Randomized controlled trial protocol of health coaching for veterans with complex chronic pain.

BACKGROUND: Pain predominant multisymptom illness (pain-CMI) refers to symptom-based conditions where pain is a primary symptom. There is initial evidence that health coaching may be efficacious in treating pain-CMI because it can be tailored to the veteran's goals and emphasizes long-term behavior change, which may indirectly impact the maintaining factors of pain-CMI (e.g., catastrophizing, poor pain control, and limited activity). This paper describes the study protocol and rationale of a randomized controlled trial that will compare the efficacy of remote-delivered health coaching in reducing disability and pain impairment for veterans with pain-CMI to remote-delivered supportive psychotherapy. METHODS: This randomized controlled trial will consist of two treatment arms: remote-delivered health coaching and remote-delivered supportive psychotherapy, the active control. Each treatment condition will consist of twelve, weekly one-on-one meetings with a study provider. In addition to the baseline assessment, participants will also complete 6-week (mid-treatment), 12-week (post-treatment), and 24-week (follow-up) assessments that consist of questionnaires that can be completed remotely. The primary aims for this study are to determine whether health coaching reduces disability and pain impairment as compared to supportive psychotherapy. We will also examine whether health coaching reduces physical symptoms, catastrophizing, limiting activity, and increasing pain control as compared to supportive psychotherapy. DISCUSSION: This study will contribute to the existing literature on pain-CMI and report the effectiveness of a novel, remote-delivered behavioral intervention.

Exploring the acceptability of behavioral interventions for veterans with persistent "medically unexplained" physical symptoms.

OBJECTIVE: This study evaluated the factors that led to enrollment in, and satisfaction with, behavioral interventions for Veterans living with Gulf War Illness (GWI). METHODS: One-on-one interviews were conducted pre- and post-intervention with participants randomized to receive either telephone delivered problem-solving treatment (n = 51) or health education (N = 49). A total of 99 Veterans were interviewed pre-intervention and 60 post-intervention. Qualitative data were thematically coded and similarities in themes across the two interventions were examined. RESULTS: Before the study began, participants reported desiring to learn new information about their GWI, learn symptom-management strategies, and support improvements to care for other patients with GWI. After the intervention, Veterans felt positively about both interventions because they built strong therapeutic relationships with providers, their experiences were validated by providers, and they were provided GWI information and symptom-management strategies. Results also suggested that interventions do not have to be designed to meet all of the needs held by patients to be acceptable. A minority of participants described that they did not benefit from the interventions. CONCLUSION: The results suggest that satisfaction with behavioral interventions for GWI is driven by a strong therapeutic relationship, validating patient's experiences with GWI, and the intervention meeting some of the patient's needs, particularly increasing knowledge of GWI and improving symptom management.

Effect of Problem-solving Treatment on Self-reported Disability Among Veterans With Gulf War Illness: A Randomized Clinical Trial.

Importance: Few evidence-based treatments are available for Gulf War illness (GWI). Behavioral treatments that target factors known to maintain the disability from GWI, such as problem-solving impairment, may be beneficial. Problem-solving treatment (PST) targets problem-solving impairment and is an evidence-based treatment for other conditions. Objective: To examine the efficacy of PST to reduce disability, problem-solving impairment, and physical symptoms in GWI. Design, Setting, and Participants: This multicenter randomized clinical trial conducted in the US Department of Veterans Affairs compared PST with health education in a volunteer sample of 511 Gulf War veterans with GWI and disability (January 1, 2015, to September 1, 2019); outcomes were assessed at 12 weeks and 6 months. Statistical analysis was conducted between January 1, 2019, and December 31, 2020. Interventions: Problem-solving treatment taught skills to improve problem-solving. Health education provided didactic health information. Both were delivered by telephone weekly for 12 weeks. Main Outcomes and Measures: The primary outcome was reduction from baseline to 12 weeks in self-report of disability (World Health Organization Disability Assessment Schedule). Secondary outcomes were reductions in self-report of problem-solving impairment and objective problem-solving. Exploratory outcomes were reductions in pain, pain disability, and fatigue. Results: A total of 268 veterans (mean [SD] age, 52.9 [7.3] years; 88.4% male; 66.8% White) were randomized to PST (n = 135) or health education (n = 133). Most participants completed all 12 sessions of PST (114 of 135 [84.4%]) and health education (120 of 133 [90.2%]). No difference was found between groups in reductions in disability at the end of treatment. Results suggested that PST reduced problem-solving impairment (moderate effect, 0.42; P = .01) and disability at 6 months (moderate effect, 0.39; P = .06) compared with health education. Conclusions and Relevance: In this randomized clinical trial of the efficacy of PST for GWI, no difference was found between groups in reduction in disability at 12 weeks. Problem-solving treatment had high adherence and reduced problem-solving impairment and potentially reduced disability at 6 months compared with health education. These findings should be confirmed in future studies. Trial Registration: ClinicalTrials.gov Identifier: NCT02161133.

Protocol for a type 1 hybrid effectiveness/implementation clinical trial of collaborative specialty care for Veterans with Gulf War Illness.

AIMS: We describe a clinical trial which is seeking to determine the effectiveness and understand implementation outcomes for tele-collaborative specialty care for Veterans with Gulf War Illness (GWI). MAIN METHODS: This study will be a hybrid type 1 randomized effectiveness-implementation trial comparing tele-collaborative specialty care to electronic consultation for Gulf War Veterans with GWI (N = 220). In tele-collaborative specialty care, the specialty provider team will deliver health coaching and problem-solving treatment to Veterans and recommend a plan for analgesic optimization. In electronic consultation, the specialty provider team will make a one-time recommendation to the primary care team for locally delivered health coaching, problem-solving treatment and analgesic optimization. The primary aim will be to determine the effectiveness of tele-collaborative specialty care as compared to electronic consultation to reduce disability related to GWI. Our secondary aim will be to understand implementation outcomes. SIGNIFICANCE: There is a need to improve care for Veterans with GWI. A potentially useful model to improve care is tele-collaborative specialty care, where the specialists work with the primary care provider to synergistically treat the patients. DISCUSSION: This is the first clinical trial to prospectively compare different models of care for Veterans with GWI. This responds to multiple calls for research to improve treatment for Veterans with GWI, including from the National Academy of Medicine.

Under-recognition of medically unexplained symptom conditions among US Veterans with Gulf War Illness.

OBJECTIVE: Conditions defined by persistent "medically unexplained" physical symptoms and syndromes (MUS) are common and disabling. Veterans from the Gulf War (deployed 1990-1991) have notably high prevalence and disability from MUS conditions. Individuals with MUS report that providers do not recognize their MUS conditions. Our goal was to determine if Veterans with MUS receive an ICD-10 diagnosis for a MUS condition or receive disability benefits available to them for these conditions. METHODS: A chart review was conducted with US Veterans who met case criteria for Gulf War Illness, a complex MUS condition (N = 204, M = 53 years-old, SD = 7). Three coders independently reviewed Veteran's medical records for MUS condition diagnosis or service-connection along with comorbid mental and physical health conditions. Service-connection refers to US Veterans Affairs disability benefits eligibility for conditions or injuries experienced during or exacerbated by military service. RESULTS: Twenty-nine percent had a diagnosis of a MUS condition in their medical record, the most common were irritable colon/irritable bowel syndrome (16%) and fibromyalgia (11%). Slightly more Veterans were service-connected for a MUS condition (38%) as compared to diagnosed. There were high rates of diagnoses and service-connection for mental health (diagnoses 76% and service-connection 74%), musculoskeletal (diagnoses 86%, service-connection 79%), and illness-related conditions (diagnoses 98%, service-connection 49%). CONCLUSION: Given that all participants were Gulf War Veterans who met criteria for a MUS condition, our results suggest that MUS conditions in Gulf War Veterans are under-recognized with regard to clinical diagnosis and service-connected disability. Veterans were more likely to be diagnosed and service-connected for musculoskeletal-related and mental health conditions than MUS conditions. Providers may need education and training to facilitate diagnosis of and service-connection for MUS conditions. We believe that greater acknowledgement and validation of MUS conditions would increase patient engagement with healthcare as well as provider and patient satisfaction with care.

"Because the country, it seems though, has turned their back on me": Experiences of institutional betrayal among veterans living with Gulf War Illness.

People living with medically unexplained symptoms (MUS) often have poor quality of life and health outcomes. Many struggle to engage with and trust in healthcare systems. This qualitative study examined how experiences with institutions influence perceptions of medical care for MUS by applying the theoretical framework of institutional betrayal to narratives of U.S. military Veterans living with Gulf War Illness (GWI). Institutional betrayal refers to situations in which the institutions people depend upon for safety and well-being cause them harm. Experiences of institutional betrayal both during active military service and when first seeking treatment appeared to shape perceptions of healthcare in this sample. Veterans expressed the belief that the military failed to protect them from environmental exposures. Veterans' concerns regarding subsequent quality of healthcare were intrinsically linked to a belief that, despite official documentation to the contrary, the predominant paradigm of both the U.S. Department of Defense and the U.S. Department of Veterans Affairs (VA) is that GWI does not exist. Veterans reported that providers are not adequately trained on treatment of GWI and do not believe Veterans' descriptions of their illness. Veterans reported taking up self-advocacy, doing their own research on their condition, and resigning themselves to decrease engagement with VA healthcare or seek non-VA care. The study's findings suggest institutional level factors have a profound impact on perceptions of care and the patient-provider relationship. Future research and policy aimed at improving healthcare for people living with MUS should consider the concept of institutional betrayal.

Understanding Veterans' Causal Attributions of Physical Symptoms.

BACKGROUND: Illness beliefs are significant contributors to health outcomes. Beliefs about the cause of physical symptoms are considered particularly important among those with medically unexplained symptoms and illnesses (MUS); yet little is known about causal beliefs among those with the most severe MUS (i.e., Veterans). The goal of the current study was to examine Veteran's causal attributions of their physical symptoms. METHOD: A total of 91 combat Veterans with MUS were surveyed using a mixed-methods design about the cause of their physical symptoms, physical symptom severity, and PTSD symptoms. Causal attributions of physical symptoms were analyzed through thematic response analysis and grouped into categories. Chi-square analysis was used to assess the distribution of causal attribution types across Veterans with varying physical symptom severity and PTSD symptom severity. RESULTS: Veterans with MUS reported an average of 7.9 physical symptoms, and attributed the cause of their symptoms to seven different categories ("Do not Know," "Stress/Mental Health," "Deployment/Environment," "Functional/Symptom," "Medically Explained," "Medically Unexplained Syndrome," and "Lifestyle"). Exploratory chi-square analysis revealed significant differences in causal attributions across physical symptom severity and severity of PTSD symptoms. Veterans with more severe PTSD and Veterans with more severe physical symptoms were more likely to attribute their MUS to stress/mental health or to a medically unexplained syndrome compared with those with low/no PTSD symptoms and physical symptom severity. Veterans with minimal PTSD and Veterans with minimal physical symptom severity were more likely to attribute the cause of their MUS to lifestyle choices (e.g., exercise/diet) compared with those with high PTSD and physical symptom severity. CONCLUSION: Veterans with MUS endorse multiple, varied causal attributions for their physical symptoms, suggesting more complex causal beliefs than typically assumed. This has important implications for patient-provider communication and development of concordance around MUS treatment.

Helpful ways providers can communicate about persistent medically unexplained physical symptoms.

BACKGROUND: Communication between patients and providers about persistent "medically unexplained" physical symptoms (MUS) is characterized by discordance. While the difficulties are well documented, few studies have examined effective communication. We sought to determine what veterans with Gulf War Illness (GWI) perceive as the most helpful communication from their providers. Veterans with GWI, a type of MUS, have historically had complex relationships with medical providers. Determining effective communication for patients with particularly complex relationships may help identify the most critical communication elements for all patients with MUS. METHODS: Two hundred and-ten veterans with GWI were asked, in a written questionnaire, what was the most useful thing a medical provider had told them about their GWI. Responses were coded into three categories with 10 codes. RESULTS: The most prevalent helpful communication reported by patients was when the provider offered acknowledgement and validation (N = 70). Specific recommendations for managing GWI or its symptoms (N = 48) were also commonly reported to be helpful. In contrast, about a third of the responses indicated that nothing about the communication was helpful (N = 63). There were not differences in severity of symptoms, disability or healthcare utilization between patients who found acknowledgement and validation, specific recommendations or nothing helpful. CONCLUSIONS: Previous research has documented the discord between patients and providers regarding MUS. This study suggests that most patients are able to identify something helpful a provider has said, particularly acknowledgement and validation and specific treatment recommendations. The findings also highlight missed communication opportunities with a third of patients not finding anything helpful.

High healthcare utilization near the onset of medically unexplained symptoms.

OBJECTIVE: Patients with medically unexplained syndromes (MUS) often do not receive appropriate healthcare. A critical time for effective healthcare is the inception of MUS. The current study examined data from a prospective longitudinal study of Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) soldiers to understand the relationship of increasing physical symptom burden to healthcare utilization. METHODS: Data was examined from a prospective study of OEF/OIF soldiers assessed before and one year after deployment (n=336). Physical symptom burden was measured with the Patient Health Questionnaire (PHQ-15). Analyses were conducted with polynomial regression and response surface analysis (RSA). RESULTS: Increases in physical symptom burden predicted greater healthcare utilization one year after deployment: primary care practitioner (slope=-0.26, F=4.07, p=0.04), specialist (slope=-0.43, F=8.67, p=0.003), allied health therapy (e.g., physical therapy) (slope=-0.41, F=5.71, p=0.02) and mental health (slope=-0.32, F=4.04, p=0.05). There were no significant difference in utilization between those with consistently high levels and those with increases in physical symptom burden. CONCLUSION: This is the first prospective study to examine, and show, a relationship between onset of clinically significant physical symptoms and greater healthcare utilization. Our data suggest that patients with increasing physical symptom burden have the same level of healthcare as patients with chronic physical symptom burden. Needed next steps are to better understand the quality of care at inception and determine how to intervene so that recommended approaches to care are provided from the onset.

Increased generalization of learned associations is related to re-experiencing symptoms in veterans with symptoms of post-traumatic stress.

One interpretation of re-experiencing symptoms in post-traumatic stress disorder (PTSD) is that memories related to emotional information are stored strongly, but with insufficient specificity, so that stimuli which are minimally related to the traumatic event are sufficient to trigger recall. If so, re-experiencing symptoms may reflect a general bias against encoding background information during a learning experience, and this tendency might not be limited to learning about traumatic or even autobiographical events. To test this possibility, we administered a discrimination-and-transfer task to 60 Veterans (11.2% female, mean age 54.0 years) self-assessed for PTSD symptoms in order to examine whether re-experiencing symptoms were associated with increased generalization following associative learning. The discrimination task involved learning to choose the rewarded object from each of six object pairs; each pair differed in color or shape but not both. In the transfer phase, the irrelevant feature in each pair was altered. Regression analysis revealed no relationships between re-experiencing symptoms and initial discrimination learning. However, re-experiencing symptom scores contributed to the prediction of transfer performance. Other PTSD symptom clusters (avoidance/numbing, hyperarousal) did not account for significant additional variance. The results are consistent with an emerging interpretation of re-experiencing symptoms as reflecting a learning bias that favors generalization at the expense of specificity. Future studies will be needed to determine whether this learning bias may pre-date and confer risk for, re-experiencing symptoms in individuals subsequently exposed to trauma, or emerges only in the wake of trauma exposure and PTSD symptom development.