Impact and efficiency of treatment across two PTSD clinical trials comparing in-person and telehealth service delivery formats.

The intent of this study is to examine treatment impact and efficiency observed when cognitive behavioral treatments for posttraumatic stress disorder (PTSD) are delivered in-person or using telehealth. This study pooled data from 268 veterans enrolled in two PTSD clinical trials. In both trials, treatment was delivered using in-home telehealth (telehealth arm), in-home in-person (in-home arm), and in-office care, where patients traveled to the Department of Veterans Affairs for either office-based telehealth or office-based in-person care (office arm). Average age was 44 (SD = 12.57); 80.9% were males. The PTSD Checklist for DSM-5 (PCL-5) was used to assess symptom severity. Treatment impact was measured by (a) the proportion of participants who completed at least eight treatment sessions and (b) the proportion with a reliable change of ≥ 10 points on the PCL-5. Treatment efficiency was measured by the number of days required to reach the end point. The proportion of participants who attended at least eight sessions and achieved reliable change on the PCL-5 differed across treatment formats (ps < .05). Participants in the in-home (75.4%) format were most likely to attend at least eight treatment sessions, followed by those in the telehealth (58.3%) and office (44.0%) formats, the latter of which required patients to travel. Participants in the in-home (68.3%, p < .001) format were also more likely to achieve reliable change, followed by those in the telehealth (50.9%) and office (44.2%) formats. There were no significant differences in the amount of time to complete at least eight sessions. Delivery of therapy in-home results in a significantly greater likelihood of achieving both an adequate dose of therapy and a reliable decrease in PTSD symptoms compared to telehealth and office formats. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Mechanisms of change in posttraumatic headache-related disability: A mediation model.

OBJECTIVE: To explore whether the association between change in headache management self-efficacy and posttraumatic headache-related disability is partially mediated by a change in anxiety symptom severity. BACKGROUND: Many cognitive-behavioral therapy treatments for headache emphasize stress management, which includes anxiety management strategies; however, little is currently known about mechanisms of change in posttraumatic headache-related disability. Increasing our understanding of mechanisms could lead to improvements in treatments for these debilitating headaches. METHODS: This study is a secondary analysis of veterans (N = 193) recruited to participate in a randomized clinical trial of cognitive-behavioral therapy, cognitive processing therapy, or treatment as usual for persistent posttraumatic headache. The direct relationship between headache management self-efficacy and headache-related disability, along with partial mediation through change in anxiety symptoms was tested. RESULTS: The mediated latent change direct, mediated, and total pathways were statistically significant. The path analysis supported a significant direct pathway between headache management self-efficacy and headache-related disability (b = -0.45, p < 0.001; 95% confidence interval [CI: -0.58, -0.33]). The total effect of change of headache management self-efficacy scores on change in Headache Impact Test-6 scores was significant with a moderate-to-strong effect (b = -0.57, p = 0.001; 95% CI [-0.73, -0.41]). There was also an indirect effect through anxiety symptom severity change (b = -0.12, p = 0.003; 95% CI [-0.20, -0.04]). CONCLUSIONS: In this study, most of the improvements in headache-related disability were related to increased headache management self-efficacy with mediation occurring through change in anxiety. This indicates that headache management self-efficacy is a likely mechanism of change of posttraumatic headache-related disability with decreases in anxiety explaining part of the improvement in headache-related disability.

Mindfulness-Based Interdisciplinary Pain Management Program for Complex Polymorbid Pain in Veterans: A Randomized Controlled Trial.

OBJECTIVE: To evaluate the effects of interdisciplinary pain management on pain-related disability and opioid reduction in polymorbid pain patients with 2 or more comorbid psychiatric conditions. DESIGN: Two-arm randomized controlled trial testing a 3-week intervention with assessments at pre-treatment, post-treatment, 6-month, and 12-month follow-up. SETTING: Department of Veterans Affairs medical facility. PARTICIPANTS: 103 military veterans (N=103) with moderate (or worse) levels of pain-related disability, depression, anxiety, and/or posttraumatic stress disorder randomly assigned to usual care (n=53) and interdisciplinary pain management (n=50). All participants reported recent persistent opioid use. Trial participants had high levels of comorbid medical and mental health conditions. INTERVENTIONS: Experimental arm-a 3-week, interdisciplinary pain management program guided by a structured manual; comparison arm-usual care in a large Department of Veterans Affairs medical facility. MAIN OUTCOME MEASURES: Oswestry Disability Index (pain disability); Timeline Followback Interview and Medication Event Monitoring System (opioid use). Analysis used generalized linear mixed model with all posttreatment observations (posttreatment, 6-month follow-up, 12-month follow-up) entered simultaneously to create a single posttreatment effect. RESULTS: Veterans with polymorbid pain randomized to the interdisciplinary pain program reported significantly greater decreases in pain-related disability compared to veterans randomized to treatment as usual (TAU) at posttreatment, 6-month, and 12-month follow-up. Aggregated mean pain disability scores (ie, a summary effect of all posttreatment observations) for the interdisciplinary pain program were -9.1 (95% CI: -14.4, -3.7, P=.001) points lower than TAU. There was no difference between groups in the proportion of participants who resumed opioid use during trial participation (32% in both arms). CONCLUSION: These findings offer the first evidence of short- and long-term interdisciplinary pain management efficacy in polymorbid pain patients, but more work is needed to examine how to effectively decrease opioid use in this population.

Cognitive Behavioral Therapy for Veterans With Comorbid Posttraumatic Headache and Posttraumatic Stress Disorder Symptoms: A Randomized Clinical Trial.

Importance: Posttraumatic headache is the most disabling complication of mild traumatic brain injury. Posttraumatic stress disorder (PTSD) symptoms are often comorbid with posttraumatic headache, and there are no established treatments for this comorbidity. Objective: To compare cognitive behavioral therapies (CBTs) for headache and PTSD with treatment per usual (TPU) for posttraumatic headache attributable to mild traumatic brain injury. Design, Setting, and Participants: This was a single-site, 3-parallel group, randomized clinical trial with outcomes at posttreatment, 3-month follow-up, and 6-month follow-up. Participants were enrolled from May 1, 2015, through May 30, 2019; data collection ended on October 10, 2019. Post-9/11 US combat veterans from multiple trauma centers were included in the study. Veterans had comorbid posttraumatic headache and PTSD symptoms. Data were analyzed from January 20, 2020, to February 2, 2022. Interventions: Patients were randomly assigned to 8 sessions of CBT for headache, 12 sessions of cognitive processing therapy for PTSD, or treatment per usual for headache. Main Outcomes and Measures: Co-primary outcomes were headache-related disability on the 6-Item Headache Impact Test (HIT-6) and PTSD symptom severity on the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) (PCL-5) assessed from treatment completion to 6 months posttreatment. Results: A total of 193 post-9/11 combat veterans (mean [SD] age, 39.7 [8.4] years; 167 male veterans [87%]) were included in the study and reported severe baseline headache-related disability (mean [SD] HIT-6 score, 65.8 [5.6] points) and severe PTSD symptoms (mean [SD] PCL-5 score, 48.4 [14.2] points). For the HIT-6, compared with usual care, patients receiving CBT for headache reported -3.4 (95% CI, -5.4 to -1.4; P < .01) points lower, and patients receiving cognitive processing therapy reported -1.4 (95% CI, -3.7 to 0.8; P = .21) points lower across aggregated posttreatment measurements. For the PCL-5, compared with usual care, patients receiving CBT for headache reported -6.5 (95% CI, -12.7 to -0.3; P = .04) points lower, and patients receiving cognitive processing therapy reported -8.9 (95% CI, -15.9 to -1.9; P = .01) points lower across aggregated posttreatment measurements. Adverse events were minimal and similar across treatment groups. Conclusions and Relevance: This randomized clinical trial demonstrated that CBT for headache was efficacious for disability associated with posttraumatic headache in veterans and provided clinically significant improvement in PTSD symptom severity. Cognitive processing therapy was efficacious for PTSD symptoms but not for headache disability. Trial Registration: ClinicalTrials.gov Identifier: NCT02419131.

In-office, in-home, and telehealth cognitive processing therapy for posttraumatic stress disorder in veterans: a randomized clinical trial.

BACKGROUND: Trauma-focused psychotherapies for combat-related posttraumatic stress disorder (PTSD) in military veterans are efficacious, but there are many barriers to receiving treatment. The objective of this study was to determine if cognitive processing therapy (CPT) for PTSD among active duty military personnel and veterans would result in increased acceptability, fewer dropouts, and better outcomes when delivered In-Home or by Telehealth as compared to In-Office treatment. METHODS: The trial used an equipoise-stratified randomization design in which participants (N = 120) could decline none or any 1 arm of the study and were then randomized equally to 1 of the remaining arms. Therapists delivered CPT in 12 sessions lasting 60-min each. Self-reported PTSD symptoms on the PTSD Checklist for DSM-5 (PCL-5) served as the primary outcome. RESULTS: Over half of the participants (57%) declined 1 treatment arm. Telehealth was the most acceptable and least often refused delivery format (17%), followed by In-Office (29%), and In-Home (54%); these differences were significant (p = 0.0008). Significant reductions in PTSD symptoms occurred with all treatment formats (p < .0001). Improvement on the PCL-5 was about twice as large in the In-Home (d = 2.1) and Telehealth (d = 2.0) formats than In-Office (d = 1.3); those differences were statistically large and significant (d = 0.8, 0.7 and p = 0.009, 0.014, respectively). There were no significant differences between In-Home and Telehealth outcomes (p = 0.77, d = -.08). Dropout from treatment was numerically lowest when therapy was delivered In-Home (25%) compared to Telehealth (34%) and In-Office (43%), but these differences were not statistically significant. CONCLUSIONS: CPT delivered by telehealth is an efficient and effective treatment modality for PTSD, especially considering in-person restrictions resulting from COVID-19. TRIAL REGISTRATION: ClinicalTrials.gov ID NCT02290847 (Registered 13/08/2014; First Posted Date 14/11/2014).

Pain-related disability, PTSD symptoms, and mood among a comorbid chronic pain and PTSD sample prior to and during the COVID-19 pandemic.

There is a knowledge gap when treating comorbid chronic pain and posttraumatic stress disorder (PTSD) during the COVID-19 pandemic. Addressing this gap, 169 individuals (57.4% female), aged 39.8 years were recruited based on levels of pain-related disability and PTSD symptoms. Participants were assessed prior to, and during, the COVID-19 pandemic. Improvements in pain-related disability were marginally attenuated for the comorbid group, compared to the chronic pain group. Results show that some condition-specific symptoms may not have been affected by the COVID-19 pandemic. Cautious interpretation is warranted due to only two time points and the lack of a diverse sample.

Persistent posttraumatic headaches and functioning in veterans: Injury type can matter.

OBJECTIVE: To characterize the relationship between head trauma types (blast injury, blunt injury, combined blast+blunt injury) with subsequent headache presentations and functioning. BACKGROUND: Posttraumatic headaches (PTHs), the most common sequelae of traumatic brain injury (TBI), are painful and disabling. More than 400,000 veterans report having experienced a TBI, and understanding the predictors of PTHs may guide treatment developments. METHODS: This study used a nested-cohort design analyzing baseline data from a randomized clinical trial of cognitive behavioral therapy for PTH (N = 190). Participants had PTH (from blast and/or blunt head trauma) and symptoms of posttraumatic stress disorder (PTSD). The Structured Diagnostic Interview for Headache-Revised and Ohio State University Traumatic Brain Injury Identification Method were used to phenotype headaches and head injury histories, respectively. RESULTS: Individuals with persistent PTHs after a combined blast and blunt head trauma were more likely (OR =3.45; 95% CI [1.41, 8.4]) to experience chronic (vs. episodic) PTHs compared with the blunt trauma only group (23/33, 70% vs. 26/65, 40%, respectively); and they were more likely (OR =2.51; 95% CI [1.07, 5.9]) to experience chronic PTH compared with the blast trauma only group (44/92, 48%). There were no differences between head injury type on headache-related disability, depression symptoms, or severity of PTSD symptoms. CONCLUSION: The combination of blast and blunt injuries was associated with headache chronicity, but not headache disability. Considering the refractory nature of chronic headaches, the potential added and synergistic effects of distinct head injuries warrant further study.

Authenticity as a Resilience Factor Against CV-19 Threat Among Those With Chronic Pain and Posttraumatic Stress Disorder.

OBJECTIVE: The novel coronavirus (2019; CV-19) is linked to increases in emotional distress and may be particularly problematic for those with pre-existing mental and physical conditions, such as chronic pain and posttraumatic stress disorder (PTSD). However, little empirical research has been published on resilience factors in these individuals. The present study aims to examine authenticity as a resilience factor among those with chronic pain and/or PTSD. METHODS: Prior to the national response to the pandemic (January 10-24, 2020), participants were screened for pain-related disability (Oswestry Disability Index; ODI) and PTSD symptoms (Posttraumatic Checklist for DSM-5; PCL-5), and on the basis of those responses were categorized into one of four groups: healthy, chronic pain only, PTSD only, or comorbid chronic pain and PTSD. During the CV-19 pandemic (May 5-May 13, 2020), participants responded again to the ODI and PCL-5, in addition to the Wood Authenticity Scale, Brief Pain Inventory, and items related to the CV-19 pandemic. RESULTS: A total of 110 participants (54.55% women), aged 42.19 (SD = 13.16), completed the survey during the pandemic. The comorbid group endorsed higher levels of CV-19 Threat and Impact compared to all other groups. Authenticity moderated this relationship relevant to CV-19 Threat among those in the chronic pain only group, and not in any other group. CONCLUSION: The comorbid group endorsed higher levels of CV-19 Threat and Impact compared to all other groups. Importantly, greater authenticity was associated with less CV-19 Threat in the chronic pain only group, and not in any other group. The present study also highlights the importance of engaging authentically for those with chronic pain during the pandemic.

Incidence (2008-2015) of post-traumatic headaches in United States military personnel.

Objective: To conduct a descriptive transversal study to evaluate the incidence and demographic characteristics of post-traumatic headache using data from the Defense Medical Epidemiology Database.Methods: A retrospective cohort study was conducted of data from 2008 to 2015 based on the International Classification of Diseases codes for both acute and chronic post-traumatic headache.Results: A total of 17,010 new cases of post-traumatic headaches were diagnosed among active duty military personnel. Reported incidence rates of post-traumatic headaches in the military increased 29-fold over the timeframe analyzed. Males enlisted in the Army were more likely to be diagnosed with post-traumatic headaches than females (O/E = 0.76), other branches, and officers.Conclusion: Findings of this study indicate that there is a significant incidence of post-traumatic headaches in the U.S. military. However, the incidence rates of post-traumatic headaches in the military are much lower than what was expected considering the number of traumatic brain injuries in the United States military reported by the Department of Defense for the same period. Additional research is needed to further evaluate these differences and the impact of PTHs on military personnel.

Study design for a randomized clinical trial of cognitive-behavioral therapy for posttraumatic headache.

Posttraumatic headache (PTH) is a common debilitating condition arising from head injury and is highly prevalent among military service members and veterans with traumatic brain injury (TBI). Diagnosis and treatment for PTH is still evolving, and surprisingly little is known about the putative mechanisms that drive these headaches. This manuscript describes the design of a randomized clinical trial of two nonpharmacological (i.e., behavioral) interventions for posttraumatic headache. Design of this trial required careful consideration of PTH diagnosis and inclusion criteria, which was challenging due to the lack of standard clinical characteristics in PTH unique from other types of headaches. The treatments under study differed in clinical focus and dose (i.e., number of treatment sessions), but the trial was designed to balance the treatments as well as possible. Finally, while the primary endpoints for pain research can vary from assessments of pain intensity to objective and subjective functional measures, this trial of PTH interventions chose carefully to establish clinically relevant endpoints and to maximize the opportunity to detect significant differences between groups with two primary outcomes. All these issues are discussed in this manuscript.

Reason to doubt the ICHD-3 7-day inclusion criterion for mild TBI-related posttraumatic headache: A nested cohort study.

BACKGROUND: Posttraumatic headache is difficult to define and there is debate about the specificity of the 7-day headache onset criterion in the current definition. There is limited evidence available to guide decision making about this criterion. METHOD: A nested cohort study of 193 treatment-seeking veterans who met criteria for persistent headache attributed to mild traumatic injury to the head, including some veterans with delayed headache onset up to 90 days post-injury, was undertaken. Survival analysis examined the proportion of participants reporting headache over time and differences in these proportions based on sex, headache phenotype, and mechanism of injury. RESULT: 127 participants (66%; 95% CI: 59-72%) reported headache onset within 7 days of head injury and 65 (34%) reported headache onset between 8 days and 3 months after head injury. Fourteen percent of participants reported pre-existing migraine before head injury, and there was no difference in the proportion of veterans with pre-existing migraine based on headache onset. Headache onset times were not associated with sex, headache phenotype, or mechanism of injury. There were no significant differences in proportion of veterans with headache onset within 7 days of head injury based on headache phenotype (70% migraine onset within 7 days, 70% tension-type headache within 7 days, 56% cluster headache within 7 days; p ≥ .364). Similar findings were observed for head injury (64% blast, 60% blunt; p = .973). There were no significant differences observed between headache onset groups for psychiatric symptoms (Posttraumatic Stress Disorder Checklist for DSM-5 = 1.3, 95% CI = -27.5, 30.1; Patient Health Questionnaire-9 Item = 3.5, 95% CI = -6.3, 3.7; Generalized Anxiety Disorder Screener = 6.5, 95% CI = -2.7, 15.6). CONCLUSIONS: Although most of the sample reported headache onset within 7 days of head injury, one-third experienced an onset outside of the diagnostic range. Additionally, veterans with headache onset within 7 days of head injury were not meaningfully different from those with later onset based on sex, headache phenotype, or mechanism of head injury. The ICHD-3 diagnostic criteria for 7-day headache onset should be expanded to 3 months. CLINICALTRIALS.GOV IDENTIFIER: NCT02419131.

A Retrospective, Epidemiological Review of Hemiplegic Migraines in a Military Population.

INTRODUCTION: Headaches are one of the world's most common disabling conditions. They are also both highly prevalent and debilitating among military personnel and can have a significant impact on fitness for duty. Hemiplegic migraines are an uncommon, yet severely incapacitating, subtype of migraine with aura for which there has been a significant increase amongst US military personnel over the past decade. To date, there has not been a scientific report on hemiplegic migraine in United States military personnel. MATERIALS AND METHODS: The aim of this study was to provide an overview of hemiplegic migraine, to analyze data on the incidence of hemiplegic migraine in US military service members, and to evaluate demographic factors associated with hemiplegic migraine diagnoses. First time diagnoses of hemiplegic migraine were extracted from the Defense Medical Epidemiological Database according to ICD-9 and ICD-10 codes for hemiplegic migraine. One sample Chi-Square goodness of fit tests were conducted on weighted demographic samples to determine whether significant proportional differences existed between gender, age, military grade, service component, race, and marital status. RESULTS: From 1997 to 2007 there were no cases of hemiplegic migraine recorded in the Defense Medical Epidemiological Database. However, from 2008 to 2017 there was a significant increase in the number of initial diagnoses of hemiplegic migraine, from 4 in 2008 to a high of 101 in 2016. From 2008 to 2017, 597 new cases of hemiplegic migraine were reported among US military service members. Disproportional incidence of hemiplegic migraine was observed for gender, X2 (1, 597) = 297.37, p <.001, age, X2 (5, 597) = 62.60, p <.001, service component, X2 (3, 597) = 31.48, p <.001, pay grade X2 (3, 597) = 57.96, p <.001, and race, X2 (2, 597) = 37.32, p <.001, but not for marital status X2 (1, 597) = 2.57, p >.05. CONCLUSION: Over the past decade, there has been a significant increase in the number of initial diagnoses of hemiplegic migraine in Active Duty United States military personnel. Based on these diagnosis rates, there is evidence to suggest that hemiplegic migraine has a higher incidence and prevalence rate among post 9/11 service members of the United States military as compared to the general population. Given the sudden increase in new patients diagnosed with hemiplegic migraine in the past decade, the global prevalence estimates of hemiplegic migraine should be reconsidered. Additionally, the impact of hemiplegic migraine on service member's duties and responsibilities deserves further consideration.

Negative Life Events (NLEs) Contributing to Psychological Distress, Pain, and Disability in a U.S. Military Sample.

Introduction: The objective was to explore how negative life events (NLEs, e.g., litigation related to pain and disability, failing most recent physical fitness test, and financial difficulties) are related to pain coping and psychological adjustment to pain in active duty military personnel. Materials and Methods: Data were gathered as part of the Evaluation of Suicidality, Cognitions, and Pain Experience study, a DoD-funded cross-sectional assessment of chronic pain and emotional coping among a cohort of military members. The investigators examined data from 147 respondents with complete survey and pain assessment data. Results: The sample was active duty, male (62.6%), in a relationship or married (83.0%), and had children (68.7%). The majority of the sample endorsed zero NLEs (72.0%); 23.8% endorsed one NLE, 4.2% endorsed two NLEs, and no one endorsed all three NLEs. A significantly higher proportion of participants endorsing one or more NLEs reported suicidal ideation compared to those who reported no NLEs (χ2(2) = 8.61, p = 0.014). A higher number of endorsed NLEs coincided with higher symptom severity related to psychosocial distress (depression, thwarted belongingness, perceived burdensomeness, PTSD, and suicide cognitions) and poor pain coping (rumination, helplessness, and less acceptance of chronic pain). Conclusions: Findings revealed that NLEs may impart a significant burden on military pain sufferers. Greater numbers of endorsed NLEs are associated with increased psychosocial distress and poor pain coping. Future longitudinal studies examining long-term psychosocial distress/poor pain coping as related to NLEs would help to elaborate the long-term consequences of NLEs on pain coping and psychosocial distress.

Design of a clinical effectiveness trial of in-home cognitive processing therapy for combat-related PTSD.

Approximately 14% of military personnel and veterans who have deployed to the combat theater are at risk for combat-related posttraumatic stress disorder (PTSD). The treatment of combat-related PTSD in active duty service members and veterans is challenging. Combat trauma may involve multiple high levels of exposure to different types of traumatic events (e.g., human carnage after explosive blasts, life threat/injuries to self/others, etc.). Many service members and veterans are unable or unwilling to receive treatment in government facilities due to avoidance, scheduling difficulties, transportation or parking problems, concerns about career advancement, or stigma associated with seeking treatment. Innovative treatment-delivery approaches are needed to help overcome these barriers. The present study is a randomized clinical trial to evaluate three versions of Cognitive Processing Therapy (CPT; [54]) for the treatment of combat-related PTSD in active duty military service members and veterans: (1) standard In-Office CPT, (2) In-Home Telebehavioral Health CPT from the provider's office to the participant's home, and (3) In-Home CPT in which the provider delivers treatment in the participant's home. Use of an equipoise-stratified randomization design allows participants to decline one of the treatment arms. This research design partly overcomes the problems active duty military and veterans face when receiving PTSD treatment by allowing them to opt out of one inappropriate or unacceptable treatment modality and still permitting randomization to the two remaining treatment modalities. This manuscript provides an overview of the research design and methods for the study.