Therapy For Veterans Research Articles

The Impact of Executive Function on Retention and Compliance in Physical Therapy in Veterans

ObjectiveTo examine retention and compliance to a novel physical therapy (PT) treatment among Veterans with and without executive function deficits (EFD+/EFD−). DesignThis study was a preplanned secondary analysis of an ongoing randomized controlled trial. SettingOutpatient PT at Department of Veterans Afffairs Boston Healthcare System. ParticipantsSeventy-two community-dwelling middle-aged and older Veterans (mean age, 72 years [range 51-91]; 87% male) with gait speed between 0.5 and 1.0 m/second were recruited from primary care practices. InterventionsEight-week moderate-to-vigorous intensity PT program. Main outcome measureVeterans’ baseline mobility, retention (dropouts), and treatment compliance and posttreatment exercise compliance to 8-week PT treatment were evaluated based on their baseline EFD status. ResultsOf the 72 participants, 22% (n=16) were EFD+. Veterans with EFD+ at baseline had worse mobility performance (Short Physical Performance Battery [SPPB], 7.7 vs 9.5, P<.001) and patient-reported mobility (Activity Measure for Post-Acute Care [AM-PAC], 57.6 vs 62.2, P<.01) after adjusting for age, gender, number of comorbidities, depressive symptoms, and pain interference. Dropout rates for EFD+ and EFD− were 44% and 25%, respectively (P>.05). In multivariable logistic regression modeling, pain interference, depressive symptoms, mobility, and living alone but not EFD status were associated with dropping out. There was no evidence of significant differences in treatment compliance or posttreatment exercise compliance, measured by the number of attended sessions and the number of posttreatment exercise days by EFD status. ConclusionEFD+ was associated with poor baseline mobility. Although the dropout rate was higher among Veterans with EFD+, we were unable to conclude whether EFD status impacts retention or compliance due to the small sample size. Further investigation is needed to determine whether EFD status may identify individuals who need additional support during and/or after rehabilitation treatment.

Guideline concordant opioid therapy in Veterans receiving VA and community care

Guideline concordant opioid therapy is a key part of the concerted effort to address the opioid crisis in the United States. The study aimed to compare the rates of guideline concordant care between veterans who solely used VA services (mono users) and veterans who used both VA services and community care (dual-system users). We used electronic health record data from the Washington DC and Baltimore VA Medical Centers from 2015 to 2019. We provided descriptive statistics as well as generalized estimating equations models to find associations between mono vs. dual-system users and each guideline outcome, controlling for demographic factors and comorbid conditions. The study found that overall rates of guideline concordant care were high in both mono and dual-system users with over 90% adherence rates for the majority of recommendations. However, there were variations in adherence to specific guidelines, with urine drug screening at initiation being the least commonly followed recommendation (8.9% of mono-user opioid initiators and 11.2% of dual-user initiators). This study also found that there was no consistent pattern of higher guideline adherence in mono vs. dual-system users but did show that through the course of this study (2015–2019) overall rates of guideline concordance increased. Future research will explore additional guideline recommendations and potential coordination issues among dual-system users.

Challenges and Opportunities in Developing an Oncology Clinical Trial Network in the United States Veterans Affairs Health Care System: The VA STARPORT Experience.

The United States Veterans Affairs (VA) Health Care System has a strong history of conducting impactful oncology randomized clinical trials (RCTs). We developed a phase II/III RCT to test the use of metastasis-directed therapy in Veterans with oligometastatic prostate cancer (OMPC)-the first VA RCT in OMPC that leverages novel imaging and advanced radiotherapy techniques. To accomplish this, we developed a clinical trial network to conduct the study. In this manuscript, we describe several challenges we encountered in study development/conduct and our strategies to address them, with the goal of helping investigators establish robust study networks to conduct clinical trials. In the study start-up, we encountered challenges in timely site activation, and leveraged project management to maximize efficiency. Additionally, there were several changes in the clinical paradigms in imaging and treatment that led to protocol amendments to ensure maximum equipoise, recruitment, and impact of the study. Specifically, we amended the trial to add de novo OMPC patients (from initially only recurrent OMPC) and expanded the study to allow up to 10 metastases (from initially five). Finally, in order to maintain local study team engagement, we developed initiatives to maximize collaboration and add value to the overall clinical program through study participation.

Ketamine-enhanced prolonged exposure therapy in veterans with PTSD: A randomized controlled trial protocol

BackgroundThe 2023 VA/DoD Clinical Practice Guideline for the Management of PTSD recommends individual, manualized trauma-focused such as Prolonged Exposure (PE) over pharmacologic interventions for the primary treatment of PTSD. Unfortunately, clinical trials of trauma-based therapies in the military and veteran population showed that 30% to 50% of patients did not demonstrate clinically meaningful symptom change. Ketamine, an FDA-approved anesthetic with potent non-competitive glutamatergic N-methyl-d-aspartate antagonistic properties, has demonstrated to enhance the recall of extinction learning and decrease fear renewal without interference of extinction training in preclinical studies. MethodsWe plan to conduct a single site RCT comparing three ketamine treatment vs. active placebo (midazolam) adjunct to PE therapy among Veterans with PTSD. Pharmacological phase will start simultaneously with PE session 1. Infusions will be administered 24 h. prior to PE session for the first 3 weeks. After PE is completed (session 10), patients will be assessed during a 3-month follow-up period at various time points. We estimate that out of 100 veterans, 80 will reach time point for primary outcome measure and will be considered for primary analysis. Secondary outcomes include severity of depression and anxiety scores, safety and tolerability of ketamine-enhanced PE therapy, cognitive performance during treatment and early improvement during PE related to the rate of dropouts during PE therapy. DiscussionResults of the proposed RCT could provide scientific foundation to distinguish the essential components of this approach, enhance the methodology, elucidate the mechanisms involved, and identify sub-PTSD populations that most likely benefit from this intervention.

Virtual Hybrid Versus In-Person Administration of Transcending Self Therapy for Veterans with Substance Use Disorders.

Veterans with substance use disorder (SUD) can show high severity and are at high risk of relapse due to trauma histories and other comorbid conditions. However, evidence-based SUD therapies may not be available to many veterans due to geographic or transportation constraints. Telehealth approaches have shown promise to improve access to different SUD therapy formats but have not been well-studied in open (rolling-admission) group therapy of in-person patients as administered by a single on-screen therapist. Social distancing required by the COVID-19 pandemic forced the transition of delivery of Transcending Self Therapy (TST) from an in-person therapist to a single remote (on-screen) therapist. In this virtual model, veterans continued to receive TST but the therapist was off site and provided therapy to veterans who were together in the same room during a 28 day residential Veterans Affairs treatment program. In a program evaluation, we compared their changes in quality of life (QoL), treatment satisfaction ratings and group therapy treatment outcomes with those of Veterans who received TST from an in-person therapist. In both groups, there was a significant increase in QoL Inventory scores from baseline to post-treatment, with no difference in improvement between treatment modalities (i.e., in-person group vs telehealth-delivered group). Veterans professed knowledge of therapy-driven skills at the end of treatment in both groups and overwhelmingly rated TST as helpful and understandable. These data extend previous findings of patient acceptability of remotely-delivered SUD treatment, here with a remote therapist administering open group therapy, as evidenced by improvement in QoL and positive patient feedback about the remote intervention.

Feasibility of Virtual Reality-Delivered Transcending Self Therapy in Veterans Undergoing Residential Substance Use Treatment

Substance Use Disorder (SUD) is common among military veterans, where post-traumatic stress disorder and other comorbidities stemming from deployment or other military experiences increase the severity of SUD and incidence of relapse. It is thus critical to discover and evaluate potential advances in SUD treatment, such as methods for enhanced patient engagement in treatment.

IMPACT OF A QUALITY IMPROVEMENT INITIATIVE ON STATIN THERAPY IN VETERANS WITH PERIPHERAL ARTERY DISEASE

IMPACT OF A QUALITY IMPROVEMENT INITIATIVE ON STATIN THERAPY IN VETERANS WITH PERIPHERAL ARTERY DISEASE

Treatment effectiveness of antibiotic therapy in Veterans with multidrug-resistant Acinetobacter spp. bacteremia.

To describe antimicrobial therapy used for multidrug-resistant (MDR) Acinetobacter spp. bacteremia in Veterans and impacts on mortality. This was a retrospective cohort study of hospitalized Veterans Affairs patients from 2012 to 2018 with a positive MDR Acinetobacter spp. blood culture who received antimicrobial treatment 2 days prior to through 5 days after the culture date. Only the first culture per patient was used. The association between treatment and patient characteristics was assessed using bivariate analyses. Multivariable logistic regression models examined the relationship between antibiotic regimen and in-hospital, 30-day, and 1-year mortality. Generalized linear models were used to assess cost outcomes. MDR Acinetobacter spp. was identified in 184 patients. Most cultures identified were Acinetobacter baumannii (90%), 3% were Acinetobacter lwoffii, and 7% were other Acinetobacter species. Penicillins-β-lactamase inhibitor combinations (51.1%) and carbapenems (51.6%)-were the most prescribed antibiotics. In unadjusted analysis, extended spectrum cephalosporins and penicillins-β-lactamase inhibitor combinations-were associated with a decreased odds of 30-day mortality but were insignificant after adjustment (adjusted odds ratio (aOR) = 0.47, 95% CI, 0.21-1.05, aOR = 0.75, 95% CI, 0.37-1.53). There was no association between combination therapy vs monotherapy and 30-day mortality (aOR = 1.55, 95% CI, 0.72-3.32). In hospitalized Veterans with MDR Acinetobacter spp., none of the treatments were shown to be associated with in-hospital, 30-day, and 1-year mortality. Combination therapy was not associated with decreased mortality for MDR Acinetobacter spp. bacteremia.

Quetiapine augmentation of cognitive processing therapy in veterans with posttraumatic stress disorder. Design and methodology of a pilot study

Background: The limited efficacy of first-line treatment of Posttraumatic Stress Disorder (PTSD) with selective serotonergic reuptake inhibitors commonly leads to the use of multiple medications that still fail to achieve symptomatic remission. VA/DOD guidelines identify trauma-focused psychotherapies as the evidence-based treatment for PTSD, but overall effectiveness is limited by reduced levels of patient engagement. Cognitive Processing Therapy (CPT) is the most widely-used trauma-focused therapy in the VA system for Veterans with PTSD. Our previous results based on a case series suggested that quetiapine mono therapy, but not risperidone or valproate, could increase engagement in CPT, thereby improving clinical outcomes through direct medication effects and indirectly through greater engagement in CPT.

THU016 - Patient and system-level factors underline offering and acceptance of alcohol use disorder therapy in veterans with cirrhosis

THU016 - Patient and system-level factors underline offering and acceptance of alcohol use disorder therapy in veterans with cirrhosis

The Magnitude and Potential Causes of Sex Disparities in Statin Therapy in Veterans with Type 2 Diabetes: A 10-year Nationwide Longitudinal Cohort Study.

Past research has shown that women eligible for statin therapy are less likely than their male counterparts to receive any statin therapy or be prescribed a statin at the guideline-recommended intensity. We compared statin treatment in men and women veterans from a national cohort of older veterans with type 2 diabetes. The Veterans Health Administration Corporate Data Warehouse and Centers for Medicare and Medicaid Services data were used to create a unique dataset and perform a longitudinal study of veterans with type 2 diabetes from 2007 to 2016. Mixed-effects logistic regression was used to model the association between the primary exposure (sex) and statin use. The study included 714,212 veterans with diabetes, including 9,608 women, with an overall mean age of 75.9years. In the unadjusted model for any statin use, women veterans had a 14% significantly lower odds of having any statin use compared with men. After adjusting for all covariates, including markers of Veterans Administration care use (service-connected disability rating, Veterans Administration use, and primary care visits) that serve as proxies for access and mental health comorbidities (depression and psychiatric disorder), this disparity narrowed from 14% to 3% and was no longer statistically significant. In the model for high-intensity statin therapy (high-intensity vs. low or none), women were 10% less likely than men to use high-intensity statins in the base model that included only time and sex. After adjusting for all measured covariates, the direction of the association changed and women had 16% higher odds of high-intensity statin use compared with men (odds ratio, 1.16; 95% confidence interval, 1.03-1.31). Consistent with prior research, in the unadjusted analysis a significant sex disparity was observed in statin use, with lower rates observed in women. For the outcome of any statin use, after adjustment for covariates that included variables that are proxies for access as well as psychiatric and depression comorbidities, this disparity lost statistical significance and narrowed. In the high-intensity statin versus low or none model, the direction of the association changed after controlling for measured covariates and women had a 16% higher odds of high-intensity statin use compared with men. This study highlights a persistent health disparity in lipid-lowering therapy for women veterans. Additional research is needed to further elucidate the reasons for and develop interventions to mitigate this persistent sex disparity in cholesterol management for veterans with diabetes.

Acceptance and forgiveness therapy for veterans with moral injury: spiritual and psychological collaboration in group treatment

The authors developed Acceptance and Forgiveness Therapy (AFT), a psychospiritual group intervention that guides veterans with moral injury experientially from a trauma-focused (damaged, broken, guilty, unforgivable, hopeless, unacceptable) to restorative (worthy, connected, hopeful, forgiven, responsible) view of self. A mental health (MH)-trained chaplain and MH provider, as co-leaders, provide psychoeducation, facilitate therapeutic interaction, and encourage home practice. The curriculum includes evidence-driven psychological interventions, spiritually oriented practices, and metaphor, story, and art to illustrate concepts and facilitate self-expression. Scores on the Brief Symptom Inventory-18 and Acceptance and Action Questionnaire-2 showed decreased distress and increased flexibility. Post-group drawings reflect renewed purpose, greater self-acceptance, and meaningful engagement with others. Retention rate across seven group administrations ranged from 50% to 100%. Outcomes suggest AFT is a promising practice for veteran moral injury meriting further study and implementation.

Video Games: A Complementary Therapy for Veterans with Serious Mental Illness

The National Institute of Mental Health defined serious mental illness (SMI) as a mental, behavioral, or emotional disorder resulting in serious functional impairment that substantially interferes with or limits one or more major life activities. The literature reveals a knowledge gap about the use of video games as a complementary alternative therapy in treating veterans with SMI. The focus of this paper will discuss and compare research studies and theories on the beneficial use of video games for veterans with SMI. Learning, cognitive, sociological theories, and the symbolic interactionist framework are a few concepts that may guide video gaming. The literature search and findings suggest the VA healthcare system has research entities to support further research and analysis to develop a program geared toward video games as a complementary therapy for veterans with SMI. The purpose of this paper is to call for discussions on the topic of video games as a complementary alternative therapy for veterans with severe mental illness (SMI).

Acceptability of a transdiagnostic behavior therapy in veterans with affective disorders.

Transdiagnostic behavior therapy (TBT) has been found to lead to significant reductions in affective disorder symptoms. However, patient satisfaction and treatment fit for TBT have not been examined. Within a sample of veterans, the current study examined the acceptability of TBT in comparison to brief behavioral activation (BA) for depression. Results found individuals in the TBT condition (compared to BA) were more satisfied with therapy, F(1, 48) = 6.68, p = .013. In addition, they were more likely to say that they would recommend this treatment to a friend, F(1, 48) = 3.76, p = .058, and that the TBT treatment helped them more effectively deal with problems, F(1, 48) = 3.29, p = .076, although these effects were significant at trend level. Individuals in the TBT condition (compared to BA) completed significantly more homework, F(1, 65) = 4.95, p = .030, and were more engaged in their homework, F(1, 65) = 3.98, p = .050. These findings are the first of their kind and suggest high patient satisfaction and homework completion/participation in participants completing TBT. These results are promising and suggest the continued dissemination and implementation of transdiagnostic treatments. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

An Interrupted Time-series Evaluation of the Association Between State Laws Mandating Prescriber Use of Prescription Drug Monitoring Programs and Discontinuation of Chronic Opioid Therapy in US Veterans.

Most states have recently passed laws requiring prescribers to use prescription drug monitoring programs (PDMPs) before prescribing opioid medications. The impact of these mandates on discontinuing chronic opioid therapy among Veterans managed in the Veterans Health Administration (VA) is unknown. We assess the association between the earliest of these laws and discontinuation of chronic opioid therapy in Veterans receiving VA health care. We conducted a comparative interrupted time-series study in the 5 states mandating PDMP use before August 2013 (Ohio, West Virginia, Kentucky, New Mexico, and Tennessee), adjusting for trends in the 17 neighboring control states without such mandates. We modeled 25 months of prescribing for each state centered on the month the mandate became effective. We included Veterans prescribed long-term outpatient opioid therapy (305 of the preceding 365 d). Our outcomes were discontinuation of chronic opioid therapy (primary outcome) and the average daily quantity of opioids per Veteran over the following 6 months (secondary outcome). We included 250 monthly cohorts with 225,665 unique Veterans and 3.4 million Veteran-months. Baseline discontinuation rates before the PDMP mandates were 0.4%-2.7% per month. Kentucky saw a discontinuation increase of 1 absolute percentage point following its PDMP mandate which decreased over time. The other 4 states had no significant association between their mandates and change in opioid discontinuation. There was no evidence of decreasing opioid quantities following PDMP mandates. We did not find consistent evidence that state laws mandating provider PDMP use were associated with the discontinuation of chronic opioid therapy within the VA for the time period studied.

Doubling of median overall survival in a nationwide cohort of veterans with stage III non-small cell lung cancer in the durvalumab era.

8546 Background: The standard of care for patients with unresectable stage III non-small cell lung cancer (NSCLC) is concurrent chemoradiotherapy followed by durvalumab maintenance based on outcomes from the PACIFIC trial. However, PACIFIC did not include Veterans, a unique population with significant co-morbidities; thus, the impact of durvalumab on survival of Veterans with stage III NSCLC is unknown. Methods: Using the U.S. Department of Veterans Affairs Corporate Data Warehouse, patients with stage III non-small cell lung cancer who received chemoradiotherapy and at least one dose of durvalumab were selected. Kaplan-Meier survival analysis and univariate Cox proportional hazards modeling were used to determine progression-free survival (PFS), overall survival (OS) and independent predictors of PFS and OS. PFS was manually extracted by review of serial surveillance scans. All statistical computations were performed using SAS 9.4 software. Results: 1106 Veterans met our inclusion criteria. The median age was 69. 95.1% (n = 1052) were male. The median Charlson Comorbidity Index was 1. 86.4% (n = 956) reported current or former tobacco use. 48.1% (n = 532) had adenocarcinoma histology, 48.4% (n = 535) squamous cell, 0.5% (n = 5) large cell, 0.3% (n = 3) neuroendocrine, and 0.1% (n = 1) sarcomatoid. 60% (n = 619) had AJCC 8th edition stage IIIA disease, 34.5% (n = 382) stage IIIB, and 3.3% (n = 36) stage IIIC. Median PFS was 19.9 months (95% CI: 16.9 – 23.6) and median OS was 34.9 months (95% CI: 29.7 – not reached). In univariate survival analyses, adenocarcinoma histology (HR 1.14, p = 0.03) predicted progression. Older age (HR 1.03, p &lt; 0.0001) and stage IIIB/IIIC disease (HR 1.05, p = 0.008) predicted inferior OS. 18.4% (n = 204) of patients completed all planned cycles of adjuvant durvalumab. The median number of durvalumab infusions received was 6 (range: 1 – 38). Among evaluable patients, 175 (19.4%) discontinued durvalumab for progression, 211 (23.4%) discontinued for suspected immune-related toxicity and 17 (1.9%) died during treatment. Conclusions: While several factors have led to the improvement of OS in patients with stage III NSCLC over time, we report a doubling of median OS in Veterans with stage III NSCLC who received chemoradiotherapy plus durvalumab as compared to historical cohorts who received chemoradiotherapy alone (1). Veterans in our study received a lower median number of durvalumab infusions as compared to patients in the PACIFIC trial (6 vs. 14), and a significant proportion discontinued durvalumab due to suspected immune-mediated toxicity (23.4%). If further analyses confirm our findings, investigation of alternative dosing regimens and/or dosing intervals of durvalumab in order to balance safety and efficacy of durvalumab therapy in Veterans is warranted. (1) Santana-Davila R et al. J Clin Oncol. 2015 Feb 20;33(6):567-74.

Resting-state connectivity subtype of comorbid PTSD and alcohol use disorder moderates improvement from integrated prolonged exposure therapy in Veterans.

Posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD) are highly comorbid and are associated with significant functional impairment and inconsistent treatment outcomes. Data-driven subtyping of this clinically heterogeneous patient population and the associated underlying neural mechanisms are highly needed to identify who will benefit from psychotherapy. In 53 comorbid PTSD/AUD patients, resting-state functional magnetic resonance imaging was collected prior to undergoing individual psychotherapy. We used a data-driven approach to subgroup patients based on directed connectivity profiles. Connectivity subgroups were compared on clinical measures of PTSD severity and heavy alcohol use collected at pre- and post-treatment. We identified a subgroup of patients associated with improvement in PTSD symptoms from integrated-prolonged exposure therapy. This subgroup was characterized by lower insula to inferior parietal cortex (IPC) connectivity, higher pregenual anterior cingulate cortex (pgACC) to posterior midcingulate cortex connectivity and a unique pgACC to IPC path. We did not observe any connectivity subgroup that uniquely benefited from integrated-coping skills or subgroups associated with change in alcohol consumption. Data-driven approaches to characterize PTSD/AUD subtypes have the potential to identify brain network profiles that are implicated in the benefit from psychological interventions - setting the stage for future research that targets these brain circuit communication patterns to boost treatment efficacy.

75. Less is More: A Physician-Driven Quality Improvement Stewardship Initiative to Reduce Excessive Duration of Antibiotic Therapy in Veterans Hospitalized with Community-Acquired Pneumonia

BackgroundThe IDSA and American Thoracic Society (IDSA/ATS) Community Acquired Pneumonia (CAP) guidelines recommend 5 days of therapy for clinically stable patients that defervesce, however, duration of therapy (DOT) is often longer. Pharmacists curb this via antimicrobial stewardship (AMS), but budgetary constraints are barriers to robust AMS programs in some hospitals. Physicians are increasingly encouraged to participate in quality improvement (QI) and are a potential resource to improve AMS. We sought to determine the impact of a prospective, physician-driven stewardship intervention on DOT and clinical outcomes in hospitalized veterans with CAP, with the goal to reduce the median DOT by at least 1 day within 5 months.MethodsThis single center, quasi-experimental QI study evaluated two concurrent physician-driven interventions over a 5-month period in an inner-city Veterans Affairs Hospital. Using DMAIC (Define, measure, analyze, improve, and control) methodology, the Chief Resident in Quality and Safety (CRQS) provided monthly education and daily audit and feedback with patient-specific DOT recommendations. Clinical outcomes were followed until 30 days post discharge.ResultsA total of 123 patients with CAP were included (57 in the historic control group and 66 in the AMS intervention group). The AMS intervention significantly increased the proportion of CAP patients treated with a 5-day treatment course (56% versus 5.3%, p< 0.0001), and reduced the proportion of patients treated beyond 7 days (12.1% versus 70.2%, p< 0.0001). Median DOT per patient was reduced significantly (5 versus 8 days, p< 0.0001). Median excess antibiotic days were significantly reduced (0 versus 3, p< 0.0001) and 118 days of unnecessary antibiotics were avoided (62 versus 180). 30-day all-cause mortality, all-cause readmission, and Clostridium difficile infection were similar between groups. Median LOS was similar between groups (p=0.246).DOT in the Historic Control Group Versus Stewardship Intervention Group ConclusionA physician driven QI stewardship intervention in hospitalized CAP patients significantly reduced the total antibiotic DOT and excess antibiotic days without adversely affecting patient outcomes. Providers can be educated through physician driven interventions resulting in substantial improvements in appropriate antibiotic use.Disclosures All Authors: No reported disclosures

Randomized controlled trial of an integrated approach to treating insomnia and improving the use of positive airway pressure therapy in veterans with comorbid insomnia disorder and obstructive sleep apnea.

Cognitive behavioral therapy for insomnia (CBTI) for comorbid insomnia and obstructive sleep apnea (OSA) has had mixed results. We integrated CBTI with a positive airway pressure (PAP) adherence program and tested effects on sleep and PAP use. 125 veterans (mean age 63.2, 96% men, 39% non-Hispanic white, 26% black/African American, 18% Hispanic/Latino) with comorbid insomnia and newly-diagnosed OSA (apnea-hypopnea index ≥ 15) were randomized to 5-weekly sessions integrating CBTI with a PAP adherence program provided by a "sleep coach" (with behavioral sleep medicine supervision), or 5-weekly sleep education control sessions. Participants and assessment staff were blinded to group assignment. Outcomes (baseline, 3 and 6 months) included Pittsburgh Sleep Quality Index (PSQI), 7-day sleep diary (sleep onset latency [SOL-D], wake after sleep onset [WASO-D], sleep efficiency [SE-D]), 7-day actigraphy (SE-A), and objective PAP use (hours/night and nights ≥ 4 h). Insomnia Severity Index (ISI), Epworth Sleepiness Scale (ESS), and Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10) were also collected. Compared to controls, intervention participants showed greater improvement (baseline to 3 and 6 months, respectively) in PSQI (-3.2 and -1.7), SOL-D (-16.2 and -15.5 minutes), SE-D (10.5% and 8.5%), SE-A (4.4% and 2.6%) and more 90-day PAP use (1.3 and 0.9 more hours/night, 17.4 and 11.3 more nights PAP ≥ 4 h). 90-day PAP use at 3 months was 3.2 and 1.9 h/night in intervention versus controls. Intervention participants also had greater improvements in ISI, ESS, and FOSQ-10 (all p < 0.05). An intervention integrating CBTI with a PAP adherence program delivered by a supervised sleep coach improved sleep and PAP use in adults with comorbid insomnia and OSA. ClinicalTrials.govStudy name: Novel Treatment of Comorbid Insomnia and Sleep Apnea in Older VeteransURL: https://clinicaltrials.gov/ct2/results?cond=&term=NCT02027558&cntry=&state=&city=&dist=Registration: NCT02027558.

Quetiapine augmentation of prolonged exposure therapy in veterans with PTSD and a history of mild traumatic brain injury: design and methodology of a pilot study

BackgroundSelective serotonergic reuptake inhibitors (SSRIs) are first-line pharmacologic treatments for patients with posttraumatic stress disorder (PTSD), but must be given over extended period of time before the onset of action. The use of SSRIs in PTSD patients with mild traumatic brain injury (mTBI) is problematic since SSRIs could exacerbate post-concussion syndrome (PCS) symptoms. VA/DOD guidelines identify trauma-focused psychotherapy as the best evidence-based treatment for PTSD, but overall effectiveness is limited by reduced levels of patient engagement and retention. A previous study from this research group suggested that quetiapine monotherapy, but not risperidone or valproate, could increase engagement in trauma-focused psychotherapy.MethodsWe report the study protocol of a pilot study funded under the South-Central Mental Illness Research, Education, and Clinical Center pilot study program from the U.S. Department of Veterans Affairs. This randomized, open-label study was designed to evaluate the feasibility of completing a randomized trial of quetiapine vs. treatment as usual to promote patient engagement in PTSD patients with a history of mTBI.DiscussionWe expect that the success of this ongoing study should provide us with the preliminary data necessary to design a full-scale randomized trial. Positive efficacy results in a full- scale trial should inform new VA guidelines for clinical practice by showing that quetiapine-related improvements in patient engagement and retention may be the most effective approach to assure that VA resources achieve the best possible outcome for veterans.Trial registrationNCT04280965.