisciplinary working group examined challenges related to integrating justice and equity into pragmatic pain management research conducted in large, integrated health systems. Our analysis draws from military and veteran health system contexts but offers strategies to consider throughout the lifecycle of pragmatic research more widely. Results: We found that PCTs present a unique opportunity to address major influences on health inequities by occupying a space between research, healthcare delivery, and the complexities of everyday life. We highlight key challenges that require attention to support complementary advancement of justice and equity via pragmatic research, offering several strategies that can be pursued. Conclusions: Efforts are needed to engage diverse stakeholders broadly and creatively in PCTs, such as through dedicated health equity working groups and other collaborative relationships with stakeholders, to support robust and inclusive approaches to research design and implementation across study settings. These considerations, while essential to pain management research, offer important opportunities toward achieving more equitable healthcare and health systems to benefit people living with pain and co-occurring conditions.

The associations between posttraumatic stress disorder and delay discounting, future orientation, and reward availability: A behavioral economic model.

The theoretical framework of behavioral economics, a metatheory that integrates operant learning and economic theory, has only recently been applied to posttraumatic stress disorder (PTSD). A behavioral economic theory of PTSD reflects an expansion of prior behavioral conceptualization of PTSD, which described PTSD in terms of respondent and operant conditioning. In the behavioral economic framework of PTSD, negatively reinforced avoidance behavior is overvalued, in part due to deficits in environmental reward, and may be conceptualized as a form of reinforcer pathology (i.e., excessive preference for and valuation of an immediate reinforcer). We investigated cross-sectional relationships between PTSD severity and several constructs rooted in this behavioral economic framework, including future orientation, reward availability, and delay discounting in a sample of 110 military personnel/veterans (87.2% male) who had served combat deployments following September 11, 2001. Total PTSD severity was inversely related to environmental reward availability, ß = -.49, ΔR2 = 0.24, p < .001; hedonic reward availability, ß = -.32, ΔR2 = 0.10, p = .001; and future orientation, ß = -.20, ΔR2 = 0.04, p = .032, but not delay discounting, r = -.05, p = .633. An examination of individual symptom clusters did not suggest that avoidance symptoms were uniquely associated with these behavioral economic constructs. The findings offer support for a behavioral economic model of PTSD in which there is a lack of positive reinforcement as well as a myopic focus on the present.

A Novel Approach to the Assessment of Fidelity to a Cognitive Behavioral Therapy for PTSD Using Clinical Worksheets: A Proof of Concept With Cognitive Processing Therapy.

Fidelity monitoring is a critical indicator of psychotherapy quality and is central to successful implementation. A major barrier to fidelity in routine care is the lack of feasible, scalable, and valid measurement strategies. A reliable, low-burden fidelity assessment would promote sustained implementation of cognitive behavioral therapies (CBTs). The current study examined fidelity measurement for cognitive processing therapy (CPT) for posttraumatic stress disorder (PTSD) using clinical worksheets. External raters evaluated patient worksheets done as a part of treatment, both guided by the therapist and completed independently as homework. Results demonstrated that fidelity ratings from CPT session worksheets were feasible and efficient. Notably, they were strongly correlated with observer ratings of the fidelity of CPT strategies that were present on the worksheets. Agreement among ratings conducted by individuals with a range of experience with CPT was acceptable to high. There was not a main effect of therapist-guided, in-session worksheet ratings on PTSD symptom change. However, patient competence in completing worksheets independently was associated with greater PTSD symptom decline and in-session, therapist-guided worksheet completion was associated with larger symptom decreases among patients with high levels of competence. With further research and refinement, rating of worksheets may be an efficient way to examine therapist and patient skill in key CPT elements, and their interactions, compared to the gold standard of observer ratings of therapy video-recordings. Additional research is needed to determine if worksheets are an accurate and scalable alternative to gold standard observer ratings in settings in which time and resources are limited.

The Military Service Sleep Assessment: an instrument to assess factors precipitating sleep disturbances in U.S. military personnel.

STUDY OBJECTIVES: Military personnel frequently experience sleep difficulties, but little is known regarding which military or life events most impact their sleep. The Military Service Sleep Assessment (MSSA) was developed to assess the impact of initial military training, first duty assignment, permanent change of station, deployments, redeployments, and stressful life events on sleep. This study presents an initial psychometric evaluation of the MSSA and descriptive data in a cohort of service members. METHODS: The MSSA was administered to 194 service members in a military sleep disorders clinic as part of a larger study. RESULTS: Average sleep quality on the MSSA was 2.14 (on a Likert scale, with 1 indicating low and 5 indicating high sleep quality), and 72.7% (n = 140) of participants rated their sleep quality as low to low average. The events most reported to negatively impact sleep were stressful life events (41.8%), followed by deployments (40.6%). Military leadership position (24.7%) and birth/adoption of a child (9.7%) were the most frequently reported stressful life events to negatively impact sleep. There were no significant differences in current sleep quality among service members with a history of deployment compared with service members who had not deployed. CONCLUSIONS: The MSSA is the first military-specific sleep questionnaire. This instrument provides insights into the events during a service member's career, beyond deployments, which precipitate and perpetuate sleep disturbances and likely chronic sleep disorders. Further evaluation of the MSSA in nontreatment-seeking military populations and veterans is required.

Targeted Assessment and Context-Tailored Implementation of Change Strategies (TACTICS) to increase evidence based psychotherapy in military behavioral health clinics: Design of a cluster-randomized stepped-wedge implementation study.

BACKGROUND: Despite efforts by the U.S. Department of Defense to train behavioral health (BH) providers in evidence-based psychotherapies (EBPs) for posttraumatic stress disorder (PTSD), numerous barriers limit EBP implementation. A context-tailored implementation approach called TACTICS (Targeted Assessment and Context-Tailored Implementation of Change Strategies) holds promise for increasing the use of EBPs such as prolonged exposure therapy (PE) in military treatment facilities. TACTICS combines a needs assessment, a rubric for selecting implementation strategies based on local barriers, an implementation toolkit, and external facilitation to support local champions and their implementation teams in enacting changes. This paper describes the rationale for and design of a study that will evaluate whether TACTICS can increase implementation of PE for PTSD and improve patient outcomes in military BH clinics relative to provider training in PE alone. METHODS: The study is a multi-site, cluster randomized, stepped-wedge trial, with the military treatment facility as the unit of analysis. Eight facilities undergo a provider-training phase, followed by 5 months of TACTICS implementation. The timing of TACTICS at each facility is randomly assigned to begin 9, 14, or 19 months after beginning the provider-training phase. Primary analyses will compare the proportion of PTSD patients receiving PE and patients' mean improvement in PTSD symptoms before and after the onset of TACTICS. DISCUSSION: TACTICS endeavors to balance standardization of empirically-supported implementation strategies with the flexibility of application necessary for success across varied clinical settings. If successful, TACTICS may represent a systematic and scalable method of promoting and supporting EBP implementation. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT03663452.

Common Data Elements in the Assessment of Military-Related PTSD Research Applied in the Consortium to Alleviate PTSD.

INTRODUCTION: Driven by the need to share data, sufficiently power studies, and allow for cross-study comparisons of medical and psychiatric diseases, the President's National Research Action Plan issued in 2013 called for the use of state-of-the-art common data elements (CDEs) for research studies. CDEs are variables measured across independent studies that facilitate methodologically sound data aggregation and study replication. Researchers in the field of military-related post-traumatic stress disorder (PTSD) have suggested applicable CDEs; however, to date, these recommendations have been conceptual and not field-tested. The Consortium to Alleviate PTSD (CAP) - an interdisciplinary and multi-institutional, military-related PTSD research consortium funded by the Departments of Defense and Veterans Affairs - generated and applied CDEs that can be used to combine data from disparate studies to improve the methodological and statistical capabilities of study findings. We provide a description and rationale for the CAP CDEs and details about administration with two main goals: (1) to encourage military-related PTSD researchers to use these measures in future studies and (2) to facilitate comparison, replication, and data aggregation. MATERIALS AND METHODS: The CAP compiled mandated (core) and optional CDEs based on the following criteria: (1) construct applicability to military-related PTSD; (2) precedence (use) in prior, related research; (3) published and strong psychometric evidence; (4) no cost (public domain); and (5) brevity, to limit participant burden. We provided descriptive statistics and internal consistency reliabilities for mandated measures from an initial cohort of around 400 participants enrolled in CAP studies. RESULTS: Mandated CDEs in the CAP were found to have very good internal consistency reliability. CONCLUSION: Although further research is needed to determine the incremental validity of these CDEs, preliminary analyses indicated that each mandated measure has very good internal consistency reliability. Investigators designing military-related PTSD research should consider using these field-tested CDEs to facilitate future data aggregation. Feedback based on empirical evidence or practical concerns to improve these CDEs is welcome.

Acute Assessment of Traumatic Brain Injury and Post-Traumatic Stress After Exposure to a Deployment-Related Explosive Blast.

Introduction: Traumatic brain injury (TBI) and post-traumatic stress disorder (PTSD) are two of the signature injuries in military service members who have been exposed to explosive blasts during deployments to Iraq and Afghanistan. Acute stress disorder (ASD), which occurs within 2-30 d after trauma exposure, is a more immediate psychological reaction predictive of the later development of PTSD. Most previous studies have evaluated service members after their return from deployment, which is often months or years after the initial blast exposure. The current study is the first large study to collect psychological and neuropsychological data from active duty service members within a few days after blast exposure. Materials and Methods: Recruitment for blast-injured TBI patients occurred at the Air Force Theater Hospital, 332nd Air Expeditionary Wing, Joint Base Balad, Iraq. Patients were referred from across the combat theater and evaluated as part of routine clinical assessment of psychiatric and neuropsychological symptoms after exposure to an explosive blast. Four measures of neuropsychological functioning were used: the Military Acute Concussion Evaluation (MACE); the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS); the Headminder Cognitive Stability Index (CSI); and the Automated Neuropsychological Assessment Metrics, Version 4.0 (ANAM4). Three measures of combat exposure and psychological functioning were used: the Combat Experiences Scale (CES); the PTSD Checklist-Military Version (PCL-M); and the Acute Stress Disorder Scale (ASDS). Assessments were completed by a deployed clinical psychologist, clinical social worker, or mental health technician. Results: A total of 894 patients were evaluated. Data from 93 patients were removed from the data set for analysis because they experienced a head injury due to an event that was not an explosive blast (n = 84) or they were only assessed for psychiatric symptoms (n = 9). This resulted in a total of 801 blast-exposed patients for data analysis. Because data were collected in-theater for the initial purpose of clinical evaluation, sample size varied widely between measures, from 565 patients who completed the MACE to 154 who completed the CES. Bivariate correlations revealed that the majority of psychological measures were significantly correlated with each other (ps ≤ 0.01), neuropsychological measures were correlated with each other (ps ≤ 0.05), and psychological and neuropsychological measures were also correlated with each other (ps ≤ 0.05). Conclusions: This paper provides one of the first descriptions of psychological and neuropsychological functioning (and their inter-correlation) within days after blast exposure in a large sample of military personnel. Furthermore, this report describes the methodology used to gather data for the acute assessment of TBI, PTSD, and ASD after exposure to an explosive blast in the combat theater. Future analyses will examine the common and unique symptoms of TBI and PTSD, which will be instrumental in developing new assessment approaches and intervention strategies.

The impact of symptom burden on the health status of service members with extremity trauma.

BACKGROUND: Service members injured in combat undergo repeated surgeries and long recoveries following a traumatic injury that produce a myriad of physical and psychological symptoms. PURPOSE: To describe the severity of pain, sleep disturbance, depression, and anxiety in service members with extremity trauma sustained during combat operations at the time of discharge from the hospital and to evaluate for differences in health status between those with and without symptom burden. METHOD: Descriptive study of 130 United States Army service members. DISCUSSION: More than 80% of the service members were classified as having symptom burden. Service members who reported one or more clinically meaningful levels of pain, sleep disturbance, depression, or anxiety reported significantly worse health status compared to those without symptom burden. CONCLUSIONS: Service members with extremity trauma experience clinically significant levels of pain, sleep disturbance, depression, and/or anxiety at the time of discharge from the hospital. The greater the service members' symptom burden, the worse their reported health status.

Ethnoracial differences in PTSD symptoms and trauma-related cognitions in treatment-seeking active duty military personnel for PTSD.

OBJECTIVE: It is uncertain whether ethnoracial factors should be considered by clinicians assessing and treating posttraumatic stress disorder (PTSD) among service members. The purpose of this study was to shed light on ethnoracial variation in the presentation of PTSD symptoms, trauma-related cognitions, and emotions among treatment-seeking active duty military personnel. METHOD: Participants were 303 male active duty military members with PTSD participating in a clinical trial (60% were self-identified as White, 19% as African American, and 21% as Hispanic/Latino). In the parent study, participants completed a baseline assessment that included clinician-administered and self-report measures of PTSD, trauma-related cognitions, and emotions. RESULTS: Multivariate hierarchical regression models were used to examine ethnoracial differences in these variables, covarying age, education, military grade, combat exposure, and exposure to other potentially traumatic events. Hispanic/Latino and African American participants reported more reexperiencing symptoms, more fear, and more guilt and numbing than White participants. All effect sizes were in the small to medium range. CONCLUSIONS: These findings suggest ethnoracial variation in PTSD symptom burden and posttraumatic cognitions among treatment-seeking service members with PTSD. Attending to cultural factors related to differences in PTSD presentation and cognitive coping strategies during the assessment and treatment process could increase rapport and lead to more comprehensive trauma processing. (PsycINFO Database Record

The need for expanded monitoring of adverse events in behavioral health clinical trials.

Monitoring for possible adverse events is ethically required by Institutional Review Boards and Good Clinical Practice guidelines for all human research involving the delivery of treatment interventions in a clinical trial. The monitoring of adverse events is a well-established and routine practice for contemporary clinical trials involving medications and medical devices. However, these same guidelines have not been fully integrated into clinical trials involving the use of behavioral health interventions and psychotherapy. Most behavioral health clinical trials limit adverse event monitoring to serious adverse events such as suicide attempts, completed suicides, and psychiatric hospitalizations. Other possible "side effects" of psychotherapy, such as temporary increases in anxiety, are often considered a normal part of therapy and are therefore not documented as possible adverse events. This manuscript reviews a variety of reasons for the limited adverse event monitoring in behavioral health clinical trials and highlights the importance of incorporating expanded adverse event monitoring into future behavioral health clinical trials. Without understanding the nature and prevalence of adverse events, patients cannot be informed adequately of the possible risks and benefits of behavioral interventions prior to engaging in treatment.

Assessment and treatment of combat-related PTSD in returning war veterans.

Over the past 9 years approximately 2 million U.S. military personnel have deployed in support of Operation Iraqi Freedom in Iraq and Operation Enduring Freedom in and around Afghanistan. It has been estimated that 5-17% of service members returning from these deployments are at significant risk for combat-related posttraumatic stress disorder (PTSD). Many of these returning war veterans will seek medical and mental health care in academic health centers. This paper reviews the unique stressors that are related to the development of combat-related PTSD. It also reviews evidence-based approaches to the assessment and treatment of PTSD, research needed to evaluate treatments for combat-related PTSD, and opportunities and challenges for clinical psychologists working in academic health centers.

The Department of Defense Congressionally Directed Medical Research Program: innovations in the federal funding of biomedical research.

In response to the lobbying efforts of the women's advocacy movement, in 1993 Congress authorized funds for a substantial increase in support of new and promising research aimed at the eradication of breast cancer. This appropriation resulted in a major expansion of the United States Army Medical Research and Materiel Command, Department of Defense Breast Cancer Research Program. The Office of Congressionally Directed Medical Research Programs was established within the United States Army Medical Research and Materiel Command to facilitate the management of the expanded extramural research program. Since that time, the programs have grown to include not just breast cancer but also prostate cancer, ovarian cancer, and neurofibromatosis. The unique appropriations to the Office of Congressionally Directed Medical Research Programs has resulted in a number of programmatic innovations. These include development of unique mechanisms of grant support, inclusion of consumer advocates on peer and programmatic review panels, and the introduction of criteria-based evaluation and scoring in peer review. This article describes these novel scientific management strategies and outlines their success in meeting program visions and goals.