Study Design and Protocol of the Multisite Pregnancy 24/7 Cohort Study.

Hypertensive disorders of pregnancy and other adverse pregnancy outcomes (APOs) are associated with an increased risk of future maternal cardiovascular disease. Physical activity during pregnancy reduces the risk of these APOs, yet few meet physical activity guidelines during pregnancy. Little is known about the role of sedentary behavior or sleep in APOs, a critical gap in knowledge given these behaviors comprise the majority of a 24-hour day. To address this knowledge gap, the Pregnancy 24/7 cohort study (2020-2025) uses 2 devices for 24-hour activity assessment in each trimester of pregnancy to examine associations of sedentary behavior, sleep, and the 24-hour activity cycle (composition of sedentary behavior, physical activity, and sleep) with hypertensive disorders and other APOs. Participants (n = 500) are recruited from the University of Iowa, University of Pittsburgh, and West Virginia University in early pregnancy and followed through delivery. The activPAL3 micro and Actiwatch Spectrum Plus are worn in each trimester for 7 days of 24-hour wear to assess the 24-hour activity cycle. APOs are abstracted from medical charts. This study will provide critical data to fuel future research examining how modifying the 24-hour activity cycle in pregnancy can improve maternal health.

Cardiomyopathy in limb girdle muscular dystrophy R9, FKRP related.

INTRODUCTION: Reported frequencies of cardiomyopathy in limb girdle muscular dystrophy R9 (LGMDR9) vary. We describe the frequency and age at onset of cardiomyopathy in an LDMDR9 cohort. METHODS: Echocardiograms from 56 subjects (157 echocardiograms) with LGMDR9 were retrospectively reviewed. The cumulative probability of having an abnormal echocardiogram as a function of age was assessed by survival analysis for interval-censored data by genotype. Correlations between cardiac and clinical function were evaluated. RESULTS: Twenty-five (45%) participants had cardiomyopathy. The median age at first abnormal echocardiogram for subjects homozygous for the c.826C>A variant was 54.2 y compared to 18.1 y for all other fukutin-related protein (FKRP) genotypes (P < .0001). There was a weak correlation between ejection fraction and 10-Meter Walk Test speed (r = 0.25), but no correlation with forced vital capacity (r = 0.08). DISCUSSION: Cardiomyopathy is prevalent among those with LGMDR9 and occurs later in subjects homozygous for the c.826C>A mutation. These data will help to guide surveillance and management.

Clinical and Practice Variations in Pediatric Acute Recurrent or Chronic Pancreatitis: Report From the INSPPIRE Study.

OBJECTIVE: The aim of the study was to determine whether clinical characteristics and management of pediatric acute recurrent pancreatitis (ARP) and chronic pancreatitis (CP) differ across INSPPIRE (INternational Study Group of Pediatric Pancreatitis: In Search for a cuRE) sites. STUDY DESIGN: Data were collected from INSPPIRE and analyzed per US regions and "non-US" sites. Between-group differences were compared by Pearson chi-square test. Differences in disease burden were compared by Kruskal-Wallis test. RESULTS: Out of the 479 subjects, 121 (25%) were enrolled in West, 151 (32%) Midwest, 45 Northeast (9%), 78 (16%) South, and 84 (18%) at non-US sites. Hispanic ethnicity was more common in South (P < 0.0001); white race in Northeast (P = 0.009). CP was less common and time from diagnosis of first acute pancreatitis to CP was longer in children at non-US sites (P = 0.0002 and P = 0.011, respectively). Genetic mutations were most common among all groups; PRSS1 variants predominated in Midwest (P = 0.002). Gallstones were more frequent in South (P = 0.002). Endoscopic retrograde cholangiopancreatography (ERCP) and computed tomography (CT) imaging were more commonly utilized in United States compared with non-United States (P < 0.0001), but there were no differences in the use of MRI/MRCP. Disease burden was highest in the West and Midwest, possibly as total pancreatectomy and islet autotransplantation (TPIAT) referral sites were located in these regions. All therapies were less commonly administered in non-US sites (P < 0.0001). CONCLUSIONS: This is the first study to describe geographical variations in the INSPPIRE cohort, which possibly reflect variations in practice and referral patterns. The underlying reason behind the lower frequency of CP and fewer treatments in non-United States sites need to be further explored.

Chronic Pancreatitis: Pediatric and Adult Cohorts Show Similarities in Disease Progress Despite Different Risk Factors.

OBJECTIVES: The aim of the present study was to investigate the natural history of chronic pancreatitis (CP); patients in the North American Pancreatitis Study2 (NAPS2, adults) and INternational Study group of Pediatric Pancreatitis: In search for a cuRE (INSPPIRE, pediatric) were compared. METHODS: Demographics, risk factors, disease duration, management and outcomes of 224 children and 1063 adults were compared using appropriate statistical tests for categorical and continuous variables. RESULTS: Alcohol was a risk in 53% of adults and 1% of children (P < 0.0001); tobacco in 50% of adults and 7% of children (P < 0.0001). Obstructive factors were more common in children (29% vs 19% in adults, P = 0.001). Genetic risk factors were found more often in children. Exocrine pancreatic insufficiency was similar (children 26% vs adult 33%, P = 0.107). Diabetes was more common in adults than children (36% vs 4% respectively, P < 0.0001). Median emergency room visits, hospitalizations, and missed days of work/school were similar across the cohorts. As a secondary analysis, NAPS2 subjects with childhood onset (NAPS2-CO) were compared with INSPPIRE subjects. These 2 cohorts were more similar than the total INSPPIRE and NAPS2 cohorts, including for genetic risk factors. The only risk factor significantly more common in the NAPS2-CO cohort compared with the INSPPIRE cohort was alcohol (9% NAPS2-CO vs 1% INSPPIRE cohorts, P = 0.011). CONCLUSIONS: Despite disparity in age of onset, children and adults with CP exhibit similarity in demographics, CP treatment, and pain. Differences between groups in radiographic findings and diabetes prevalence may be related to differences in risk factors associated with disease and length of time of CP.

Recommendations for Diagnosis and Management of Autoimmune Pancreatitis in Childhood: Consensus From INSPPIRE.

OBJECTIVES: Autoimmune pancreatitis (AIP) represents a complex immune-mediated pancreas disorder. Pediatric AIP (P-AIP) is rare. We have recently summarized the characteristic features of P-AIP. We now aim to develop recommendation statements to standardize the diagnostic and therapeutic approach to P-AIP and facilitate future research in the field. METHODS: A panel of pediatric gastroenterologists participating in the International Study Group of Pediatric Pancreatitis: In search for a cuRE was formed to discuss and then vote on 15 recommendation statements. A consensus of at least 80% was obtained following 3 voting rounds and revision of the statements. RESULTS: We have now generated 15 statements to help standardize the approach to diagnosis and management of P-AIP. CONCLUSIONS: The first P-AIP recommendation statements developed by the International Study Group of Pediatric Pancreatitis: In search for a cuRE group are intended to bring standardization to the diagnosis and treatment of this rare childhood disorder. These statements may help guide a uniform approach to patient care and facilitate future research studies.

Autoimmune Pancreatitis in Children: Characteristic Features, Diagnosis, and Management.

OBJECTIVES: Autoimmune pancreatitis (AIP) is an increasingly recognized disease entity, but data in children are limited. AIP presentation and outcome in children might differ from the adult experience. We aim to determine the characteristic features of AIP in children. METHODS: Data about clinical symptoms, imaging, histology, and treatment were collected using two sources: (i) a systematic literature search and (ii) the INSPPIRE database, the largest international multicenter study of pancreatitis in children and the Cliniques Universitaires St-Luc (CUSL) registry. RESULTS: We identified 48 AIP cases: 30 from literature review, 14 from INSPPIRE, and 4 from CUSL. The median age at diagnosis was 13 years (range 2-17 years). Abdominal pain (43/47, 91%) and/or obstructive jaundice (20/47, 42%) were the most common symptoms at diagnosis. Elevated serum IgG4 levels were only observed in 9/40 (22%) children. Cross-sectional imaging studies were abnormal in all children including hypointense global or focal gland enlargement (39/47, 83%), main pancreatic duct irregularity (30/47, 64%), and common bile duct stricture (26/47, 55%). A combination of lymphoplasmacytic inflammation, pancreatic fibrosis, and ductal granulocyte infiltration were the main histological findings (18/25, 72%). Children with AIP had a prompt clinical response to steroids. Complications of AIP included failure of exocrine (4/25, 16%) and endocrine (3/27, 11%) pancreas function. CONCLUSIONS: Pediatric AIP has a distinct presentation with features similar to type 2 AIP in adults. This comprehensive report on the largest group of children with AIP to date is expected to help with the diagnosis and management of this disease and pave the way for future research studies.

Early-Onset Acute Recurrent and Chronic Pancreatitis Is Associated with PRSS1 or CTRC Gene Mutations.

OBJECTIVES: To assess whether the age of onset was associated with unique features or disease course in pediatric acute recurrent pancreatitis (ARP) or chronic pancreatitis (CP). STUDY DESIGN: Demographic and clinical information on children with ARP or CP was collected at INSPPIRE (INternational Study Group of Pediatric Pancreatitis: In Search for a CuRE) centers. The Cochran-Armitage trend test and Jonckheere-Terpstra test were used to examine for differences between pediatric age groups (<6, 6-11, and ≥12 years). RESULTS: Between September 2012 and March 2016, 342 children with ARP or CP were enrolled; 129 (38%) were <6 years of age at the time of first diagnosis of acute pancreatitis, 111 (32%) were 6-11 years of age, and 102 (30%) were ≥12 years of age. Early-onset disease was associated with mutations in cationic trypsinogen (PRSS1) (P < .01), chymotrypsin C (CTRC) (P = .01), family history of acute pancreatitis (P = .02), family history of CP (P < .01), biliary cysts (P = .04), or chronic renal failure (P = .02). Later-onset disease was more commonly present with hypertriglyceridemia (P = .04), ulcerative colitis (P = .02), autoimmune diseases (P < .0001), or medication use (P < .01). Children with later-onset disease also were more likely to visit the emergency department (P < .05) or have diabetes (P < .01). CONCLUSIONS: Early-onset pancreatitis is associated strongly with PRSS1 or CTRC mutations and family history of pancreatitis. Children with later-onset disease are more likely to have nongenetic risk factors. Future studies are needed to investigate whether the disease course, response to therapy, or clinical outcomes differ relative to the timing of disease onset.

Masking of syndrome of inappropriate antidiuretic hormone secretion: the isonatremic syndrome.

OBJECTIVE: To determine whether the administration of isotonic saline in patients undergoing spinal fusion surgery prevents the development of hyponatremia, thus masking the detection of syndrome of inappropriate antidiuretic hormone secretion (SIADH). STUDY DESIGN: Prospective observational cohort study conducted in pediatric patients undergoing spinal fusion surgery. Using established criteria for diagnosing SIADH with the exception of serum sodium as a criterion, we separated patients into those with and without masked SIADH. Random cortisol levels were measured in the perioperative period to test for adrenal insufficiency to exclude it as a cause for natriuresis and hyponatremia. RESULTS: Of the 40 patients included in the study, 13 (32%; 95% CI, 19%-49%) met study criteria for masked SIADH. The serum sodium levels between the 2 groups were not different throughout the postoperative period. The antidiuretic hormone levels were increased at 24-48 hours after surgery (20.4 pg/mL in masked SIADH group vs 6.6 pg/mL in no masked SIADH group, P = .04). Subjects with masked SIADH demonstrated a tendency for weight gain (3.9 kg vs 2.5 kg, P = .058), which was maximal on postoperative day 2. Cortisol levels were similar between the groups. CONCLUSION: Masked SIADH (SIADH-like state without hyponatremia) commonly occurs in the postoperative period in children and young adults undergoing spinal fusion surgery. Early postoperative evaluation and recognition may result in appropriate management of patient's fluid balance.

Living Well: Protocol for a web-based program to improve quality of life in rural and urban ovarian cancer survivors.

BACKGROUND: Ovarian cancer (OC) survivors commonly experience chronic symptoms including anxiety, depression, sleep disturbances, fatigue, physical symptoms, poor health-related quality of life (HRQOL), and a generally poor prognosis. Additionally, factors such as social isolation, stress, and depression are associated with key biological processes promoting tumor progression and poorer survival. Accessible psychosocial interventions to improve HRQOL and clinical outcomes are needed. This need is particularly true in rural settings where survivors may have less access to clinic-based support systems. METHODS: The Living Well Study, a cluster-randomized Phase II multi-site clinical trial, is designed to evaluate the efficacy of a group-based, web-delivered psychosocial intervention (Mindful Living) verses a Health Promotion active control (Healthy Lifestyles) in increasing HRQOL and decreasing perceived stress (primary outcomes), depressive mood, anxiety, and fatigue (secondary outcomes) for 256 OC survivors who are <5 years post-primary therapy. Mindful Living targets key concerns of OC survivors and teaches stress reduction skills and coping strategies utilizing cognitive behavioral, mindfulness, and acceptance and commitment therapies. Healthy Lifestyles provides lifestyle information including exercise, nutrition, sleep, and other survivorship topics. Interventions consist of 11 consecutive weekly group sessions lasting 1.5-2 h led by trained facilitators and two booster sessions. Participants complete psychosocial questionnaires at baseline, post-intervention, at 6-months, and at 12-months. A subset completes bloodspots for analysis of inflammatory biology. CONCLUSION: Easily accessible psychosocial interventions addressing key concerns of OC survivors are an unmet need. The Mindful Living intervention has the potential to substantially enhance HRQOL and decrease distress in OC survivors. Trial registrationclinicaltrials.gov Identifier: NCT04533763.

Family Medicine Clinician Screening and Barriers to Communication on Food Insecurity: A CERA General Membership Survey.

PURPOSE: Food insecurity (FI) is a hidden epidemic associated with worsening health outcomes affecting 33.8 million people in the US in 2021. Although studies demonstrate the importance of health care clinician assessment of a patient's food insecurity, little is known about whether Family Medicine clinicians (FMC) discuss FI with patients and what barriers influence their ability to communicate about FI. This study evaluated FM clinicians' food insecurity screening practices to evaluate screening disparities and identify barriers that influence the decision to communicate about FI. METHODS: Data were gathered and analyzed as part of the 2022 Council of Academic Family Medicine's Educational Research Alliance survey of Family Medicine general membership. RESULTS: The majority of respondents reported (66.9%) that their practice has a screening system for food insecurity, and most practices used a verbal screen with staff other than the clinician (41%) at specific visits (63.8%). Clinicians reported "rarely or never asking about FI" 40% of the time and only asking "always or frequently" 6.7% of the time. Inadequate time during appointments (44.5%) and other medical issues taking priority (29.4%) were identified as the most common barriers. The lack of resources available in the community was a significant barrier for clinicians who worked in rural areas. CONCLUSIONS: This survey provides insight into food insecurity screening disparities and identifies obstacles to FMC screening, such as time constraints, lack of resources, and knowledge of available resources. Understanding current communication practices could create opportunities for interventions to identify food insecurity and impact "Food as Medicine."

Non-cancer life stressors contribute to impaired quality of life in ovarian cancer patients.

OBJECTIVES: Diagnosis and treatment for a life threatening illness such as cancer are known to be psychologically impactful. However, little is known about the influence that non-cancer life stressors have on the quality of life (QOL) of ovarian cancer patients. The goal of the present study was to examine associations between non-cancer life stressors and QOL in 123 women with invasive epithelial ovarian cancer who were followed prospectively and longitudinally for one year. METHODS: Mixed models for repeated measures were used to examine the relationship between life stressors and QOL pre-surgery and one year later, while adjusting for age, cancer stage, depressive symptoms, anxiety, and chemotherapy status (at one year). Prospective associations between QOL pre-surgery and one-year QOL were also examined. RESULTS: Number and severity of life stressors were unrelated to QOL of participants before surgery. At one year, however, participants experiencing a greater number of life stressors reported poorer concurrent physical well-being (PWB) (p=0.015), functional well-being (FWB) (p<0.0001), social well-being (SWB) (p=0.0003), and total QOL (p<0.0001). Similar effects were found for life event severity. Finally, experiencing a greater number of life stressors pre-surgery predicted poorer overall QOL one year post-diagnosis (p<0.0001). CONCLUSIONS: Non-cancer life stressors can substantially impact long-term QOL of ovarian cancer patients, adjusting for medical variables such as chemotherapy and cancer stage, thus highlighting the importance of evaluating the stress burden of patients in ongoing cancer care.

The Fibromyalgia Transcutaneous Electrical Nerve Stimulation in Physical Therapy Study Protocol: A Multisite Embedded Pragmatic Trial.

OBJECTIVES: Transcutaneous electrical nerve stimulation (TENS) is a nonpharmacological intervention that provides an electrical current through the skin to produce analgesia. The primary purpose of this study is to examine if the addition of TENS to routine physical therapy improves movement-evoked pain in individuals with fibromyalgia in a physical therapy clinical setting. METHODS: Fibromyalgia TENS in Physical Therapy Study is a phase III embedded pragmatic clinical trial funded through the National Institutes of Health Helping to End Addiction Long-Term Initiative. This trial will utilize a randomized cluster design that includes more than 110 physical therapists in 24 to 30 physical therapy clinics within 6 health care systems and 7 states. Clinics will be randomized to TENS or No-TENS, stratified by health care system and clinic size. The plan is to enroll 600 participants, with all participants completing physical therapy as prescribed by their physical therapist. Participants at TENS clinics will utilize TENS for a minimum of 2-hour per day while at the physical therapy clinic and at home when active. The primary outcome is reduction in movement-evoked pain from baseline to day 60 on an 11-point numeric rating scale when participants sit and stand 5 times (Sit and Stand Test). Secondary outcomes include resting pain and fatigue, pain interference, fibromyalgia disease activity, movement-evoked fatigue, multidimensional assessment of fatigue, rapid assessment of physical activity, patient global impression of change, and common data elements shared across studies supported through the Helping to End Addiction Long-Term Initiative. IMPACT: The findings from this study will provide effectiveness data on TENS for individuals with fibromyalgia for health care policymakers, clinicians, and insurers. Data from this study will also inform future pragmatic trials for nonpharmacological interventions and chronic musculoskeletal pain conditions.

Active choice but not too active: public perspectives on biobank consent models.

PURPOSE: Despite important recent work, US public attitudes toward specific biobank consent models are not well understood. Public opinion data can help shape efforts to develop ethically sound and publicly trusted mechanisms for informing and consenting prospective biobank donors. The purpose of this study was to explore public perspectives toward a range of consent models currently being used or considered for use among comprehensive US biobanks. METHODS: The study used an exploratory mixed-methods design, using focus groups and telephone surveys. Eligible participants were English-speaking residents in the catchment area of a comprehensive biobank being developed at the University of Iowa. RESULTS: Forty-eight participants in seven focus groups and 751 survey participants were recruited. Biobanks were unfamiliar to almost all study participants but were seen as valuable resources. Most focus group (63%) and survey (67%) participants preferred a prospective opt-in over an opt-out consent approach. Broad, research-unspecific consent was preferred over categorical and study-specific consent models for purposes of approving future research use. CONCLUSION: Many individuals may want to make an active and informed choice at the point of being approached for biobank participation but are prepared to consent broadly to future research use and to forego additional choices as a result.

Adverse Childhood Experiences Predict Common Neurodevelopmental and Behavioral Health Conditions among U.S. Children.

OBJECTIVE: Adverse childhood experiences (ACEs) can have a significant but variable effect on childhood neurodevelopment. The purpose of this study was to quantify and compare the associations between "household challenge" ACEs and common childhood neurodevelopmental and behavioral health conditions, using nationally representative U.S. METHOD: This study used data from the 2016-2019 National Survey of Children's Health, a nationwide, population-based, cross-sectional survey. Seven household challenge ACEs (not including child maltreatment) were reported by parents/guardians: parental death, incarceration, divorce/separation, family violence, mental illness, substance abuse, and poverty. Logistic regression with sample weights was used to estimate the odds ratio (OR) for 15 parent-reported neurodevelopmental and behavioral health conditions, by the number of reported ACEs. A dose-response relationship was examined by applying tests of orthogonal polynomial contrasts to fitted logistic regression models. RESULTS: Down syndrome, Tourette syndrome and cerebral palsy were not associated with household challenge ACEs, whereas behavior/conduct problems, depression, and substance abuse were strongly associated, with adjusted ORs ranging from 6.36 (95% confidence interval (CI) 5.53, 7.32) to 9.19 (95% CI 7.79, 10.84). Other neurodevelopmental conditions not traditionally associated with childhood adversity showed moderate yet robust associations with ACEs, including autism (adjusted OR 2.15, 95% CI 1.64, 2.81), learning disability (adjusted OR 3.26, 95% CI 2.80, 3.80), and attention deficit hyperactivity disorder (adjusted OR 3.95, 95% CI 3.44, 4.53). The ORs increased with the number of ACEs, showing significant positive linear trends. CONCLUSION: We found significant dose-dependent or cumulative associations between ACEs and multiple neurodevelopmental and behavioral conditions.

Exercise with Nutrition Education to Improve Quality of Life of Adolescent and Young Adult Cancer Survivors: A Pilot Study.

Purpose: Most evidence for the relationship between physical activity, nutrition education, and late effects from cancer treatment come from cross-sectional studies. The purpose of this pilot study was to determine if 8 weeks of exercise and nutrition education in adolescent and young adult (AYA) survivors positively affects fatigue, quality of life, health-related fitness, and dietary intake. Methods: The exercise program targeted improvement in multiple areas of health-related fitness. A Registered Dietitian conducted nutrition education sessions with goal setting. To encourage activity, social engagement, and support, participants connected to a study-specific group. Fatigue and QoL (FACIT, PedsQL Teen, and Young Adult), health-related fitness (cardiovascular endurance, flexibility, muscular strength and endurance, anthropometrics), nutrition knowledge, and dietary intake assessments were conducted at weeks 1 and 10. Participant perceptions of strengths and weaknesses within the program were assessed after program completion. Results: Twenty four (16.6 ± 2.8 years) AYA cancer survivors began and completed the program. Problems with fatigue (PedsQL Teen and Young Adult) significantly improved along with decreased perceived barriers to exercise. Participants significantly improved cardiovascular endurance, flexibility, and muscular strength and endurance. Trying to make healthy nutrition choices, understanding how to read nutrition labels, and identifying a saturated fat significantly improved without a significant change in dietary intake. Participants' favorite program components related to exercise and social support. Conclusion: In view of the short- and long-term impacts of cancer diagnosis, treatment, and survivorship, as well as the benefits of physical activity on these factors, exercise programs with social support should be considered adjuvant therapy among AYA cancer survivors.

Long-term efficacy of biofeedback therapy for dyssynergic defecation: randomized controlled trial.

OBJECTIVES: Although biofeedback therapy is effective in the short-term management of dyssynergic defecation, its long-term efficacy is unknown. Our aim was to compare the 1-year outcome of biofeedback (manometric-assisted pelvic relaxation and simulated defecation training) with standard therapy (diet, exercise, laxatives) in patients who completed 3 months of either therapy. METHODS: Stool diaries, visual analog scales (VASs), colonic transit, anorectal manometry, and balloon expulsion time were assessed at baseline, and at 1 year after each treatment. All subjects were seen at 3-month intervals and received reinforcement. Primary outcome measure (intention-to-treat analysis) was a change in the number of complete spontaneous bowel movements (CSBMs) per week. Secondary outcome measures included bowel symptoms, changes in dyssynergia, and anorectal function. RESULTS: Of 44 eligible patients with dyssynergic defecation, 26 agreed to participate in the long-term study. All 13 subjects who received biofeedback, and 7 of 13 who received standard therapy, completed 1 year; 6 failed standard therapy. The number of CSBMs per week increased significantly (P<0.001) in the biofeedback group but not in the standard group. Dyssynergia pattern normalized (P<0.001), balloon expulsion time improved (P=0.0009), defecation index increased (P<0.001), and colonic transit time normalized (P=0.01) only in the biofeedback group. CONCLUSIONS: Biofeedback therapy provided sustained improvement of bowel symptoms and anorectal function in constipated subjects with dyssynergic defecation, whereas standard therapy was largely ineffective.

One-Day Acceptance and Commitment Therapy Compared to Support for Depressed Migraine Patients: a Randomized Clinical Trial.

In patients with migraine, depression is associated with poorer medical prognosis, decreased quality of life, and increased risk of suicidality and disability; yet, behavioral interventions have rarely been investigated. The current study compared the efficacy of two 1-day (5- to 6-h) interventions for co-occurring migraine and depression: (1) acceptance and commitment therapy plus migraine education (ACT-ED), and (2) support plus migraine education (S-ED). One hundred and thirty-six patients with comorbid depression and migraine were randomized to a treatment. One hundred and three (76%) completed the ACT-ED (N = 56) or S-ED (N = 47) workshop. Primary outcomes were depression diagnosis and symptoms. Secondary outcomes were anxiety symptoms, headache-related disability and general functioning, and quality of life. Assessments were completed at baseline and 3 and 6 months following the workshop. At the 6-month follow-up, on categorical outcomes, a significantly greater number of people in the ACT-ED condition no longer met criteria for a major depressive episode and exhibited a > 50% drop in symptoms on the Hamilton Rating Scale of Depression. Similarly, though, weaker results were found when examining depressive symptoms dimensionally. On secondary outcomes, people in the ACT-ED condition exhibited significantly greater improvements in anxiety, headache-related disability, and quality of social relationships, compared to S-ED, No differences between groups were observed in general functioning. A 1-day (5- to 6-h) ACT workshop can deliver substantial and lasting benefits to depressed migraineurs, over and above those provided by group support and education. This approach is an attractive alternative to weekly psychotherapy. Clinicaltrials.gov # NCT02108678.

One-day Acceptance and Commitment Therapy workshop for preventing persistent post-surgical pain and dysfunction in at-risk veterans: A randomized controlled trial protocol.

OBJECTIVE: Persistent post-surgical pain is common among patients undergoing surgery, is detrimental to patients' quality of life, and can precipitate long-term opioid use. The purpose of this randomized controlled trial is to assess the effects of a behavioral intervention offered prior to surgery for patients at risk for poor post-surgical outcomes, including persistent pain and impaired functioning. METHODS: Described herein is an ongoing randomized, patient- and assessor-blind, attention-controlled multisite clinical trial. Four hundred and thirty Veterans indicated for total knee arthroplasty (TKA) with distress and/or pain will be recruited for this study. Participants will be randomly assigned to a one-day (~5 h) Acceptance and Commitment Therapy workshop or one-day education and attention control workshop. Approximately two weeks following their TKA surgery, patients receive an individualized booster session via phone. Following their TKA, patients complete assessments at 1 week, 6 weeks, 3 months, and 6 months. RESULTS: The primary outcomes are pain intensity and knee-specific functioning; secondary outcomes are symptoms of distress and coping skills. Mediation analyses will examine whether changes in symptoms of distress and coping skills have an impact on pain and functioning at 6 months in Veterans receiving ACT. This study is conducted mostly with older Veterans; therefore, results may not generalize to women and younger adults who are underrepresented in this veteran population. CONCLUSIONS: The results of this study will provide the first evidence from a large-scale, patient- and assessor-blind controlled trial on the effectiveness of a brief behavioral intervention for the prevention of persistent post-surgical pain and dysfunction.