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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 ofuncertainty, 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

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 M-age = 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.

Aims: To determine the cost effectiveness and cost utility of arthrocentesis as an initial treatment for temporomandibular joint (TMJ) arthralgia compared to usual care. Methods: A two-armed, parallel-design, randomized controlled trial (RCT) was conducted in the Netherlands from January 2009 to June 2012 that included patients with TMJ arthralgia. Patients were randomly allocated to arthrocentesis (n = 40) or usual care (n = 40) for initial treatment. Arthrocentesis consisted of rinsing the intra-articular space with isotonic saline, and usual care included a soft diet, physical therapy, and splint therapy. The duration of the usual care program was 6 weeks, and follow-up was conducted 3, 12, and 26 weeks after its completion. Generalized estimated equation multivariate models were assessed in order to correct for the dependency of repeated measurements in the longitudinal data analysis. An independent samples t test was used to compare the arthrocentesis group with the usual care group for TMJ pain after 26 weeks. Cost effectiveness (total cost from a societal view) was related to TMJ pain (as measured on a visual analog scale [0 to 100 mm]) and to cost utility (quality-adjusted life years). Results: TMJ pain declined more quickly in the arthrocentesis group (n = 36) than in the usual care group (n = 36) (regression coefficient beta = -10.76; 95% confidence interval [CI] = -17.75 to -3.77; P = .003). The estimated mean total (ie, societal) cost over 26 weeks was (sic)589 (US $795) in the arthrocentesis group and (sic)1,680 (US $2,266) in the usual care group. Arthrocentesis was associated with a lower mean cost and better health outcomes than usual care in 98% and 95% of the bootstrap simulations, respectively. Conclusion: The results of this study suggest that, from an economical perspective, arthrocentesis may be superior to usual care for the initial treatment of TMJ pain, as it had better health outcomes and lower costs than usual care.

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 webcite). Date registered: 12 February 2012 Keywords: Cognitive adaptation training; CAT; Functioning; Severe mental illness; Schizophrenia; Quality of life; Nursing intervention; Cognitive remediation

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. Trial registration Current Controlled Trials: ISRCTN88987322. Registered 13 May 2014.

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.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 more on the total problems scale of the Child Behaviour 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 are 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).NTR2242.