Comparing the clinical and cost-effectiveness of remote (telehealth and online) cognitive behavioral therapy-based treatments for high-impact chronic pain relative to usual care: study protocol for the RESOLVE multisite randomized control trial.

BACKGROUND: Cognitive behavioral therapy for chronic pain (CBT-CP) is an effective but underused treatment for high-impact chronic pain. Increased access to CBT-CP services for pain is of critical public health importance, particularly for rural and medically underserved populations who have limited access due to these services being concentrated in urban and high income areas. Making CBT-CP widely available and more affordable could reduce barriers to CBT-CP use. METHODS: As part of the National Institutes of Health Helping to End Addiction Long-term® (NIH HEAL) initiative, we designed and implemented a comparative effectiveness, 3-arm randomized control trial comparing remotely delivered telephonic/video and online CBT-CP-based services to usual care for patients with high-impact chronic pain. The RESOLVE trial is being conducted in 4 large integrated healthcare systems located in Minnesota, Georgia, Oregon, and Washington state and includes demographically diverse populations residing in urban and rural areas. The trial compares (1) an 8-session, one-on-one, professionally delivered telephonic/video CBT-CP program; and (2) a previously developed and tested 8-session online CBT-CP-based program (painTRAINER) to (3) usual care augmented by a written guide for chronic pain management. Participants are followed for 1 year post-allocation and are assessed at baseline, and 3, 6, and 12 months post-allocation. The primary outcome is minimal clinically important difference (MCID; ≥ 30% reduction) in pain severity (composite of pain intensity and pain-related interference) assessed by a modified 11-item version of the Brief Pain Inventory-Short Form at 3 months. Secondary outcomes include pain severity, pain intensity, and pain-related interference scores, quality of life measures, and patient global impression of change at 3, 6, and 12 months. Cost-effectiveness is assessed by incremental cost per additional patient with MCID in primary outcome and by cost per quality-adjusted life year achieved. Outcome assessment is blinded to group assignment. DISCUSSION: This large-scale trial provides a unique opportunity to rigorously evaluate and compare the clinical and cost-effectiveness of 2 relatively low-cost and scalable modalities for providing CBT-CP-based treatments to persons with high-impact chronic pain, including those residing in rural and other medically underserved areas with limited access to these services. TRIAL REGISTRATION: ClinicalTrials.gov NCT04523714. This trial was registered on 24 August 2020.

Suicide Deaths Before and During the Coronavirus Disease 2019 Pandemic: An Interrupted Time-series Study.

INTRODUCTION: With stressors that are often associated with suicide increasing during the coronavirus disease 2019 (COVID-19) pandemic, there has been concern that suicide mortality rates may also be increasing. Our objective was to determine whether suicide mortality rates increased during the COVID-19 pandemic. METHODS: We conducted an interrupted time-series study using data from January 2019 through December 2020 from 2 large integrated health care systems. The population at risk included all patients or individuals enrolled in a health plan at HealthPartners in Minnesota or Henry Ford Health System in Michigan. The primary outcome was change in suicide mortality rates, expressed as annualized crude rates of suicide death per 100,000 people in 10 months following the start of the pandemic in March 2020 compared with the 14 months prior. RESULTS: There were 6,434,675 people at risk in the sample, with 55% women and a diverse sample across ages, race/ethnicity, and insurance type. From January 2019 through February 2020, there was a slow increase in the suicide mortality rate, with rates then decreasing by 0.45 per 100,000 people per month from March 2020 through December 2020 (SE=0.19, P=0.03). CONCLUSIONS: Overall suicide mortality rates did not increase with the pandemic, and in fact slightly declined from March to December 2020. Our findings should be confirmed across other settings and, when available, using final adjudicated state mortality data.

Chronic health conditions, acute health events, and healthcare utilization among adults over age 50 in Hawai'i who use cannabis: A matched cohort study.

BACKGROUND: Research on cannabis-related health outcomes in diverse older adults is limited. The current study utilized a matched cohort study design to compare older adults in Hawai'i with identified cannabis diagnoses and matched controls on chronic health conditions, acute health events, and healthcare utilization from 2016 to 2020. METHOD: Patients age 50 + were identified using ICD-10 diagnostic codes for cannabis use, abuse, and dependence using electronic health record data from an integrated health system (Kaiser Permanente Hawai'i). Those with cannabis diagnoses (n = 275) were compared to matched non-using controls (n = 275; based on age, sex) on chronic health conditions (coronary heart disease, hypertension, COPD, chronic non-cancer pain), acute health events (myocardial infarction, respiratory symptoms, stroke, persistent or cyclic vomiting, injuries), and healthcare utilization (outpatient, inpatient, and emergency department visits) following case identification for two years. RESULTS: Participants were 19.3% Native Hawaiian/Pacific Islander, 24.4% Asian, 47.8% White, and 8.5% Other/Unknown, with an average age of 62.8 years (SD=7.3). Adjusting for covariates as possible, participants with a cannabis diagnosis had significantly greater risk of coronary heart disease, chronic non-cancer pain, stroke, myocardial infarction, cyclic vomiting, and injuries, over time, compared to controls. Cannabis use was associated with any and greater frequency of outpatient, inpatient, and emergency department visits. CONCLUSIONS: In a diverse sample, older adults who used cannabis had worse health conditions and events and used more health services over a two-year period. Future studies should evaluate cannabis-related health outcomes, effects of cannabis problem severity, as well as implications for healthcare in aging populations.

A Primary Care-Based Cognitive Behavioral Therapy Intervention for Long-Term Opioid Users With Chronic Pain : A Randomized Pragmatic Trial.

BACKGROUND: Chronic pain is common, disabling, and costly. Few clinical trials have examined cognitive behavioral therapy (CBT) interventions embedded in primary care settings to improve chronic pain among those receiving long-term opioid therapy. OBJECTIVE: To determine the effectiveness of a group-based CBT intervention for chronic pain. DESIGN: Pragmatic, cluster randomized controlled trial. (ClinicalTrials.gov: NCT02113592). SETTING: Kaiser Permanente health care systems in Georgia, Hawaii, and the Northwest. PARTICIPANTS: Adults (aged ≥18 years) with mixed chronic pain conditions receiving long-term opioid therapy. INTERVENTION: A CBT intervention teaching pain self-management skills in 12 weekly, 90-minute groups delivered by an interdisciplinary team (behaviorist, nurse, physical therapist, and pharmacist) versus usual care. MEASUREMENTS: Self-reported pain impact (primary outcome, as measured by the PEGS scale [pain intensity and interference with enjoyment of life, general activity, and sleep]) was assessed quarterly over 12 months. Pain-related disability, satisfaction with care, and opioid and benzodiazepine use based on electronic health care data were secondary outcomes. RESULTS: A total of 850 patients participated, representing 106 clusters of primary care providers (mean age, 60.3 years; 67.4% women); 816 (96.0%) completed follow-up assessments. Intervention patients sustained larger reductions on all self-reported outcomes from baseline to 12-month follow-up; the change in PEGS score was -0.434 point (95% CI, -0.690 to -0.178 point) for pain impact, and the change in pain-related disability was -0.060 point (CI, -0.084 to -0.035 point). At 6 months, intervention patients reported higher satisfaction with primary care (difference, 0.230 point [CI, 0.053 to 0.406 point]) and pain services (difference, 0.336 point [CI, 0.129 to 0.543 point]). Benzodiazepine use decreased more in the intervention group (absolute risk difference, -0.055 [CI, -0.099 to -0.011]), but opioid use did not differ significantly between groups. LIMITATION: The inclusion of only patients with insurance in large integrated health care systems limited generalizability, and the clinical effect of change in scores is unclear. CONCLUSION: Primary care-based CBT, using frontline clinicians, produced modest but sustained reductions in measures of pain and pain-related disability compared with usual care but did not reduce use of opioid medication. PRIMARY FUNDING SOURCE: National Institutes of Health.

A Pilot Study to Adapt a Trauma-Informed, Mindfulness-Based Yoga Intervention for Justice-Involved Youth.

The purpose of the present study was to adapt and pilot a trauma-informed, mindfulness-based yoga (TIMBY) intervention focused on enhancing self-regulation among youth in the Georgia Department of Juvenile Justice system. In this article we (1) describe the process by which we systematically adapted an evidence-based protocol specifically for this population, (2) describe the nature of and rationale for those adaptations, (3) present some preliminary qualitative findings based on interviews with youth participants, and (4) briefly summarize how the adapted protocol will be evaluated in the subsequent feasibility trial. The iterative drafting and revision process involved modifications to a well-established, protocolized Trauma-Informed Yoga program and was identified by the project advisory board and t h rough formal interviews with intervention staff. Qualitative interviews were conducted with youth participants concerning intervention impact, credibility, and satisfaction. Several needed modifications were identified so that the intervention would be contextually appropriate for justice-involved youth. Thirty youth were enrolled in the pilot study: 77% we re Non - Hispanic Black/African-American, 18% were Non-Hispanic White, and 5% were Hispanic White. The average age was 16.45 years (range 14-20). The youth consistently reported satisfaction with the sessions and positive beliefs about how the sessions were helping them with a range of physical and psychological/ emotional challenges. Adaptations to the protocol in the present study highlight how mindfulness-based interventions for justice-involved youth need to consider what is both developmentally suitable for youth and appropriate in a justice setting. A feasibility study using this revised TIMBY protocol is underway at four Georgia Department of Juvenile Justice facilities to formally identify the barriers and facilitators to implementation for the present study and a future, larger-scale trial.

Substance use disorders and risk of suicide in a general US population: a case control study.

BACKGROUND: Prior research suggests that substance use disorders (SUDs) are associated with risk of suicide mortality, but most previous work has been conducted among Veterans Health Administration patients. Few studies have examined the relationship between SUDs and suicide mortality in general populations. Our study estimates the association of SUDs with suicide mortality in a general US population of men and women who receive care across eight integrated health systems. METHODS: We conducted a case-control study using electronic health records and claims data from eight integrated health systems of the Mental Health Research Network. Participants were 2674 men and women who died by suicide between 2000-2013 and 267,400 matched controls. The main outcome was suicide mortality, assessed using data from the health systems and confirmed by state death data systems. Demographic and diagnostic data on substance use disorders and other health conditions were obtained from each health system. First, we compared descriptive statistics for cases and controls, including age, gender, income, and education. Next, we compared the rate of each substance use disorder category for cases and controls. Finally, we used conditional logistic regression models to estimate unadjusted and adjusted odds of suicide associated with each substance use disorder category. RESULTS: All categories of substance use disorders were associated with increased risk of suicide mortality. Adjusted odds ratios ranged from 2.0 (CI 1.7, 2.3) for patients with tobacco use disorder only to 11.2 (CI 8.0, 15.6) for patients with multiple alcohol, drug, and tobacco use disorders. Substance use disorders were associated with increased relative risk of suicide for both women and men across all categories, but the relative risk was more pronounced in women. CONCLUSIONS: Substance use disorders are associated with significant risk of suicide mortality, especially for women, even after controlling for other important risk factors. Experiencing multiple substance use disorders is particularly risky. These findings suggest increased suicide risk screening and prevention efforts for individuals with substance use disorders are needed.

Benefits and challenges of using service dogs for veterans with posttraumatic stress disorder.

OBJECTIVE: Veterans with posttraumatic stress disorder (PTSD) are increasingly seeking service dogs to help them manage trauma-related symptoms, yet literature describing service dog use in this population is scant. The goal of this study was to document the benefits and challenges experienced by veterans with service dogs trained to assist with PTSD-related needs. METHOD: Participants were veterans (N = 41) with service dogs, and their caregivers (n = 8), recruited through community-based service dog training agencies. We conducted in-depth interviews and observed training sessions as part of a larger study, and used thematic analysis to characterize data. RESULTS: Veterans reported that service dogs reduced hypervigilance by alerting and creating boundaries, and disrupted nightmares, improving sleep quality and duration. Dogs also helped veterans turn their attention away from invasive trauma-related thoughts. Additional reported benefits included improved emotional connections with others, increased community participation and physical activity, and reduced suicidal impulses and medication use. Demands of training, adjustment to life with a service dog, and delayed benefits were challenging for many veterans and caregivers. CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: Veterans report that service dogs help reduce PTSD symptoms and facilitate recovery and realization of meaningful goals. Service dogs may be a reasonable option for veterans who are reluctant to pursue or persist with traditional evidence-based treatments. Additional rigorous research on the effectiveness of service dogs for this population is warranted. (PsycINFO Database Record

Interdisciplinary team-based care for patients with chronic pain on long-term opioid treatment in primary care (PPACT) - Protocol for a pragmatic cluster randomized trial.

BACKGROUND: Chronic pain is one of the most common, disabling, and expensive public health problems in the United States. Interdisciplinary pain management treatments that employ behavioral approaches have been successful in helping patients with chronic pain reduce symptoms and regain functioning. However, most patients lack access to such treatments. We are conducting a pragmatic clinical trial to test the hypothesis that patients who receive an interdisciplinary biopsychosocial intervention, the Pain Program for Active Coping and Training (PPACT), at their primary care clinic will have a greater reduction in pain impact in the year following than patients receiving usual care. METHODS/DESIGN: This is an effectiveness-implementation hybrid pragmatic clinical trial in which we randomize clusters of primary care providers and their patients with chronic pain who are on long-term opioid therapy to 1) receive an interdisciplinary behavioral intervention in conjunction with their current health care or 2) continue with current health care services. Our primary outcome is pain impact (a composite of pain intensity and pain-related interference) measured using the PEG, a validated three-item assessment. Secondary outcomes include pain-related disability, patient satisfaction, opioids dispensed and health care utilization. An economic evaluation assesses the resources and costs necessary to deliver the intervention and its cost-effectiveness compared with usual care. A formative evaluation employs mixed methods to understand the context for implementation in the participating health care systems. DISCUSSION: This trial will inform the feasibility of implementing interdisciplinary behavioral approaches to pain management in the primary care setting, potentially providing a more effective, safer, and more satisfactory alternative to opioid-based chronic pain treatment. Clinical Trials Registration Number: NCT02113592.

An Observational Study of Service Dogs for Veterans With Posttraumatic Stress Disorder.

OBJECTIVES: This study examined needs related to posttraumatic stress disorder (PTSD), assistance by service dogs, and feasibility of data collection among veterans receiving service dogs. METHODS: Questionnaires assessed PTSD-related needs and services performed or expected to be performed by service dogs among 78 veterans who had or were on a wait list for a service dog (average age, 42; women, 31%). Analyses compared pre-post characteristics among 22 veterans who received a service dog as part of the study (91% follow-up; average follow-up=3.37±2.57 months). RESULTS: Veterans reported that the most important services performed were licking or nudging veterans to help them "stay present," preventing panic, and putting space between veterans and strangers. High follow-up rates and improvements in outcomes with moderate to large effect sizes among recipients of study-provided dogs suggest further study is warranted. CONCLUSIONS: Service dogs may be feasible supports for veterans with PTSD; randomized clinical trials are needed to assess effectiveness.

Prevalence and Predictors of Complementary and Alternative Medicine Use in a Large Insured Sample of Children with Autism Spectrum Disorders.

PURPOSE: The purpose of the present study was to examine the prevalence and predictors of complementary and alternative medicine (CAM) use as well as parental perceptions of CAM efficacy in a large, geographically diverse sample of children with Autism Spectrum Disorders (ASD). METHODOLOGY: Data were obtained from a web-based survey administered to parents of children with ASD at four sites participating in the Mental Health Research Network (MHRN). The web survey obtained information about services and treatments received by children with ASD as well as the caregivers' experiences with having a child with ASD. RESULTS: Approximately 88% of the sample had either used CAM in the past or had recently used some type of CAM. The following characteristics were associated with CAM use: greater parental education, younger child age, a mix of regular and special classroom settings and prescription drug use in the past three months. CONCLUSIONS: The use of CAM was very prevalent in this large, geographically diverse sample of children with ASD. It is critical that providers be prepared to discuss the advantages and potential side effects with families to help them make well-informed health care decisions and prevent possible CAM-drug interactions.

Validation of Autism Spectrum Disorder Diagnoses in Large Healthcare Systems with Electronic Medical Records.

To identify factors associated with valid Autism Spectrum Disorder (ASD) diagnoses from electronic sources in large healthcare systems. We examined 1,272 charts from ASD diagnosed youth <18 years old. Expert reviewers classified diagnoses as confirmed, probable, possible, ruled out, or not enough information. A total of 845 were classified with 81% as a confirmed, probable, or possible ASD diagnosis. The predictors of valid ASD diagnoses were >2 diagnoses in the medical record (OR 2.94; 95% CI 2.03-4.25; p < 0.001) and being male (OR 1.51; 95% CI 1.05-2.17; p = 0.03). In large integrated healthcare settings, at least two diagnoses can be used to identify ASD patients for population-based research.

National prevalence of receipt of antidepressant prescriptions by persons without a psychiatric diagnosis.

OBJECTIVE: The study addressed recent concerns regarding increasing prescription of antidepressant drugs to patients with no recorded psychiatric diagnosis. METHODS: Records from ten large integrated health systems in the Mental Health Research Network were used to examine diagnoses received by 1,011,946 health plan members who filled at least one antidepressant prescription in 2010. RESULTS: Among individuals filling antidepressant prescriptions, psychiatric diagnoses recorded during the year were depressive disorders (48%), anxiety disorders (27%), bipolar disorders (3%), and attention deficit disorders (3%). The proportion of those filling prescriptions who had no psychiatric diagnosis was 39%, which fell to 27% after the analysis excluded prescriptions for antidepressants often prescribed for nonpsychiatric indications (tricyclic antidepressants, trazodone, and bupropion). CONCLUSIONS: Prescription of antidepressants to patients without an appropriate diagnosis appears to be less common than previously reported.

Prevalence and predictors of complementary and alternative medicine use in African-Americans with acquired immune deficiency syndrome.

BACKGROUND: The use of complementary and alternative medicine (CAM) among Human Immunodeficiency Virus (HIV)-positive individuals is becoming increasingly widespread. Unfortunately, some CAM therapies may jeopardize the efficacy of conventional HIV medication, making it critical to understand CAM use among this population. OBJECTIVE: To investigate the prevalence and predictors of CAM use in a theory-driven, multidimensional manner. METHODS: African-American individuals who had received a diagnosis of acquired immune deficiency syndrome (AIDS) were recruited. The computer-administered survey asked questions about participants' CAM use and various psychosocial and socio-demographic characteristics. Participants' most recent CD4+ cell counts and HIV RNA levels were abstracted from medical records. Linear regression analyses, adjusted for potential confounders, were conducted to assess the independent contribution of various factors in explaining frequency of CAM use. RESULTS: One hundred and eighty two subjects participated in the survey. Results indicate that most (94%) participants used at least one type of CAM therapy. The majority of participants (79.7%) used CAM therapies as a complement (rather than an alternative) to their HIV medications though half had not discussed these therapies with their healthcare providers. Female sex, high yearly income, high health literacy and high HIV RNA levels were associated with a greater frequency of CAM use, while stronger emotional well-being was associated with a lower frequency of CAM use. CONCLUSIONS: The implications of these findings are discussed and suggestions for future research are provided.

The assessment of complementary and alternative medicine use among individuals with HIV: a systematic review and recommendations for future research.

OBJECTIVES: The use of complementary and alternative medicine (CAM), a group of health care practices and products that are not considered part of conventional medicine, has increased in recent years, particularly among individuals with human immune deficiency virus (HIV). Assessing the prevalence and predictors of CAM use among HIV-positive populations is important because some CAM therapies may adversely affect the efficacy of conventional HIV medications. Unfortunately, CAM use is not comprehensively or systematically assessed among HIV-positive populations. Therefore, the aim of the present study was to evaluate the quality of the instruments employed in observational studies assessing CAM use among HIV-positive populations by examining the degree to which these studies (1) evaluated the psychometric properties of their CAM instruments and (2) assessed the multidimensional nature of CAM use. DESIGN: A systematic review of studies was undertaken and specific review criteria were used to guide the inclusion of studies. Specifically, articles were included that were published in English and in a peer-reviewed journal between 1997 and 2007, recruited HIV-positive study participants, and assessed CAM use. Thirty-two (32) studies met these inclusion criteria. RESULTS: Results suggest that CAM assessment among HIV-positive populations continues to be problematic. For example, approximately 20% of the studies assessed the reliability and 3% assessed the validity of the CAM instrument employed. CONCLUSIONS: CAM assessment--regardless of the specific study population--is a complex and challenging task. However, CAM instruments will not become more refined over time in the absence of rigorous psychometric evaluation. Future research must assess reliability and validity and report these data in a clear and nuanced manner.

Use of complementary and alternative medicine among men with prostate cancer in a rural setting.

UNLABELLED: The purpose of this study was to examine the prevalence and predictors of complementary and alternative medicine (CAM) use among rural patients with localized prostate cancer. The study also examined the participants' disclosure of CAM use to their physicians. Baseline and 6-month follow-up data were taken from a study examining the factors that influence treatment choice and quality of life among men diagnosed with and being treated for localized prostate cancer residing in rural southwest Georgia (N = 321). A total of 291 participants were interviewed at baseline and 6-month follow-up. FINDINGS: At baseline, 26.4% reported ever using CAM. Among them, dietary supplements were the most commonly used (75%), and 56% of patients did not disclose their CAM use to their physicians. At 6-month follow-up, 11% of the study sample reported using CAM since starting treatment (half of these were new users). The proportions of CAM users who reported taking dietary supplements after treatment were significantly lower than the corresponding proportions before treatment. CAM use after treatment was more common among those who selected surgery and watchful waiting. While 44% of the sample disclosed using CAM to their doctors before treatment, 61% after treatment began (P = 0.05). We found that CAM use after cancer treatment in this population was markedly less common than in nationally reported data for cancer patients. In line with national patterns, younger and more educated rural patients were significantly more likely to have ever used CAM and to use it after treatment.

Development and evaluation of a complementary and alternative medicine use survey in African-Americans with acquired immune deficiency syndrome.

OBJECTIVES: The purpose of the current study was to develop and evaluate the psychometric properties of a culturally- and stage-of-disease-appropriate measure of complementary and alternative medicine (CAM) use among a population of African-American individuals with acquired immune deficiency syndrome (AIDS) using a mixed-method design. DESIGN: Data were collected in two phases. In phase 1, qualitative data were used to refine an existing CAM measure for the specific study population in the present study. In phase 2, this refined instrument was implemented in a larger sample. The resulting numeric data were analyzed to evaluate the psychometric properties of the revised CAM instrument. SETTING: Data were collected from patients who were receiving care from the infectious disease clinic of a large, public, urban hospital in the Southeastern United States. SUBJECTS: Patients were eligible to participate if they (1) were receiving their care from the clinic, (2) had an AIDS diagnosis, (3) were identified as African-American, (4) were > or =21 years of age, (5) spoke English, and (6) were not cognitively impaired. MEASURES: Focus groups in phase 1 were conducted with a semistructured focus group guide. Participants also completed a basic sociodemographic survey. Phase 2 participants used programmed laptops to answer questions about their CAM use and several sociodemographic questions. RESULTS: Information from the focus groups prompted some substantive revisions in the already-existing CAM survey. The revised instrument had satisfactory face validity and adequate test-retest reliability (r = 0.79). Furthermore, the instrument factored in a manner that was interpretable and consistent with prior findings. CONCLUSIONS: In order for human immunodeficiency virus health care providers to provide the best care to their patients, they need to be informed about the types and frequency of CAM use among their patients. This can be accomplished by methodologically developing CAM instruments, rigorously implementing and assessing these instruments, and then disseminating the findings to researchers and practitioners.