Feasibility, acceptability, and depression outcomes of a randomized controlled trial of Mindful Self-Compassion for Teens (MSC-T) for adolescents with subsyndromal depression.

INTRODUCTION: Adolescents are experiencing high rates of depressive symptoms, with negative consequences to their long-term health. Group-based, mindful self-compassion programs show promise in mitigating the development of more significant depression in at-risk adolescents. However, the lack of well-designed, active control conditions has limited the ability to examine the efficacy of such interventions. METHODS: Fifty-nine adolescents (Mage = 15.81, 70% female) with subsyndromal depressive symptoms from the Southeastern US were randomized to group-based Mindful Self-Compassion for Teens (N = 30) or a newly developed active control Healthy Lifestyles group (N = 29) during 2018 and 2019. Participants attended 8 weekly "main" sessions followed by 6 monthly continuation sessions. The feasibility and acceptability of participation in both groups were measured using attrition, attendance, credibility, and satisfaction data. Depression scores were collected weekly, and self-compassion scores were collected five times across 36 weeks. RESULTS: Both groups were equally feasible and acceptable during the 8-week program period; however, monthly continuation sessions were poorly attended in both groups. The risk of developing clinically significant depression was 2.6 times higher in the control group compared with the self-compassion group (p = .037) across 36 weeks. Depression significantly decreased in the self-compassion group, while it significantly increased in the control group. Both groups increased significantly in reports of self-compassion. These findings are on par with results noting the efficacy of cognitive-based interventions for high-risk adolescents; follow-up studies with larger sample sizes should be conducted to confirm these findings. CONCLUSIONS: Initial examination suggests Mindful Self-Compassion for Teens programming is feasible, acceptable, and efficacious in preventing the development of clinically significant depression in adolescents with subsyndromal depression. Future studies may benefit from refinements to the self-compassion measurement and/or the attention control condition; moreover, larger sample sizes are needed to confirm results.

Feasibility and Preliminary Effectiveness of an Online Meditation Intervention in Young Adults With Concussion History.

CONTEXT: Mindfulness interventions (yoga, meditation) in traumatic brain injury populations show promising improvements in injury outcomes. However, most studies include all injury severities and use in-person, general programming lacking accessibility and specificity to the nuance of concussion. Therefore, this study investigated the feasibility and preliminary effectiveness of an online, concussion-focused meditation intervention among young adults with a concussion history. DESIGN: Unblinded, single-arm, pilot intervention. METHODS: Fifteen young adults aged 18 to 30 with a concussion history within the past 5 years completed 10 to 20 minutes per day of online, guided meditations for 6 weeks. Feasibility was assessed using the Feasibility of Intervention Measure. Concussion symptoms were measured using the Rivermead Post-Concussion Symptom Questionnaire, perceived stress the Perceived Stress Scale-10, and mindfulness the Five Facet Mindfulness Questionnaire. Descriptive statistics described the study sample and determined intervention adherence and feasibility. Paired sample t tests were used to examine preintervention/postintervention changes in concussion symptoms, perceived stress, and mindfulness, with descriptive statistics further detailing significant t tests. RESULTS: Fifteen participants were enrolled, and 12 completed the intervention. The majority completed 5+ days per week of the meditations, and Feasibility of Intervention Measure (17.4 [1.8]) scores indicated high feasibility. Concussion symptom severity significantly decreased after completing the meditation intervention (11.3 [10.3]) compared with before the intervention (24.5 [17.2]; t[11] = 3.0, P = .01). The number of concussion symptoms reported as worse than before their concussion significantly decreased after completing the meditation intervention (2.7 [3.9]) compared with before the intervention (8.0 [5.7]; t[11] = 3.7, P = .004). Postintervention, 83.33% (n = 10) reported lower concussion symptom severity, and 75.00% (n = 9) reported less concussion symptoms as a mild, moderate, or severe problem (ie, worse than before injury). CONCLUSIONS: Findings suggest positive adherence and feasibility of the meditation intervention, with the majority reporting concussion symptom improvement postintervention. Future research is necessary to expand these pilot findings into a large trial investigating concussion-specific meditation programming.

Leukocyte inflammatory phenotype and function in migraine patients compared with matched non-migraine volunteers: a pilot study.

BACKGROUND: Migraine is a neurological condition characterized by chronic inflammation. However, not much is known about the potential role of peripheral blood immune cells in the pathophysiology of migraine. METHODS: We investigated the status of peripheral blood immune cells of 15 adults with frequent episodic or chronic migraine recruited chronologically from a randomized clinical trial (RCT) on Nutrition for Migraine (NCCIH 5R01AT007813-05) and 15 non-migraine, healthy volunteers (control) matched by age, gender, and Body Mass Index (BMI). Continuous variables were presented as means ± standard deviationas well as medians, and comparisons between patients and healthy volunteers were performed with non-parametric Wilcoxon signed rank tests. Statistical analysis was performed using Stata (StataCorp. 2019. Stata Statistical Software). Fluorescence-Activated Cell Sorting (FACS) data were processed using FlowJo software (Ashland, OR: Becton, Dickenson and Company; 2019). RESULTS: We observed that migraineurs had a significantly lower percentage of non-classical monocytes (CD14+CD16++) in blood circulation, compared to the control group. In addition, Migraineurs also showed a significantly lower percentage of blood CD3+CD4+ helper T cells and CD4+CD25+ regulatory T cells, compared to controls. Differences in leukocyte surface markers between chronic migraine patients and their matched controls were more prominent than those between episodic migraine patients and their matched controls. CONCLUSIONS: Our results suggest that migraine is associated with dysregulated peripheral immune homeostasis and that inflammation and autoimmunity may play a role in its pathophysiology.

Effects of Mindfulness-Based Stress Reduction on Experimental Pain Sensitivity and Cortisol Responses in Women With Early Life Abuse: A Randomized Controlled Trial.

OBJECTIVE: Early life abuse (ELAb) initiates pathophysiological cascades resulting in long-term maladaptive stress responsivity, hyperalgesia, and an increased risk of psychopathology. Mindfulness-based stress reduction (MBSR) is effective in modifying psychological and somatic symptoms; thus, we predicted that MBSR would be particularly efficacious for women with ELAb. METHOD: Medically healthy women (mean age = 31 years) with or without a history of early (≤13 years) physical or sexual abuse provided self-report measures and were tested in the laboratory before and after randomization to standard MBSR (n = 52) or social support (SSG) (n = 60) for 8 weeks. The laboratory procedure involved pain testing using the cold pressor and temporal summation of heat pain (indexing central sensitization) procedures, and exposure to the Trier Social Stress Test. Plasma cortisol in response to the experimental protocol was assessed as area under the curve (AUC). RESULTS: The interventions differentially impacted pain sensitivity and cortisol AUC for women with ELAb, as MBSR increased the temporal summation of heat pain intensity ratings (p = .024) and reduced cortisol AUC (p = .004). For women without ELAb, MBSR decreased cold pressor tolerance (p = .045) and decreased the temporal summation of heat pain intensity ratings relative to SSG (p = .024). Both MBSR and SSG improved depression symptoms and emotion regulation abilities (p values < .001); however, MBSR was associated with greater benefits in describing emotions (p = .008) and impulse control (p = .017) for women with ELAb. CONCLUSIONS: Women with ELAb benefited from MBSR-specific improvements in central sensitization, mindfulness skills, and emotion regulation abilities. This is the first study to examine the efficacy of MBSR in modifying affective and somatic symptoms based on ELAb status and provides evidence for considering ELAb in tailoring treatment approaches.Trial Registration: ClinicalTrials.gov Identifier: NCT01995916; https://clinicaltrials.gov/ct2/show/NCT01995916.

Comparing prospective headache diary and retrospective four-week headache questionnaire over 20 weeks: Secondary data analysis from a randomized controlled trial.

BACKGROUND: Headache diaries and recall questionnaires are frequently used to assess headache frequency and severity in clinical and research settings. METHODS: Using 20 weeks of data from an intervention trial with 182 participants, we evaluated concordance between an electronic headache diary administered on a daily basis and designed to capture the presence and severity of headaches on an hourly basis (the headache diary) and a recall questionnaire, with retrospective estimation of the number of headache days assessed on a monthly basis. We further examined whether the duration or severity of headaches assessed by the electronic diary impacted concordance between these two measures. RESULTS: Over the course of four 28-day periods, people with migraine participating in a dietary intervention reported an average of 13.7 and 11.1 headache days in the headache diary and recall questionnaire, respectively. CONCLUSION: Over time, the concordance between headache days reported in these two measures tended to increase; however, the recall questionnaire headache estimates were lower than the diary measures in all four periods. When analysis was restricted to headaches lasting 8 hours or more, the number of headache days was more closely aligned with days reported in the recall questionnaire, indicating that the accuracy of recall estimates is likely to be influenced by headache duration. Restriction of analyses to moderate-to-severe headaches did not change results as much as headache duration. The findings indicate that recall questionnaires administered on a monthly basis may underestimate headache frequency and therefore should not be used interchangeably with headache diaries.Clinical Trials.gov Identifier: NCT02012790.

Feasibility and Acceptability of an Abbreviated, Four-Week Mindfulness Program for Chronic Pain Management.

OBJECTIVE: The Mindfulness-Based Stress Reduction program is effective at improving chronic pain outcomes, but the time demand hinders participation. This preliminary study evaluated the feasibility, acceptability, and potential effects of providing an abbreviated mindfulness program for patients with chronic pain. DESIGN: A single-arm, mixed-methods, pre-post intervention study. SETTING: An outpatient rehabilitation clinic at an academic medical center. SUBJECTS: Participants were N = 23 adults with chronic pain who were new to mindfulness practice. METHODS: Mindfulness-based Stress Reduction was adapted to shorten the program to four weekly 90-minute sessions and to focus content on pain management. Three cohorts of six to nine participants completed baseline and post-treatment measures of 1) patient-reported outcomes, including pain intensity, pain interference, physical functioning, depressive/anxiety symptoms, positive affect and well-being, and sleep disturbance; 2) pain medication dosages; 3) psychosocial variables including pain acceptance, pain catastrophizing, and perceived stress; 4) dispositional mindfulness, as well as postintervention structured interviews about their experiences. RESULTS: Acceptable rates of retention and attendance and high ratings of satisfaction indicated that the intervention was feasible and acceptable. In interviews, participants found the program acceptable and beneficial and provided suggestions to improve it. From pre- to post-treatment, significant improvements were reported in all measures except physical functioning and anxiety. CONCLUSIONS: In adults with chronic pain, a four-week mindfulness program is feasible and acceptable, addresses the barrier of a lengthy program, and may improve quality of life and psychological functioning. An appropriately powered randomized controlled trial with a comparison group is needed to assess the intervention's effectiveness.

Trends in Yoga, Tai Chi, and Qigong Use Among US Adults, 2002-2017.

OBJECTIVES: To examine the characteristics and temporal trends of yoga, tai chi, and qigong (YTQ) use among US adults. METHODS: Using the 2002, 2007, 2012, and 2017 National Health Interview Surveys, we examined the prevalence, patterns, and predicting factors of YTQ use by Taylor series linear regression, the Wald F χ2 test, and multivariable logistic regression models (n = 116 404). RESULTS: YTQ use increased from 5.8% in 2002 to 14.5% in 2017 (P ≤ .001). Only 6.6% of YTQ users were referred by their medical doctors, and approximately one third disclosed their use of YTQ to medical professionals. Reasons for using YTQ included (1) YTQ was beneficial, (2) YTQ focused on the whole person, and (3) YTQ was natural. Acute and chronic pain, arthritis, and depression were the top 3 medical conditions for which people used YTQ the most. CONCLUSIONS: YTQ use is increasing substantially, mainly because of its natural and holistic healing approach toward health and chronic diseases. Future studies aiming to explore how to best integrate YTQ into the current health care system are warranted.

A mindful self-compassion videoconference intervention for nationally recruited posttreatment young adult cancer survivors: feasibility, acceptability, and psychosocial outcomes.

PURPOSE: Young adult (YA) cancer survivors report substantial distress, social isolation, and body image concerns that can impede successful reintegration into life years after treatment completion. Mindful Self-Compassion (MSC) interventions focus on developing mindfulness and self-compassion for managing distress, hardships, and perceived personal inadequacies. An MSC intervention would be beneficial in supporting YA survivors' management of psychosocial challenges that arise in survivorship; however, a telehealth intervention modality is essential for reaching this geographically dispersed population. We conducted a single-arm feasibility study of an MSC 8-week videoconference intervention for nationally recruited YA survivors (ages 18-29). METHODS: The MSC intervention was group-based, 90-minute videoconference sessions, held weekly over 8 weeks, with audio-supplemented home practice. Feasibility and acceptability were assessed via attendance rate and an intervention satisfaction scale. Baseline to post-intervention changes in psychosocial outcomes (body image, anxiety, depression, social isolation, posttraumatic growth, resilience, self-compassion, mindfulness) were assessed using paired t tests and Cohen's d effect sizes. RESULTS: Thirty-four participants were consented and 25 attended a videoconference group. Feasibility was established with 84% attending at least six of the eight sessions, and intervention acceptability was high (M = 4.36, SD = 0.40, score range = 1-5). All psychosocial outcomes, except for resilience, demonstrated significant changes (p < 0.002), with medium to large effect sizes (Cohen's d > 0.5). CONCLUSION: YA survivors are interested in receiving an MSC videoconference intervention. Feasibility, acceptance, and potential psychosocial benefits of the intervention were demonstrated. Findings can be applied toward the design of an efficacy randomized controlled trial to improve quality of life for YA survivors in transition after cancer treatment.

Comparative Benefits and Harms of Antidepressant, Psychological, Complementary, and Exercise Treatments for Major Depression: An Evidence Report for a Clinical Practice Guideline From the American College of Physicians.

BACKGROUND: Primary care patients and clinicians may prefer options other than second-generation antidepressants for the treatment of major depressive disorder (MDD). The comparative benefits and harms of antidepressants and alternative treatments are unclear. PURPOSE: To compare the benefits and harms of second-generation antidepressants and psychological, complementary and alternative medicine (CAM), and exercise treatments as first- and second-step interventions for adults with acute MDD. DATA SOURCES: English-, German-, and Italian-language studies from multiple electronic databases (January 1990 to September 2015); trial registries and gray-literature databases were used to identify unpublished research. STUDY SELECTION: Two investigators independently selected comparative randomized trials of at least 6 weeks' duration on health outcomes of adult outpatients; nonrandomized studies were eligible for harms. DATA EXTRACTION: Reviewers abstracted data on study design, participants, interventions, and outcomes; rated the risk of bias; and graded the strength of evidence. A senior reviewer confirmed data and ratings. DATA SYNTHESIS: 45 trials met inclusion criteria. On the basis of moderate-strength evidence, cognitive behavioral therapy (CBT) and antidepressants led to similar response rates (relative risk [RR], 0.90 [95% CI, 0.76 to 1.07]) and remission rates (RR, 0.98 [CI, 0.73 to 1.32]). In trials, antidepressants had higher risks for adverse events than most other treatment options; no information from nonrandomized studies was available. The evidence was too limited to make firm conclusions about differences in the benefits and harms of antidepressants compared with other treatment options as first-step therapies for acute MDD. For second-step therapies, different switching and augmentation strategies provided similar symptom relief. LIMITATION: High dropout rates, dosing inequalities, small sample sizes, and poor assessment of adverse events limit confidence in the evidence. CONCLUSION: Given their similar efficacy, CBT and antidepressants are both viable choices for initial treatment of MDD. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

Age and Gender Differences in the Associations of Self-Compassion and Emotional Well-being in A Large Adolescent Sample.

Adolescence is a challenging developmental period marked with declines in emotional well-being; however, self-compassion has been suggested as a protective factor. This cross-sectional survey study (N = 765, grades 7th to 12th; 53 % female; 4 % Hispanic ethnicity; 64 % White and 21 % Black) examined whether adolescents' self-compassion differed by age and gender, and secondly, whether its associations with emotional well-being (perceived stress, life satisfaction, distress intolerance, depressive symptoms, and anxiety) also differed by age and gender. The findings indicated that older females had the lowest self-compassion levels compared to younger females or all-age males. Self-compassion was associated with all emotional well-being measures, and gender and/or age moderated the associations with anxiety and depressive symptoms. Among older adolescents, self-compassion had a greater protective effect on anxiety for boys than for girls. Additionally, older adolescents with low and average self-compassion had greater levels of depressive symptoms than those with high self-compassion. These results may inform for whom and at what age self-compassion interventions may be implemented to protect adolescents from further declines in emotional well-being.

Weathering the seasons of cancer survivorship: mind-body therapy use and reported reasons and outcomes by stages of cancer survivorship.

PURPOSE: Mind-body therapies (MBTs), a subset of complementary and alternative medicine (CAM), are used by cancer survivors to manage symptoms related to their cancer experience. MBT use may differ by cancer survivorship stage (i.e., acute, short-term, long-term) because each stage presents varying intensities of medical activities, associated emotions, and treatment effects. We examined the relationship between MBT use and survivorship stage (acute <1 year; short-term 1 to 5 years; long-term >5 years since diagnosis) using the CAM supplement of the 2012 National Health Interview Survey. We also examined reported reasons for and outcomes of MBT use and frequency of MBT types. METHODS: The sample included cancer survivors (N = 3076) and non-cancer controls (N = 31,387). Logistic regression tested the relationship of MBT use and survivorship stage. Weighted percentages were calculated by survivorship stage for reported reasons and outcomes of use and frequency of MBT types. RESULTS: MBT use varied by cancer survivorship stage (p = 0.02): acute (8.3 %), short-term (15.4 %), long-term (11.7 %) survivorship and non-cancer controls (13.2 %). In the adjusted model, short-term survivors had 35 % greater odds of MBT use than did controls (95 % CI 1.00, 1.83). Reasons for and outcomes of MBT use varied among the survivorship stages, with more acute survivors reporting medical-related reasons and more short-term survivors reporting to manage symptoms. CONCLUSIONS: MBT may fulfill different symptom management needs at varying stages of survivorship. These findings can help inform supportive care services of survivors' use of MBT for symptom burden at each stage and the allocation of these services.

From a state to a trait: Trajectories of state mindfulness in meditation during intervention predict changes in trait mindfulness.

Theory suggests that heightening state mindfulness in meditation practice over time increases trait mindfulness, which benefits psychological health. We prospectively examined individual trajectories of state mindfulness in meditation during a mindfulness-based intervention in relation to changes in trait mindfulness and psychological distress. Each week during the eight-week intervention, participants reported their state mindfulness in meditation after a brief mindfulness meditation. Participants also completed pre- and post-intervention measures of trait mindfulness and psychological symptoms. Tests of combined latent growth and path models suggested that individuals varied significantly in their rates of change in state mindfulness in meditation during the intervention, and that these individual trajectories predicted pre-post intervention changes in trait mindfulness and distress. These findings support that increasing state mindfulness over repeated meditation sessions may contribute to a more mindful and less distressed disposition. However, individuals' trajectories of change may vary and warrant further investigation.

Are Formal and Informal Home Mindfulness Practice Quantities Associated With Outcomes? Results From a Pilot Study of a Four-Week Mindfulness Intervention for Chronic Pain Management.

Background: The association between home mindfulness practice quantity in standard length mindfulness-based interventions (MBIs) and chronic pain outcomes is variable. Few studies focus on abbreviated MBIs (< 8 weeks) and distinguish between formal guided practices and informal practices in daily life. Objectives: To characterize home mindfulness practice and explore associations between home practice quantity and pre-to-post-outcome changes after an MBI for chronic pain. Methods: In this single-arm study, 21 adults with chronic pain (mean age = 54 years, 81% White, mean pain duration = 7 years) completed an MBI with four weekly group sessions. Pre and post self-report measures of pain intensity/interference, physical function, depression, anxiety, positive affect, sleep disturbance (all PROMIS measures), and pain acceptance, catastrophizing, perceived stress and mindfulness were completed, along with daily surveys of formal (mindfulness of breath, body scan) and informal (breathing space, mindfulness of daily activities) practice. Bivariate correlations and multivariable regression models were used to assess the association between days and minutes of practice and change in outcomes. Results: On average, formal practice was completed on 4.3 days per week and 13.5 minutes per day. Informal practice was completed on 3.5 days per week and 8.6 minutes per day. Formal practice was not significantly correlated with outcomes (Spearman's ρ = |.01|-|.32|), whereas informal practice was correlated with multiple outcomes (ρ = |.04|-|.66|). Number of days practiced informally was associated with improved pain interference, physical function, sleep disturbance, and catastrophizing (p's ≤ .05). Number of minutes practiced informally was associated with improved pain interference, anxiety, positive affect, and catastrophizing (p's ≤ .05). Conclusion: Informal home practice quantity, but not formal practice quantity, is associated with improved outcomes during an abbreviated MBI for chronic pain. For these MBIs, it is important to evaluate the distinct roles of formal and informal practice. ClinicalTrialsgov Registration: NCT03495856.

Protocol of the HARMONY study: A culturally relevant, randomized-controlled, stress management intervention to reduce cardiometabolic risk in African American women.

BACKGROUND: African American Women (AAW) are at high risk for stress-related cardiometabolic (CM) conditions including obesity, heart disease, and diabetes. Prior interventions lack attention to culturally-nuanced stress phenomena (Superwoman Schema [SWS], contextualized stress, and network stress), which are positively and significantly associated with unhealthy eating and sedentary behavior. PURPOSE: The HARMONY Study is designed to test a culturally tailored mindfulness-based stress management intervention to address SWS, contextualized stress, and network stress as potential barriers to adherence to healthy exercise and eating goals. The study will help AAW build on their strengths to promote cardiometabolic health by enhancing positive reappraisal, self-regulation, and self-efficacy as protective factors against chronic stress-inducing biobehavioral morbidity and mortality risk. METHODS: This two-arm, randomized-controlled trial will test the effects of two group-based, online interventions. HARMONY 1 includes culturally-tailored exercise and nutrition education. HARMONY 2 includes mindfulness-based stress reduction, exercise, and nutrition education. We aim to recruit 200 AAW ≥ 18 years old with CM risk. RESULTS: Primary outcomes (actigraphy and carotenoid levels) and secondary outcomes (body composition, inflammatory markers, glucose metabolism, and stress) are being collected at baseline and 4-, 8-, and 12-months post-intervention. Intent-to-treat, data analytic approaches will be used to test group differences for the primary outcomes. DISCUSSION: This study is the first to address culturally-nuanced stress phenomena in AAW (SWS, network stress, and contextualized stress) using culturally-tailored stress management, exercise, and nutrition educational approaches to reduce biobehavioral CM risk among AAW. Quantitative and qualitative results will inform the development of scalable and sustainable CM risk-reduction programming for AAW. TRIAL REGISTRATION: The Multiple PIs registered the clinical trial (Identifier: NCT04705779) and reporting of summary results in ClinicalTrials.gov in accordance with the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information, within the required timelines.

Integrative medical group visits for patients with chronic pain: results of a pilot single-site hybrid implementation-effectiveness feasibility study.

Background: Approximately 20% of adults in the United States experience chronic pain. Integrative Medical Group Visit (IMGV) offers an innovative approach to chronic pain management through training in mindfulness, nutrition, and other mind-body techniques combined with peer support. To date, there are no studies on IMGV implementation, despite its promise as a feasible non-pharmacological intervention for chronic pain management. In this study, we assessed the feasibility of implementing IMGV and assessing its effectiveness for chronic pain. Methods: Implementation Mapping was used to develop and evaluate implementation strategies for IMGV. Strategies included disseminating educational materials, conducting ongoing training, and conducting educational meetings. IMGV was delivered by three healthcare providers: an allopathic physician, registered yoga teacher, and naturopathic physician. The effectiveness of IMGV on patient health outcomes was assessed through qualitative interviews and a Patient-Reported Outcomes Scale (PROMIS-29). Provider perspectives of acceptability, appropriateness, and feasibility were assessed through periodic reflections (group interviews reflecting on the process of implementation) and field notes. Paired t-tests were used to assess changes between scores at baseline and post intervention. Qualitative data were coded by three experienced qualitative researchers using thematic content analysis. Results: Of the initial 16 patients enrolled in research, 12 completed at least two sessions of the IMGV. Other than fatigue, there was no statistically significant difference between the pre- and post-scores. Patients reported high satisfaction with IMGV, noting the development of new skills for self-care and the supportive community of peers. Themes from patient interviews and periodic reflections included the feasibility of virtual delivery, patient perspectives on acceptability, provider perspectives of feasibility and acceptability, ease of recruitment, complexity of referral and scheduling process, balancing medical check-in with group engagement, and nursing staff availability. Conclusions: IMGV was feasible, acceptable, and effective from the perspectives of patients and providers. Although statistically significant differences were not observed for most PROMIS measures, qualitative results suggested that participants experienced increased social support and increased pain coping skills. Providers found implementation strategies effective, except for engaging nurses, due to staff being overwhelmed from the pandemic. Lessons learned from this pilot study can inform future research on implementation of IMGV.

Dietary fatty acids improve perceived sleep quality, stress, and health in migraine: a secondary analysis of a randomized controlled trial.

Background: Migraine is a prevalent disabling condition often associated with comorbid physical and psychological symptoms that contribute to impaired quality of life and disability. Studies suggest that increasing dietary omega-3 fatty acid is associated with headache reduction, but less is known about the effects on quality of life in migraine. Methods: After a 4-week run-in, 182 adults with 5-20 migraine days per month were randomized to one of the 3 arms for sixteen weeks. Dietary arms included: H3L6 (a high omega-3, low omega-6 diet), H3 (a high omega-3, an average omega-6 diet), or a control diet (average intakes of omega-3 and omega-6 fatty acids). Prespecified secondary endpoints included daily diary measures (stress perception, sleep quality, and perceived health), Patient-Reported Outcome Measurement Information System Version 1.0 ([PROMIS©) measures and the Migraine Disability Assessment (MIDAS). Analyses used linear mixed effects models to control for repeated measures. Results: The H3L6 diet was associated with significant improvements in stress perception [adjusted mean difference (aMD): -1.5 (95% confidence interval: -1.7 to -1.2)], sleep quality [aMD: 0.2 (95% CI:0.1-0.2)], and perceived health [aMD: 0.2 (0.2-0.3)] compared to the control. Similarly, the H3 diet was associated with significant improvements in stress perception [aMD: -0.8 (-1.1 to -0.5)], sleep quality [aMD: 0.2 (0.1, 0.3)], and perceived health [aMD: 0.3 (0.2, 0.3)] compared to the control. MIDAS scores improved substantially in the intervention groups compared with the control (H3L6 aMD: -11.8 [-25.1, 1.5] and H3 aMD: -10.7 [-24.0, 2.7]). Among the PROMIS-29 assessments, the biggest impact was on pain interference [H3L6 MD: -1.8 (-4.4, 0.7) and H3 aMD: -3.2 (-5.9, -0.5)] and pain intensity [H3L6 MD: -0.6 (-1.3, 0.1) and H3 aMD: -0.6 (-1.4, 0.1)]. Discussion: The diary measures, with their increased power, supported our hypothesis that symptoms associated with migraine attacks could be responsive to specific dietary fatty acid manipulations. Changes in the PROMIS© measures reflected improvements in non-headache pain as well as physical and psychological function, largely in the expected directions. These findings suggest that increasing omega-3 with or without decreasing omega-6 in the diet may represent a reasonable adjunctive approach to reducing symptoms associated with migraine attacks. Trial Registration: ClinicalTrials.gov NCT02012790.

Therapeutic mechanisms of a mindfulness-based treatment for IBS: effects on visceral sensitivity, catastrophizing, and affective processing of pain sensations.

Irritable bowel syndrome (IBS) is a prevalent functional disorder characterized by abdominal pain and hypervigilance to gastrointestinal sensations. We hypothesized that mindfulness training (MT), which promotes nonreactive awareness of emotional and sensory experience, may target underlying mechanisms of IBS including affective pain processing and catastrophic appraisals of gastrointestinal sensations. Seventy five female IBS patients were randomly assigned to participate in either 8 weeks of MT or a social support group. A theoretically grounded, multivariate path model tested therapeutic mediators of the effect of MT on IBS severity and quality of life. Results suggest that MT exerts significant therapeutic effects on IBS symptoms by promoting nonreactivity to gut-focused anxiety and catastrophic appraisals of the significance of abdominal sensations coupled with a refocusing of attention onto interoceptive data with less emotional interference. Hence, MT appears to target and ameliorate the underlying pathogenic mechanisms of IBS.

Aerobic exercise, mindfulness meditation, and stress-reduction in high-stress, college-based young adults: A pilot study.

This pilot study assessed the feasibility and combined effect of aerobic exercise (AE) and mindfulness meditation (MM), compared with MM alone and a control (CON) condition, on stress, anxiety, and depression in high-stress college-based young adults. Thirty-two participants (84.4% F, 20.5 ± 2.7 years, 23.9 ± 5.0 kg/m2) were randomized to a four-week, AE + MM (n = 16), MM (n = 10), or control intervention (n = 6). ANOVA revealed non-significant, but noteworthy group x time interactions (perceived stress: p = 0.09; anxiety/depression: p = 0.07). Both AE + MM and MM seem to be feasible strategies to reduce levels of stress, anxiety and depression in college-based young adults.