Combining Esketamine and Prolonged Exposure for PTSD: A Proof-of-Concept Clinical Trial

Jul 12, 2025

Approximately 70% of Americans will experience a traumatic event in their lifetime, and 8% of those individuals will develop posttraumatic stress disorder. Rates of PTSD are even greater among military populations, at 14% or higher, making it one of the most common mental health conditions associated with military combat deployments.

Established, efficacious treatments exist—particularly trauma-focused, cognitive-behavioral therapies such as Prolonged Exposure and Cognitive Processing Therapy. However, there is room for improvement, especially with more-difficult-to-treat combat-related PTSD, for which recovery rates hover around 50%.

Given the prevalence, chronicity, and debilitating nature of PTSD, additional and more effective treatment options are critically needed. A growing area of interest is in combination therapy, in which an evidence-based psychotherapy is augmented with medication, potentially leading to greater symptom reduction and remission for more individuals.

Rationale for this novel approach

Ketamine, a medication commonly used for anesthesia, shows promise for this purpose. Pilot studies suggest it can improve outcomes when combined with trauma-focused therapy. Researchers believe this is due to ketamine’s enhancement of neuroplasticity, or brain flexibility, which supports therapeutic learning. However, all current PTSD trials with ketamine have administered it intravenously, which is costly, time intensive and requires a team of medical specialists.

In recent years, ketamine has been FDA approved in a more easily administered nasal spray form called esketamine, or Spravato®, for treatment-resistant depression.
With this advancement, STRONG STAR is conducting a novel pilot study led by Casey Straud, PsyD, ABPP, at The University of Texas Health Science Center at San Antonio, evaluating the use of esketamine with the massed format of Prolonged Exposure (PE) therapy for PTSD.

How the trial works

The trial is open to military personnel, veterans, and civilians with PTSD. Each weekday for 2 weeks, patients will meet with a therapist for a 90-minute PE session (10 sessions total), in which they recall and talk about their trauma. After the Monday, Wednesday and Friday sessions (6 times in all), they will be administered a dose of esketamine under professional supervision.

Since the medication enhances neuroplasticity for 48 to 72 hours after administration, researchers believe this schedule will keep patients in a state of maximum neuroplasticity throughout treatment. In turn, investigators expect patients’ heightened brain flexibility to better enable them to process their trauma and what they’ve learned in therapy in a more meaningful way.

Expected outcomes

Through this first study ever to combine esketamine with trauma-focused therapy for PTSD, researchers aim to provide proof of concept. They will examine the feasibility of this combination therapy, how well it is accepted and tolerated by patients, and its preliminary benefits. Is there a signal that this novel therapeutic combination leads to greater symptom reduction and occurrences of remission? If the pilot study is successful, researchers hope to use their findings to guide a full-scale, randomized clinical trial.

Augmenting Massed Cognitive Processing Therapy to Prevent Suicide Risk Among Patients With PTSD

Jan 27, 2025

With its rising rates over the past 20 years, suicide tragically has become one of the top two causes of death among U.S. service members. For military veterans, the risk of death by suicide is 1.5 times that of civilians, among whom suicide rates have risen by 30% since 1999, placing suicide in the top 10 causes of death in the United States.

This has made suicide prevention efforts a top priority for the Department of Defense. One intervention specifically identified as warranting further research is Crisis Response Planning, or CRP. In CRP, the patient and therapist sit down together and, in less than 30 minutes, develop a plan to help the patient identify when they are in crisis and how to effectively reduce their distress. The plan, which fits on a notecard they can keep in their pocket, identifies warning signs, self-regulatory strategies, reasons for living, sources of social support, and professional and crisis services.

CRP shows great potential to help save lives. Research has found that rapid reductions in suicidal thoughts during treatment are associated with reduced risk for suicide attempts. Relatedly, a randomized clinical trial (RCT) led by Craig Bryan, PsyD, ABPP, of The Ohio State University showed that acutely suicidal military personnel who received CRP showed significantly faster reductions in suicidal ideation (or suicidal thoughts) during the following month than those who received treatment as usual, and they were 76% less likely to attempt suicide. In further research, Dr. Bryan showed that CRP reduces suicidal thoughts within hours of the intervention.

Moving the research forward

These findings are highly encouraging and provide empirical support for CRP’s efficacy in reducing suicidal thoughts and behaviors. However, more studies are needed to confirm the effectiveness of CRP in different clinical settings and with different groups of military personnel. In this effort, Dr. Bryan is leading a STRONG STAR-affiliated RCT at Fort Hood in Central Texas to examine the impact of adding CRP to an evidence-based PTSD therapy for military personnel with PTSD and recent suicidal thoughts and/or behavior.

It is important to look at this population because PTSD is a signature wound of post-9/11 military conflicts and a significant risk factor for suicide. In fact, it is one of the few psychiatric conditions that distinguishes people who have attempted suicide from those who have only thought about it, suggesting that PTSD facilitates the transition from suicidal thought to action.

The trauma-focused PTSD treatment used in this study, Cognitive Processing Therapy (CPT), has been shown to produce large reductions in PTSD symptoms and in suicidal ideation. Dr. Bryan’s research also found that CPT’s effects on reducing suicidal ideation are accelerated when therapy sessions are delivered daily for two weeks (called “massed” CPT) versus the typical schedule of weekly sessions over several months.

Researchers believe that combining the two treatments could have a positive compounding effect, as some previous research suggests. In a pilot study of Dr. Bryan’s, adding CRP to CPT led to faster and larger reductions in suicidal ideation among military and veterans with PTSD as well as reductions in suicide attempts during follow-up. Research by the study team suggests that rapid reductions in suicidal ideation may also be important for PTSD recovery.

How the study works, and what investigators aim to determine

In this study, 150 military personnel with PTSD or subthreshold PTSD, meaning they have most but not all symptoms of PTSD, will be randomly assigned to one of two study arms: (1) massed CPT plus CRP or (2) massed CPT coupled with typical suicide risk management strategies, referred to as “usual care.”

Researchers will follow study participants for up to one year to assess for suicidal ideation and monitor for suicidal attempts. Analyses with these data will be used to address the primary aim of the study, which is to determine if adding CRP to CPT effectively reduces suicidal behavior.

During treatment, participants also will be asked to wear a Fitbit device and complete surveys on their smartphone multiple times per day to track their physical activity level, sleep quality, and mood in real-time. Researchers will analyze these data to identify early indicators of recovery or treatment nonresponse, which they will use to develop new guidelines to help clinicians decide if their patients are getting better or are at risk for attempting suicide during or after treatment.

Finally, researchers will conduct qualitative interviews with participants to collect their feedback about what they found to be the most – and least – useful parts of treatment. This information will provide clues for further improving and refining treatments to prevent suicide and promote recovery from PTSD.

The ultimate benefit is expected to be improved methods for preventing suicidal attempts and saving lives, for the benefit of our military service members and veterans and their families, with implications for suicide prevention in the larger global community.

Treatment of TBI-Related Tinnitus and Comorbid PTSD: Examination of Neurobiological Markers Related to Symptom Improvement

Jan 13, 2025

When you think of posttraumatic stress disorder and tinnitus, you might not think they have anything to do with each other. PTSD is a mental health condition that can develop after being part of or witnessing a traumatic event, while tinnitus is a phantom auditory perception—like ringing in the ears—without any objective noise source.

But in fact, they share a strong relationship. They often occur together, particularly after a mild traumatic brain injury (mTBI) or concussion. They cause similar psychological distress with many overlapping symptoms. They also appear to be associated with activity in similar neurobiological networks in the brain.

How do tinnitus and PTSD affect each other?

Like other physical and psychological health conditions, PTSD and tinnitus are often worse when they appear together, but their influence on each other is unclear. Does PTSD make tinnitus worse or more distressing? Does tinnitus exacerbate PTSD symptoms? Or do they have a mutual impact on each other?

There is some evidence that PTSD is the exacerbator, as research shows it impacts tinnitus more than any other potentially co-occurring psychological health condition such as depression. Results of a pilot study led by John Moring, PhD, APBB, at The University of Texas Health Science Center at San Antonio had the same implication. In individuals with PTSD and tinnitus, treatment with a cognitive-behavioral therapy for PTSD called Cognitive Processing Therapy not only led to reductions in PTSD symptoms but also made patients’ tinnitus less distressing.

Research study aims to investigate

Based on these findings, Dr. Moring and his STRONG STAR Consortium colleagues designed a randomized crossover clinical trial with three goals in mind:

Shed light on the direction of the relationship between PTSD and tinnitus;
Provide guidance for the field on the best sequence of therapeutic interventions (e.g., treat PTSD first or tinnitus first);
Identify neurobiological markers in the brain that can be used as neuromodulatory targets for brain stimulation treatments for PTSD and tinnitus.

How the study works

For this study, researchers will recruit 160 military service members and veterans in the San Antonio, Texas, area who have experienced mTBI and who have co-occurring tinnitus and PTSD. Half of study participants will receive Cognitive Processing Therapy (CPT), an evidence-based treatment for PTSD, followed by Progressive Tinnitus Management (PTM), an evidence-based audiology program that includes cognitive-behavioral therapy to help manage tinnitus distress and improve life function. The other half of participants will receive the same treatments but in the opposite order.

Participants in both arms will undergo symptom assessments before treatment begins, between treatment with CPT and PTM, and following completion of both treatments. In addition, 50 study participants will be randomized to receive resting-state functional magnetic resonance imaging (rs-fMRI) before treatment and after all treatment is completed, allowing researchers to identify biomarkers in the brain that correlate with symptom improvement.

Expected outcomes

Findings from this study will shed light on whether (1) it is clinically indicated to treat PTSD prior to TBI-related tinnitus; (2) it is clinically indicated to treat TBI-related tinnitus prior to PTSD; or (3) it is a bidirectional relationship, and either treatment will provide diffuse effects for both PTSD and bothersome tinnitus.

In this way, results are expected to guide clinical practice guidelines regarding the selection and sequence of treatment for those with comorbid TBI-related tinnitus and PTSD, resulting in more immediate relief for the individual. Meanwhile, the neurobiological examination of mechanisms of improvement could lead to the development of neuromodulatory therapies, such as transcranial magnetic stimulation (TMS), to target specific brain regions associated with both conditions.

This could greatly improve care for and the quality of life of the hundreds of thousands of service members and veterans affected by TBI, PTSD and tinnitus. Treatment advances also would extend more broadly to the general population, in which 740 million adults worldwide suffer from tinnitus.

Implementing and Evaluating a Patient-Centered PTSD Treatment Program for Military Personnel

Sep 25, 2024

The past 20 years of research, including by STRONG STAR, has yielded sufficient evidence for the efficacy of several therapies for posttraumatic stress disorder in military personnel. Similarly, success with different delivery formats – spread out over several weeks, condensed into one or two weeks, in-office, in-home, or via telehealth – has made evidence-based treatments more appealing and accessible to the military community.

Yet PTSD recovery rates are still not as high in military as compared to civilian populations, and there seems to be a reluctance among military personnel first to initiate and then to complete PTSD treatment. Some report that’s due to feeling like a particular treatment is not well-suited to them or their situation, while others have expressed frustration over a seeming lack of control over their treatment.

Empower patients, improve care?

If service members seeking PTSD treatment could be presented with more options and allowed to engage in informed, shared decision making about the treatment they receive, might that increase their likelihood of initiating, more fully engaging in, and completing treatment – and in the process lead to improved recovery rates and increased patient satisfaction?

Answering that question is the aim of a STRONG STAR study led by Initiating Principal Investigator (PI) Alan Peterson, PhD (Lt Col, USAF, Ret.), and Early Career Partnering PI Vanessa Jacoby, PhD, of The University of Texas Health Science Center at San Antonio.

How the study works

The study will involve active duty military personnel at Fort Hood and evaluate a shared-decision-making model of patient-centered healthcare that has been shown to maximize patient engagement and satisfaction. Military participants will be offered and receive thorough descriptions of a menu of evidence-based, cognitive-behavioral therapies to include Prolonged Exposure (PE), Cognitive Processing Therapy (CPT), and Written Exposure Therapy (WET). Options also will be provided on treatment frequency (condensed or spread out over several weeks), treatment modality (in the clinic or via telehealth), and length (number of sessions may vary by treatment type and/or patient response).

This two-step, partially randomized preference trial will then follow a process that allows patients with a strong preference to select their particular treatment and others to identify treatment arms to which they are willing to be randomized. Investigators will examine which patient characteristics and preferences lead to selection of and improved outcomes with different treatment options, with the goal of guiding future efforts in personalized medicine.

Expected benefit

Investigators also will compare these outcomes to prior randomized clinical trials with military personnel that did not involve shared decision making. They hypothesize that those who engage in shared decision making will (1) show higher rates of treatment completion and (2) have larger reductions in PTSD symptoms posttreatment.

If their hypotheses are correct, this model could be recommended to help improve PTSD care across the Military Health System for service members with a PTSD diagnosis who avoid treatment or who drop out prematurely.

Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) for mTBI: A Targeted, Randomized Controlled Trial

May 21, 2024

STRONG STAR Consortium investigators are taking a synergistic approach as they try to improve patient recovery after a mild traumatic brain injury (mTBI), or concussion. Their innovative combination of therapies aims to address both vestibular and psychological health issues that commonly co-occur, increasing functional impairment and prolonging recovery.

About 380,000 post-9/11 military service members have experienced a TBI, and 60% of those report problems related to the vestibular system, a sensory system in the inner ear that creates a sense of balance and spatial orientation. Problems can include dizziness, vertigo (feeling of spinning or floating), blurred vision, and gait and balance issues. Meanwhile, about a third of those with a TBI also report psychological health issues including anxiety, depression, and posttraumatic stress.

Researchers believe vestibular and psychological health problems share some underlying mechanisms and that, by targeting both in a timely way, they can achieve greater symptom reductions more quickly and better prevent these problems from becoming chronic or causing additional complications.

The approach

Led by Anthony Kontos, PhD, of the University of Pittsburgh, the STRONG STAR team will evaluate a four-week program called ACTIVE in a military population at the Intrepid Spirit Center at Fort Hood, Texas, and a civilian population at the University of Pittsburgh’s UPMC Sports Medicine Concussion Program.

As part of usual care, all participants will receive targeted vestibular rehabilitation, which involves exercises that reduce vestibular symptoms, impairment, and recovery time following mTBI.

The ACTIVE arm will receive the standard-of-care services plus a psychological health intervention called Acceptance and Commitment Therapy, or ACT. ACT is a talk therapy associated with long-lasting improvements in psychological health and functional outcomes by enhancing psychological flexibility. That is the ability to persist in or change behaviors to pursue one’s personal values and goals, even in the presence of unwanted thoughts, emotions, and physiological sensations.

ACT and targeted vestibular rehabilitation have been studied separately but never together. The research team believes that their combination in this study will provide synergistic effects that lead to a greater reduction in symptoms, impairment, and functional limitations and accelerate return to regular activity compared to usual care.

Measuring success, guiding future treatment

To provide more objective markers of vestibular function and treatment efficacy, this study will utilize the I-Portal Portable Assessment System (I-PAS). This tool was developed through the group’s previous research and provides an objective, portable, noninvasive assessment of changes in vestibular function that correspond with treatment efficacy.

As part of the study, researchers also will consider how personal and injury characteristics are related to treatment response – knowledge that could guide future care to best meet patient needs.

If proven successful, the proposed ACTIVE intervention will provide an evidence-based, personalized medicine approach with which military and civilian TBI care providers can decrease the short- and long-term effects of mTBI and related psychological health issues. This would greatly increase the quality of life for TBI patients and their families, and for the military as a whole, enhance operational readiness.

A Randomized Clinical Trial of Quetiapine Monotherapy vs. Treatment as Usual Polypharmacy for Postconcussive Syndrome in Veterans

Apr 15, 2024

Mild traumatic brain injury (mTBI) is a signature wound of post-9/11 wars, affecting hundreds of thousands of military veterans. After surviving the injury, many may continue to struggle not only with a variety of postconcussive symptoms, but also with the side effects of the multiple medications typically used to treat them.

With no FDA-approved therapies for postconcussive syndrome, treatment usually involves several prescriptions to treat various physical, neurological, and psychological symptoms as patients present with them. So one patient may be on a cocktail of medicines to help with headaches, concentration problems, neuropathic pain, fatigue, insomnia and anxiety. Each of those medications has its own side effects, most of which match other postconcussive and posttraumatic stress symptoms.

It’s easy to see, then, how patients can feel like nothing is helping, and doctors can have difficulty determining what’s working, what’s not, and how to make effective treatment adjustments.

Testing whether less is better

Seeing the problems of current polypharmacy approaches, STRONG STAR investigators are conducting a large randomized clinical trial (RCT) to evaluate the efficacy of using one medication – quetiapine – to treat a variety of postconcussive symptoms and improve patients’ function and quality of life. Quetiapine is an atypical antipsychotic medication that acts on multiple neurotransmitter receptors and therefore has the potential to help with multiple symptoms.

The study team is led by Muhammad Rais Baig, MD, with the Polytrauma Rehabilitation Center at the South Texas Veterans Health Care System and on the faculty at The University of Texas Health Science Center at San Antonio.

Dr. Baig previously led a pilot study evaluating quetiapine therapy compared to treatment as usual in veterans with posttraumatic stress disorder (PTSD), which frequently co-occurs in mTBI patients and has many symptoms in common. In that pilot study, quetiapine led to increased engagement in and completion of trauma-focused therapy. Importantly, it also resulted in overall improvement in both PTSD and mTBI symptoms.

Those findings led to the hope that quetiapine may be a useful monotherapy for those who have experienced mTBI, allowing providers to address multiple symptoms and patients to experience better outcomes with fewer negative side effects.

RCT design

In the current trial, 146 veterans with symptoms of mTBI and posttraumatic stress will be enrolled at the South Texas and the New Mexico VA Health Care Systems. Half will be randomly assigned to continue “treatment as usual” with their currently prescribed prescription medications. The other half will be assigned to the quetiapine arm. They will gradually reduce other prescribed medications for mTBI symptoms until they are taking quetiapine only.

At the end, investigators will examine whether quetiapine alone was more effective in reducing postconcussive symptoms and related functional disability, and whether it led to improved quality of life for participants. They also will explore whether quetiapine monotherapy enhances mTBI recovery by reducing medication side effects and increasing engagement in other rehabilitation services.

Expected benefits

An evidence-based monotherapy could greatly improve the outcomes of veterans suffering from postconcussive symptoms following mTBI, as they could benefit from greater symptom reduction with fewer adverse side effects. This in turn could lead to their greater utilization of complementary rehabilitation services and even better outcomes. At the national level, positive findings from this study could be expected to influence the joint Department of Veterans Affairs/Department of Defense Clinical Practice Guidelines, minimize polypharmacy practices, and reduce the ongoing demands of an unremitted chronic condition affecting thousands of veterans.

Combining Stellate Ganglion Block with Prolonged Exposure for PTSD: A Randomized Clinical Trial

Mar 06, 2024

Prolonged Exposure (PE) therapy is the most widely researched behavioral therapy for posttraumatic stress disorder (PTSD) and has shown to be an effective treatment. However, recovery rates have not been as high among military personnel and veterans as with civilians. Massed PE, delivered during a shortened period of 10 daily sessions over two weeks, has shown to be more effective and better received among this population than standard treatment, with fewer patients dropping out.

PE therapy can be challenging because, to help patients process and gain control over their traumatic memories, it requires them to retell the story of their traumatic experience, a part of the therapy called imaginal exposure. PE also involves gradual exposure to real-world situations that are safe but that trigger memories or feelings associated with the trauma. The related, temporary increase in physiological stress can make the therapy difficult to tolerate and potentially decrease efficacy.

Other research has demonstrated improvements in PTSD symptoms from a stellate ganglion block (SGB), an injection of a local anesthetic into a group of nerves located on the side of the throat, which are part of the sympathetic nervous system. But the results were temporary, requiring subsequent SGB injections to reduce the symptoms again.

Pilot study shows potential for improved outcomes

In a recent pilot study, STRONG STAR investigators led by Alan L. Peterson, PhD (Lt Col, USAF Ret.), of The University of Texas Health Science Center at San Antonio, combined massed PE with SGB. This combination resulted in the greatest reduction in PTSD symptoms seen in any of the 25 clinical trials conducted by STRONG STAR and the Consortium to Alleviate PTSD to date. And the symptom reductions lasted over time.

The investigators believe they achieved these results because the SGB reduced physiological arousal, allowing patients to engage more productively during their therapy sessions. Participants reported lower physiological distress but were still able to access their emotions during the imaginal exposure and post-exposure processing.

Further testing with a randomized clinical trial

Dr. Peterson’s team will now test this combined treatment approach with 140 patients with PTSD diagnosis recruited from military treatment facilities at Fort Hood and at Joint Base San Antonio-Fort Sam Houston, both in Texas.

All patients will receive massed PE therapy, but only half will receive a real SGB injection. The other half will receive a placebo injection for purposes of the study. However, following their study assessment one month posttreatment, those who received a placebo will be offered an SGB.

Expected outcomes and ultimate benefits

The investigators hypothesize that the patients receiving the SGB with massed PE will show greater reductions in PTSD symptoms than those receiving the placebo. They also believe that those receiving the SGB will experience less physiological arousal during imaginal exposure, compared to the placebo group, and that those decreases will be associated with greater reductions in PTSD symptoms.

They believe that if the study is successful, it could not only improve mental health outcomes for individuals, but also potentially improve long-term retention of active duty military personnel, decrease suicide rates among service members, and decrease medical costs associated with treating PTSD and comorbid conditions.

Randomized Controlled Trial of Intensive Multi-Couple Group Therapy for PTSD Versus Relationship Education in Military Couples

Sep 07, 2023

Posttraumatic stress disorder (PTSD) is highly prevalent in military and veteran populations, who also have a high dropout rate from individual PTSD therapy. PTSD also can contribute to difficulties within intimate relationships and to partner psychological distress. The state of intimate relationships can help or interfere with recovery from PTSD. Relationship problems also can contribute to attrition from the military and suicide risk.

Couple-based approaches to PTSD treatment offer the potential to address these complex problems as they strive to treat PTSD and enhance relationships at the same time. However, the length of existing couple-based PTSD treatments—15 sessions for up to five months—makes it difficult for many couples to get treatment; it also presents challenges for large-scale dissemination within the military and VA healthcare systems.

Early success with a creative approach to caring for couples

To address these limitations, investigators with the Consortium to Alleviate PTSD conducted a pilot study of a brief version of Cognitive-Behavioral Conjoint Therapy for PTSD (CBCT for PTSD) in which the treatment was delivered over two days to multiple couples at the same time using a retreat workshop format.

This compressed format decreased many of the logistical barriers that make it hard for couples to participate in and complete the 15-session version of CBCT for PTSD while capturing a majority of the benefits of the original therapy format. These included improvements in service members’ and veterans’ PTSD and related symptoms (depression, anxiety, anger), partners’ psychological well-being, and couples’ relationship adjustment.

Randomized trial will compare two treatments

STRONG STAR investigators led by Steffany Fredman, PhD, of The Pennsylvania State University will build on the success of that pilot study by testing the abbreviated, intensive, multi-couple group format of CBCT for PTSD (AIM-CBCT for PTSD) as a standalone treatment for PTSD in military and veteran couples in a larger sample (120 couples). AIM-CBCT will be compared to another intervention that also involves couples going away together to work on their relationships.

The comparison condition is the Prevention and Relationship Education Program (PREP), which research has shown to enhance couples’ psychological and relational well-being. This well-established, multi-couple, group-based, relationship education program has been adapted for military couples and widely disseminated in a weekend workshop format through the Army Chaplain Corps.

The study will test the efficacy of AIM-CBCT for PTSD in comparison to PREP in (1) treating PTSD, (2) treating co-occurring symptoms, (3) improving partner psychological distress, and (4) improving both partners’ relationship satisfaction.

The research team believes that if this study proves successful, AIM-CBCT for PTSD has the potential to be quickly scaled up within the Military Health System as a standalone treatment for PTSD with broad treatment effects, while improving access to care for PTSD and helping maintain a strong and effective military.

Accelerated Treatment for Co-occurring Insomnia, Nightmares, and PTSD

Aug 24, 2023

An estimated 20% of military service members suffer from clinically significant insomnia, 20% from nightmares, and 15% from posttraumatic stress disorder (PTSD). These disorders are highly interrelated, as they commonly occur together and can each worsen symptoms of the others and make them more difficult to treat.

When these conditions become chronic, they can impair both physical and psychological health and decrease quality of life. Therefore, effective and efficient treatments are sorely needed to help hundreds of thousands of affected service members. Fortunately, there are evidence-based treatments for all three conditions. Unfortunately, these treatments typically focus on one of the disorders and do not specifically address the interplay of vexing comorbidities. Addressing all three conditions, then, typically requires separate individual treatments in succession. That can take months to complete, causing discouragement, interfering with personal and military schedules, and otherwise leading to high patient drop-out rates.

Proposing a faster, three-pronged treatment approach

After previous success in using condensed approaches to deliver evidence-based therapy for PTSD, STRONG STAR investigators have developed a research study to evaluate an accelerated treatment method that integrates front-line therapies for co-occurring insomnia, nightmares, and PTSD.

The study is led by Carmen McLean, PhD, with the VA’s National Center for PTSD and Stanford University. It will begin with a pilot study in San Antonio involving service members at Wilford Hall Ambulatory Surgical Center and, based on the pilot study’s success, move on to a full-scale randomized clinical trial (RCT).

All participants will receive Written Exposure Therapy for PTSD, also known as WET. This brief, five-session treatment was shown in a previous STRONG STAR trial to be as effective as a longer, gold-standard treatment for PTSD in military service members.

Concurrently, participants will receive one of two sleep interventions. Half will receive education in good sleep hygiene, which involves establishing a sleep environment and sleep behaviors that are conducive to good sleep in both quantity and quality. The other half will receive an accelerated form of Cognitive-Behavioral Therapy for Insomnia and Nightmares, known as CBTi+n. CBTi+n was developed as a way to combine separate, evidence-based treatment approaches for insomnia and nightmares. The combined therapy has shown promise in initial clinical trials where it was delivered once weekly for six weeks.

The pilot study for this project will evaluate the conjoint delivery of WET and CBTi+n and the optimal schedule for an accelerated treatment format. Based on the success of the pilot study, investigators aim to develop a large RCT to determine the treatment’s efficacy. Their primary aim is to examine how well cognitive-behavioral treatment for insomnia and nightmares reduces sleep problems when integrated with PTSD treatment and delivered in an accelerated treatment format. They also want to explore the impact of the added sleep treatment on PTSD symptoms.

Expected benefits

If CBTi+n integrated with WET in an accelerated treatment format is found efficacious, it could be broadly disseminated throughout the military health system and make it easier for service members to seek and complete treatment for—and potentially recover from—co-occurring PTSD, insomnia, and nightmares. This could greatly benefit the mental and physical health and quality of life for individual military personnel and positively impact military readiness. The same treatment method likewise could be well utilized by VA and civilian providers to help veterans and members of the general public who suffer from the same conditions. In addition, this novel treatment approach could serve as an implementation model for addressing other psychological health disorders in service members, veterans, and civilian populations.

An Effectiveness-Implementation Trial of Functional Restoration for Chronic Pain Management in Active Duty Military Personnel

Aug 11, 2023

Chronic pain has a major detrimental effect on operational readiness across all branches of the U.S. military and is the single greatest condition related to medical disability within the U.S. Department of Veterans Affairs.

Although there are several effective, evidence-based treatments for acute pain such as medications, injections, devices, and surgeries, most of them are not similarly effective for chronic pain. In addition, the military has been seeking alternatives to opioid medications, a mainstay of treatment, due to increasing rates of addiction and negative side effects.

Interdisciplinary, multicomponent, functional restoration programs (FRPs) targeting the biological, behavioral, psychological, and social aspects of chronic pain are the evidence-based treatments with the strongest scientific support for chronic pain management. FRPs use a rehabilitation model designed to increase physical functioning, improve pain coping skills, and increase the opportunity to return to work.

However, it has been difficult to achieve widespread implementation of these programs in the Military Health System (MHS), because the establishment of an FRP is clinically and administratively complex and very different from routine chronic pain management practices.

Working to bring effective chronic pain management to military clinics

Addressing the need for effective chronic pain management, STRONG STAR investigators have launched a project to accelerate the implementation of FPRs across the MHS, doing so under the leadership of partnering principal investigators by Alan Peterson, PhD (Lt Col, USAF Ret.), of The University of Texas Health Science Center at San Antonio and Katherine Comtois, PhD, of the University of Washington.

The study is an extension of two successful randomized clinical trials (RCTs) conducted by STRONG STAR researchers to evaluate an FRP called Functional and Occupational Rehabilitation for Troops (FORT). Investigators will test the effectiveness of FORT with active duty military personnel with chronic pain at six MHS clinics nationwide, where they also will test a strategy designed to promote implementation of this treatment approach at the six clinics.

How the program works

FORT includes education about chronic pain, relaxation, and stress management; cognitive and behavioral therapies designed to improve pain coping and increase physical activity; individually tailored and gradually increasing physical and occupational therapy exercises; strategies for activity pacing and functional activation; and specialized modules for addressing pain-related concerns such as stigma, depression, and insomnia.

Some patients in the study will receive FORT plus the established treatment as usual for chronic pain. Their progress will be compared to another group that simply receives treatment as usual.

Aspects of FORT implementation that the team plans to develop at the military treatment facilities include establishment of support from clinical and administrative leadership, allocation of clinical space and personnel, use of effective criteria for screening patients, commitment of sufficient time for clinical treatment, and use of complementary and integrative medicine approaches. They later will assess for the extent that those elements have been adopted at the military clinics, along with the number of FORT programs offered per year.

Expected benefits

This research potentially could provide an effective way to implement improved treatment for chronic pain, help more affected service members maintain their careers, improve operational readiness, and decrease military and VA costs associated with military separation due to pain-related disability.