Purpose: This study aims to determine the feasibility of a phone-delivered mindfulness intervention in patients with defibrillators and to obtain preliminary indications of efficacy on mindfulness and anxiety.

Methods: Clinically stable outpatients were randomized to a mindfulness intervention (eight weekly individual phone sessions) or to a scripted follow-up phone call. We used the Hospital Anxiety and Depression Scale and the Five Facets of Mindfulness to measure anxiety and mindfulness, and multivariate linear regression to estimate the intervention effect on pre-post-intervention changes in these variables.

Results: We enrolled 45 patients (23 mindfulness and 22 control; age, 43–83; 30 % women). Retention was 93 %; attendance was 94 %. Mindfulness (beta = 3.31; p = 0.04) and anxiety (beta = −1.15; p = 0.059) improved in the mindfulness group.

Conclusions: Mindfulness training can be effectively phone-delivered and may improve mindfulness and anxiety in cardiac defibrillator outpatients.

Methods: Frequency of private spiritual activity (prayer, Bible reading, and meditation) was selfreported at year 5 of follow-up. Cardiovascular outcomes were centrally adjudicated, and cardiovascular risk was estimated from proportional hazards models.

Results: Final models included 43,708 women (mean age: 68.9±7.3; median follow-up: 7.0 years) free of cardiac disease through year 5 of follow-up. In age-adjusted models private spiritual activity was associated with increased cardiovascular risk (HR: 1.16; CI 1.02, 1.31, weekly vs. never; 1.25; CI 1.11, 1.40, daily vs. never). In multivariate models adjusted for demographics, lifestyle, risk factors, and psychosocial factors, such association remained significant only in the group with daily activity (HR 1.16; CI: 1.03, 1.30). Subgroup analyses indicate this association may be driven by the presence of severe chronic diseases.

Conclusion: In aging women, higher frequency of private spiritual activity was associated with increased cardiovascular risk, likely reflecting a mobilization of spiritual resources in order to cope with aging and illness.

The study sample included 46 ICD outpatients (32 M, 14 F; age range 43-83). An inverse association between HADS and FACIT-SWB scores was found, persisting after adjustment for demographics, anxiety/depression, medications, therapist support, and functional status (F = 0.001; β= -0.31, CI: -0.44, -0.19). In conclusion, spiritual well-being was independently associated with lower psychological distress in ICD outpatients. Spiritual well-being could act as a protective factor against psychological distress in these high-risk patients.

Design and Methods: Consecutive, clinically stable outpatients (n=52) will be screened for study eligibility within a month of an ICD-related procedure or ICD shock and will be randomly assigned to MBI or to usual care. MBI patients will receive eight weekly individual phone sessions based on two mindfulness practices (awareness of breath and body scan) plus home practice with a CD for 20 minutes daily. Patients assigned to usual care will be offered the standard care planned by the hospital. Assessments will occur at baseline and at the completion of the intervention (between 9 and 12 weeks after randomization). The primary study outcome is feasibility; secondary outcomes include anxiety, mindfulness, and number of administered shocks during the intervention period.

Conclusions: If proven feasible and effective, phone delivered mindfulness-based interventions could improve psychological distress in ICD outpatients with serious cardiovascular conditions.

Methods: We conducted a secondary analysis in 93,676 women enrolled in the observational arm of the Women’s Health Initiative. Constipation was evaluated at baseline by a self-administered questionnaire and rated as none, mild, moderate, severe. Baseline associations between constipation and risk factors for CV disease were determined using cross-tabulations and chi-square statistics. Estimates of the risk of CV events (cumulative end-point including mortality for coronary heart disease, MI, angina, PTCA, CABG, stroke and TIA) in the different constipation categories (vs. no constipation) were derived from Cox proportional hazard regression models. CV outcomes were centrally validated.

Results: The analysis included 76,870 women. Mean follow-up was 6.4 years (max. 9.3). Constipation was associated with age, race, smoking, diabetes, high cholesterol, family history of MI, hypertension, obesity, lack of physical activity, low fiber intake, and depression (all p<0.001). Women with moderate and severe constipation had a higher number of CV events (14.7 and 18.9/1000 person-years, respectively, vs. 9.6/1000 person-years in the no constipation group) and a higher risk of CV events (unadjusted HR, moderate vs. none: 1.53; CI: 1.39, 1.68); severe vs. none: HR: 1.97; CI: 1.66, 2.33). After adjustment for demographics, risk factors for CHD, dietary factors, medications and depression, women reporting moderate constipation still had a higher risk of CV events (HR:1.13; CI: 1.03,1.24) as did women with severe constipation (HR 1.28; CI: 1.08,1.53).

Conclusion: Moderate and severe constipation appear to be independently associated with an increased risk of CV events in menopausal women. Since constipation is easily assessed, it may be helpful in identifying women at risk, in whom preventive screening for coronary risk factors may be indicated.

Methods. The study was conducted at the Electrophysiology Service at the UMass Memorial Medical Center. All consecutive patients who recently underwent an ICD procedure or received ICD shocks were screened for eligibility to participate in a pilot randomized controlled trial in which an eight session, phone-delivered, weekly MBI was compared to a usual care condition. Assessments were performed at baseline and post-intervention. A cross-sectional design was used for aims 2 and 3. Anxiety was assessed using the Hospital Anxiety and Depression Scale; a shortened version of the Five Facets of Mindfulness questionnaire was used to evaluate mindfulness.

Results. Thirty patients (21 M, 9 F; mean age 63.1 ±10.3 years) were enrolled in the study. The methods ultimately adopted to screen, recruit, and retain study participants were feasible to conduct and satisfactory to ICD outpatients, and the study intervention was safe. Phone delivery resulted in excellent retention rates and limited costs. Assessments of treatment fidelity showed that the content of the intervention was delivered as intended in almost 100% of cases.

The study findings do not show a decrease in the overall prevalence of anxiety in ICD patients compared with earlier cohorts; anxiety was associated with young age, low socio-economic status and previous psychological morbidity, but not with ICD-related factors including prior shock delivery.

Finally, baseline mindfulness was most strongly associated with previous psychological morbidity (in particular, depression), and current anxiety symptoms.

Conclusion. Psychological morbidity appears to be the major determinant of anxiety in the patients currently enrolled in the study. Dispositional mindfulness is inversely associated with current anxiety and depression and with prior psychological morbidity, supporting the hypothesis of a modulating role of mindfulness on the processing of negative emotions. A phone-delivered, individual MBI is feasible, acceptable to patients and can be adequately delivered by trained instructors. The findings from this dissertation work support the need for larger clinical trials of MBI in ICD patients.

BACKGROUND:

Vitamin D may plausibly reduce the occurrence of depression in postmenopausal women; however, epidemiologic evidence is limited, and few prospective studies have been conducted.

OBJECTIVE:

We conducted a cross-sectional and prospective analysis of vitamin D intake from foods and supplements and risk of depressive symptoms.

DESIGN:

Study participants were 81,189 members of the Women's Health Initiative (WHI) Observational Study who were aged 50-79 y at baseline. Vitamin D intake at baseline was measured by food-frequency and supplement-use questionnaires. Depressive symptoms at baseline and after 3 y were assessed by using the Burnam scale and current antidepressant medication use.

RESULTS:

After age, physical activity, and other factors were controlled for, women who reported a total intake of ≥800 IU vitamin D/d had a prevalence OR for depressive symptoms of 0.79 (95% CI: 0.71, 0.89; P-trend < 0.001) compared with women who reported a total intake of <100 IU vitamin D/d. In analyses limited to women without evidence of depression at baseline, an intake of ≥400 compared with <100 IU vitamin D/d from food sources was associated with 20% lower risk of depressive symptoms at year 3 (OR: 0.80; 95% CI: 0.67, 0.95; P-trend = 0.001). The results for supplemental vitamin D were less consistent, as were the results from secondary analyses that included as cases women who were currently using antidepressant medications.

CONCLUSIONS:

Overall, our findings support a potential inverse association of vitamin D, primarily from food sources, and depressive symptoms in postmenopausal women. Additional prospective studies and randomized trials are essential in establishing whether the improvement of vitamin D status holds promise for the prevention of depression, the treatment of depression, or both.

METHODS: We conducted a secondary analysis in 93,676 women enrolled in the observational arm of the Women's Health Initiative. Constipation was evaluated at baseline by a self-administered questionnaire. Estimates of the risk of cardiovascular events (cumulative end point including mortality from coronary heart disease, myocardial infarction, angina, coronary revascularization, stroke, and transient ischemic attack) were derived from Cox proportional hazards models adjusted for demographics, risk factors, and other clinical variables (median follow-up 6.9 years).

RESULTS: The analysis included 73,047 women. Constipation was associated with increased age, African American and Hispanic descent, smoking, diabetes, high cholesterol, family history of myocardial infarction, hypertension, obesity, lower physical activity levels, lower fiber intake, and depression. Women with moderate and severe constipation experienced more cardiovascular events (14.2 and 19.1 events/1000 person-years, respectively) compared with women with no constipation (9.6/1000 person-years). After adjustment for demographics, risk factors, dietary factors, medications, frailty, and other psychological variables, constipation was no longer associated with an increased risk of cardiovascular events except for the severe constipation group, which had a 23% higher risk of cardiovascular events.

CONCLUSION: In postmenopausal women, constipation is a marker for cardiovascular risk factors and increased cardiovascular risk. Because constipation is easily assessed, it may be a helpful tool to identify women with increased cardiovascular risk.

AIM: To review the methodology of previously published studies of psychosocial interventions in ICD patients, according to CONSORT statement guidelines for non-pharmacological interventions, and provide recommendations for future research.

METHODS: We electronically searched the PubMed, PsycInfo and Cochrane databases. To be included, studies needed to be published in a peer-reviewed journal between 1980 and 2008, to involve a human population aged 18+ years and to have an experimental design.

RESULTS: Twelve studies met the eligibility criteria. Samples were generally small. Interventions were very heterogeneous; most studies used cognitive behavioural therapy (CBT) and exercise programs either as unique interventions or as part of a multi-component program. Overall, studies showed a favourable effect on anxiety (6/9) and depression (4/8). CBT appeared to be the most effective intervention. There was no effect on the number of shocks and arrhythmic events, probably because studies were not powered to detect such an effect. Physical functioning improved in the three studies evaluating this outcome. Lack of information about the indication for ICD implantation (primary vs. secondary prevention), limited or no information regarding use of anti-arrhythmic (9/12) and psychotropic (10/12) treatment, lack of assessments of providers' treatment fidelity (12/12) and patients' adherence to the intervention (11/12) were the most common methodological limitations.

CONCLUSIONS: Overall, this review supports preliminary evidence of a positive effect of psychosocial interventions on anxiety and physical functioning in ICD patients. However, these initial findings must be interpreted cautiously because of important methodological limitations. Future studies should be designed as large RCTs, whose design takes into account the specific challenges associated with the evaluation of behavioural interventions.

Similarly strong evidence indicates that smoking cessation alone can result in a 36% reduction in the crude relative risk of mortality in smokers who quit versus those who do not.5 The risk decreases rapidly: after only 1 year of cessation, quitters have a lower relative risk (RR=0.63) of death from coronary heart disease (CHD) than do nonquitters, which decreases even further (RR=0.38) after 3 years of cessation. Consequently, efforts to find effective treatments to enhance smoking cessation are of great importance.