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• This is the first cost-effectiveness analysis for yoga in patients with depression. • A yoga intervention was added to treatment as usual for young women with MDD. • Adding yoga was likely to be cost-effective compared to treatment as usual only. • This was mainly due to decreased work absenteeism. In a randomized controlled trial in the Netherlands, we studied the (cost)effectiveness of adding a mindful yoga intervention (MYI+TAU) to treatment as usual (TAU) for young women with major depressive disorder (MDD). In this paper, we present the results of the economic analyses. Societal costs and health outcomes were prospectively assessed during 15 months for all randomized participants (n = 171). Symptoms of depression (Depression Anxiety and Stress Scales; DASS) and quality adjusted life years (QALYs) were used as health outcomes in the economic analyses. Mean total societal costs during the 15 months of the study were €11.966 for the MYI+TAU group and €13.818 for the TAU group, differences in mean total societal costs were not statistically significant. Health outcomes (DASS and QALY) were slightly in favour of MYI+TAU, but differences between groups were not statistically significant. Combining costs and health outcomes in cost-effectiveness analyses indicated that MYI+TAU is likely to be cost-effective compared to TAU which was confirmed by sensitivity analyses. Although there were limitations in the cost-effectiveness analysis, findings from this study suggest that MYI+TAU warrants future attention for the potential to be cost-effective compared to TAU for young women with MDD. [ABSTRACT FROM AUTHOR]

Objective: To examine the added value of a 9-week mindful yoga intervention (MYI) as add-on to treatment as usual (TAU) in reducing depression for young women (18–34 years) with major depressive disorder (MDD). Method: Randomized controlled trial (RCT; n = 171) comparing TAU + MYI with TAU-only. Assessments were at baseline, postintervention, and at 6- and 12-month follow-up. Primary outcome measures were clinician-rated and self-reported symptoms of depression, together with a diagnostic interview to establish MDD diagnosis that was restricted to the baseline and 12-month follow-up assessments. Quality of life in various domains was assessed as secondary outcome measure. As potential mediators for treatment efficacy, we included self-report measures of rumination, self-criticism, self-compassion, intolerance of uncertainty, perceived body awareness and dispositional mindfulness, together with behavioral measures of attentional bias (AB) and depression-related self-associations. Results: Adding MYI to TAU did not lead to greater reduction of depression symptoms, lower rate of MDD diagnosis or increase in quality of life in various domains of functioning at post and follow-up assessments. There were no indirect effects through any of the potential mediators, with the exception of self-compassion. Conclusion: Adding MYI to TAU appeared not more efficacious than TAU-only in reducing depression symptoms in young women. What is the public health significance of this article?: Overall, this study suggests that adding a mindful yoga intervention to treatment as usual for young women with depression does not lead to increased benefits in terms of stronger reduction in symptoms of depression, lower rate of major depressive disorder diagnosis, or better quality of life within various domains of functioning. [ABSTRACT FROM AUTHOR]

Objective: Whereas in the U.S. and Canada the Individual Placement and Support (IPS) model has proven to be highly effective in enhancing employment perspectives for persons with severe mental illnesses, the evidence base is less abundant in countries with a different socioeconomic climate. The aim of this study was to examine the effectiveness of IPS in the Dutch socioeconomic context. Method: A multisite randomized controlled trial was performed following 151 persons with severe mental illnesses expressing an explicit wish for regular employment, comparing IPS with traditional vocational rehabilitation (TVR). Primary outcome was the proportion of persons who were competitively employed over a period of 30 months. Secondary outcomes were self-reported quality of life, self-esteem and mental health. Additionally, the impact of being engaged in competitive employment on these secondary outcomes was examined. Results: In 30 months, 44% of IPS participants found competitive work, compared with 25% of participants supported by TVR. No direct effect of IPS on mental health, self-esteem or quality of life was found. Being competitively employed before follow-up measurements was significantly associated with an increase in mental health, self-esteem and quality of life. Conclusions and Implications for Practice: This study strongly confirms that IPS is an effective method in helping people with severe mental illnesses find competitive work also in countries characterized by a relatively protective socioeconomic climate putting up unintended barriers to employment. The implementation of IPS on a larger scale seems warranted, and new studies are needed on the mechanisms through which IPS works. [ABSTRACT FROM AUTHOR]

Objectives: Despite the gains made by current first‐line interventions for major depressive disorder (MDD), modest rates of treatment response and high relapse indicate the need to augment existing interventions. Following theory and initial research indicating the promise of mindful yoga interventions (MYIs), this study examines mindful yoga as a treatment of MDD. Methods/Design: This randomized controlled trial uses a sample of young females (18–34 years) to examine the efficacy and cost‐effectiveness of a 9‐week manualized MYI added to treatment as usual (TAU) versus TAU alone. Primary outcome measures consist of clinician‐administered (Hamilton Depression Rating Scale) and self‐report (Depression‐Anxiety‐Stress Scales) measures of depression. Underlying mechanisms will be examined, including rumination, negative self‐evaluation, intolerance of uncertainty, interoceptive awareness, and dispositional mindfulness. Assessments were conducted at preintervention and will be conducted at postintervention, 6‐, and 12‐month follow up. Results: The baseline sample consists of 171 females (88 were randomized into the MYI), reporting a baseline Mage = 25.08 years (SDage = 4.64), MHamilton‐depression = 18.39 (SDHamilton = 6.00), and a MDASS‐depression = 21.02 (SDDASS = 9.36). Conclusion: This trial will provide important information regarding the benefits of adding yoga‐based interventions to TAU for young women with MDD and the mechanisms through which such benefits may occur. [ABSTRACT FROM AUTHOR]

Background: People with Severe Mental Illness (SMI) frequently experience problems with regard to societal participation (i.e. work, education and daily activities outside the home), and require professional support in this area. The Boston University approach to Psychiatric Rehabilitation (BPR) is a comprehensive methodology that can offer this type of support. To date, several Randomised Controlled Trials (RCT's) investigating the effectiveness of BPR have yielded positive outcomes with regard to societal participation. However, information about the cost-effectiveness and budgetary impact of the methodology, which may be important for broader dissemination of the approach, is lacking. BPR may be more cost effective than Care As Usual (CAU) because an increase in participation and independence may reduce the costs to society. Therefore, the aim of this study is to investigate, from a societal perspective, the cost-effectiveness of BPR for people with SMI who wish to increase their societal participation. In addition, the budget impact of implementing BPR in the Dutch healthcare setting will be assessed by means of a budget impact analysis (BIA) after completion of the trial. Methods: In a multisite RCT, 225 adults (18-64 years of age) with SMI will be randomly allocated to the experimental (BPR) or the control condition (CAU). Additionally, a pilot study will be conducted with a group of 25 patients with severe and enduring eating disorders. All participants will be offered support aimed at personal rehabilitation goals, and will be monitored over a period of a year. Outcomes will be measured at baseline, and at 6 and 12 months after enrolment. Based on trial results, further analyses will be performed to assess cost-effectiveness and the budgetary impact of implementation scenarios. Discussion: The trial results will provide insight into the cost-effectiveness of BPR in supporting people with SMI who would like to increase their level of societal participation. These results can be used to make decisions about further implementation of the method. Also, assessing budgetary impact will facilitate policymaking. The large sample size, geographic coverage and heterogeneity of the study group will ensure reliable generalisation of the study results. [ABSTRACT FROM AUTHOR]

Background: Despite the well-known importance of cognitive deficits for everyday functioning in patients with severe mental illness (SMI), evidence-based interventions directed at these problems are especially scarce for SMI patients in long-term clinical facilities. Cognitive adaptation Training (CAT) is a compensatory approach that aims at creating new routines in patients' living environments through the use of environmental supports. Previous studies on CAT showed that CAT is effective in improving everyday functioning in outpatients with schizophrenia. The aim of this study is to evaluate the effect of CAT as a nursing intervention in SMI patients who reside in long-term clinical facilities. Methods/Design: This is a multicenter cluster randomized controlled trial comparing CAT (intervention group) as a nursing intervention to treatment as usual (control group). The primary goal is to evaluate the effectiveness of CAT on everyday functioning. Secondary outcomes are quality of life, empowerment and apathy. Further, an economic evaluation will be performed. The study has a duration of one year, with four follow-up assessments at 15, 18, 21 and 24 months for the intervention group. Discussion: There is a need for evidence-based interventions that contribute to the improvement of the functional recovery of long-term residential patients. If our hypotheses are confirmed, it may be recommended to include CAT in the guidelines for SMI care and to implement the method in standardized care. [ABSTRACT FROM AUTHOR]

Background: There is ample evidence from observational prospective studies that maternal depression or anxiety during pregnancy is a risk factor for adverse psychosocial outcomes in the offspring. However, to date no previous study has demonstrated that treatment of depressive or anxious symptoms in pregnancy actually could prevent psychosocial problems in children. Preventing psychosocial problems in children will eventually bring down the huge public health burden of mental disease. The main objective of this study is to assess the effects of cognitive behavioural therapy in pregnant women with symptoms of anxiety or depression on the child's development as well as behavioural and emotional problems. In addition, we aim to study its effects on the child's development, maternal mental health, and neonatal outcomes, as well as the cost-effectiveness of cognitive behavioural therapy relative to usual care.Methods/design: We will include 300 women with at least moderate levels of anxiety or depression at the end of the first trimester of pregnancy. By including 300 women we will be able to demonstrate effect sizes of 0.35 or over on the total problems scale of the child behavioural checklist 1.5-5 with alpha 5% and power (1-beta) 80%.Women in the intervention arm are offered 10-14 individual cognitive behavioural therapy sessions, 6-10 sessions during pregnancy and 4-8 sessions after delivery (once a week). Women in the control group receive care as usual.Primary outcome is behavioural/emotional problems at 1.5 years of age as assessed by the total problems scale of the child behaviour checklist 1.5-5 years.Secondary outcomes will be mental, psychomotor and behavioural development of the child at age 18 months according to the Bayley scales, maternal anxiety and depression during pregnancy and postpartum, and neonatal outcomes such as birth weight, gestational age and Apgar score, health care consumption and general health status (economic evaluation).Trial Registration: Netherlands Trial Register (NTR): NTR2242. [ABSTRACT FROM AUTHOR]

Background: Maintenance treatment with antidepressants is the leading strategy to prevent relapse and recurrence in patients with recurrent major depressive disorder (MDD) who have responded to acute treatment with antidepressants (AD). However, in clinical practice most patients (up to 70-80%) are not willing to take this medication after remission or take too low dosages. Moreover, as patients need to take medication for several years, it may not be the most cost-effective strategy. The best established effective and available alternative is brief cognitive therapy (CT). However, it is unclear whether brief CT while tapering antidepressants (AD) is an effective alternative for long term use of AD in recurrent depression. In addition, it is unclear whether the combination of AD to brief CT is beneficial. Methods/design: Therefore, we will compare the effectiveness and cost-effectiveness of brief CT while tapering AD to maintenance AD and the combination of CT with maintenance AD. In addition, we examine whether the prophylactic effect of CT was due to CT tackling illness related risk factors for recurrence such as residual symptoms or to its efficacy to modify presumed vulnerability factors of recurrence (e.g. rigid explicit and/or implicit dysfunctional attitudes). This is a multicenter RCT comparing the above treatment scenarios. Remitted patients on AD with at least two previous depressive episodes in the past five years (n = 276) will be recruited. The primary outcome is time related proportion of depression relapse/recurrence during minimal 15 months using DSM-IV-R criteria as assessed by the Structural Clinical Interview for Depression. Secondary outcome: economic evaluation (using a societal perspective) and number, duration and severity of relapses/recurrences. Discussion: This will be the first trial to investigate whether CT is effective in preventing relapse to depression in recurrent depression while tapering antidepressant treatment compared to antidepressant treatment alone and the combination of both. In addition, we explore explicit and implicit mediators of CT. Trial registration: Netherlands Trial Register (NTR): NTR1907 [ABSTRACT FROM AUTHOR]

Background: Moderate to severe osteoarthrosis is the most common indication for Total Hip Arthroplasty (THA). Minimally Invasive Total Hip Surgery (MIS) and computer-navigated surgery were introduced several years ago. However, the literature lacks well-designed studies that provide evidence of superiority of computer-navigated MIS over a conventional THA technique. Hence, the purpose of this study is to compare (cost)effectiveness of computer-navigated MIS with a conventional technique for THA. It is our hypothesis that computer-navigated MIS will lead to a quicker recovery during the early postoperative period (3 months), and to an outcome at least as good 6 months postoperatively. We also hypothesize that computer-navigated MIS leads to fewer perioperative complications and better prosthesis positioning. Furthermore, cost advantages of computer-navigated MIS over conventional THA technique are expected. Methods/design: A cluster randomized controlled trial will be executed. Patients between the ages of 18 and 75 admitted for primary cementless unilateral THA will be included. Patients will be stratified using the Charnley classification. They will be randomly allocated to have computer-navigated MIS or conventional THA technique. Measurements take place preoperatively, perioperatively, and 6 weeks and 3 and 6 months postoperatively. Degree of limping (gait analysis), self-reported functional status and health-related quality of life (questionnaires) will be assessed preoperatively as well as postoperatively. Perioperative complications will be registered. Radiographic evaluation of prosthesis positioning will take place 6 weeks postoperatively. An evaluation of costs within and outside the healthcare sector will focus on differences in costs between computer-navigated MIS and conventional THA technique. Discussion: Based on studies performed so far, few objective data quantifying the risks and benefits of computer-navigated MIS are available. Therefore, this study has been designed to compare (cost) effectiveness of computer-navigated MIS with a conventional technique for THA. The results of this trial will be presented as soon as they become available. [ABSTRACT FROM AUTHOR]

Background: Despite the well-known importance of cognitive deficits for everyday functioning in patients with severe mental illness (SMI), evidence-based interventions directed at these problems are especially scarce for SMI patients in long-term clinical facilities. Cognitive adaptation Training (CAT) is a compensatory approach that aims at creating new routines in patients' living environments through the use of environmental supports. Previous studies on CAT showed that CAT is effective in improving everyday functioning in outpatients with schizophrenia. The aim of this study is to evaluate the effect of CAT as a nursing intervention in SMI patients who reside in long-term clinical facilities.Methods/design: This is a multicenter cluster randomized controlled trial comparing CAT (intervention group) as a nursing intervention to treatment as usual (control group). The primary goal is to evaluate the effectiveness of CAT on everyday functioning. Secondary outcomes are quality of life, empowerment and apathy. Further, an economic evaluation will be performed. The study has a duration of one year, with four follow-up assessments at 15, 18, 21 and 24 months for the intervention group.Discussion: There is a need for evidence-based interventions that contribute to the improvement of the functional recovery of long-term residential patients. If our hypotheses are confirmed, it may be recommended to include CAT in the guidelines for SMI care and to implement the method in standardized care.Trial Registration: Nederlands Trial Register (identifier: NTR3308 ). Date registered: 12 February 2012. [ABSTRACT FROM AUTHOR]