Pilot Study of Brain Stimulation Combined with Writing Therapy for PTSD

Jul 01, 2023

Symptoms of posttraumatic stress disorder (PTSD) include intrusive memories about the event, physiological hyperarousal such as always being on edge, sleep problems, and negative effect on a person’s mood and thoughts. All of this can have significant, long-term effects on health and functioning.

Evidence-based psychotherapies can help many patients, but there remains room for improvement, as too many patients do not significantly improve following treatment.

New approaches to treatment could help more people to recover from trauma.

The field of non-invasive brain stimulation is rapidly gaining attention as a potential treatment for PTSD based on its ability to restore healthy activity in regions of the brain associated with PTSD and its treatment.

Research is needed to determine the safety, feasibility, and benefits of non-invasive brain stimulation for those with PTSD. Toward that end, a STRONG STAR-affiliated research team led by Casey Straud, PsyD, a faculty member at The University of Texas Health Science Center at San Antonio, will conduct a randomized controlled pilot study of transcranial direct current stimulation (tDCS) vs. a placebo.

How the study and treatment will work

The study will involve 40 adults with PTSD receiving five weekly sessions of Written Exposure Therapy (WET), an evidence-based, behavioral psychotherapy for PTSD. By random assignment, half also will receive tDCS, while half will receive a placebo treatment that only appears to be administering tDCS. Study participants will include military veterans and non-veteran civilians in the San Antonio area who are seeking treatment for PTSD.

WET involves patients writing about their trauma and then discussing the written narrative with a therapist. In this study, patients will receive tDCS or placebo during the writing part of the therapy session, via electrodes secured to the head with elastic bands. During stimulation, a mild current flows between the electrodes passing through the brain to complete the circuit. The current is believed to enhance the resting potential of neurons that typically are overly active in brains of PTSD patients.

The study team also will monitor physical responses to stress via devices placed on the non-writing hand to measure heart rate and sweat production.

Pilot study expectations

The investigators believe that the study will show that tDCS is safe and compatible with WET, and that WET plus tDCS will result in greater reductions in PTSD symptoms than WET plus placebo. If successful, the pilot study could provide rationale for a larger study in the effort to add more treatment options for individuals with PTSD.

Two-Armed Pilot Randomized Controlled Trial of Massed Prolonged Exposure Plus Cannabidiol or Placebo for Posttraumatic Stress Disorder

Feb 24, 2022

Up to 20 percent of U.S. military service members who have deployed since Sept. 11, 2001, suffer from posttraumatic stress disorder (PTSD). While evidence-based treatments for PTSD are available, combat-related PTSD is more difficult to treat than cases found in the civilian population. Because of the great need to heal the psychological traumatic injuries incurred by our war fighters, researchers are engaged in ongoing efforts to improve treatments.

Recent research suggests that cannabidiol (CBD), a substance derived from the cannabis plant, may help to regulate brain functions that have become dysregulated due to trauma exposure. CBD interacts with a brain component known as the endocannabinoid system and already is approved by the U.S. Food and Drug Administration (FDA) for treating seizure disorders.

Early evidence also suggests that CBD can help to relieve pain, reduce anxiety and depression, and enhance learning. CBD may also help individuals recover from traumatic events by reducing anxiety and increasing their ability to talk about and make sense of painful memories, two key components of Prolonged Exposure (PE), a leading therapy for PTSD.

Pilot study evaluates combined impact of CBD and behavior therapy

This STRONG STAR-affiliated pilot study led by principal investigator Casey Straud, PsyD, of The University of Texas Health Science Center at San Antonio, will evaluate the potential benefits of administering either CBD or a placebo to a group of 24 patients receiving PE. Their therapy will be in the form of Massed PE, which involves patients receiving daily therapy sessions for 10 days, rather than the standard PE, in which patients receive weekly sessions over the course of a few months.

Twelve of the patients will receive Epidiolex, an FDA-approved, pharmaceutical-grade medication with CBD as its only active component. The other 12 will receive a placebo.

Expected impact

The investigators hypothesize that those receiving CBD will have greater symptom reductions than those in the placebo condition. In addition, they expect that the patients taking CBD will have lower average heart rates during therapy sessions, higher levels of critical biomarkers associated with stress reduction and lower levels of cortisol, a hormone that increases in response to stress. They predict that those measurable physical differences will be associated with improved PTSD symptom reductions.

Any positive findings have the potential to improve PTSD outcomes for service members and veterans and expand understanding of the relationship between PTSD, CBD, and the endocannabinoid system.

Web-Based Provider Training for Cognitive Behavioral Therapy for Nightmares

Feb 24, 2022

An estimated 315,000 U.S. military service members experience chronic nightmares that only a handful of mental health providers know how to treat directly. People who suffer from nightmares report greater substance use, physical health problems, insomnia, and posttraumatic stress disorder (PTSD) symptoms, all of which can compromise military readiness and quality of life. They also are at increased risk for suicidal ideation, suicidal attempts, or suicide completion. If left untreated, nightmares can persist for decades.

While Cognitive Behavioral Therapy for Nightmares (CBT-N) is endorsed by the American Academy of Sleep Medicine as effective for treatment of nightmares related to trauma and PTSD, few providers know how to deliver these treatments, and training opportunities are rare. This is true for the Defense Health Agency, Veterans Health Administration, and in clinics that serve civilians.

CBT-N involves writing a different storyline for the nightmare and repeatedly imagining the new dream before sleep. This gives the mind a different path to follow during sleep. The therapy also can include education about sleep and trauma, identifying and modifying unhelpful sleep habits, relaxation training, and written exposure therapy to nightmare content (similar to treatments for PTSD).

Training via: CBTNightmaresweb.org

A team led by Kristi Pruiksma, PhD, of The University of Texas Health Science Center at San Antonio aims to fill that gap by developing an online training program for CBT-N. This training via a site called CBTNightmaresweb would require less time and cost less than live workshops, while ensuring that providers receive state-of-the-science CBT-N training.

The team will work with leaders in the field, agencies, decision-makers and providers to develop and refine the program. They will then test it with a group of 100 providers who will complete either the CBTNightmaresweb training or a live workshop. The team then will compare the two groups’ reactions to and satisfaction with the training they received and will assess their learning via simulated treatment sessions.

The overarching goal of developing CBTNightmaresweb is to facilitate the delivery of nightmare treatment to improve the sleep and quality of life of service members, veterans, and civilians suffering from nightmares related to trauma. The U.S. military would benefit from improvements in the operational readiness and physical and mental health of its personnel.

Service-Connected Life Trajectory Comparison of Psychiatric Aeromedical Evacuation and Non-Psychiatric Aeromedical Evacuation Patients From 2001 to 2015

Jan 01, 2022

Numerous epidemiological research studies have been conducted on the military population, but relatively little research has looked at psychiatric aeromedical evacuations from deployed settings. Thus, the long-term impact of these evacuations is not known.

A previous STRONG STAR-affiliated study, OIF/OEF Psychiatric MEDEVACS, examined the career impacts and risk factors for a sample of nearly 10,000 U.S. military personnel who received a psychiatric aeromedical evacuation from Iraq or Afghanistan between 2001 and 2013. That study found that more than half had separated from active duty, were discharged, or were on temporary disability retirement status at the time of the analysis. And it found no relationship between severity of an evacuee’s condition and the reason for separation or discharge. This suggests that psychiatric aeromedical evacuation from the combat zone is often a military career-ending event.

Comparison groups

This new STRONG STAR-affiliated, retrospective study will build on the previous one by adding comparison groups. The research team will analyze the long-term physical and mental health outcomes among active duty service members with and without deployment experience and those with and without history of aeromedical evacuation.

The study team hypothesizes that they will find differences in long-term adverse physical and mental health outcomes between service members aeromedically evacuated from theater for psychiatric reasons, those aeromedically evacuated from theater for non-psychiatric reasons, those never evacuated from combat, and those who never deployed.

The analysis will include data from sample groups of individuals who served in the U.S. military between Jan. 1, 2001, and Dec. 31, 2015. It will be based on data obtained from multiple sources within the U.S. Department of Defense, including the TRANSCOM Regulating and Command & Control Evaluation System, Defense Manpower Data Center, Defense Health Agency, and Air Evacuation Registry.

Clarifying the long-term impact

The investigators believe that the analysis comparing military personnel with a variety of service histories will provide an even clearer picture of the long-term impact of psychiatric aeromedical evacuation. They believe that could influence the military to recommend treatment of some psychiatric patients in theater, which could prevent some evacuations as well as make evacuation flights safer for patients and crews. Results of this study also may help the military to clarify current aeromedical evacuation guidelines, develop improved screening tools and standards of care, and enhance training.

The Efficacy of 90-Minute vs. 60-Minute Sessions of Prolonged Exposure for PTSD: A Randomized Controlled Trial in Active Duty Military Personnel

May 26, 2017

With up to 20 percent of post-9/11 combat veterans suffering from posttraumatic stress disorder (PTSD) symptoms, our nation needs to provide effective treatments to the greatest number of people possible.

One form of therapy proven effective, Prolonged Exposure (PE), is recommended by the Institute of Medicine and being rolled out by the Departments of Defense (DoD) and Veterans Affairs (VA) to help service members and veterans recover from PTSD. A major barrier to that rollout, however, is that PE typically is delivered in 90-minute sessions. That makes it difficult for military and VA mental health clinicians to provide PE because, due to large patient loads and federal scheduling policies, they usually must limit therapy sessions to 60 minutes. But if PE could be shown to maintain high success rates with shorter sessions, more military and VA providers could offer this powerful therapy.

Testing shorter exposure sessions

A key element of PE is a procedure known as “imaginal exposure,” during which patients recall and recount their trauma memories. Preliminary evidence has suggested that patients may benefit greatly from PE even when the time spent in imaginal exposure is shortened to fit into a 60-minute session.

In this STRONG STAR-affiliated clinical study, Edna Foa, PhD, of the University of Pennsylvania and her research team will evaluate the delivery of PE in 60-minute sessions. They will enroll 160 San Antonio-area active duty service members, randomly assign them to receive PE treatment with 60- or 90-minute sessions, and compare outcomes of the two groups. All treatment sessions will be conducted at a non-military site. The cause of the PTSD may include various types of trauma (e.g., combat, attacks, sexual or physical assault, childhood trauma, abuse, accidents) and does not have to be service-related.

In addition to measuring progress based on patients’ subjective self-reporting and clinicians’ objective assessments, the investigators seek to gain insight on how PE works – and which components of the therapy are most beneficial – by observing changes in patients’ physical symptoms of stress. Physical symptoms to be monitored include heart rate, which accelerates during stress, and skin electrical conductivity, which increases as a result of stress-induced perspiration. Tracking of physical changes during different parts of the therapy could yield insight on how PE helps patients recover from PTSD and, based on that knowledge, ways of enhancing this and other PTSD treatments to increase their effectiveness.

Potential benefits

Data from this study showing high success rates from shortened PE sessions could lead to increased availability of this powerful therapy for hundreds of thousands of combat veterans. More military and VA clinicians could offer PE, because it would fit within the time constraints of their heavy workload and federal scheduling policies. The military and general public would benefit from enhanced readiness of our Armed Forces and reduced public costs of service members’ lost work time and veterans’ disability benefits. Civilian therapists also may be more likely to use PE therapy if they had available a 60-minute format compatible with insurance reimbursement requirements. Finally, study findings about how and why PE is such an effective treatment could provide insights on how to improve PTSD treatment even further.

Clinical Effectiveness Trial of In-Home Cognitive Processing Therapy for Combat-Related PTSD

Apr 19, 2016

Will more military service members and veterans participate in effective treatment programs for posttraumatic stress disorder (PTSD)–and perhaps even receive a higher level of care–if that treatment is delivered in their own home? Is such a treatment format even feasible? Those are questions posed by Dr. Alan Peterson of The University of Texas Health Science Center at San Antonio and co-investigator Dr. Patricia Resick of Duke University Medical Center in a STRONG STAR-affiliated study on the effectiveness of in-home Cognitive Processing Therapy (CPT) for combat-related PTSD.

Study rationale and objectives

Even as evidence-based therapies for PTSD are becoming more readily available within the Departments of Defense (DoD) and Veterans Affairs (VA), a recent report by the RAND Corporation shows that the majority of military members and veterans are not receiving adequate care for the psychological wounds they received from tours in Iraq and Afghanistan. Reasons likely vary and are believed to include the following:

concerns about the stigma of seeking mental health care;
job and scheduling conflicts;
an inability to access traditional care in mental health clinics because of limited mobility and transportation issues, particularly among those who are seriously injured or living in rural areas.

This study will evaluate the feasibility and efficacy of a treatment delivery method that could help overcome these barriers to care, potentially making effective PTSD treatment more accessible to underserved military personnel and veterans. It will evaluate one of the leading treatments for PTSD, a form of counseling known as Cognitive Processing Therapy (CPT), when delivered in service members’ and veterans’ homes, either through in-person therapist visits or via video teleconference (similar to Skype), as compared to standard, face-to-face treatment in a therapist’s office.

Why in-home therapy might be better

Traditional CPT already has been shown to yield recovery rates as high as 80% with civilian PTSD patients, and to a lesser degree with veterans with combat-related PTSD. Researchers hypothesize that in-home delivery may further improve CPT’s efficacy in treating both PTSD and related problems, such as depression, alcohol dependence, and family strain. Reasons include the decreased likelihood of patients to miss appointments as well as therapists’ enhanced ability to see and address patients’ personal barriers to successful treatment.

Who will benefit if home-based CPT delivery is shown to be as or more effective than in-office care?

The VA and DoD: Both would have valuable new methods for delivering evidence-based treatment to currently underserved active duty and veteran populations.

Military and veteran PTSD patients: They could see improved access to high-quality care that could give them a greater chance at full recovery, enabling them to resume happy, productive lives in continued military service or as civilians.

Military and VA mental health providers: They would have an opportunity to tailor and enhance individual patient care to potentially improve treatment outcomes. Providers could capitalize on insights gained in the home to (1) help patients translate therapy lessons to daily life; (2) recognize and address environmental and lifestyle factors, as well as co-occurring social and mental health problems, that impede recovery from PTSD; and (3) better manage high-risk and suicidal patients by gaining a clearer sense of overall risk and a direct path to effective risk-management interventions.

The Impact of the Treatment of PTSD on Comorbid Insomnia and Pain

Apr 08, 2015

Insomnia and pain are two of the symptoms most commonly reported by military personnel who have returned from deployment to Operation Iraqi Freedom and Operation Enduring Freedom. They also are common comorbidities of posttraumatic stress disorder (PTSD). Doctors have numerous issues to consider when treating each problem individually, but when physical and psychological disorders such as these present themselves as a group, diagnosis and treatment become even more complicated as one condition aggravates another.

For example, the nightmares of PTSD and the pain of a physical trauma can keep one from sleeping; a lack of sleep can slow down the body’s physical and mental healing process; and strong medications used to treat severe pain and even sleeping pills can further alter one’s mental state. Many of these medications also carry the risk of causing drug dependence, which can cause even further complications in treating PTSD. In these situations, it can quickly become difficult for health care professionals to discern what ailment – or therapy – is causing a particular problem and how best to tailor their patients’ treatment.

STRONG STAR Consortium Coordinator COL Stacey Young-McCaughan, PhD, RN (U.S. Army, Retired), is trying to provide valuable insight on the interrelation of PTSD comorbidities to help unravel this tangled web and guide improved treatment.

New study provides in-depth analysis, could help health care providers tailor therapy

In a new exploratory study for STRONG STAR, Dr. Young-McCaughan will extend preliminary results from a study she previously conducted as she evaluates the interrelation of comorbid insomnia, pain and PTSD as seen in participants of other STRONG STAR randomized clinical trials. She will do an in-depth analysis to determine if the successful treatment of PTSD will in turn reduce comorbid insomnia and pain, or whether additional therapies are needed to treat these conditions. Conversely, she will analyze whether comorbid insomnia and pain have a negative effect on participants’ response to PTSD therapy. This would potentially indicate that these comorbidities need to be targeted specifically as part of a comprehensive plan to treat PTSD effectively.

Additional insights gained from this investigation could improve the ability of mental health professionals to tailor patients’ treatment to achieve the best possible outcomes.

Mechanisms of Vulnerability to PTSD: The Role of Early Life Stressors

Apr 08, 2015

It is understandable that a trauma experienced early in life could leave psychological scars, making it more difficult for the same individual to recover from a subsequent trauma later in life. In fact, scientific studies have shown an association between early life events and later susceptibility to posttraumatic stress disorder.

But can traumatic events in our childhood leave more than psychological scars? Could they also leave physical “scars,” perhaps by altering the expression of one or more of our genes, creating a biological reason why one individual might be more susceptible to PTSD than another? And if that is the case, could a drug therapy be developed to counter or reverse that biological disturbance? Could that therapy then be used to help prevent or treat PTSD?

These are questions being posed by Randy Strong, PhD and his collaborators, David Morilak, PhD, and Alan Frazer, PhD, of the University of Texas Health Science Center at San Antonio as they conduct a STRONG STAR preclinical investigation on the role of early life stressors and mechanisms of vulnerability to PTSD.

The hypothesis

Although every person who suffers from PTSD has experienced a traumatic stress, the majority of trauma-exposed persons do not develop PTSD, leading researchers to question what unique characteristics of PTSD patients impair the normal recovery process. This study is investigating one possibility, testing the hypothesis that early life stressors cause alterations in the expression of genes, specifically genes that regulate hypothalamic pituitary adrenal (HPA) axis activity, and that these changes increase a person’s susceptibility to PTSD following another traumatic event later in life. The HPA axis is an important component of the neuroendocrine system that regulates several bodily functions, including response to stress.

The hypothesis being tested by this study is based on findings from preclinical studies in which a chemical process called DNA methylation was used in rats to program the activity of genes regulating HPA activity in response to early life events, such as differences in maternal care or in pre- and perinatal exposure to a type of steroids called glucocorticoids. Observations reveal that these experimental animal models mimic processes observed in humans in whom early life events are associated with the development of PTSD. Moreover, the programming of changes in the HPA axis in experimental models is strikingly similar to the effects on the HPA axis described in PTSD. Thus, these studies may provide a molecular link between early environment and gene expression. Most importantly, preclinical studies suggest that these epigenetic changes may be reversed or prevented by pharmacological treatment with serotonergic drugs such as SSRIs, histone deacetylase inhibitors, and methyl donors.

The experiment

In a preclinical study for STRONG STAR, Drs. Strong, Morilak and Frazer are looking at the impact of pre- and perinatal stressors in Sprague-Dawley rats when paired with a second experimental stressor in adulthood. In particular, they are observing physiological and neurochemical changes and various aspects of behavior, such as whether the animals show an active or passive coping behavior when presented with a challenge or mildly stressful situation. Other behavioral measures correspond with the types of behaviors seen in humans with PTSD, such as the tendency to withdraw from social groups, hyper-arousal, and avoidance of certain situations. The research team is also observing the treatment effects of the SSRI sertraline in rats that exhibit symptomatic behaviors. From these investigations, they expect to learn more about how early life stress impacts one’s vulnerability to PTSD in adulthood and whether serotonegic drugs can be used to prevent or reverse epigenetic risk factors for the disorder.