Economic evaluation of preventive cognitive therapy versus care as usual in cognitive behavioral therapy responders.

Background: The highly recurrent nature of Major Depressive Disorder is a major contributor to disability and health care costs. Several studies indicate that recurrence may be prevented with Preventive Cognitive Therapy (PCT). This study is the first to perform an economic evaluation of PCT in comparison with care as usual for recurrently depressed patients who experienced two or more depressive episodes and remitted after receiving Cognitive Behavioural Therapy. Methods: An economic evaluation from the societal perspective was performed alongside a randomized trial (N = 214). Health-related quality of life (QALYs), depression-free days, health care utilization, and productivity losses were measured between randomization and 15 months follow-up. The costs were indexed to the reference year 2014. Results: QALY gains did not differ significantly between the groups (p = 0.69). Depression-free days were higher after PCT (p = 0.02). Societal costs of PCT were 10,417 euro and for care as usual 9,545 euro per person. We found a 47% likelihood that PCT led to additional QALYs at higher costs, and there was a 26% likelihood that PCT led to fewer QALYs at higher costs. When depression-free days was used as an outcome, we found PCT had a 72% likelihood of leading to more depression-free days at higher costs than care as usual and a 27% likelihood of leading to more depression-free days at lower societal costs. Limitations: The 15-month follow-up might be too short to draw long-term conclusions about the cost-effectiveness of the PCT. The data collected for this study is part of an RCT to examine the effectiveness of adding PCT to care as usual. Therefore, the study was powered primarily to detect an effect in time to relapse/recurrences. Conclusion: The economic evaluation is slightly in favour of the PCT condition when depression-free days is used as an outcome. PCT is not cost-effective given the high costs per additional QALYs from the societal perspective when QALYs are the effect measure. Clinical trial registration: https://www.onderzoekmetmensen.nl/en, identifier NL2482.

Medication strategies in first episode psychosis patients: A survey among psychiatrists.

AIM: There is an ongoing debate regarding the optimal timing of discontinuation of antipsychotic drugs for patients with first episode psychosis. Although most guidelines recommend maintenance therapy for at least 1 or 2 years after reaching remission, study results indicate that early discontinuation may be beneficial for at least a subsample of patients. To date, little is known about which medication strategies are applied in patients recovering from a first psychotic episode. In this study, we examined the beliefs and practices of clinicians on medication discontinuation. METHODS: We performed a survey among 50 experienced Dutch psychiatrists to assess how often specific treatment strategies have been applied in the past 12 months, as well as their knowledge and expectations with respect to medication discontinuation. RESULTS: Psychiatrists estimated that, after remission, they continued medication at the same dose for at least 12 months in 51.2% of cases, continued in a reduced dose in 33.8% of cases and discontinued medication in 9.1% of cases after 4.4 months of remission on average. Although the medication is discontinued in only a relatively small proportion of patients, almost half of all clinicians (45.9%) used this strategy at least once in the past 12 months. CONCLUSIONS: There is substantial practice variation in antipsychotic medication strategies after remission from a first psychotic episode. Future research on long-term effects of early medication discontinuation can guide clinicians in making evidence-based decisions when treating first-episode patients.

Subjective Medication Satisfaction With Antipsychotic Polypharmacy in a Naturalistic Inpatient and Outpatient Sample.

Objective: The aim of this study was to examine satisfaction with pharmacologic treatment in patients who received antipsychotic polypharmacy compared to antipsychotic monotherapy.Methods: This longitudinal cohort study was conducted in two mental health care institutes in Amsterdam, the Netherlands, among a randomly selected sample of in- and outpatients with a severe mental illness. Analyses were performed on data collected in 2011 for 185 patients who were diagnosed with schizophrenia or unspecified psychosis according to DSM-IV criteria. The outcome measure was the Treatment Satisfaction Questionnaire for Medication, version II. One-way analyses of covariance were performed to examine differences in treatment satisfaction between patients who received antipsychotic polypharmacy compared to antipsychotic monotherapy while controlling for the effects of clozapine, antipsychotic dose, and use of long-acting injectable antipsychotics.Results: Twenty percent of patients in this sample received 2 antipsychotic agents; in half of those patients, this involved a combination with clozapine. Polypharmacy resulted in less satisfaction with side effects compared to monotherapy (P = .002). No difference was found in perceived effectiveness (P = .168) or overall medication satisfaction (P = .379).Conclusions: These results confirm that antipsychotic polypharmacy is common in a random in- and outpatient sample. Patients who receive 2 antipsychotic agents are just as positive about the effectiveness and ease of use of and overall satisfaction with their medication compared to those who receive antipsychotic monotherapy. They are, however, less satisfied with perceived side effects of their medication, which may indicate that side effect profiles of antipsychotic combinations are less favorable.

Economic Evaluation of the SOS Training to Reduce Victimization in Dual Diagnosis Patients.

OBJECTIVE: Economic evaluations of interventions for dual diagnosis patients are scarce. A recent randomized controlled trial has supported the effectiveness of the Self-wise, Otherwise, Streetwise (SOS) training to reduce victimization in dual diagnosis patients. The purpose of the current study was to analyze the cost-effectiveness and cost-utility of the SOS training as an add-on to care as usual (CAU). METHODS: We performed an economic evaluation from a societal perspective alongside the SOS trial. Participants were 250 dual diagnosis patients recruited at three locations from a large urban psychiatric service in the Netherlands. The main outcomes were treatment response for victimization and quality-adjusted life years (QALYs). Both costs and effects were measured across a 14-month follow-up. RESULTS: There was no significant difference between CAU + SOS and CAU in total costs (mean difference €4,859; 95% CI [-€4,795 to €14,513]) and QALY gains (mean difference 0.0012; 95% CI [-0.05 to 0.05]). Significantly more participants in CAU + SOS achieved treatment response for victimization compared to CAU (68% vs. 54%; mean difference 0.14; 95% CI [0.02 to 0.26]). The cost-effectiveness analysis indicated an 83% likelihood that CAU + SOS resulted in a higher treatment response rate for victimization at higher costs compared to CAU. The cost-utility analysis indicated that adding SOS-training to CAU is probably not cost-effective at conventional willingness-to-pay levels for QALYs. CONCLUSIONS: At a societal willingness-to-pay of €38,000 or more per extra treatment responder, adding SOS-training to usual care is probably more attractive than usual care alone with regard to cost-effectiveness. This is a considerable willingness to pay. However, the direct costs of offering the SOS training are expected to be minor. Our findings should be interpreted with caution due to the short follow-up period and absence of data on potential reductions in police and judicial costs other than prison costs.

To continue or not to continue? Antipsychotic medication maintenance versus dose-reduction/discontinuation in first episode psychosis: HAMLETT, a pragmatic multicenter single-blind randomized controlled trial.

BACKGROUND: Antipsychotic medication is effective for symptomatic treatment in schizophrenia-spectrum disorders. After symptom remission, continuation of antipsychotic treatment is associated with lower relapse rates and lower symptom severity compared to dose reduction/discontinuation. Therefore, most guidelines recommend continuation of treatment with antipsychotic medication for at least 1 year. Recently, however, these guidelines have been questioned as one study has shown that more patients achieved long-term functional remission in an early discontinuation condition-a finding that was not replicated in another recently published long-term study. METHODS/DESIGN: The HAMLETT (Handling Antipsychotic Medication Long-term Evaluation of Targeted Treatment) study is a multicenter pragmatic single-blind randomized controlled trial in two parallel conditions (1:1) investigating the effects of continuation versus dose-reduction/discontinuation of antipsychotic medication after remission of a first episode of psychosis (FEP) on personal and social functioning, psychotic symptom severity, and health-related quality of life. In total 512 participants will be included, aged between 16 and 60 years, in symptomatic remission from a FEP for 3-6 months, and for whom psychosis was not associated with severe or life-threatening self-harm or violence. Recruitment will take place at 24 Dutch sites. Patients are randomized (1:1) to: continuation of antipsychotic medication until at least 1 year after remission (original dose allowing a maximum reduction of 25%, or another antipsychotic drug in similar dose range); or gradual dose reduction till eventual discontinuation of antipsychotics according to a tapering schedule. If signs of relapse occur in this arm, medication dose can be increased again. Measurements are conducted at baseline, at 3, and 6 months post-baseline, and yearly during a follow-up period of 4 years. DISCUSSION: The HAMLETT study will offer evidence to guide patients and clinicians regarding questions concerning optimal treatment duration and when to taper off medication after remission of a FEP. Moreover, it may provide patient characteristics associated with safe dose reduction with a minimal risk of relapse. TRIAL STATUS: Protocol version 1.3, October 2018. The study is active and currently recruiting patients (since September 2017), with the first 200 participants by the end of 2019. We anticipate completing recruitment in 2022 and final assessments (including follow-up 3.5 years after phase one) in 2026. TRIAL REGISTRATION: European Clinical Trials Database, EudraCT number 2017-002406-12. Registered 7 June 2017.

Preventive cognitive therapy versus care as usual in cognitive behavioral therapy responders: A randomized controlled trial.

OBJECTIVE: The optimization of long-term outcomes is an important goal in the treatment of major depressive disorder. Offering subsequent preventive cognitive therapy (PCT) to patients who responded to acute cognitive behavioral therapy (CBT) may reduce the risk of relapse/recurrence. METHOD: Therefore, a multicenter randomized controlled trial was conducted comparing the addition of eight weekly sessions of PCT to care as usual (CAU) versus CAU alone in patients with a history of depression in remission following treatment with CBT. A total of 214 recurrently depressed patients who remitted following treatment with CBT were randomized to PCT (n = 107) or CAU (n = 107). Primary outcome was time to relapse/recurrence over 15 months and was assessed by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I). Secondary outcomes were depressive symptoms measured by the Inventory of Depressive Symptomatology-Self Report and number and severity of relapses/recurrences measured by the SCID-I. RESULTS: Over the 15-month follow-up, the addition of PCT significantly delayed time to relapse/recurrence relative to CAU alone, hazard ratio = 1.807 (number needed to treat = 8.1), p = .02, 95% CI [1.029, 3.174]. No significant differences were found between the conditions on number or severity of relapses/recurrences and residual symptoms. CONCLUSION: Adding PCT was significantly more effective than CAU alone in delaying time to relapse/recurrence of depression over a period of 15 months among CBT responders. After response on CBT, therapists should consider providing PCT to recurrently depressed patients. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Linking childhood emotional abuse and depressive symptoms: The role of emotion dysregulation and interpersonal problems.

Childhood abuse is a major public health problem that has been linked to depression in adulthood. Although different types of childhood abuse often co-occur, few studies have examined their unique impact on negative mental health outcomes. Most studies have focused solely on the consequences of childhood physical or sexual abuse; however, it has been suggested that childhood emotional abuse is more strongly related to depression. It remains unclear which underlying psychological processes mediate the effect of childhood emotional abuse on depressive symptoms. In a cross-sectional study in 276 female college students, multiple linear regression analyses were used to determine whether childhood emotional abuse, physical abuse, and sexual abuse were independently associated with depressive symptoms, emotion dysregulation, and interpersonal problems. Subsequently, OLS regression analyses were used to determine whether emotion dysregulation and interpersonal problems mediate the relationship between childhood emotional abuse and depressive symptoms. Of all types of abuse, only emotional abuse was independently associated with depressive symptoms, emotion dysregulation, and interpersonal problems. The effect of childhood emotional abuse on depressive symptoms was mediated by emotion dysregulation and the following domains of interpersonal problems: cold/distant and domineering/controlling. The results of the current study indicate that detection and prevention of childhood emotional abuse deserves attention from Child Protective Services. Finally, interventions that target emotion regulation skills and interpersonal skills may be beneficial in prevention of depression.

Self-wise, Other-wise, Streetwise (SOS) training, an intervention to prevent victimization in dual-diagnosis patients: results from a randomized clinical trial.

BACKGROUND AND AIMS: Patients with co-occurring substance use and other mental disorders are vulnerable to crime victimization, yet no evidence-based preventive interventions exist. Our aim was to test the efficacy of a new intervention, Self-wise, Other-wise, Streetwise training (SOS training), to prevent victimization in these dual-diagnosis patients as an add-on to care as usual. DESIGN: Multi-site single-blind parallel randomized controlled trial. SETTING: Three sites within one psychiatric service in Amsterdam, the Netherlands. PARTICIPANTS: Adult in-patients and out-patients with dual diagnosis (n = 250), who were predominantly male (70.4%), aged on average 42.1 years, and diagnosed with 3.7 DSM-IV disorders. INTERVENTION AND COMPARATOR: Care as usual, consisting of pharmacotherapy combined with individual psychotherapy, group psychotherapy and/or supportive counselling (n = 125) was compared with care as usual plus SOS training: a 6-week, 12-session manualized group training focused on enhancing emotion regulation skills, conflict resolution skills and street skills (n = 125). MEASUREMENTS: Victimization was assessed with the Safety Monitor, the Dutch equivalent of the International Crime Victims Survey, in a face-to-face assessment. The primary outcome measure was treatment response (yes/no), with 'yes' defined as reporting at least a 50% reduction in the number of past-year victimization incidents at the 14-month follow-up compared with baseline. Analyses were performed according to the intention-to-treat principle. FINDINGS: The proportion of participants achieving treatment response for total victimization was 54.0% in the control group and 67.6% in the experimental group, a significant difference [odds ratio (OR) = 1.78, 95% confidence interval (CI) = 1.02-3.11, P = 0.042]. Treatment response for violent victimization was achieved by 68.7% of the control group and 79.3% of the experimental group (OR = 1.75, 95% CI = 0.91-3.34, P = 0.092). With a Bayes factor of 2.26, this result was inconclusive. CONCLUSIONS: Among dual-diagnosis patients, care as usual plus Self-wise, Other-wise, Streetwise training was more effective in preventing victimization than care as usual alone.

The association between the number of previous episodes and modifiable vulnerability factors in remitted patients with recurrent depression.

OBJECTIVE: Remitted patients with a history of several previous major depressive episodes have a higher risk of relapse/recurrence than patients with fewer previous episodes, and the probability of another episode increases progressively with each successive episode. This study examines the association between the number of previous episodes and modifiable vulnerability factors in remitted patients with recurrent depression. METHODS: Patients with recurrent depression (DSM-IV-diagnosed) who were in remission (N = 214) were recruited between September 2011 and July 2016. The association was examined between the number of previous episodes and the following factors: i.e. interpersonal functioning, daily stress, sense of mastery, coping and dysfunctional beliefs. RESULTS: A history of more previous episodes was associated with higher levels of interpersonal problems (P < .001), daily stress (P = .04) and a lower sense of mastery (P = .05). Interpersonal problems were most strongly associated with more previous episodes in a Generalized Linear Regression model. In the domain of interpersonal problems, the subscales that showed the strongest relationship were domineering/controlling, vindictive/self-centred, socially inhibited and self-sacrificing. CONCLUSIONS: Patients with a history of more depressive episodes reported higher levels of interpersonal problems, daily stress and a lower sense of mastery. Future studies should examine these factors in a longitudinal cohort and look at whether the effect of interventions to prevent relapse can be explained by targeting these psychological factors. TRIAL REGISTRATION: Netherlands Trial Register: 2599.

Day hospital mentalization-based treatment v. specialist treatment as usual in patients with borderline personality disorder: randomized controlled trial.

BACKGROUND: Day hospital mentalization-based treatment (MBT-DH) is a promising treatment for borderline personality disorder (BPD) but its evidence base is still limited. This multi-site randomized trial compared the efficacy of MBT-DH delivered by a newly set-up service v. specialist treatment as usual (S-TAU) tailored to the individual needs of patients, and offered by a well-established treatment service. METHODS: Two mental healthcare institutes in The Netherlands participated in the study. Patients who met DSM-IV criteria for BPD and had a score of ⩾20 on the borderline personality disorder severity index (BPDSI) were randomly allocated to MBT-DH (N = 54) or S-TAU (N = 41). The primary outcome variable was the total score on the BPDSI. Secondary outcome variables included symptom severity, quality of life, and interpersonal functioning. Data were collected at baseline and every 6 months until 18-month follow-up, and were analyzed using multilevel analyses based on intention-to-treat principles. RESULTS: Both treatments were associated with significant improvements in all outcome variables. MBT-DH was not superior to S-TAU on any outcome variable. MBT-DH was associated with higher acceptability in BPD patients compared v. S-TAU, reflected in significantly higher early drop-out rates in S-TAU (34%) v. MBT-DH (9%). CONCLUSIONS: MBT-DH delivered by a newly set-up service is as effective as specialist TAU in The Netherlands in the treatment of BPD at 18-month follow-up. Further research is needed to investigate treatment outcomes in the longer term and the cost-effectiveness of these treatments.

Prevention of violent revictimization in depressed patients with an add-on internet-based emotion regulation training (iERT): study protocol for a multicenter randomized controlled trial.

BACKGROUND: Psychiatric patients are at high risk of becoming victim of a violent crime compared to the general population. Although most research has focused on patients with severe mental illness, depressed patients have been demonstrated to be prone to victimization as well. Victimization is associated with more severe symptomatology, decreased quality of life, and high risk of revictimization. Hence, there is a strong need for interventions that focus on preventing violent revictimization. Since emotion dysregulation is associated with both victimization and depression, we developed an internet-based Emotion Regulation Training (iERT) to reduce revictimization in depressed patients. This study aims to evaluate the clinical and cost-effectiveness of iERT added to Treatment As Usual (TAU) in reducing incidents of violent revictimization among depressed patients with a recent history of victimization. Furthermore, this study aims to examine secondary clinical outcomes, and moderators and mediators that may be associated with treatment outcomes. METHODS: In a multicenter randomized controlled trial with parallel group design, patients with a major depressive disorder and a history of violent victimization over the past three years (N = 200) will be allocated to either TAU + iERT (N = 100) or TAU only (N = 100), based on computer-generated stratified block randomization. Assessments will take place at baseline, 8 weeks, 14 weeks, and 6 months after start of treatment, and 12, 24, and 36 months after baseline. The primary outcome measure is the total number of violent victimization incidents at 12 months after baseline, measured with the Safety Monitor: an adequate self-report questionnaire that assesses victimization over the preceding 12 months. Secondary outcome measures and mediators include emotion dysregulation and depressive symptomatology. An economic evaluation with the societal perspective will be performed alongside the trial. DISCUSSION: This study is the first to examine the effectiveness of an intervention aimed at reducing violent revictimization in depressed patients. If effective, iERT can be implemented in mental health care, and contribute to the well-being of depressed patients. Furthermore, the results will provide insight into underlying mechanisms of revictimization. TRIAL REGISTRATION: The study is registered at the Netherlands Trial Register ( NTR5822 ). Date of registration: 4 April 2016.

Factors associated with victimization in dual diagnosis patients.

BACKGROUND: Patients with a substance use disorder and co-occurring mental disorder are prone to victimization. There is a lack of research identifying variables related to violent and property victimization in this high risk group. The aim of this study was to identify factors associated with violent and property victimization in male and female dual diagnosis patients in order to identify targets for prevention. METHODS: In a cross-sectional study, victimization and demographic, clinical and psychological characteristics were assessed in 243 treatment-seeking patients with dual diagnosis. Patients were recruited in an addiction-psychiatry clinic and an allied outpatient care facility in Amsterdam, The Netherlands. RESULTS: In a multiple logistic regression analysis, violent victimization was independently associated with younger age, female gender, violent offending and a self-sacrificing and overly accommodating interpersonal style (p<0.001; χ2=108.83, d.f.=8, R2=0.49) in dual diagnosis patients. In male patients, violent victimization was independently associated with younger age, violent offending and a self-sacrificing and overly accommodating interpersonal style (p<0.001; χ2=91.90, d.f.=7, R2=0.56). In female patients, violent victimization was independently positively associated with homelessness, violent offending, a domineering/controlling interpersonal style, and negatively associated with being socially inhibited and cold/distant (p<0.001; χ2=34.08, d.f.=4, R2=0.53). Property victimization was independently associated with theft offending (p<0.001, χ2=26.99, d.f.=5, R2=0.14). CONCLUSIONS: Given the high prevalence of victimization in dual diagnosis patients and its related problems, preventive interventions should be developed. Interventions should target interpersonal skills to decrease vulnerability to victimization, address the overlap between victimization and offending and incorporate gender-specific elements.

Medication Adherence Decisions in Patients With Schizophrenia.

Medication nonadherence is common in patients with schizophrenia. Nonadherence affects approximately half of all patients and may increase the risk of relapse and hospitalization. Although it is an intensively studied phenomenon, we have little understanding of underlying mechanisms leading to nonadherence. In this article, using quantitative and qualitative study results and psychological decision theory, we present a model of medication adherence decisions in patients with schizophrenia that may be useful for clinicians and those involved in the development of adherence interventions or adherence research. The model focuses on the function and meaning of medication from a patient perspective. Although the model is a simplified description of the decision-making process related to medication use, it does explain the role of some important aspects such as insight, side effects, efficacy, and social influences. We also discuss how this may explain the high and persistent rates of nonadherence. Finally, we discuss some implications for clinical practice.​​.

Gender differences in characteristics of physical and sexual victimization in patients with dual diagnosis: a cross-sectional study.

BACKGROUND: Patients with substance use disorders and co-occurring mental health disorders are vulnerable to violent victimization. However, no evidence-based interventions are available to reduce patients' vulnerability. An exploration of the characteristics of physical and sexual violence can provide valuable information to support the development of interventions for these patients. This study aimed to examine gender differences in characteristics of violent victimization in patients with dual diagnosis. METHODS: In this cross-sectional survey study recent incidents of physical and sexual assault were examined with the Safety Monitor in 243 patients with dual diagnosis. Chi-square tests were used to examine gender differences in the prevalence of physical and sexual victimization. Fisher's exact tests and Fisher-Freeman-Halton exact tests were used to determine whether there were significant differences between victimized men and women with regard to perpetrators, locations, reporting to the police and speaking about the assault with others. RESULTS: There was no significant difference in the prevalence of physical violence in men (35%) and women (47%) with dual diagnosis. There was a significant association between gender of the victim and type of perpetrator (P < .001). Men were most often physically abused by a stranger or an acquaintance, whereas women were most frequently abused by an (ex)partner. Sexual violence was more prevalent in women (29%) compared to men (4%) (P < .001). Patients with dual diagnosis were unlikely to report incidents of physical abuse and sexual assault to the police and to speak about it with caregivers. CONCLUSIONS: Characteristics of physical violence are different for men and women with dual diagnosis. Women with dual diagnosis are more often victims of sexual violence compared to men. Interventions aimed at reducing patients' vulnerability for victimization should take gender differences into account.

The burden of disease in patients eligible for mentalization-based treatment (MBT): quality of life and costs.

BACKGROUND: Mentalization-Based Treatment (MBT) is a promising, though expensive treatment for severely ill patients with Borderline Personality Disorder (BPD). A high burden of disease in terms of quality of life (QoL) and life years lost can be a reason to prioritize mental health interventions, and specifically for BPD patients. Moreover, when the societal costs of the illness are high, spending resources on high treatment costs would be more easily legitimized. Therefore, the purpose of this study was to calculate the burden of disease of BPD patients eligible for MBT. METHODS: The 403 patients included in this study were recruited from two mental health care institutes in the Netherlands. All patients were eligible for MBT. Burden of disease consisted of QoL, measured with the EuroQol EQ-5D-3L, and costs, calculated using the Trimbos and Institute for Medical Technology Assessment Questionnaire for Costs Associated with Psychiatric Illness. RESULTS: The mean QoL index score was .48. The mean total costs in the year prior to treatment were €16,879 per patient, of which 21 % consisted of productivity costs. CONCLUSIONS: The burden of disease in BPD patients eligible for MBT is high, which makes it more likely that society is willing to invest in treatment for these patients. However, this finding should not be interpreted as a license to unlimitedly use resources to reimburse treatment for severe BPD patients, as these findings do not provide any information on the effectiveness of MBT or other available treatment programs for BPD. The effectiveness of available treatments should be evident by studies on the effectiveness of the treatment itself and by comparing the effectiveness of these treatments to treatment as usual and to other treatment options for BPD patients. TRIAL REGISTRATION: The data on this paper came from two trials: NTR2175 and NTR2292 .

The role of avoidant and obsessive-compulsive personality disorder traits in matching patients with major depression to cognitive behavioral and psychodynamic therapy: A replication study.

BACKGROUND: Barber and Muenz (1996) reported that cognitive behavior therapy (CBT) was more effective than interpersonal therapy (IPT) for depressed patients with elevated levels of avoidant personality disorder, while IPT was more effective than CBT in patients with elevated levels of obsessive-compulsive personality disorder. These findings may have important clinical implications, but have not yet been replicated. METHODS: We conducted a study using data from a randomized clinical trial comparing the efficacy of CBT and short-term psychodynamic supportive psychotherapy in the outpatient treatment of depression. RESULTS: We found no evidence indicating that avoidant patients may benefit more from CBT compared to short-term psychodynamic supportive therapy (SPSP). CONCLUSIONS: Our results indicate that treatment effect does not depend on the level of avoidance, or obsessive-compulsiveness personality disorders further examine the influence of personality disorders on the effectiveness of CBT or psychodynamic therapy in the treatment of depression.

Self-wise, Other-wise, Streetwise (SOS) training: a novel intervention to reduce victimization in dual diagnosis psychiatric patients with substance use disorders: protocol for a randomized controlled trial.

BACKGROUND: Psychiatric patients are more likely to be victims of crime than others in the community. Dual diagnosis patients with comorbid psychiatric and substance use disorders are especially prone to victimization. Victimization is associated with substance abuse, more severe symptomatology and homelessness. There is a strong need for interventions to reduce victimization in this population. We developed the Self-wise, Other-wise, Streetwise (SOS) training to reduce victimization in patients with dual diagnosis. METHODS/DESIGN: This study is a randomized controlled trial using a parallel group design to determine the effectiveness of adding the SOS training to care as usual. Patients with dual diagnosis (N = 250) will be allocated to either care as usual plus SOS training (N = 125) or care as usual only (N = 125) using computer-generated stratified block randomization. To compare effectiveness participants will be interviewed at baseline and 2, 8 and 14 months follow-up. The primary outcome measure is treatment response (yes/no), defined as either no victimization at 14 months follow-up or at least a 50% reduction in incidents of victimization at 14 months follow-up compared to baseline assessment. Victimization is measured with the Safety Monitor, an adequate self-report instrument used by Statistics Netherlands to measure victimization on a large scale in the Netherlands. Outcome assessors are blind to treatment allocation. An economic evaluation will be performed alongside the randomized controlled trial and will take the societal perspective. DISCUSSION: This study is the first randomized controlled trial to examine the effectiveness of an intervention that aims to reduce victimization in patients with dual diagnosis. If the intervention is effective it can be implemented in mental health care and contribute to the safety and well-being of patients. TRIAL REGISTRATION: Dutch Trial Register (NTR): 4472, date of registration: 24-03-2014.

Preventive Cognitive Therapy versus Treatment as Usual in preventing recurrence of depression: protocol of a multi-centered randomized controlled trial.

BACKGROUND: Major depressive disorder (MDD) is projected to rank second on a list of 15 major diseases in terms of burden in 2030. The contribution of MDD to disability and health care costs is largely due to its highly recurrent nature. Therefore, part of the efforts to reduce the disabling effects of depression should focus on preventing recurrence, especially in patients at high risk of recurrence. The best established effective psychological intervention is cognitive therapy, with indications for prophylactic effects after remission. METHODS/DESIGN: In this randomized controlled trial (cost-) effectiveness of Preventive Cognitive Therapy (PCT) after response to Acute Cognitive Therapy (A-CT) will be evaluated in comparison with Treatment As Usual (TAU). Remitted patients that responded to A-CT treatment with at least two previous depressive episodes will be recruited. Randomization will be stratified for number of previous episodes. Follow-ups are at 3, 6, 12 and 15 months. The primary outcome measure will be the time to relapse or recurrence of depression meeting DSM-IV criteria for a major depressive episode on the Structured Clinical Interview for DSM-VI Axis I Disorders (SCID-I). Costs will be measured from a societal perspective. DISCUSSION: This study is the first to examine the addition of PCT to TAU, compared to TAU alone in patients that recovered from depressive disorder with A-CT. Alongside this effect study a cost effectiveness analysis will be conducted. Furthermore, the study explores potential moderators to examine what works for whom. TRIAL REGISTRATION: Netherlands Trial Register (NTR): 2599 , date of registration: 11-11-2010.

Day Hospital Mentalization-Based Treatment (MBT-DH) versus treatment as usual in the treatment of severe borderline personality disorder: protocol of a randomized controlled trial.

BACKGROUND: Severe borderline personality disorder is associated with a very high psychosocial and economic burden. Current treatment guidelines suggest that several manualized treatments, including day hospital Mentalization-Based Treatment (MBT-DH), are effective in these patients. However, only two randomized controlled trials have compared manualized MBT-DH with treatment as usual. Given the relative paucity of data supporting the efficacy and cost-effectiveness of MBT-DH, the possible influence of researcher allegiance in one of the trials, and potential problems with the generalization of findings to mental health systems in other countries, this multi-site randomized trial aims to investigate the efficacy and cost-effectiveness of manualized MBT-DH compared to manualized specialist treatment as usual in The Netherlands. METHODS/DESIGN: The trial is being conducted at two sites in The Netherlands. Patients with a DSM-IV-TR diagnosis of borderline personality disorder and a score of ≥ 20 on the Borderline Personality Disorder Severity Index were randomly allocated to MBT-DH or treatment as usual. The MBT-DH program consists of a maximum of 18 months' intensive treatment, followed by a maximum of 18 months of maintenance therapy. Specialist treatment as usual is provided by the City Crisis Service in Amsterdam, a service that specializes in treating patients with personality disorders, offering manualized, non-MBT interventions including family interventions, Linehan training, social skills training, and pharmacotherapy, without a maximum time limit. Patients are assessed at baseline and subsequently every 6 months up to 36 months after the start of treatment. The primary outcome measure is the frequency and severity of manifestations of borderline personality disorder as assessed by the Borderline Personality Disorder Severity Index. Secondary outcome measures include parasuicidal behaviour, symptomatic distress, social and interpersonal functioning, personality functioning, attachment, capacity for mentalizing and quality of life. Cost-effectiveness is assessed in terms of the cost per quality-adjusted life year. Outcomes will be analyzed using multilevel analyses based on intention-to-treat principles. DISCUSSION: Severe borderline personality disorder is a serious psychological disorder that is associated with high burden. This multi-site randomized trial will provide further data concerning the efficacy and cost-effectiveness of MBT-DH for these patients. TRIAL REGISTRATION: NTR2175.

The predictive validity of subjective adherence measures in patients with schizophrenia.

Despite frequent use of subjective adherence measures in patients with schizophrenia as well as other chronic conditions, there are several reports that question the validity of these instruments. Three well known, representative subjective measures are the Medication Adherence Questionnaire (MAQ), the Drug Attitude Inventory (DAI), and the Compliance Rating Scale (CRS). In this study we explored the predictive validity of these instruments in a European sample of 119 stabilized outpatients with schizophrenia. Clinical outcome variables were relapse and admission to a psychiatric hospital during a follow-up period of 12 months. Results indicate that the predictive validity of all three measures was poor. The MAQ was the least problematic predictor for relapse (Nagelkerke R(2) = 0.09), and time to relapse (R(2) = 0.07) and had the best sensitivity for relapse (63.6%) as well as admission (87.5%). The MAQ and CRS were both moderate predictive for admission (Nagelkerke R(2) = 0.21, and R(2) = 0.29). We conclude that the validity of the instruments studied here is questionable and have limited clinical relevance. Given the feasibility and ease of most subjective instruments, researchers may be tempted to use them but should be aware of the serious drawbacks of these instruments.