Cost effectiveness and budgetary impact of the Boston University approach to Psychiatric Rehabilitation for societal participation in people with severe mental illness: a randomised controlled trial protocol.

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.

Cost-effectiveness analysis of the treatment of posttraumatic stress disorder related to childhood abuse: comparison of phase-based treatment and direct trauma-focused treatment.

Background: Policymakers, health insurers, and health care providers are becoming increasingly interested in cost-effectiveness analyses (CEA's) when choosing between possible treatment alternatives, as costs for mental health care have been increasing in recent years. Objective: The current study compared the cost-effectiveness and cost-utility of a phased-based treatment approach that included a preparatory stabilization phase with direct trauma-focused treatment in patients with PTSD and a history of childhood abuse. Methods: A cost-effectiveness analysis was conducted based on data from a randomized controlled trial of 121 patients with PTSD due to childhood abuse. A phase-based treatment (Eye Movement Desensitization and Reprocessing [EMDR] therapy preceded by Skills Training in Affect and Interpersonal Regulation [STAIR]; n = 57) was compared with a direct trauma-focused treatment (EMDR therapy only; n = 64). The primary outcome of cost-effectiveness was the proportion of patients with remitted PTSD. Quality-adjusted life years (QALY) were used as the primary outcome measure for cost-utility analysis. Results: Although the results of the cost-effectiveness analyses yielded no statistically significant differences between the two groups, the mean societal costs per patient differed significantly between the STAIR-EMDR and EMDR therapy groups (€19.599 vs. €13.501; M cost differences = €6.098, CI (95%) = [€117; €12.644]). Conclusion: STAIR-EMDR is not cost-effective compared with EMDR-only therapy. Since trauma-focused treatment is less time-consuming, non-trauma-focused phase-based, treatment does not seem to be a viable alternative for the treatment of PTSD due to adverse childhood events.Clinical trial registration: https://onderzoekmetmensen.nl/nl/trial/22074, identifier NL5836.

Cost-effectiveness of a mindful yoga intervention added to treatment as usual for young women with major depressive disorder versus treatment as usual only: Cost-effectiveness of yoga for young women with depression.

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.

Preventing mood and anxiety disorders in youth: a multi-centre RCT in the high risk offspring of depressed and anxious patients.

BACKGROUND: Anxiety and mood disorders are highly prevalent and pose a huge burden on patients. Their offspring is at increased risk of developing these disorders as well, indicating a clear need for prevention of psychopathology in this group. Given high comorbidity and non-specificity of intergenerational transmission of disorders, prevention programs should target both anxiety and depression. Further, while the indication for preventive interventions is often elevated symptoms, offspring with other high risk profiles may also benefit from resilience-based prevention programs. METHOD/DESIGN: The current STERK-study (Screening and Training: Enhancing Resilience in Kids) is a randomized controlled clinical trial combining selected and indicated prevention: it is targeted at both high risk individuals without symptoms and at those with subsyndromal symptoms. Individuals without symptoms meet two of three criteria of the High Risk Index (HRI; female gender, both parents affected, history of a parental suicide (attempt). This index was developed in an earlier study and corresponds with elevated risk in offspring of depressed patients. Children aged 8-17 years (n = 204) with subthreshold symptoms or meeting the criteria on the HRI are randomised to one of two treatment conditions, namely (a) 10 weekly individual child CBT sessions and 2 parent sessions or (b) minimal information. Assessments are held at pre-test, post-test and at 12 and 24 months follow-up. Primary outcome is the time to onset of a mood or anxiety disorder in the offspring. Secondary outcome measures include number of days with depression or anxiety, child and parent symptom levels, quality of life, and cost-effectiveness. Based on models of aetiology of mood and anxiety disorders as well as mechanisms of change during interventions, we selected potential mediators and moderators of treatment outcome, namely coping, parent-child interaction, self-associations, optimism/pessimism, temperament, and emotion processing. DISCUSSION: The current intervention trial aims to significantly reduce the risk of intergenerational transmission of mood and anxiety disorders with a short and well targeted intervention that is directed at strengthening the resilience in potentially vulnerable children. We plan to evaluate the effectiveness and cost-effectiveness of such an intervention and to identify mechanisms of change. TRIAL REGISTRATION: NTR2888.

Mindful yoga intervention as add-on to treatment as usual for young women with major depressive disorder: Results from a randomized controlled trial.

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. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Cognitive-behavioural therapy for persistent and recurrent psychosis in people with schizophrenia-spectrum disorder: cost-effectiveness analysis.

BACKGROUND: Evidence on cost-effectiveness is important to make well-informed decisions regarding care delivery. AIMS: To determine the balance between costs and health outcomes of cognitive-behavioural therapy (CBT) compared with treatment as usual (TAU) in people with schizophrenia who have persistent and recurrent symptoms of psychosis. TRIAL NUMBER: ISRCTN57292778. METHOD: A total of 216 people were randomised and followed up for 18 months. The primary clinical outcome measure was time functioning within the normal range. Normal functioning was defined as social functioning within the 95% range of the general population and no or minimal suffering and/or no or minimal affect on daily life of persistent psychotic symptoms. The difference in number of days was estimated. Using a societal perspective, cost differences were estimated and combined with clinical outcome to yield an incremental cost-effectiveness ratio (ICER). Uncertainty was accessed using bootstrapping and displayed by means of a cost-effectiveness acceptability curve. RESULTS: In the CBT group, participants experienced 183 days of normal social functioning, whereas the TAU group experienced 106 days. The ICER was €47 per day of normal functioning gained. Cognitive-behavioural therapy implies higher costs, yet results in better health outcomes. Sensitivity analyses showed that targeting individuals who have not been hospitalised before receiving CBT results in an ICER of €14 per day normal functioning gained. CONCLUSIONS: Days of normal functioning improved in the CBT condition compared with TAU, but this gain in health was associated with additional societal costs.

Disrupting the rhythm of depression: design and protocol of a randomized controlled trial on preventing relapse using brief cognitive therapy with or without antidepressants.

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.

A mindful yoga intervention for young women with major depressive disorder: Design and baseline sample characteristics of a randomized controlled trial.

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.

Cost-effectiveness of a psychoeducational relapse prevention program for depression in primary care.

BACKGROUND: Major depression is a prevalent mental disorder with a high risk of relapses and recurrences, which are associated with considerable burden for patients and high costs for society. Despite these negative consequences, only few studies have focused on interventions aimed at the prevention of recurrences in primary care patients with depression. AIMS OF THE STUDY: To assess the cost-effectiveness of a psychoeducational prevention program (PEP) aimed at improving the long-term outcome of depression in primary care. METHODS: Recruitment took place in the northern part of the Netherlands, patients were referred by general practitioners. In total 267 patients were included in the study and randomly assigned to usual care (UC) or UC with one of three forms of PEP; PEP alone, psychiatric consultation followed by PEP (psychiatrist-enhanced PEP), and cognitive behavioral therapy followed by PEP (CBT-enhanced PEP). Costs and health outcomes were registered at three month intervals during the 36 months follow-up of the study. Primary outcome measure was the proportion of depression-free time. RESULTS: Mean total costs during the 36 months of the study were 8200 euros in the UC group, 9816 euros in the PEP group, 9844 euros in the psychiatrist-enhanced PEP group, and 9254 euros in the CBT-enhanced PEP group. Costs of productivity losses, hospital admissions, contacts with regional institutions for mental healthcare, and medication use contributed substantially to the total costs in each group. Results of the primary outcome measure were less positive for PEP than for UC, but slightly better in the enhanced PEP groups. If decision-makers are willing to pay up to 300 euros for an additional proportion of depression-free time, UC is most likely to be the optimal intervention. For higher willingness to pay, CBT-enhanced PEP seems most efficient. DISCUSSION: The basic PEP intervention was not cost-effective in comparison with UC. The economic impact of productivity losses associated with depression, and the importance of including these costs in economic studies, was illustrated by the findings of this study. Due to the drop-out of patients during the 36 months follow-up period, economic analyses had to account for missing data, which may complicate the interpretation of the results. Although Quality-Adjusted Life Years (QALYs) could not be assessed for all the patients, the results of analyses focusing on QALYs supported the overall conclusion that PEP is not cost-effective. IMPLICATIONS FOR HEALTH CARE PROVISION AND POLICIES: Results indicated that PEP should not be implemented in the Dutch healthcare system. Furthermore, is seems highly unlikely that PEP could be cost-effective in other (comparable) European healthcare systems. IMPLICATIONS FOR FURTHER RESEARCH: The relatively positive economic results for CBT-enhanced PEP imply that UC enriched with CBT (but without PEP) might be cost-effective in preventing relapses in primary care patients with depression. The actual consequences of CBT for relapse prevention will have to be studied in further detail, both from a clinical and economic point of view.

Cost Effectiveness of Arthrocentesis Compared to Conservative Therapy for Arthralgia of the Temporomandibular Joint: A Randomized Controlled Trial.

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 ß = -10.76; 95% confidence interval [CI] = -17.75 to -3.77; P = .003). The estimated mean total (ie, societal) cost over 26 weeks was €589 (US $795) in the arthrocentesis group and €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.

Effectiveness of computer-navigated minimally invasive total hip surgery compared to conventional total hip arthroplasty: design of a randomized controlled trial.

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.

Cost-effectiveness analysis in severe mental illness: outcome measures selection.

BACKGROUND: Most economic evaluations conducted in mental healthcare did not include widely recommended preference-based health outcomes like the QALY (Quality-Adjusted Life Years). Instead, studies have mainly been designed as cost-effectiveness analyses that include single outcome measures aimed at a (disease) specific aspect of health. AIMS OF THE STUDY: To raise awareness about the potential problems related to the selection of outcome measures for economic studies in patient populations with severe mental illness. Furthermore, to make suggestions that may prevent these problems in future economic evaluations. METHODS: Data of a previously conducted economic evaluation assessing the cost-effectiveness of the HIT (Hallucination focused Integrative Treatment) intervention in patients with schizophrenia were used for the analyses presented in the current paper. Economic analyses based on the results of the selected primary health outcome (Positive and Negative Syndrome Scale: PANSS) were compared with results based on various other health outcomes assessed during the study, including QALYs. RESULTS: No relevant differences between groups were found on the single primary health outcome initially included in the cost-effectiveness analysis. In contrast, relevant and significant differences were identified on three of the four additionally assessed health outcomes. Conclusions based on the results of multiple cost-effectiveness analyses and acceptability curves were strongly in favour of the experimental intervention when including these three additional instruments. QALY results did not show differences between groups. DISCUSSION: Selecting between outcome measures for cost-effectiveness analysis in the field of mental healthcare appears to be a complicated process, which may have considerable consequences for the results of economic studies and subsequent policy decisions. It was argued that inconsistent results across the selected primary health outcome and additionally assessed health outcomes should explicitly be presented to decision-makers. Until there is consensus on a preference-based instrument suited for severe mental illness, QoL instruments could be applied instead of instruments aimed at specific aspects of health. IMPLICATIONS FOR HEALTH POLICIES: Decision-makers in the field of mental healthcare should be careful when interpreting results of economic studies that included outcome measures aimed at a specific aspect of health. Such instruments may provide too narrow a view on relevant changes in health and findings may be difficult to generalise. Due to current reservations on the use of QALYs in mental healthcare, QALY outcomes should be considered in the context of the results of additionally assessed health outcomes.

Pregnancy Outcomes After a Maternity Intervention for Stressful Emotions (PROMISES): A Randomised Controlled Trial.

UNLABELLED: 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). TRIAL REGISTRATION: NTR2242.

Effectiveness and cost-effectiveness of cognitive adaptation training as a nursing intervention in long-term residential patients with severe mental illness: study protocol for a randomized controlled trial.

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.

Effectiveness of individual placement and support for people with severe mental illness in The Netherlands: a 30-month randomized controlled trial.

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.

PRegnancy Outcomes after a Maternity Intervention for Stressful EmotionS (PROMISES): study protocol for a randomised controlled trial.

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.

Cognitive self-therapy for chronic depression and anxiety: a multi-centre randomized controlled study.

BACKGROUND: Non-professional treatment programmes are presumed to relieve the extensive need for care of anxiety and depression disorders. This study investigates the effectiveness of cognitive self- therapy (CST) in the treatment of depression or generalized anxiety disorder. METHOD: Patients (n=151) were randomized to receive CST or treatment as usual (TAU) in a trial lasting for 18 months, measuring symptoms (SCL-90; main outcome), social functions, quality of life and utilization of care. RESULTS: Patients in both conditions improved significantly, but no difference was found between the conditions. Reduction of symptoms, improvement of social functions and medical utilization were maintained at the end of the 18 months. Medical care utilization (therapist contact and hospitalization) was lower for CST than for TAU. No suicides occurred. CONCLUSIONS: Cognitive self-therapy is likely to decrease the need for care of chronic depression and anxiety disorders, but it has not been proven to be more effective than treatment as usual.