Treatment for Posttraumatic Stress Disorder in Military and Veteran Populations: Final Assessment (2014)

7

Effective and Safe Care

All health care systems strive to provide effective and safe interventions to improve or maintain the health of their patients, including prevention efforts. In this report the term effective is used to mean that a specific posttraumatic stress disorder (PTSD) service or program results in a better outcome for the service member or veteran compared with other services or programs, including no service or program. The term safe means that the risk of harm is acceptable and well characterized. Although the effectiveness of many PTSD treatments is well established, a specific treatment might not be equally effective in all people, nor is any treatment necessarily appropriate for all patients for all presentations of PTSD or at every point along its course.

The phase 1 report reviewed the evidence base for many prevention approaches and treatments for PTSD, including psychotherapy, pharmacotherapy, and complementary and alternative therapies. That report also considered the treatment of several common comorbidities such as traumatic brain injury (TBI) and chronic pain. This chapter considers whether and how Department of Defense (DoD) and Department of Veterans Affairs (VA) are achieving success in providing effective and safe treatments for PTSD and the difficulties that they have experienced in delivering these treatments.

DETERMINING EFFECTIVE CARE

Clinical practice guidelines provide recommendations on the best practices for the treatment of a condition on the basis of reviews of scientific

evidence and expert consensus. State-of-the-science guidelines assess the strength of the evidence, the manner in which evidence was collected and evaluated, and the populations to which it pertains. Implementation strategies, such as reminders in the medical record and decision support tools, can help ensure that clinicians adhere to guidelines (IOM, 2013a,b). The Institute of Medicine (IOM) has established standards for the development of trustworthy clinical practice guidelines (IOM, 2011).

DoD and VA developed the VA/DoD Clinical Practice Guideline for Management of Post-Traumatic Stress in 2004 and updated it 2010. This joint guideline, which meets the IOM guideline standards, reflects the evidence base (and safety concerns, if applicable) for first-line and other psychotherapies and pharmacotherapies for PTSD, including complementary and alternative therapies, and delivery formats (group versus individual sessions). The guideline also provides brief advice on assessing comorbidities in patients who have PTSD, where best to treat them (for example, in a primary care versus specialty clinic), and the effects of the comorbidities on PTSD treatment (VA/DoD, 2010). Although there are VA/DoD guidelines for treating some conditions that may co-occur with PTSD—such as major depressive disorder, TBI, or substance use disorder—there is no guideline that addresses specifically the concurrent treatment of PTSD and its common comorbidities (http://www.healthquality.va.gov).

In its phase 1 report, the committee recommended that DoD and VA mental health care providers follow their own guideline.¹ The committee also concurred strongly with the guideline recommendation that “patients who are diagnosed with PTSD should be offered one of the evidence-based trauma-focused psychotherapeutic interventions that include components of exposure and/or cognitive restructuring; or stress inoculation training,” as well as “selective serotonin reuptake inhibitors (SSRIs), for which fluoxetine, paroxetine, or sertraline have the strongest support, or serotonin norepinephrine reuptake inhibitors (SNRIs), for which venlafaxine has the strongest support, for the treatment of PTSD” (VA/DoD, 2010). A 2013 meta-analysis of treatment efficacy for PTSD was consistent with the VA/DoD guideline in finding that cognitive therapy including cognitive processing therapy (CPT); exposure therapy, such as prolonged exposure (PE) therapy; and eye movement desensitization and reprocessing (EMDR)

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¹ The committee uses the VA/DoD clinical practice guideline to define evidence-based treatments as ones “that are most strongly supported by randomized control trials” (VA/DoD, 2010). That aligns with the Substance Abuse and Mental Health Services Administration definition of evidence-based interventions: “strong evidence means that the evaluation of an intervention generates consistently positive results for the outcomes targeted under conditions that rule out competing explanations for effects achieved (e.g., population and contextual differences)” (Center for Substance Abuse Prevention, 2009).

were effective psychotherapies, and SSRIs were the most effective pharmacotherapies (Watts et al., 2013).

Some of the first-line evidence-based treatments, such as PE, have manuals that provide detailed protocols for their use. Adherence to the manuals in a manner that is sensitive to individual patients’ needs can help to ensure that the treatments are effective, although modifications may be necessary to address patient needs and preferences. Frequent and consistent monitoring of patient symptoms and outcomes are also important to determine the effectiveness of a PTSD treatment and to indicate if and when modifications may be necessary. Adequate monitoring, education, and support from the health care provider can help ensure patient compliance, identify adverse reactions, and track treatment responses.

DELIVERY OF EFFECTIVE CARE

Optimal delivery of evidence-based treatment for PTSD requires organizational resources and leadership support, an organizational culture that expects and rewards the delivery of those treatments (Foa et al., 2013), and adherence to the VA/DoD guideline for PTSD and treatment manuals. Delivery of evidence-based psychotherapy and pharmacotherapy will also be influenced by a patient’s needs, the provider’s clinical judgment, and the treatment setting. For example, some patients may prefer to be treated in a primary care clinic, whereas others may require care in a specialty intensive program. Clinicians also need to be aware of any comorbid conditions a patient might have—not only physical or other mental health conditions but psychosocial problems such as relationship issues—because these conditions may need to be addressed before or concurrently with PTSD treatment.

Stepped care is one approach that may improve the delivery of effective treatment (Zatzick et al., 2004, 2013). In this model, first-line, evidence-based treatments are offered initially, but if a patient does not respond adequately or is reluctant to engage in such treatments, a provider may try second-line or third-line, lower-intensity approaches—such as psychoeducation, a complementary or alternative therapy, or sleep aids—to treat the patient’s PTSD symptoms. Repeated measurements of PTSD symptoms then allow the “stepping up” of care to higher-intensity, evidence-based interventions for patients who remain symptomatic. Measurement-based stepped care may be an optimal approach to integrating treatment-engagement strategies such as psychoeducation with established evidence-based PTSD interventions.

DEPARTMENT OF DEFENSE

This section examines DoD performance regarding the use of evidence-based and other interventions for PTSD and how those interventions are delivered to service members. Ways in which DoD has achieved success or faced challenges in providing effective interventions for the prevention and diagnosis of and treatment for PTSD in service members are discussed. The use of evidence-based treatments, complementary and alternative treatments, and prevention and resilience programs in DoD is also considered.

Determining Effective Care

Evidence-Based Treatment

The Army Medical Command has mandated that all military treatment facility commanders, mental health care providers, and other medical care providers deliver evidence-based care for PTSD according to the VA/DoD clinical practice guideline (U.S. Army, 2012b). However, DoD and the service branches lack data on whether the guideline is being used by providers to inform treatment decisions (IOM, 2013c). They do not track and evaluate the types of treatments that patients receive or their outcomes although efforts to do so have begun, for example, the Army’s Behavioral Health Data Portal (see Chapter 4).

A RAND Corporation study of PTSD, depression, and TBI in service members returning from Afghanistan and Iraq estimated that 53% of those who met criteria for PTSD had sought help from a mental health care provider, but fewer than half of those who sought help received minimally adequate treatment. Minimally adequate treatment with a psychotropic drug was considered to be use of the prescribed medication for as long as the provider wanted to use it and at least four visits with a provider in the preceding 12 months. Minimally adequate psychotherapy was defined as at least eight visits, each lasting at least 30 minutes, with a mental health professional in the preceding 12 months (Tanielian and Jaycox, 2008).

No DoD data on the use of evidence-based psychotherapy and patient outcomes were available because such data are not collected at the national or service branch level. Data on prescriptions for pharmaceuticals that are used to treat for PTSD (and other mental health conditions) were available, but those data must be interpreted cautiously because, although the Food and Drug Administration has approved two drugs for PTSD—sertraline (Zoloft, Lustral) and paroxetine (Paxil, Pevexa)—it is not possible to determine whether they or any of the other drugs were prescribed specifically for PTSD rather than for a comorbid condition.

A small amount of data has been collected on intensive PTSD outpa-

tient programs in DoD. The Tri-service Integrator of Outpatient Programming Systems (TrIOPS) in the DoD Deployment Health Clinical Center surveyed 15 such programs and found that 13 of them used cognitive behavioral therapy, 10 used CPT, 5 used PE, and 8 used EMDR; how often the psychotherapies were used in the programs was not reported (O’Toole, 2012). No details on the survey methods or response rates were provided.

Complementary and Alternative Therapies

Military personnel use complementary and alternative therapies for a variety of health conditions, including PTSD, but DoD does not have data on what therapies are available on or near installations or on the number of service members who may use them and why. Goertz et al. (2013) found that 45% of 16,146 military survey participants reported use of at least one complementary or alternative treatment in the preceding year. The 2004–2006 Millennium Cohort Study found that of 86,131 participants in all service branches and components, 41% reported use of any of the 12 complementary and alternative therapies listed in the survey in the preceding year. Of those who had a self-reported diagnosis of PTSD (2.3% of participants), fewer than 5% used any provider-assisted or self-administered complementary and alternative treatment (Jacobson et al., 2009).

Several PTSD programs in DoD use complementary and alternative therapies such as acupuncture, meditation, neurofeedback, and relaxation techniques, and some DoD mental health care providers and service members find benefits in those therapies for PTSD. The National Intrepid Center of Excellence and the Overcoming Adversity and Stress Injury Support programs use the therapies is to calm some of the hypervigilance symptoms of PTSD and to keep patients engaged in treatment until they are ready for or are able to access more trauma-focused therapy such as PE or CPT (Koffman and Helms, 2013; Sargent et al., 2013). Thirteen of the 15 PTSD intensive outpatient programs surveyed by TrIOPS offered some form of complementary and alternative treatment (O’Toole, 2012). The Warrior Resilience Center at Fort Bliss, Texas, is using a combination of evidence-based treatments and several complementary therapies (such as acupuncture, Reiki, and meditation) to treat soldiers who have PTSD (see Chapter 3 for more information on this program). Although the evidence base to support the effectiveness of most of these treatments is lacking, a few studies show positive results (see phase 1 report).

Prevention and Resilience

Preventing the development of mental health problems, including PTSD, has been a goal of DoD for many years. Each service branch has

developed its own resilience or stress control training programs to help service members cope with the stresses of military life, particularly deployments and combat, and to prevent the development or exacerbation of mental health problems. In 2011, DoD Instruction 6490.05Maintenance of Psychological Health in Military Operations required the service branches to evaluate on an annual basis the quality and effectiveness of their combat and operational stress control programs. The long-term effect of such resilience training on preventing PTSD after exposure to a traumatic event is unknown, but some programs, such as the Army’s Comprehensive Soldier and Family Fitness (CSF2), are collecting data to assess its effectiveness (Harms et al., 2013). The Army is required to conduct a study of all its resilience programs and specifically to assess the effectiveness of CSF2 and report its findings to Congress by October 2014.

The CSF2 program (described in Chapter 3) is based in part on the Penn Resilience Program and the Army’s earlier Battlemind program. In an extensive review of the CSF2 program, Steenkamp et al. (2013) found that although some aspects of the program may be beneficial to soldiers and their families, the global assessment tool used by the Army to measure outcomes in the CSF2 program does not assess PTSD symptoms and so could not be used to determine any association between resilience training and prevention of PTSD, and no other evidence is available on its short-term or long-term effectiveness. The Army found in its own assessments of CSF2 that “there is currently no evidence that [the Penn Resilience Program] is effective among adults or in settings outside of schools” (Harms et al., 2013). Furthermore, CSF2 had no direct effect on the incidence of PTSD, depression, or anxiety. The Army noted that “resilience training will likely result in only a slight reduction in the odds of a soldier experiencing one of these negative outcomes [PTSD, depression, or anxiety] as a result of the training.” Furthermore, in an internal non-peer-reviewed report of the effect of Master Resiliency Training on five mental health diagnoses (including PTSD), no differences were found in the rates of diagnoses of mental health, after controlling for deployment, between those who received Master Resilience Training and those who did not (Harms et al., 2013).

A recent IOM study of DoD programs to prevent mental health disorders was also critical of the CSF2 program. The study found that although some statistically significant improvement was seen in a few global assessment tool subscales that are part of CSF2, the effect sizes were very small, and there were no clinically meaningful differences between pretest and posttest scores (IOM, 2014). Moreover, the study concluded that the shortcomings in DoD’s use of evidence-based practices for its prevention and resilience programs could have adverse effects on the mental health and well-being of service members and their families. It was recommended that DoD use only evidence-based programs and policies and eliminate

non-evidence-based programming. The committee believes that this recommendation could be expanded to include all PTSD screening, diagnosis, treatment, and rehabilitation programs in DoD.

The Navy, Marine Corps, and Air Force have also established service-specific stress control programs for all their members (see Chapter 3). But as with the Army CSF2 program, there is a lack of data with which to assess their effectiveness in fostering resilience and preventing mental health problems.

Delivery of Effective Care

DoD helps to ensure that its PTSD interventions are effective and safe by training providers in evidence-based psychotherapies (see Chapter 6). The Army recommends that its mental health providers use the VA/DoD clinical practice guideline and other evidence-based assessment tools (OTSG/ MEDCOM Policy Memo 12-035, April 10, 2012). The Navy has begun to assess compliance with the guideline on a quarterly basis, but results are not available (U.S. Navy, 2013).

One study of the use of evidence-based psychotherapy for PTSD by trained DoD staff was identified. Borah et al. (2013) found that 25% of Air Force providers trained in PE or CPT had not seen a single PTSD patient since training; 80% of those who saw at least one PTSD patient had used CPT at least once, and 70% of those trained in PE had used it at least once. Barriers to applying the training included lack of time to deliver it as required and lack of posttraining supervision.

At site visits, the primary reason given for lack of treatment fidelity among DoD mental health care providers in outpatient clinics was staff shortages. Although DoD providers are able to schedule a service member for an initial consultation within the required number of days (Pritt, 2013), follow-up appointments might be available only every 4–6 weeks thereafter rather than the recommended 1–2 weeks. To reduce the scheduling delays, service members may be given an appointment with any provider who has an opening, rather than a preferred provider, potentially resulting in treatment continuity issues.

DoD intensive outpatient programs for PTSD deliver treatments in a variety of modalities and settings. For example, the Warrior Resilience Center at Fort Bliss, the Warrior Combat Stress Reset Program at Fort Hood, and the National Intrepid Center of Excellence at the Walter Reed National Military Medical Center differ in length, patient needs and characteristics, and use of adjunctive therapies. To make the PTSD intensive outpatient programs more consistent throughout the service branches and to encourage the use of standardized assessment tools and treatment outcome measures, TrIOPS has formed a network of 21 specialized PTSD

programs (intensive outpatient, partial hospitalization or day treatment, and residential). TrIOPS intends to serve as a central source to facilitate communication, collaboration, process improvement, and dissemination of best practices, standards of care, and program effectiveness among DoD specialized PTSD programs (O’Toole, 2012). This effort to coordinate delivery of specialized PTSD programs is commendable, but there is no information on whether the TrIOPS effort has resulted in more consistent and effective care throughout these programs.

DEPARTMENT OF VETERANS AFFAIRS

This section examines VA’s use of evidence-based and other interventions for PTSD and how the interventions are delivered to veterans. VA achievements and challenges in providing effective and safe interventions for the prevention and diagnosis of and treatment for PTSD in veterans of all eras are also considered. Effective care for veterans is discussed with a focus on evidence-based treatments and complementary and alternative therapies.

Determining Effective Care

VA seeks to provide all veterans who have mental health conditions access to effective, evidence-based practices as clinically appropriate, and to ensure the availability of sufficient staff to provide the treatments with fidelity to their manuals. Its guiding documents encourage the use of evidence-based care for PTSD: the VA/DoD Clinical Practice Guideline for Management of Post-Traumatic Stress (VA/DoD, 2010), and Handbook 1160.05, Local Implementation of Evidence-Based Psychotherapies for Mental and Behavioral Health Conditions. Handbook 1160.05 governs VA mental health care and specifies the goals of and procedures for evidence-based psychotherapies (but not pharmacotherapy) at the local level (VA, 2012a). It covers access and capacity requirements, clinic and scheduling needs, treatment planning and clinical implementation, and training needs (OMHO, 2013b). VA Handbook 1160.01, Uniform Mental Health Services in VA Medical Centers and Clinics, requires that all PTSD specialty programs and services be able to meet the treatment needs of veterans who have co-occurring PTSD and substance use disorder (VA, 2008).

Evidence-Based Treatment

To address the challenges of delivering evidence-based psychotherapy, VA facilities are required to provide all veterans who have PTSD access to PE or CPT (VA, 2008). Individual VA medical centers and very large

community-based outpatient clinics (CBOCs)—those servicing more than 10,000 unique veterans each year—must provide adequate staff to deliver evidence-based psychotherapy when it is clinically indicated. Large and middle-size CBOCs may provide PE and CPT through telehealth when necessary (VA, 2008). Eftekhari et al. (2013) evaluated 1,931 veterans who had PTSD and were treated by 804 VA clinicians who had completed a 4-day experimental training workshop for PE. After PE treatment, the fraction of veterans who met the criteria for PTSD on the basis of PTSD Checklist (PCL) scores decreased from 87.6% to 46.2%.

The 39 specialized intensive PTSD programs (SIPPs) in the VA vary with regard to size, the population served, and program goals and methods. In 2012, an average of 45% of veterans admitted to the SIPPs received CPT (range, 15–76%), 8% received PE (range, 0–67%), 72% received another type of psychotherapy (range, 47–83%), and 72% received other unspecified therapies (range, 46–83%) (VA, 2012b). Veterans in the SIPPs do not have substantially improved outcomes on the basis of mean preadmission and 4-month follow-up scores on the Mississippi short form (38 vs 38.6), the Northeast Program Evaluation Center PTSD scale (17.1 vs 15.6), or the PCL (65.9 vs 60.2) (VA, 2012b). Why the programs had such poor outcomes is unknown; however, this lack of effectiveness for SIPPs is not new. Fontana and Rosenheck (1997) compared outcomes for long-stay SIPPs with short-stay specialized evaluation and brief treatment PTSD units and with nonspecialized general psychiatric units for 1 year after discharge. They found that veterans in all three programs showed improvement at the time of discharge, but these improvements disappeared over the follow-up period, especially among veterans who had participated in the long-stay programs. Long-stay programs cost $18,000 more per patient per year but were no more effective than short-stay intensive PTSD programs. It is unclear why, after more than 15 years of poorly sustained outcomes and high costs, the VA has not used these findings on the SIPPs to improve care for veterans who are being treated for PTSD.

In 2012, VA also had 436 PTSD specialist sites in medical centers, CBOCs, and outpatient clinics and 127 specialized PTSD outpatient programs (SOPPs) around the country. In contrast with the SIPPs, VA collects PCL scores only at intake for veterans in the SOPPs; no after-treatment PCLs are collected (VA, 2012b). Lack of treatment outcome data (as discussed in Chapter 4) contributes to the committee’s (and VA’s) inability to assess the effectiveness of treatment that veterans receive in the SOPPs or from PTSD specialists.

Bernardy et al. (2012) found that 81–84% of all veterans who had a diagnosis of PTSD in VA in 1999–2009 received at least one psychotropic medication. In particular, the use of first-line SSRIs or SNRIs rose from 50% in 1999 to about 59% in 2009. The use of low-dose quetiapine and

nonbenzodiazepines increased by 9.7% and 9.1%, respectively, over the years, whereas use of tricyclic antidepressants (about 10%), nefazodone (about 11.7%), and benzodiazepines (about 6.7%) decreased. Moreover, the decline in benzodiazepine use was offset by increase in use (from 4% in 2007 to 13% in 2009) of closely related nonbenzodiazepine hypnotics, primarily the gamma-aminobutyric acid agonist drug zolpidem once it became a VA formulary-approved drug in 2008. In a 2012, 52% of veterans in SIPPs received some form of pharmacotherapy (range, 21–76%) (VA, 2012b). Garfield et al. (2011) found that of VA patients who had comorbid depression and PTSD, 25% received no antidepressant pharmacotherapy, 25% received some pharmacotherapy, and 50% received adequate antidepressant treatment.

Vet Centers are not subject to the same care requirements as are VA medical centers or CBOCs. They do not have to make PE or CPT treatments available to all veterans who use their services, although many of them are able to do so (Fisher, 2014). In a survey of 27 Vet Centers, 21 provided one or more forms of evidence-based therapy (VA Office of Inspector General, 2011).

Complementary and Alternative Therapies

Similar to military personnel, many veterans use complementary and alternative treatments for PTSD. Cohen et al. (2013) surveyed 683 veterans about their use of different therapies for PTSD; of the 292 veterans who reported using any therapy for PTSD, 24% used a complementary or alternative modality—generally meditation, yoga, or acupuncture—and 61% used a complementary or alternative therapy in conjunction with conventional treatments, such as psychotherapy or pharmacotherapy. One study found that the use of complementary and alternative therapies among veterans is comparable to their use by the general public (Micek et al., 2007). Other surveys not specific to PTSD have found that nearly three-quarters of veterans who do not use complementary and alternative therapies would do so if they were offered at VA, and 40% of complementary and alternative medicine users would use additional ones if they were provided (Campbell et al., 2006; McEachrane-Gross et al., 2006).

Many VA specialized PTSD treatment programs incorporate such complementary and alternative therapies as guided imagery, progressive muscle relaxation, and stress management–relaxation therapy, but there is considerable variability in what is offered in any particular program. In a survey of 125 of the specialized programs (outpatient, residential, and inpatient), 120 of them reported offering at least one complementary or alternative therapy (Libby et al., 2012). An average of 75% of patients who were admitted to SIPPs received an unspecified therapy that was not PE, CPT, another form

of psychotherapy, or pharmacology (VA, 2012b). Among the 166 SIPPs and SOPPs, 77 (46%) offered complementary and alternative treatments in the program, and some programs made referrals for these therapies to external providers (VA, 2012b). For example, at Roseburg Health Care System a recreational therapist coordinates many of the complementary and alternative therapies offered through the residential PTSD program, including origami, tai chi, and community outings. Other VA sites, such as the Palo Alto Health Care System have or partner with programs in which veterans who have PTSD train service dogs for other veterans.

Delivery of Effective PTSD Care

Delivery of effective interventions for PTSD requires that providers be able to schedule appointments for evidence-based treatments for the recommended length of time and frequency (for example, PE requires 90-minute sessions, preferably at least once a week for 8–15 weeks). The 2012 VA Office of Mental Health Operations (OMHO) survey of 140 medical facilities found that 31% of VA medical centers reported that they had difficulty in scheduling evidence-based psychotherapy with fidelity, and 40% of the facilities reported that they needed to improve access to evidence-based treatments and reduce excessive wait times for those treatments. The ability of CBOCs to provide evidence-based psychotherapy was noted specifically as needing improvement at 36% of the sites. Large patient caseloads contributed to scheduling problems, as did pressure to keep appointments to 30 minutes, which is not in compliance with recommended session length for PE and CPT (OMHO, 2013a). Using automated coding of provider notes, Shiner et al. (2013) found that evidence-based psychotherapies were used less often than reported by administrative coding (6.6 sessions vs 9.1 sessions, respectively, over 6 months), and that only 6.3% of the veterans in the sample of outpatient PTSD clinics received at least one session of PE or CPT. Among 20,284 veterans who had PTSD, VA administrative data showed that only 64% received either medication or counseling for PTSD, and only 33% of the total sample received “minimally adequate treatment,” defined as receiving at least four 30-day supplies of psychiatric or antidepressant medications or at least eight counseling visits (Spoont et al., 2010).

A 2012 evaluation of nearly 300 VA staff who had received CPT training found a statistically significant number of them agreed that adherence to the CPT protocol increased patient satisfaction with therapy, improved patient outcomes, was effective for most patients visiting outpatient PTSD clinics, and did not increase therapist burnout. The two most frequently reported reasons for not starting CPT with more patients were “having

no or little room in their schedule” and “workload is too heavy” (Chard et al., 2012).

It may be easier to provide evidence-based psychotherapy in residential settings because there is usually sufficient time to deliver them during the veterans’ stay. In 2012, the average length of stay in a SIPP was 46 days (range, 4–221 days) (VA, 2012b). However, it might not always be possible to continue weekly outpatient therapy sessions once patients leave the residential program. About 79% of veterans who leave a SIPP receive some form of aftercare or are referred to another treatment program (VA, 2012b). Such transitions from inpatient care to outpatient care were cited as concerns in the OMHO report. Only 24% of facilities met the performance measure for timely follow-up of patients after discharge from inpatient or residential programs. The most common reasons for the delays were lack of established policies to assist with the transition, difficulties in scheduling follow-up appointments, and locating appropriate follow-up services in other VA facilities or in the community (OMHO, 2013a).

VA is increasing its use of telehealth to improve delivery of evidence-based treatment to veterans who have PTSD and live in underserved areas. Some 30% of CBOCs reported having telehealth services for mental health available (OMHO, 2013a). Telehealth can help providers to deliver evidence-based psychotherapy and pharmacotherapy to veterans in facilities that lack appropriate staff or whose staff do not have enough time to deliver weekly psychotherapy sessions.

PATIENT SAFETY IN DOD AND VA

Patient safety is often neglected by health care practitioners and organizations. Although patient safety usually refers to the recognition and reporting of adverse effects that occur most commonly in connection with drug therapy and physically invasive procedures, they are also important in connection with other interventions, including psychotherapy. Harm can occur from prescribed pharmacotherapies and from the use of nonprescription products (dietary supplements, alcohol, and over-the-counter medications) and from exacerbation of existing symptoms during psychotherapy. The VA/DoD guideline for PTSD recommends that patients be assessed for safety, including assessment of the risk of harm to self and others (VA/ DoD, 2010).

Patient Monitoring

Frequent and routine monitoring of patients for possible adverse effects of pharmacotherapy or psychotherapy is imperative to ensure safety. Mechanisms to monitor both patients and providers can be built into health care systems (IOM, 2000). Interdisciplinary team-based care and

cross-checks—such as checklists, chart reminders, and record reviews—can substantially enhance patient safety (IOM/NAE, 2013). Monitoring needs to occur at key stages of treatment—for example, at treatment initiation, shortly after initiation, periodically thereafter, and when treatments are changed—or when a patient is in crisis. Patients who are not monitored adequately may discontinue care and those that abruptly or prematurely cease the use of PTSD medications because of side effects or lack of response may have withdrawal symptoms or other complications that pose safety risks.

One safety issue that may be overlooked is the use of purchased care providers to treat service members or veterans who have PTSD. Because those providers do not have access to a service members’ or veterans’ electronic health records, they may not be aware of all medications (prescribed, over-the-counter, and supplements) that patients are taking. This lack of information increases the potential for drug interactions or adverse effects if additional medications are prescribed. Obtaining a complete treatment history, including the use of all interventions, whether evidence-based, over-the-counter, complementary and alternative, or psychoeducation, can improve patient safety.

Contraindicated Medications

Of particular concern for patients who have PTSD is the use of antipsychotics and benzodiazepines for its treatment as these medications can have serious adverse effects. The VA/DoD guideline advises against their use for PTSD because of a lack of efficacy data, and DoD and VA are working to decrease the prescribing of these medications for service members and veterans who have PTSD. In February 2012, DoD issued Guidance for Providers Prescribing Atypical Antipsychotic Medication, which cautions that these drugs are not approved as treatments for PTSD or sleep disturbances and recommends monitoring of and provider training in their use. In April 2012, the Army issued Policy Guidance on the Assessment and Treatment of Post-Traumatic Stress Disorder (U.S. Army, 2012b), which specifies that the use of benzodiazepines and atypical antipsychotics to treat for combat-related PTSD is contraindicated and strongly discourages their use. Data are not yet available to determine the effects of these guidance documents on the use of these medications in DoD.

A review of almost 357,000 veterans who had PTSD found that 25.6% of veterans were prescribed second-generation antipsychotics and 80.2% of those prescriptions were from mental health care providers, and 37.0% of the veterans were prescribed benzodiazepines and 68.8% of the prescriptions were from mental health care providers (Abrams et al., 2013). This study indicates that veterans who have PTSD are frequently prescribed medications that are not recommended by the VA/DoD guideline, and the

majority of these prescriptions come from mental health care providers who should be knowledgeable about the recommended medications for PTSD. VA has introduced a tracking system to monitor the use of benzodiazepines and antipsychotics in patients who have PTSD, as part of a system-wide effort to increase treatment safety. It is unclear what actions will result from this monitoring, but this is an important step in promoting a critical and careful approach to pharmacotherapy in veterans who have PTSD. A study of 32 VA medical centers found that the recommended metabolic monitoring of patients beginning antipsychotic use was inconsistent, depended somewhat on a patient’s diagnosis, and was below national standards (Mittal et al., 2013). With use of antipsychotics to treat for resistant depression and anxiety, the detection and management of metabolic side effects remains important.

Polypharmacy

Polypharmacy (the use of multiple drugs for a health condition) and overmedication should not be confused in prescribing medications for service members and veterans who have PTSD. Prescribing multiple medications or polypharmacy in itself does not necessarily prompt a safety concern; instead it is the manner in which medications are prescribed (for example, one provider or multiple providers) and the level of oversight (such as regular follow-up appointments and appointments with the same provider) that need attention. Polypharmacy is a valid concern in that the risk of untoward effects is expected to increase with the number of concomitant drugs. The use of multiple drugs may be warranted and is more likely to be encountered in veterans than in the active-duty military population for a number of reasons, including a higher degree of chronicity and accumulation of comorbid disorders over a veteran’s lifespan, and there are fewer restrictions on the types of medications that may be used with veterans than with active-duty service members.

DoD has recognized that the concomitant use of multiple medications can be a safety issue for service members who take multiple drugs for their PTSD and for any comorbidities, such as substance use disorder and chronic pain (Defense Health Board, 2011; U.S. Army, 2012a). DoD data show that from 2004 to 2013 there was a steady increase in the number of concurrent drugs prescribed to patients who had a primary diagnosis of PTSD, including the use of multiple psychotropic drugs (see Table 7-1). For active-duty service members, medications that impair alertness or reaction time may compromise fitness for duty.

VA data show that from 2008 to 2012 for newly diagnosed veterans who have PTSD, the use of multiple medications has decreased. The number of veterans who are receiving no medications has increased substantially

TABLE 7-1 Percentage of Service Members with a Primary Diagnosis of PTSD Receiving Psychotropic Medications

SOURCE: Kennell and Associates, 2013.

TABLE 7-2 Percentage of Newly Diagnosed Veterans Receiving Medications for PTSD

SOURCE: NEPEC, 2013.

and the number receiving only one medication has increased slightly (see Table 7-2) (NEPEC, 2013).

SUMMARY

The VA/DoD Clinical Practice Guideline for Management of Post-Traumatic Stress reflects the evidence base (and safety concerns) for first-line psychotherapies and pharmacotherapies used to treat for PTSD—PE, CPT, EMDR, stress inoculation training, SSRIs, and SNRIs—and adherence to it can help ensure effective treatment of service members and veterans. The guideline also assesses other therapies with less robust evidence bases such as complementary and alternative therapies, couple therapy, and group versus individual therapies. Frequent and consistent monitoring of patients’ PTSD symptoms, comorbidities, and outcomes is important to determining the effectiveness and safety of a treatment.

DoD attempts to ensure the delivery of effective care for PTSD by recommending that all mental health care providers use the VA/DoD guideline. Some evidence-based psychotherapies also have manuals that indicate the length and frequency of treatment sessions. Adherence to the guideline and treatment manuals by DoD providers is not tracked, but studies indicate that many service members do not receive adequate evidence-based treatment for their PTSD. The primary reason given for not adhering to the

PTSD guideline or treatment manuals is a lack of time to schedule appointments at the recommended frequency and duration. Complementary and alternative therapies are used as adjunct treatments for PTSD symptoms in some specialized PTSD programs and by individual service members. However, as with first-line treatments, the use of these therapies and their effectiveness are not tracked or evaluated. Each service branch has developed a resilience and combat and operational stress control program for preventing mental health problems in service members, but the effectiveness of these programs has not been determined.

VA strives to provide effective and safe care for PTSD through the use of the Uniform Mental Health Services in VA Medical Centers and Clinics handbook and the VA/DoD clinical practice guideline. As with DoD, VA does not track adherence to either the guideline or the handbook, and the psychotherapy a veteran receives is not recorded in the electronic health record; pharmacotherapy is captured in the record. Studies indicate that many veterans do not receive evidence-based treatments in the recommended manner. Long wait times for and between appointments can reduce the effectiveness of any of the treatments. More specialized treatment for PTSD is given in the VA SOPPs and SIPPs. Data from 2012 indicate that most veterans in SIPPs had little or no improvement in their PCL scores at 4 months after treatment, although the reasons for this lack of improvement are not known. Comparable outcome data are not available for other treatment settings such as SOPPs or general mental health clinics. Some Vet Centers offer evidence-based treatment for PTSD, but again, there is a lack of data on how many veterans receive such care and whether it is effective.

Most service members and veterans who have PTSD receive some form of pharmacotherapy, in some cases multiple prescriptions. As the number of patients receiving multiple medications continues to grow, so do safety concerns about drug interactions and the use of contraindicated medications. DoD does not have a system in place to monitor these safety issues, but VA has recently implemented a system to monitor the use of antipsychotics and benzodiazepines.

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