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Background: Receiving epidural analgesia during labor can possibly have negative consequences for mother and child. Yet, the use of epidural analgesia rapidly increased in the Netherlands over the last decade. Since antenatal plans for labor pain relief have been related to epidural analgesia use during labor, the aim of the current study was to develop a Labor Pain Relief Attitude Questionnaire for pregnant women (LPRAQ-p)., Methods: Three focus group interviews were conducted with pregnant women, new mothers and caregivers and 13 candidate items were derived. Psychometric properties were tested with explorative factor analysis in sample I (N = 429) and a subsequent confirmatory factor analysis in a different sample II (N = 432)., Results: The explorative factor analysis suggested a two-factor seven-item solution: a 'women's perception' and 'social environment' subscale. The confirmatory factor analysis confirmed an excellent six-item model fit with appropriate internal consistency. Higher scores on the six-item LPRAQ-p indicate greater willingness for request of pain relief medication during labor. Two-tailed t-tests showed that women with elevated levels of depression and pregnancy-specific distress symptoms, nulliparous women and multiparous women with complications during a previous delivery had greater willingness for request of pain relief medication during labor. Linear regression showed that the most important association with higher scores on the LPRAQ-p were high pregnancy-specific distress symptoms., Conclusions: This study showed the LPRAQ-p to be a valid instrument to evaluate attitude towards labor pain relief in pregnant women. High scores on this questionnaire are associated with high levels of pregnancy-specific distress symptoms.

Background: The increasing number of operative deliveries is a topic of major concern in modern obstetrics. Maternal thyroid function is of known influence on many obstetric parameters. Our objective was to investigate a possible relation between maternal thyroid function, and operative deliveries. Secondary aim was to explore whether thyroid function was related to specific reasons for operative deliveries., Methods: In this prospective cohort study, low-risk Caucasian women, pregnant of a single cephalic fetus were included. Women with known auto-immune disease, a pre-labour Caesarean section, induction of labour, breech presentation or preterm delivery were excluded. In all trimesters of pregnancy the thyroid function was assessed. Differences in mean TSH and FT4 were assessed using t-test. Mean TSH and FT4 levels for operative deliveries were determined by one way ANOVA. Repeated measurement analyses were performed (ANOVA), adjusting for BMI, partiy, maternal age and gestational age at delivery., Results: In total 872 women were included, of which 699 (80.2%) had a spontaneous delivery. At 36 weeks gestation women who had an operative delivery had a significantly higher mean TSH (1.63 mIU/L versus 1.46 mIU/L, p = 0.025) and lower mean FT4 (12.9 pmol/L versus 13.3 pmol/L, p = 0.007)) compared to women who had a spontaneous delivery. Mean TSH was significantly higher (p = 0.026) and mean FT4 significantly lower (p = 0.030) throughout pregnancy for women with an operative delivery due to failure to progress in second stage of labour, compared to women with a spontaneous delivery or operative delivery for other reasons., Conclusions: Increased TSH and decreased FT4 seem to be associated with more operative vaginal deliveries and Caesarean sections. After adjusting for several confounders the association remained for operative deliveries due to failure to progress in second stage of labour, possibly to be explained by less efficient uterine action.

Background: The HAPPY study is a large prospective longitudinal cohort study in which pregnant women (N ≈ 2,500) are followed during the entire pregnancy and the whole first year postpartum. The study collects a substantial amount of psychological and physiological data investigating all kinds of determinants that might interfere with general well-being during pregnancy and postpartum, with special attention to the effect of maternal mood, pregnancy-related somatic symptoms (including nausea and vomiting (NVP) and carpal tunnel syndrome (CTS) symptoms), thyroid function, and human chorionic gonadotropin (HCG) on pregnancy outcome of mother and foetus., Methods/design: During pregnancy, participants receive questionnaires at 12, 22 and 32 weeks of gestation. Apart from a previous obstetric history, demographic features, distress symptoms, and pregnancy-related somatic symptoms are assessed. Furthermore, obstetrical data of the obstetric record form and ultrasound data are collected during pregnancy. At 12 and 30 weeks, thyroid function is assessed by blood analysis of thyroid stimulating hormone (TSH), free thyroxine (FT4) and thyroid peroxidase antibodies (TPO-Ab), as well as HCG. Also, depression is assessed with special focus on the two key symptoms: depressed mood and anhedonia. After childbirth, cord blood, neonatal heel screening results and all obstetrical data with regard to start of labour, mode of delivery and complications are collected. Moreover, mothers receive questionnaires at one week, six weeks, four, eight, and twelve months postpartum, to investigate recovery after pregnancy and delivery, including postpartum mood changes, emotional distress, feeding and development of the newborn., Discussion: The key strength of this large prospective cohort study is the holistic (multifactorial) approach on perinatal well-being combined with a longitudinal design with measurements during all trimesters of pregnancy and the whole first year postpartum, taking into account two physiological possible markers of complaints and symptoms throughout gestation: thyroid function and HCG. The HAPPY study is among the first to investigate within one design physiological and psychological aspects of NVP and CTS symptoms during pregnancy. Finally, the concept of anhedonia and depressed mood as two distinct aspects of depression and its possible relation on obstetric outcome, breastfeeding, and postpartum well-being will be studied.

Background: Objective was to determine whether fear for external cephalic version (ECV) and depression are associated with the success rate of ECV in women with a breech presentation at term., Methods: Prospective study conducted in the Catharina Hospital Eindhoven between October 2007 and May 2012. Participants fulfilled The Edinburgh Depression Scale (EDS) questionnaire and expressed their degree of fear on a visual analogue scale from one to ten before ECV. Obstetric factors were evaluated as well. Primary outcome was the relation between psychological factors (fear for ECV and depression EDS scores) and ECV success rate. Secondary outcome was a possible relation between fear for ECV and increased abdominal muscle tension., Results: The overall success rate was 55% and was significantly lower (p < 0.001) in nulliparous women (44.3%) compared with parous women (78.0%). Fear for ECV and depression EDS-scores were not related with ECV success rate. Parity, placental location, BMI and engagement of the fetal breech were obstetric factors associated with ECV outcome. There was no relation between fear for ECV and abdominal muscle tone., Conclusion: Fear for ECV and depression were not related with ECV success rate in this study. Engagement of the fetal breech was the most important factor associated with a successful ECV., Trial Registration Ebis: The Eindhoven Breech Intervention Study, NCT00516555.

Background: Anxiety disorders are prevalent and associated with poor prognosis in patients with coronary artery disease (CAD). However, studies examining screening of anxiety disorders in CAD patients are lacking. In the present study we evaluated the prevalence of anxiety disorders in patients with CAD and diagnostic utility of self-rating scales for screening of anxiety disorders., Methods: Five-hundred and twenty-three CAD patients not receiving psychotropic treatments at initiation of rehabilitation program completed self-rating scales (Hospital Anxiety and Depression Scale or HADS; Spielberger State-Anxiety Inventory or SSAI; and Spielberger Trait-Anxiety Inventory or STAI) and were interviewed for generalized anxiety disorder (GAD), social phobia, panic disorder and agoraphobia (Mini-International Neuropsychiatric Interview or MINI)., Results: Thirty-eight (7%) patients were diagnosed with anxiety disorder(s), including GAD (5%), social phobia (2%), agoraphobia (1%) and panic disorder (1%). Areas under the ROC curve of the HADS Anxiety subscale (HADS-A), STAI and SSAI for screening of any anxiety disorder were .81, .80 and .72, respectively. Optimal cut-off values for screening of any anxiety disorders were ≥ 8 for the HADS-A (sensitivity = 82%; specificity = 76%; and positive predictive value (PPV) = 21%); ≥ 45 for the STAI (sensitivity = 89%; specificity = 56%; and PPV = 14%); and ≥ 40 for the SSAI (sensitivity = 84%; specificity = 55%; PPV = 13%). In a subgroup of patients (n = 340) scoring below the optimal major depressive disorder screening cut-off value of HADS-Depression subscale (score <5), the HADS-A, STAI and SSAI had moderate-high sensitivity (range from 69% to 89%) and low PPVs (≤ 22%) for GAD and any anxiety disorders., Conclusions: Anxiety disorders are prevalent in CAD patients but can be reliably identified using self-rating scales. Anxiety self-rating scales had comparable sensitivities but the HADS-A had greater specificity and PPV when compared to the STAI and SSAI for screening of anxiety disorders. However, false positive rates were high, suggesting that patients with positive screening results should undergo psychiatric interview prior to initiating treatment for anxiety disorders and that routine use of anxiety self-rating scales for screening purposes can increase healthcare costs. Anxiety screening has incremental value to depression screening for identifying anxiety disorders.

Background: Sufficient exercise is important for people with Type 2 Diabetes Mellitus (T2DM), as it can prevent future health problems. Despite, it is estimated that only 30-40% of people with T2DM are sufficiently active. One of the psychosocial constructs that is believed to influence physical activity behaviour, is exercise self-efficacy. The goal of this study is to evaluate a patient-tailored exercise intervention for people with T2DM that takes exercise self-efficacy into account., Methods/design: This study is conducted as a non-randomized controlled clinical trial. Patients are eligible when they are diagnosed with T2DM, exercise less than advised in the ADA guideline of 150 min/week of moderate-intensity aerobic physical activity, have an BMI >25 and are between 18 and 80 years old. Recruitment takes place at a Primary care organization of general practitioners and practice nurses in the south of the Netherlands.Participants are allocated to three groups: An advice intervention -for participants with a high exercise self-efficacy score- in which participants receive a patient-tailored exercise intervention, an intensive intervention -for participants with a low exercise self-efficacy score- in which participants receive a patient-tailored exercise intervention accomplished by a group based intervention, and a control group in which participants receive regular Dutch diabetes care. The primary outcome measure of this study is physical activity. Secondary outcome measures are health status, (symptoms of) depression, exercise self-efficacy, Body Mass Index (BMI), blood pressure and glycemic control., Discussion: We aimed to design an intervention that can be implemented in Primary care, but also to design an easy accessible program. This study is innovative as it is -to our best knowledge- the first study that takes level of exercise self-efficacy of people with T2DM into account by means of giving extra support to those with the lowest exercise self-efficacy. If the program succeeds in increasing the amount of physical activity it can be implemented in regular primary care., Trial Registration: Dutch Trial Register NTR2734.

Background: Chronic obstructive pulmonary disease (COPD) and asthma are common chronic diseases that are frequently accompanied by depression and/or anxiety. However, symptoms of depression and anxiety are often not recognized and therefore not treated. Currently, only a few studies have tested new clinical approaches that could improve the treatment of co-morbid depression and anxiety in these groups of patients., Methods/design: The present randomized controlled study will be conducted within the framework of PoZoB (Praktijk Ondersteuning Zuid-Oost Brabant), a large primary care organization in the Netherlands. Patients with asthma/COPD and co-morbid anxiety/depression will be included in order to test the effectiveness of a disease management approach to treat these co-morbid disorders. Important elements of this approach are: 1) systematic screening to improve detection of anxiety and depression 2) treatment in case of positive screening 3) monitoring of anxiety and depression 4) intensified treatment in case of non-remission (stepped care)., Discussion: The present study is a large primary care study on the treatment of co-morbid depression and anxiety in patients with asthma and COPD. Strengths of this study are its randomized design, the focus on implementation in primary care and the fact that it applies the latest findings on the treatment of depression and anxiety. First results are expected in 2012/2013.

Background: Depression and anxiety are common co-morbid health problems in patients with type 2 diabetes. Both depression and anxiety are associated with poor glycaemic control and increased risk of poor vascular outcomes and higher mortality rates. Results of previous studies have shown that in clinical practice, treatment of depression and anxiety is far from optimal as these symptoms are frequently overlooked and undertreated., Methods/design: This randomised controlled trial will examine the effectiveness of a disease management programme treating symptoms of depression and anxiety in primary care patients with Type 2 diabetes. Patients will be randomized on patient level in 1:1 ratio. Random block sizes of 2 and 4 are used. The disease management programme consists of screening, stepped treatment and monitoring of symptoms (n = 80). This will be compared to care as usual (n = 80)., Discussion: The disease management model for co-morbid depression and anxiety in primary care patients with diabetes is expected to result in reduced symptoms of depression and anxiety, improved quality of life, reduced diabetes specific distress and improved glyceamic control, compared to care as usual., Trial Registration: Dutch Trial Register NTR2626.

Background: Falls are one of the main causes of fractures in elderly people and after a recent fracture, the risk of another fall is increased, resulting in subsequent fracture. Therefore, risk factors for future falls should be determined. We prospectively investigated the relationship between depression and the incidence of falls in post-menopausal women after a low-energy fracture., Methods: At baseline, 181 women aged 60 years and older who presented with a recent low-energy fracture were evaluated at the fracture and osteoporosis outpatient clinics of two hospitals. As well as clinical evaluation and bone mineral density tests, the presence of depression (measured using the Edinburgh Depression Scale, EDS, depression cut-off > 11) and risk factors for falling were assessed. During two years of follow-up, the incidence of falls was registered annually by means of detailed questionnaires and interviews., Results: Seventy-nine (44%) of the women sustained at least one fall during follow-up. Of these, 28% (n = 22) suffered from depression at baseline compared to 10% (n = 10) of the 102 women who did not sustain a fall during follow-up (Χ(2) = 8.76, df = 1, p = .003). Multiple logistic regression showed that the presence of depression and co-morbidity at baseline were independently related to falls (OR = 4.13, 95% CI = 1.58-10.80; OR = 2.25, 95% CI = 1.11-4.56, respectively) during follow-up., Conclusions: The presence of depression in women aged 60 years and older with recent low-energy fractures is an important risk factor for future falls. We propose that clinicians treating patients with recent low-energy fractures should anticipate not only on skeletal-related risk factors for fractures, but also on fall-related risk factors including depression., (© 2011 van den Berg et al; licensee BioMed Central Ltd.)

Background: Pregnant women with high levels of stress, depression and/or anxiety are at increased risk for adverse perinatal outcomes and impaired neurologic and emotional development of the offspring. Pregnancy specific instruments to measure psychological functioning during gestation are scarce and do not define items based on in-depth interviews of pregnant and recently delivered women. The current study developed a pregnancy specific scale that measures psychological functioning using in-depth interviews., Methods: Three focus groups were formed to discuss issues most relevant to pregnancy distress; 22 candidate items were derived for pilot testing (study I, n = 419) its psychometric properties by means of explorative factor analyses (EFA). This resulted in a 17-item TPDS which was further explored by confirmatory factor analyses (CFA) and concurrent and construct validity assessment (study II, n = 454)., Results: EFA in study I suggested a two component solution (negative affect (NA) and partner involvement (PI)). CFA in study II resulted in a higher order model of the NA subscale into three more subscales: NA regarding confinement, delivery and general health. TPDS, EPDS and GAD-7 were all significantly correlated., Conclusions: The TPDS constitutes a valid and user friendly instrument to assess pregnancy distress. In addition to its proven ability to pick up pregnancy specific negative affect it also includes an important sub-scale measuring perceived partner involvement.

Background: Depression is a common complication in type 2 diabetes (DM2), affecting 10-30% of patients. Since depression is underrecognized and undertreated, it is important that reliable and validated depression screening tools are available for use in patients with DM2. The Edinburgh Depression Scale (EDS) is a widely used method for screening depression. However, there is still debate about the dimensionality of the test. Furthermore, the EDS was originally developed to screen for depression in postpartum women. Empirical evidence that the EDS has comparable measurement properties in both males and females suffering from diabetes is lacking however., Methods: In a large sample (N = 1,656) of diabetes patients, we examined: (1) dimensionality; (2) gender-related item bias; and (3) the screening properties of the EDS using factor analysis and item response theory., Results: We found evidence that the ten EDS items constitute a scale that is essentially one dimensional and has adequate measurement properties. Three items showed differential item functioning (DIF), two of them showed substantial DIF. However, at the scale level, DIF had no practical impact. Anhedonia (the inability to be able to laugh or enjoy) and sleeping problems were the most informative indicators for being able to differentiate between the diagnostic groups of mild and severe depression., Conclusions: The EDS constitutes a sound scale for measuring an attribute of general depression. Persons can be reliably measured using the sum score. Screening rules for mild and severe depression are applicable to both males and females.

Background: Approximately 20-40% of outpatients with diabetes experience elevated levels of emotional distress, varying from disease-specific distress to general symptoms of anxiety and depression. The patient's emotional well-being is related to other unfavorable outcomes, like reduced quality of life, sub-optimal self-care, impaired glycemic control, higher risk of complications, and increased mortality rates. The purpose of this study is to test the effectiveness of a new diabetes-specific, mindfulness-based psychological intervention. First, with regard to reducing emotional distress; second, with respect to improving quality of life, dispositional mindfulness, and self-esteem of patients with diabetes; third, with regard to self-care and clinical outcomes; finally, a potential effect modification by clinical and personality characteristics will be explored., Methods/design: The Diabetes and Mindfulness study (DiaMind) is a randomized controlled trial. Patients with diabetes with low levels of emotional well-being will be recruited from outpatient diabetes clinics. Eligible patients will be randomized to an intervention group or a wait-list control group. The intervention group will receive the mindfulness program immediately, while the control group will receive the program eight months later. The primary outcome is emotional distress (anxiety, stress, depressive symptoms), for which data will be collected at baseline, four weeks, post intervention, and after six months follow-up. In addition, self-report data will be collected on quality of life, dispositional mindfulness, self-esteem, self-care, and personality, while complications and glycemic control will be assessed from medical files and blood pressure will be measured. Group differences will be analyzed with repeated measures analysis of covariance.The study is supported by grants from the Dutch Diabetes Research Foundation and Tilburg University and has been approved by a medical ethics committee., Discussion: It is hypothesized that emotional well-being, quality of life, dispositional mindfulness, self-esteem, self-care, and blood pressure will improve significantly more in the mindfulness group compared to the control group. Results of this study can contribute to a better care for patients with diabetes with lowered levels of emotional well-being. It is expected that the first results will become available in 2012., Trial Registration: Dutch Trial Register NTR2145.

Background: To investigate the relation between maternal thyroid function and the outcome of external cephalic version (ECV) in breech presentation., Methods: Prospective cohort study in 141 women (≥ 35 weeks gestation) with a singleton fetus in breech. Blood samples for assessing thyroid function were taken prior to ECV. Main outcome measure was the relation between maternal thyroid function and ECV outcome indicated by post ECV ultrasound., Results: ECV success rate was 77/141 (55%), 41/48 (85%) in multipara and 36/93 (39%) in primipara. Women with a failed ECV attempt had significantly higher TSH concentrations than women with a successful ECV (p < 0.001). Multiple logistic regression showed that TSH (OR: 0.52, 95% CI: 0.30-0.90), nulliparity (OR: 0.11, 95% CI: 0.03-0.36), frank breech (OR: 0.30, 95% CI: 0.10-0.93) and placenta anterior (OR: 0.31, 95% CI: 0.11-0.85) were independently related to ECV success., Conclusions: Higher TSH levels increase the risk of ECV failure., Trial Registration Number: ClinicalTrials.gov: NCT00516555.

Background: Depression is a common psychiatric complication of diabetes, but little is known about the natural course and the consequences of depressive symptoms in primary care patients with type 2 diabetes. While depression has been related to poor glycemic control and increased risk for macrovascular disease, its association with microvascular complications remains understudied. The predictive role of other psychological risk factors such as Type D (distressed) personality and the mechanisms that possibly link depression and Type D personality with poor vascular outcomes are also still unclear., Methods/design: This prospective cohort study will examine: (1) the course of depressive symptoms in primary care patients with type 2 diabetes; (2) whether depressive symptoms and Type D personality are associated with the development of microvascular and/or macrovascular complications and with the risk of all-cause or vascular mortality; and (3) the behavioral and physiological mechanisms that may mediate these associations. The DiaDDZoB Study is embedded within the larger DIAZOB Primary Care Diabetes study, which covers a comprehensive cohort of type 2 diabetes patients treated by over 200 primary care physicians in South-East Brabant, The Netherlands. These patients will be followed during their lifetime and are assessed annually for demographic, clinical, lifestyle and psychosocial factors. Measurements include an interviewer-administered and self-report questionnaire, regular care laboratory tests and physical examinations, and pharmacy medication records. The DiaDDZoB Study uses data that have been collected during the original baseline assessment in 2005 (M0; N = 2,460) and the 2007 (M1; N = 2,225) and 2008 (M2; N = 2,032) follow-up assessments., Discussion: The DiaDDZoB Study is expected to contribute to the current understanding of the course of depression in primary care patients with type 2 diabetes and will also test whether depressed patients or those with Type D personality are at increased risk for (further) development of micro- and cardiovascular disease. More knowledge about the mechanisms behind this association is needed to guide new intervention studies.