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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: 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]