Iterative Design, Feasibility, and Preliminary Efficacy Testing for the Development of a Cooperative Card Game Intervention to Reduce Loneliness and Foster Social Connection.

Objective: To present the design, development, and pilot testing of Connections, an empirically derived cooperative card game intervention to reduce loneliness and enhance connection. Materials and Methods: Theory and empirical evidence from domains such as self-disclosure, interpersonal closeness, and serious games informed the design of this game. Iterative design was used to develop the intervention, followed by feasibility and preliminary efficacy pilot testing. Results: Pilot testing showed that participants felt confident playing the game and found Connections to be enjoyable, interesting, and helpful in building connections with others, and would recommend the game to others. Preliminary evaluation found statistically significant benefits across multiple domains after playing the game. Participants reported decreases in loneliness, depressed mood, and anxiousness (ps < 0.02). Additionally, participants reported increases in looking forward to forming new connections with others in the future, the degree to which they felt like opening up and talking to others, and the amount they felt like they had in common with others (ps < 0.05). Conclusion: Pilot testing of Connections demonstrated feasibility and preliminary impact among a community sample. Future development plans include minor revisions to the game instructions followed by more rigorous testing of the feasibility, usability, and efficacy of Connections among various settings and populations, with large samples and controlled trials.

Effects of a virtual voice-based coach delivering problem-solving treatment on emotional distress and brain function: a pilot RCT in depression and anxiety.

Consumer-based voice assistants have the ability to deliver evidence-based treatment, but their therapeutic potential is largely unknown. In a pilot trial of a virtual voice-based coach, Lumen, delivering problem-solving treatment, adults with mild-to-moderate depression and/or anxiety were randomized to the Lumen intervention (n = 42) or waitlist control (n = 21). The main outcomes included changes in neural measures of emotional reactivity and cognitive control, and Hospital Anxiety and Depression Scale [HADS] symptom scores over 16 weeks. Participants were 37.8 years (SD = 12.4), 68% women, 25% Black, 24% Latino, and 11% Asian. Activation of the right dlPFC (neural region of interest in cognitive control) decreased in the intervention group but increased in the control group, with an effect size meeting the prespecified threshold for a meaningful effect (Cohen's d = 0.3). Between-group differences in the change in activation of the left dlPFC and bilateral amygdala were observed, but were of smaller magnitude (d = 0.2). Change in right dlPFC activation was also meaningfully associated (r ≥ 0.4) with changes in self-reported problem-solving ability and avoidance in the intervention. Lumen intervention also led to decreased HADS depression, anxiety, and overall psychological distress scores, with medium effect sizes (Cohen's d = 0.49, 0.51, and 0.55, respectively), compared with the waitlist control group. This pilot trial showed promising effects of a novel digital mental health intervention on cognitive control using neuroimaging and depression and anxiety symptoms, providing foundational evidence for a future confirmatory study.

Within-person associations of optimistic and pessimistic expectations with momentary stress, affect, and ambulatory blood pressure.

BACKGROUND AND OBJECTIVES: Although dispositional optimism and pessimism have been prospectively associated with health outcomes, little is known about how these associations manifest in everyday life. This study examined how short-term optimistic and pessimistic expectations were associated with psychological and physiological stress processes. METHODS: A diverse sample of adults (N = 300) completed a 2-day/1-night ecological momentary assessment and ambulatory blood pressure (ABP) protocol at ∼45-minute intervals. RESULTS: Moments that were more optimistic than typical for a person were followed by moments with lower likelihood of reporting a stressor, higher positive affect (PA), lower negative affect (NA), and less subjective stress (SS). Moments that were more pessimistic than typical were not associated with any affective stress outcome at the following moment. Neither optimism nor pessimism were associated with ABP, and did not moderate associations between reporting a stressor and outcomes. DISCUSSION: These findings suggest that intraindividual fluctuations in optimistic and pessimistic expectations are associated with stressor appraisals.

Computing Components of Everyday Stress Responses: Exploring Conceptual Challenges and New Opportunities.

Repeated assessments in everyday life enables collecting ecologically valid data on dynamic, within-persons processes. These methods have widespread utility and application and have been extensively used for the study of stressors and stress responses. Enhanced conceptual sophistication of characterizing intraindividual stress responses in everyday life would help advance the field. This article provides a pragmatic overview of approaches, opportunities, and challenges when intensive ambulatory methods are applied to study everyday stress responses in "real time." We distinguish between three stress-response components (i.e., reactivity, recovery, and pileup) and focus on several fundamental questions: (a) What is the appropriate stress-free resting state (or "baseline") for an individual in everyday life? (b) How does one index the magnitude of the initial response to a stressor (reactivity)? (c) Following a stressor, how can recovery be identified (e.g., when the stress response has completed)? and (d) Because stressors may not occur in isolation, how can one capture the temporal clustering of stressors and/or stress responses (pileup)? We also present initial ideas on applying this approach to intervention research. Although we focus on stress responses, these issues may inform many other dynamic intraindividual constructs and behaviors (e.g., physical activity, physiological processes, other subjective states) captured in ambulatory assessment.

Design and Formative Evaluation of a Virtual Voice-Based Coach for Problem-solving Treatment: Observational Study.

BACKGROUND: Artificial intelligence has provided new opportunities for human interactions with technology for the practice of medicine. Among the recent artificial intelligence innovations, personal voice assistants have been broadly adopted. This highlights their potential for health care-related applications such as behavioral counseling to promote healthy lifestyle habits and emotional well-being. However, the use of voice-based applications for behavioral therapy has not been previously evaluated. OBJECTIVE: This study aimed to conduct a formative user evaluation of Lumen, a virtual voice-based coach developed as an Alexa skill that delivers evidence-based, problem-solving treatment for patients with mild to moderate depression and/or anxiety. METHODS: A total of 26 participants completed 2 therapy sessions-an introductory (session 1) and a problem-solving (session 2)-with Lumen. Following each session with Lumen, participants completed user experience, task-related workload, and work alliance surveys. They also participated in semistructured interviews addressing the benefits, challenges and barriers to Lumen use, and design recommendations. We evaluated the differences in user experience, task load, and work alliance between sessions using 2-tailed paired t tests. Interview transcripts were coded using an inductive thematic analysis to characterize the participants' perspectives regarding Lumen use. RESULTS: Participants found Lumen to provide high pragmatic usability and favorable user experience, with marginal task load during interactions for both Lumen sessions. However, participants experienced a higher temporal workload during the problem-solving session, suggesting a feeling of being rushed during their communicative interactions. On the basis of the qualitative analysis, the following themes were identified: Lumen's on-demand accessibility and the delivery of a complex problem-solving treatment task with a simplistic structure for achieving therapy goals; themes related to Lumen improvements included streamlining and improved personalization of conversations, slower pacing of conversations, and providing additional context during therapy sessions. CONCLUSIONS: On the basis of an in-depth formative evaluation, we found that Lumen supported the ability to conduct cognitively plausible interactions for the delivery of behavioral therapy. Several design suggestions identified from the study including reducing temporal and cognitive load during conversational interactions, developing more natural conversations, and expanding privacy and security features were incorporated in the revised version of Lumen. Although further research is needed, the promising findings from this study highlight the potential for using Lumen to deliver personalized and accessible mental health care, filling a gap in traditional mental health services.

Intra-individual Associations of Perceived Stress, Affective Valence, and Affective Arousal with Momentary Cortisol in a Sample of Working Adults.

BACKGROUND: Research pairing ecological momentary assessment (EMA) methodology and ambulatory cortisol during daily life is still rare, as is careful testing of the within-person associations between stress, affect, and cortisol. Using a circumplex approach, we considered both valence and arousal components of affect. PURPOSE: To examine the within-person covariation of momentary cortisol with momentary perceived stress, affective valence, and affective arousal in everyday life. METHODS: 115 working adults (Mage = 41.2; 76% women; 76% white) completed six EMA surveys per day over 3 days. Each assessment included reports of perceived stress and affect (used to construct indicators of affective valence and arousal), followed by a saliva sample (from which cortisol was assessed). Multi-level models were used to examine the momentary associations between perceived stress, affective valence, affective arousal, and cortisol. RESULTS: Moments characterized by higher perceived stress were associated with higher cortisol (p = .036). Affective valence covaried with cortisol (p = .003) such that more positive valence was associated with lower cortisol and more negative valence with higher cortisol. Momentary affective arousal was not related to cortisol (p = .131). When all predictors were tested in the same model, only valence remained a significant predictor of cortisol (p = .047). CONCLUSION: Momentary perceived stress and affective valence, but not affective arousal, were associated with naturalistic cortisol. Cortisol was more robustly associated with affective valence than perceived stress or affective arousal. These findings extend our understanding of how moments of stress and particular characteristics of affective states (i.e., valence but not arousal) may "get under the skin" in daily life.

Effects of a light therapy intervention on diurnal salivary cortisol in fatigued cancer survivors: A secondary analysis of a randomized controlled trial.

OBJECTIVE: Altered diurnal cortisol rhythms are a potential mechanism through which symptoms of fatigue are maintained in post-treatment cancer survivors. Exposure to early morning bright light may target this underlying dysregulation, resulting in improved diurnal cortisol patterns, subsequently improving symptoms of fatigue. This research investigates the effects of a 4-week light therapy intervention on the diurnal cortisol slopes and output in fatigued cancer survivors. METHODS: Post-treatment adult cancer survivors who met diagnostic criteria for cancer-related fatigue were randomly assigned to receive either a bright white light (BWL) or dim red light (DRL) device, used daily for 30 min over four consecutive weeks. Assessments of fatigue and salivary cortisol were collected at baseline and post-intervention. Cortisol was sampled four times per day (waking, noon, 5 pm, bedtime) for three days at each timepoint. Diurnal cortisol slopes and total cortisol output were calculated at baseline and post-intervention. Linear mixed models were used to analyze the data. RESULTS: Seventy-seven participants were included in this analysis (BWL n = 40; DRL n = 37). Participants in both groups displayed increased steepness in cortisol slope (B = -0.02, p = .01, Cohen's d = 0.57) and increased total cortisol output (B = 9.58, p = .03, Cohen's d = 0.49) from baseline to post-intervention, indicating only a moderate effect of time. Neither diurnal cortisol slopes nor total cortisol output mediated the relationship between the light therapy intervention and fatigue levels. CONCLUSION: Though the results of this trial are promising for light therapy as an effective intervention to reduce fatigue in cancer survivors, this does not appear to be achieved through alterations in neuroendocrine function. ClinicalTrials.gov registration #: NCT01780623.

A multimethod approach examining the relative contributions of optimism and pessimism to cardiovascular disease risk markers.

Although dispositional optimism and pessimism are associated with cardiovascular disease (CVD), their relative independence and unique contributions to CVD risk are unclear. This study addressed these issues by using multiple indicators of optimism and pessimism and linking them to objective risk factors for CVD. A diverse sample of adults (N = 300) completed baseline assessments (including global reports of optimism and pessimism), a 2-day/1-night EMA protocol with ambulatory blood pressure (BP) at 45-min intervals, and had inflammatory markers and carotid intima media imaging collected. EMA reports of momentary positive and negative expectations were averaged to form intraindividual (person) means of optimism and pessimism, respectively. Optimism and pessimism were only modestly correlated between- and within-assessment methods. Higher pessimism, regardless of assessment method, predicted both lower odds of whether BP dipping occurred and a smaller degree of dipping, but was unrelated to other biomarkers. Optimism was not uniquely predictive of CVD risk factors. Pessimism thus appears to exhibit stronger relative contribution to risk indicators of CVD than optimism.

Understanding stress reports in daily life: a coordinated analysis of factors associated with the frequency of reporting stress.

Although stress is a common experience in everyday life, a clear understanding of how often an individual experiences and reports stress is lacking. Notably, there is little information regarding factors that may influence how frequently stress is reported, including which stress dimension is measured (i.e., stressors-did an event happen, subjective stress-how stressed do you feel, conditional stress-how stressful a stressor was) and the temporal features of that assessment (i.e., time of day, day of study, weekday vs. weekend day). The purpose of the present study was to conduct a coordinated analysis of five independent ecological momentary assessment studies utilizing varied stress reporting dimensions and temporal features. Results indicated that, within days, stress was reported at different frequencies depending on the stress dimension. Stressors were reported on 15-32% of momentary reports made within a day; across days, the frequency ranged from 42 to 76% of days. Depending on the cutoff, subjective stress was reported more frequently ranging about 8-56% of all moments within days, and 40-90% of days. Likewise, conditional stress ranged from just 3% of moments to 22%, and 11-69% of days. For the temporal features, stress was reported more frequently on weekdays (compared to weekend days) and on days earlier in the study (relative to days later in the study); time of day was inconsistently related to stress reports. In sum, stress report frequency depends in part on how stress is assessed. As such, researchers may wish to measure stress in multiple ways and, in the case of subjective and conditional stress with multiple operational definitions, to thoroughly characterize the frequency of stress reporting.

Online Positive Affect Journaling in the Improvement of Mental Distress and Well-Being in General Medical Patients With Elevated Anxiety Symptoms: A Preliminary Randomized Controlled Trial.

BACKGROUND: Positive affect journaling (PAJ), an emotion-focused self-regulation intervention, has been associated with positive outcomes among medical populations. It may be adapted for Web-based dissemination to address a need for scalable, evidence-based psychosocial interventions among distressed patients with medical conditions. OBJECTIVE: This study aimed to examine the impact of a 12-week Web-based PAJ intervention on psychological distress and quality of life in general medical patients. METHODS: A total of 70 adults with various medical conditions and elevated anxiety symptoms were recruited from local clinics and randomly assigned to a Web-based PAJ intervention (n=35) or usual care (n=35). The intervention group completed 15-min Web-based PAJ sessions on 3 days each week for 12 weeks. At baseline and the end of months 1 through 3, surveys of psychological, interpersonal, and physical well-being were completed. RESULTS: Patients evidenced moderate sustained adherence to Web-based intervention. PAJ was associated with decreased mental distress and increased well-being relative to baseline. PAJ was also associated with less depressive symptoms and anxiety after 1 month and greater resilience after the first and second month, relative to usual care. CONCLUSIONS: Web-based PAJ may serve as an effective intervention for mitigating mental distress, increasing well-being, and enhancing physical functioning among medical populations. PAJ may be integrated into routine medical care to improve quality of life. TRIAL REGISTRATION: ClinicalTrials.gov NCT01873599; https://clinicaltrials.gov/ct2/show/NCT01873599 (Archived by WebCite at http://www.webcitation.org/73ZGFzD2Z).

Is Perceived Growth Associated with Momentary Indicators of Health and Well-Being in People with Asthma or Rheumatoid Arthritis?

BACKGROUND: Perceived growth (PG) refers to perceptions of positive changes that unfold over time after experiencing trauma. Higher PG is often associated with positive long-term health, but the processes through which PG may influence health are unclear. The present study examines two potential pathways among individuals living with asthma or RA: (1) by promoting momentary indicators of health and well-being in everyday life, and (2) by buffering against stress. METHOD: In a micro-longitudinal design, 128 participants with asthma (n = 97) or rheumatoid arthritis (n = 31) reported perceived growth using the Post-Traumatic Growth (PTG) Inventory and subsequently completed ecological momentary assessments (EMAs) for one week. Participants were signaled five times a day to report on health-related indicators, including affect, disease interference, social interactions, and stress. RESULTS: Multilevel modeling revealed that higher PTG was associated with significantly less negative affect and greater positive affect in everyday life. There were no significant associations between PTG and momentary disease interference, pleasantness of social interactions, or stress, nor evidence that PTG buffered against effects of stress on health-related outcomes. CONCLUSIONS: This research highlights the utility of examining PG in everyday life. Results suggest that closer examination of momentary affect as a process by which PG may facilitate positive health outcomes is warranted.

Bright light therapy improves cancer-related fatigue in cancer survivors: a randomized controlled trial.

PURPOSE: Cancer-related fatigue (CRF) is a common and distressing symptom that can persist after cancer treatment has concluded. Bright light therapy has shown preliminary efficacy in reducing CRF, but its impact on other psychosocial factors is unclear. The purpose was to examine the impact of a 1-month light therapy intervention on fatigue, mood, and quality of life in cancer survivors with fatigue. METHODS: This 4-week blinded randomized controlled trial recruited cancer survivors who met diagnostic criteria for CRF. Participants were randomly assigned to receive a light therapy device that produced either bright white light (BWL; intervention) or dim red light (DRL; active control). Participants were instructed to use the device daily for 30 min upon waking for 28 days. The primary outcome, fatigue, was assessed weekly. Secondary outcomes assessed pre- and post-intervention included mood, depressive symptoms, and quality of life. RESULTS: A total of 81 participants were randomly assigned to receive BWL (n = 42) or DRL (n = 39). Analyses revealed a group-by-time interaction for fatigue (p = .034), wherein the BWL condition reported a 17% greater reduction in fatigue than those in the DRL condition (between group d = .30). There were also significant improvements over time for both groups on measures of mood, depressive symptoms, and quality of life (p's < .01). CONCLUSIONS: BWL was associated with greater improvements in fatigue and both groups displayed improvements on secondary psychosocial outcomes. IMPLICATIONS FOR CANCER SURVIVORS: These findings, along with previous reports of light therapy for CRF, support the use of this intervention to improve fatigue in cancer survivors.

Clinical practice guidelines on the evidence-based use of integrative therapies during and after breast cancer treatment.

Answer questions and earn CME/CNE Patients with breast cancer commonly use complementary and integrative therapies as supportive care during cancer treatment and to manage treatment-related side effects. However, evidence supporting the use of such therapies in the oncology setting is limited. This report provides updated clinical practice guidelines from the Society for Integrative Oncology on the use of integrative therapies for specific clinical indications during and after breast cancer treatment, including anxiety/stress, depression/mood disorders, fatigue, quality of life/physical functioning, chemotherapy-induced nausea and vomiting, lymphedema, chemotherapy-induced peripheral neuropathy, pain, and sleep disturbance. Clinical practice guidelines are based on a systematic literature review from 1990 through 2015. Music therapy, meditation, stress management, and yoga are recommended for anxiety/stress reduction. Meditation, relaxation, yoga, massage, and music therapy are recommended for depression/mood disorders. Meditation and yoga are recommended to improve quality of life. Acupressure and acupuncture are recommended for reducing chemotherapy-induced nausea and vomiting. Acetyl-L-carnitine is not recommended to prevent chemotherapy-induced peripheral neuropathy due to a possibility of harm. No strong evidence supports the use of ingested dietary supplements to manage breast cancer treatment-related side effects. In summary, there is a growing body of evidence supporting the use of integrative therapies, especially mind-body therapies, as effective supportive care strategies during breast cancer treatment. Many integrative practices, however, remain understudied, with insufficient evidence to be definitively recommended or avoided. CA Cancer J Clin 2017;67:194-232. © 2017 American Cancer Society.

The LITE study: Rationale and protocol for a randomized controlled trial of light therapy for cancer-related fatigue in cancer survivors.

UNLABELLED: Fatigue is a common and distressing symptom that can last for months or years in up to one-third of cancer survivors. Despite its prevalence, the nature and mechanisms of cancer-related fatigue are poorly understood and the available treatments may not provide sufficient relief. Fatigue has been identified as a significant contributor to decreased quality of life, making it an important target for intervention. One approach that may be a safe and inexpensive treatment is bright light therapy. METHODS: This study is a 4-week blinded randomized controlled trial. Subjects will be men and women who meet criteria for cancer-related fatigue and have completed cancer treatment. Subjects will be randomly assigned to receive a Litebook treatment device that produces either bright white light (treatment) or dim red light (active control). The devices will be used daily for 30min upon waking for a period of four weeks. The primary outcome, fatigue, will be measured with the Multidimensional Fatigue Symptom Inventory-SF. Secondary outcomes include mood disturbance, sleep quality, quality of life, diurnal cortisol, and inflammatory biomarkers. Fatigue assessments will be completed weekly and secondary outcomes will be assessed at pre- and post-intervention. CONCLUSIONS: The current research will examine the effect of light exposure on cancer-related fatigue and its potential psychological, behavioral, and biological mechanisms. If successful, this research would support the use of light therapy for the management of persistent fatigue in cancer survivors, expanding existing treatment options. It may also improve upon the current understanding of the mechanisms that underlie cancer-related fatigue.

A systematic review and meta-analysis of randomized controlled trials of cognitive behavior therapy for insomnia (CBT-I) in cancer survivors.

This review examined the efficacy of cognitive behavior therapy for insomnia (CBT-I) in people diagnosed with cancer. Studies were identified through November 2014 using multiple databases, clinical trial records, and bibliography searches. Inclusion was limited to randomized controlled trials of CBT-I conducted in individuals with a cancer diagnosis who had clinically relevant insomnia. The primary outcome variable was sleep efficiency (SE) as measured by sleep diary. Eight studies including data from 752 cancer survivors met inclusion criteria. CBT-I resulted in a 15.5% improvement in SE relative to control conditions (6.1%) from pre- to post-intervention, with a medium effect size (ES: d = 0.53). Overall, sleep latency was reduced by 22 min with an ES of d = 0.43, compared to a reduction of 8 min in the control conditions. Wake after sleep onset was reduced by 30 min with an ES of d = 0.41, compared to 13 min in the control conditions. Large effect sizes were observed for self-reported insomnia severity (d = 0.77) for those patients who received CBT-I, representing a clinically relevant eight point reduction. Effects were durable up to 6 mo. The quality of the evidence supports a strong recommendation for the use of CBT-I among cancer survivors.

Sleeping well with cancer: a systematic review of cognitive behavioral therapy for insomnia in cancer patients.

Individuals with cancer are disproportionately affected by sleep disturbance and insomnia relative to the general population. These problems can be a consequence of the psychological, behavioral, and physical effects of a cancer diagnosis and treatment. Insomnia often persists for years and, when combined with already high levels of cancer-related distress, may place cancer survivors at a higher risk of future physical and mental health problems and poorer quality of life. The recommended first-line treatment for insomnia is cognitive behavioral therapy for insomnia (CBT-I), a non-pharmacological treatment that incorporates cognitive and behavior-change techniques and targets dysfunctional attitudes, beliefs, and habits involving sleep. This article presents a comprehensive review of the literature examining the efficacy of CBT-I on sleep and psychological outcomes in cancer patients and survivors. The search revealed 12 studies (four uncontrolled, eight controlled) that evaluated the effects of CBT-I in cancer patients or survivors. Results suggest that CBT-I is associated with statistically and clinically significant improvements in subjective sleep outcomes in patients with cancer. CBT-I may also improve mood, fatigue, and overall quality of life, and can be successfully delivered through a variety of treatment modalities, making it possible to reach a broader range of patients who may not have access to more traditional programs. Future research in this area should focus on the translation of evidence into clinical practice in order to increase awareness and access to effective insomnia treatment in cancer care.

High trait rumination is associated with blunted nighttime diastolic blood pressure dipping.

BACKGROUND: Blunted blood pressure (BP) dipping during nighttime sleep has been associated with an increased risk of cardiovascular events. Psychological traits have been associated with prolonged cardiovascular activation and a lack of cardiovascular recovery. This activation may extend into nighttime sleep and reduce BP dipping. PURPOSE: This study aims to evaluate the association between trait rumination and nighttime BP dipping. METHODS: Sixty women scoring either high or low on trait rumination underwent one 24-h ambulatory BP monitoring session. Self-reported wake and sleep times were used to calculate nighttime BP. RESULTS: High trait rumination was associated with less diastolic blood pressure (DBP) dipping relative to low trait rumination. Awake ambulatory BP, asleep systolic blood pressure (SBP) and DBP, and asleep SBP dipping were not associated with trait rumination. CONCLUSIONS: In a sample of young women, high trait rumination was associated with less DBP dipping, suggesting that it may be associated with prolonged cardiovascular activation that extends into nighttime sleep, blunting BP dipping.

Effects of omega-3 fatty acid supplementation on heart rate variability at rest and during acute stress in adults with moderate hypertriglyceridemia.

OBJECTIVE: This study examined the dose-dependent effects of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) supplementation on heart rate variability (HRV) at rest and during standard laboratory stress tasks. We also investigated whether EPA + DHA supplementation was associated with changes in mood state. METHODS: This placebo-controlled, double-blind, randomized, three-period crossover trial (8-week treatment, 6-week washout) compared two doses of EPA + DHA supplementation (0.85 and 3.4 g/d) in 26 adults with elevated triglycerides. After each treatment period, HRV was assessed during an acute stress protocol that included a resting baseline, standard laboratory stress tasks (speech task and cold pressor), and recovery periods. In addition, mood state was assessed. RESULTS: Root mean square of successive differences in interbeat interval and total power increased 9.9% and 20.6%, respectively, after the high dose relative to placebo (Tukey p = .016 and .012, respectively). The low dose was not significantly different from the high dose or placebo dose. There was a trend for a treatment effect on high-frequency HRV (p = .058), with 21.0% greater power observed after the high dose compared with placebo (Tukey p = .052). Mood did not differ between treatments, and there was no association between mood state and HRV. CONCLUSIONS: In healthy adults with elevated triglycerides, supplementation of 3.4 g/d EPA + DHA resulted in greater HRV, whereas 0.85 g/d EPA + DHA had no effect. These results indicate that EPA + DHA supplementation may improve autonomic tone in adults at increased risk for cardiovascular disease within 8 weeks. TRIAL REGISTRATION: NCT00504309 (ClinicalTrials.gov).

Mindfulness-based stress reduction for the treatment of irritable bowel syndrome symptoms: a randomized wait-list controlled trial.

BACKGROUND: Irritable bowel syndrome (IBS) is a functional disorder of the lower gastrointestinal (GI) tract affected by stress, which may benefit from a biopsychosocial treatment approach such as mindfulness-based stress reduction (MBSR). PURPOSE: A treatment as usual (TAU) wait-list controlled trial was conducted in Calgary, Canada to investigate the impact of MBSR on IBS symptoms. It was hypothesized that MBSR patients would experience greater reduction in overall IBS symptom severity and self-reported symptoms of stress relative to control patients. METHOD: Ninety patients diagnosed with IBS using the Rome III criteria were randomized to either an immediate MBSR program (n = 43) or to wait for the next available program (n = 47). Patients completed IBS symptom severity, stress, mood, quality of life (QOL), and spirituality scales pre- and post-intervention or waiting period and at 6-month follow-up. Intent-to-treat linear mixed model analyses for repeated measures were conducted, followed by completers analyses. RESULTS: While both groups exhibited a decrease in IBS symptom severity scores over time, the improvement in the MBSR group was greater than the controls and was clinically meaningful, with symptom severity decreasing from constantly to occasionally present. Pre- to post-intervention dropout rates of 44 and 23 % for the MBSR and control groups, respectively, were observed. At 6-month follow-up, the MBSR group maintained a clinically meaningful improvement in overall IBS symptoms compared to the wait-list group, who also improved marginally, resulting in no statistically significant differences between groups at follow-up. Improvements in overall mood, QOL, and spirituality were observed for both groups over time. CONCLUSIONS: The results of this trial provide preliminary evidence for the feasibility and efficacy of a mindfulness intervention for the reduction of IBS symptom severity and symptoms of stress and the maintenance of these improvements at 6 months post-intervention. Attention and self-monitoring and/or anticipation of MBSR participation may account for smaller improvements observed in TAU patients.