Project Remission: Maximizing Outcomes with Intensive Treatments for Combat-Related PTSD

Dec 22, 2017

This study by the Consortium to Alleviate PTSD aims to maximize improvements and, if possible, treat patients with combat-related PTSD into remission so they can return to full fitness for military duty or successfully integrate into civilian life.

The need for tailored, intensive treatment programs

Effective treatment of combat-related PTSD requires tailored and enhanced approaches that work quickly in getting PTSD into remission. The leading exposure therapies, in which patients confront traumatic memories and environmental triggers rather than avoid them, show 80 percent success rates with civilian victims of assault, accidents, and similar traumas. But the rate of remission with service members and veterans has been lower and often is less than 50 percent of those studied.

Reasons for the lower success rate with combat PTSD include the fact that service members in combat zones are more likely to experience multiple types of trauma and repeated exposure to trauma. That may require extra time and attention to address multiple, varied traumatic memories and more trauma-related issues. Also, military culture may increase concerns about the stigma of mental health care, perhaps making service members reluctant to seek treatment in the first place, while work schedules may interfere with patients’ ability to complete treatment.

How the CAP IOP study works

With those challenges in mind, Alan Peterson, PhD, of The University of Texas Health Science Center at San Antonio and the South Texas Veterans Health Care System leads a study for the Consortium to Alleviate PTSD to evaluate two versions of intensive outpatient treatment programs for military service members and veterans with PTSD. Patients involved in this study will participate in a three-week, fulltime treatment program at a designated treatment center. The aim with this approach is to both maximize improvements and streamline the treatment length.

The study will compare two intensive, enhanced forms of Prolonged Exposure (PE), the PTSD treatment with the most scientific support for efficacy with civilians.

Rather than the traditional PE treatment of 10 therapy sessions delivered over a period of three to four months, participants will receive more sessions in a shorter time period, three weeks. They will be randomly placed into one of two treatment arms with different levels of therapy enhancement:

  • Massed-PE format, with 15 daily sessions over three weeks, or
  • Intensive Outpatient PE (IOP-PE) format, also with 15 daily sessions over three weeks, but with additional enhancements to better tailor the treatment to those with combat-related PTSD or otherwise help improve treatment outcomes.

The researchers hypothesize that both formats will result in improved outcomes over standard PE delivery and that IOP-PE will provide maximum benefit. Participants in this randomized clinical trial will include 100 active duty military service members recruited worldwide and 100 veterans, treated at military and Department of Veterans Affairs sites in South and Central Texas.

Potential benefits

If the intensive outpatient format is found to be highly effective at reducing PTSD symptoms, it will offer the military and VA a valuable option that would increase access to care, boost patient retention, and improve treatment outcomes. It also could enable creation of specialized PTSD treatment centers to which service members could travel from around the world for short-term, state-of-the-art care. This would make it possible for more service members to stay on active duty and for veterans to reintegrate more quickly into civilian life, potentially saving the nation millions of dollars in long-term disability payments to veterans.

Ketamine for Antidepressant-Resistant PTSD

Jan 23, 2017

Although hundreds of thousands of active duty military personnel and veterans suffer from posttraumatic stress disorder, there are only two U.S. Food and Drug Administration-approved medications for treating PTSD. Both of those medications are a type of drug called monoaminergic antidepressants. Unfortunately, approximately 45 percent of PTSD patients do not improve from treatment with antidepressants. Many of those who do respond to antidepressants only show a partial improvement and continue to suffer from significant PTSD symptoms.

Mounting evidence indicates that the anesthetic ketamine produces a rapid and potent improvement in up to 90 percent of patients with severe antidepressant-resistant depression. Pilot evidence and case reports also indicate that ketamine may be effective for treating PTSD, but it has not been tested in active duty military personnel or veterans.

To further understanding of this potential treatment, principal investigator John Krystal, MD, of Yale University School of Medicine has developed a study for the Consortium to Alleviate PTSD. Dr. Krystal and his team of investigators will examine the safety and effectiveness of ketamine in active duty military personnel and veterans with antidepressant-resistant PTSD.

The study also will evaluate:

  • Whether treatment benefits may be extended safely through repeated dosing,
  • Whether different dosage levels affect treatment, and
  • How long the benefit of treatment lasts for those who respond to ketamine treatment.

Dr. Krystal and his research team seek to determine in this multi-site, double-blind clinical trial whether ketamine produces a rapid and sustained reduction in PTSD and depression symptoms, as compared to placebo.

Investigators will conduct the study at the Clinical Neurosciences Division of the U.S. Department of Veterans Affairs’ National Center for PTSD at the VA Medical Center in West Haven, Conn.; at the Minneapolis VA Health Care System; and at the U.S. Army’s San Antonio Military Medical Center. They will randomly place nearly 200 study participants into one of three treatment conditions, consisting of either one of two dosage levels of ketamine administered intravenously or a placebo. After the dosage period ends, investigators will follow up with the study participants for four weeks. All study participants who do not experience significant clinical improvement in PTSD symptoms at the end of the 4-week trial will be given the option of receiving a single dose of ketamine.

The number of participants makes this the largest known clinical trial of ketamine in any population.

Expected benefits

Because many PTSD sufferers do not respond to treatment with antidepressants, other treatment options are needed. If successful, this study will provide valuable data on the potential of ketamine to help antidepressant-resistant PTSD patients.

Investigators also believe that it is the first test of the therapeutic effects of ketamine in the veteran and active duty military population, as well as the first placebo-controlled, multi-site trial to determine the dose-related effects of repeated ketamine on PTSD. That will yield valuable information on the efficacy of a drug that could bring relief to help active duty personnel to resume their military careers, and to help veterans transition to civilian lives without PTSD.

Brief Cognitive Behavioral Treatment of Deployment-Related PTSD in Primary Care Settings: A Randomized Controlled Trial

Mar 18, 2015

Just as the nature of their jobs makes active-duty military personnel more likely to experience trauma and associated posttraumatic stress, it also can make them less likely to seek the help they need to cope with that stress and heal from its effects. Fearing a stigma associated with seeking mental health treatment, members of the military may face concerns that they will be viewed negatively by their peers or that their supervisors will consider them unfit for continued duty or for a desired promotion. They might also be unable to set aside the amount of time required for the treatment programs currently available through mental health clinics.

The two evidence-based therapies with the most empirical support for their efficacy in treating PTSD – Prolonged Exposure (PE) and Cognitive Processing Therapy (CPT) – were both developed for use in specialty mental health clinics, and both are typically delivered in weekly 90-minute individual sessions over a 10- to 12-week period. This model of care may not be feasible for an active-duty member of the military who is working long hours in a job that provides limited opportunity to commit extended time to medical appointments; it also might be a deterrent to someone who wishes to be discreet about seeking mental health treatment. Thus, time-intensive psychotherapy delivered in a traditional mental health setting might not reach a significant portion of military members in need of assistance.

Increasing accessibility to PTSD treatment

In an effort to overcome the barriers faced by military personnel who need mental health care for PTSD, Lt Col Jeffrey Cigrang, PhD, at Wright-Patterson Air Force Base, Ohio, has developed a novel study for STRONG STAR. This study is testing the feasibility, safety and efficacy of providing psychotherapy treatment within the primary care setting, which may prove to be a more favorable environment both in terms of acceptability and reach to military members for a variety of reasons.

For one, the military services have already developed and implemented post-deployment health surveys that screen for PTSD using the primary care clinic. Also, in recent years, behavioral health consultants (BHCs) have been integrated into primary care clinics both in military and civilian settings. These developments increase opportunities to identify PTSD early on and to intervene before symptoms or conditions become chronic. Dr. Cigrang believes that early interventions with less symptomatic patients may allow for evidence-based treatments for PTSD to be adapted to fit within the time constraints of primary care clinics and still obtain clinically significant effects. In addition, he believes this type of care will be better utilized by men and women in uniform, because anecdotal evidence indicates that military personnel feel less stigmatized when accessing mental health services in primary care.

For this study, Dr. Cigrang has developed and is evaluating a brief cognitive-behavioral therapy (CBT) protocol for treating PTSD that can be implemented by mental health providers working in an integrated primary care setting. The protocol includes intervention methods from both Prolonged Exposure and Cognitive Processing Therapy that have proven effective in the mental health setting, but these methods have been adapted for use in the time-constrained environment of primary care. For example, rather than being treated in 60- or 90-minute sessions, patients are scheduled for 30-minute appointments.

Pilot Study

The study investigators initiated a pilot study to examine feasibility of the experimental CBT protocol and initial effectiveness with OIF/OEF veterans. The pilot study measured within subject changes in a series of clinical cases which allowed the investigators to evaluate the general effectiveness of this treatment approach when used in clinical practice in military primary care settings.

Pilot study findings showed that the primary care treatment reduced symptoms of PTSD and depression, and overall mental health functioning improved. Cigrang 2011

Study aims

This investigation will be used to determine:

  • whether Operation Iraqi Freedom/Operation Enduring Freedom/Operation New Dawn veterans with PTSD will accept an offer of CBT treatment in the primary care setting;
  • if this type of brief CBT protocol will significantly reduce patients’ PTSD symptoms in comparison to a minimal contact condition, and if the degree of improvement compares favorably with that seen by patients who receive care in specialty mental health settings; and
  • whether there are characteristics of patients at pretreatment that predict how well they will respond to PTSD treatment in primary care.

Ultimately, the investigators hope to deliver another very effective means of fighting the battle against PTSD being waged by a significant portion of active-duty and veteran military personnel.

Individual PE vs. Couples’ Cognitive-Behavioral Therapy for Combat-Related PTSD

Aug 18, 2010

The military family plays a much more complex role in a soldier’s life than simply “keeping the home fires burning.” In fact, family members play a significant role in how service members adjust in the aftermath of their combat experiences. Studies of veterans from previous wars have found that the presence of adequate social support following combat is one of the strongest predictors of successful adjustment, and the absence of such support is associated with the persistence of posttraumatic stress disorder (PTSD). Families often represent the chief source of support, so developing programs to assist military families in adjusting to deployment and providing support to the returning combatant is vital.

Unfortunately, the individuals most in need of family support may be least able to obtain it. Symptoms of PTSD, such as emotional numbing, irritability, and anhedonia, or the inability to experience pleasure in normally pleasurable acts, can push loved ones away and cause relationships to deteriorate. Studies reveal that both veterans and their partners report significant marital and family problems associated with veterans’ PTSD symptoms, including lower relationship satisfaction, less cohesive relationships, less emotional expression and intimacy in their relationships, and more conflict in the relationships. Studies also have found elevated levels of anger, hostility, conflict, and violence in the families of veterans with PTSD.

The interdependence of individual and family adjustment can lead to a negatively spiraling process. As individual distress and PTSD symptoms worsen, family difficulties are likely to increase, and as family difficulties increase, so does stress upon the individual. But this process does not have to be only negative; it also can work in a positive direction. When families are able to provide a safe, stable environment for the returning service members, they can help to promote a more positive adjustment process, and when service members are able to reach out and reconnect with family members, it can strengthen the family structure.

Getting the family to help with treatment, and treatment to help the family

Several treatments have been proposed or developed to address the needs of families following trauma. Some focus on relieving family distress rather than focusing on a particular individual’s PTSD symptoms. Alternatively, other programs focus on the role of the partner and family members in helping the trauma survivor to recover from the symptoms arising from the trauma. These approaches are not mutually exclusive, and one recently developed program, Cognitive-Behavioral Couples Therapy (CBCT) for PTSD, includes techniques designed both to treat PTSD and to reduce relationship distress. This program has shown promising results in small, uncontrolled studies of combat veterans with chronic PTSD.

Now, under the direction of Candice Monson, PhD, of Canada’s Ryerson University, the STRONG STAR Consortium has designed a study to examine the efficacy of this treatment in a sample of active-duty military personnel who have recently returned from combat deployments. This randomized clinical trial compares traditional Prolonged Exposure therapy, which involves only the individual service member, to CBCT, which includes the service member’s partner. It also includes behavioral communication skills training in addition to psychoeducation and cognitive interventions based on Cognitive Processing Therapy. Because the CBCT protocol addresses both individual and couple-level distress, Dr. Monson expects to see greater improvement in couple functioning with this treatment as she explores the role that military spouses can play in PTSD treatment and recovery.

Treatment of Chronic Stress Reaction and Chronic Pain after Traumatic Orthopedic Injury

Aug 18, 2010

Chronic pain after a traumatic orthopedic injury and posttraumatic stress disorder (PTSD) are each major concerns for the U.S. military in their own right. Both conditions have a direct impact on military readiness and are leading causes of medical discharges from active duty, as well as long-term VA disability, according to a 2006 report by the U.S. Department of Defense and the U.S. Department of Veterans Affairs. When these conditions become chronic, they can lead to a lifetime of pain and suffering for veterans and potentially contribute to an array of socioeconomic difficulties. In financial terms, the costs associated with the treatment of these conditions exceed hundreds of billions of dollars annually.

As different as these two conditions are, they are not necessarily separate problems that can be addressed in isolation from each other, because they frequently come together in one “unwanted package,” and each adversely affects the other. An increasing body of evidence from civilian studies suggests that individuals who experience physical trauma are likely to experience symptoms of significant psychosocial distress as well. In fact, one specific study published by A.J. Starr and colleagues in 2004 identified over half of a civilian sample of orthopedic trauma patients who met criteria for PTSD after their injury. To date, these studies have not been replicated in a military population, but it is suspected that the rates of comorbid orthopedic trauma and PTSD would be similar to those found in civilians, if not higher. The problem is not just that physical trauma can lead to the development of PTSD. Studies have also shown that PTSD affects patients’ reports of physical complaints, and PTSD is among the variables that are most predictive of functional outcome following injury.

Making matters worse, recent research by M.J. Bosse and colleagues suggests that individuals experiencing comorbid chronic pain and traumatic stress may respond poorly to treatment targeting only one diagnosis, contributing to the chronicity and severity of both PTSD and pain. On the positive side, data from other studies suggest that early interventions for orthopedic trauma pain and related traumatic stress can be effective in preventing chronic pain or PTSD syndromes.

The potential of cognitive therapy in treating both PTSD and pain: A STRONG STAR investigation

Robert Gatchel, PhD, of The University of Texas at Arlington hopes to build on these positive findings through a novel study he has designed for STRONG STAR to examine the effects of combining preventive pain and PTSD treatments for trauma patients. As part of their investigation, Dr. Gatchel and his co-investigators will identify the comorbidity of orthopedic trauma and traumatic stress in an active-duty military population, and they will evaluate a preventive behavioral health treatment strategy aimed at helping to retard or halt the development of PTSD and/or chronic pain syndromes. The study will examine the efficacy of multiple treatment options, utilizing a four-group randomized experimental design to measure the effects of cognitive behavioral therapies targeting pain treatment only, PTSD treatment only, and the treatment of both pain and PTSD compared to treatment as usual.

Evaluations of these four groups will be conducted at pretreatment, immediately at posttreatment, and at 6- and 12-month follow-up periods in order to determine differential outcomes on numerous variables. The investigators hypothesize that treating individuals with chronic pain and PTSD symptoms (e.g., lasting 12 weeks or more) through a proven psychosocial model will help to improve psychological, socioeconomic and physical symptoms of these chronic clinical syndromes. They further aim to demonstrate the efficacy of these early treatments in facilitating the return to active duty of military personnel living with pain and traumatic stress. Finally, they also expect to have a positive impact on other psychosocial and socioeconomic outcomes, such as work retention, additional health-care utilization, depression symptoms, health-related quality of life, and perceived disability.

The benefits of success

If Dr. Gatchel and his colleagues successfully demonstrate that integrating pain and PTSD treatments leads to improved outcomes for wounded warriors, the payoff will be substantial: affected military personnel could potentially enjoy a greatly improved quality of life; the U.S. Department of Defense could save billions of dollars in elevated treatment costs attributable to comorbid pain and PTSD; and thousands of civilian trauma patients could benefit from this improved treatment method.