Efficacy and cost-effectiveness of an experimental short-term inpatient Dialectical Behavior Therapy (DBT) program: Study protocol for a randomized controlled trial

__Abstract__ Background: Borderline Personality Disorder (BPD) is a serious psychiatric condition associated with substantial mortality, burden and public health costs. DBT is the treatment model with the largest number of published research articles showing effectiveness. However, some patients are not sufficiently engaged in outpatient treatment while presenting severe parasuicidal behavior, making hospitalization necessary. The Center for Personality Disorders Jelgersma developed an intensive 12-week inpatient DBT program that (i) rapidly reduces core borderline symptoms like suicidal behavior, (ii) minimizes the negative effects of an inpatient setting, and (iii) enhances compliance with outpatient treatment. We evaluate the (cost-) effectiveness of this experimental program.Methods/design: Seventy patients, aged 18 to 45 years with a primary diagnosis of BPD, showing a chronic pattern of parasuicidal gestures and/or reporting high degrees of severity of other borderline symptoms, are randomly allocated to the control and intervention groups. Subjects in the control group receive standard outpatient DBT, provided in one of three regular mental health settings in GGZ Rivierduinen. Subjects in the intervention group receive 12 weeks of intensified inpatient DBT plus six months of standard DBT, provided in the Center for Personality Disorders Jelgersma. The primary outcome is the number of suicide attempts/self-harming acts. Secondary outcomes are severity of other borderline complaints, quality of life, general psychopathological symptoms and health care utilization and productivity costs. Data are gathered using a prospective, two (group: intervention and control) by five (time of measurement) repeated measures factorial design.Participants will complete three-monthly outcome assessments in the course of therapy: at baseline, and 12, 24, 36 and 52 weeks after the start of the treatment. The period of recruitment started in March 2012 and the study will end in December 2014.Discussion: Highly suicidal outpatient patients can pose a dilemma for mental health care professionals. Although hospitalization seems inevitable under some circumstances, it has proven to be harmful in its own right. This paper outlines the background and methods of a randomized trial evaluating the possible surplus value of a short-term inpatient DBT program

Effectiveness of step-down versus outpatient dialectical behaviour therapy for patients with severe levels of borderline personality disorder

__Background:__ Step-down dialectical behaviour therapy (DBT) is a treatment consisting of 3 months of residential DBT plus 6 months of outpatient DBT. The program was specifically developed for people suffering from severe borderline personality disorder (BPD). The present study examines the effectiveness and cost-effectiveness of stepdown DBT compared to 12 months of regular, outpatient DBT. __Methods:__ Eighty-four participants reporting high levels of BPD-symptoms (mean age 26 years, 95% female) were randomly assigned to step-down versus standard DBT. Measurements were conducted at baseline and after 3, 6, 9 and 12 months. The Lifetime Parasuicide Count and BPD Severity Index (BPDSI) were used to assess suicidal behaviour, non-suicidal self-injury (NSSI) and borderline severity. Costs per Quality Adjusted Life Year (QALY) were calculated using data from the EQ-5D-3L and the Treatment Inventory Cost in Psychiatric Patients (TIC-P). __Results:__ In step-down DBT, 95% of patients started the program, compared to 45% of patients in outpatient DBT. The probability of suicidal behaviour did not change significantly over 12 months. The probability of NSSI decreased significantly in step-down DBT, but not in outpatient DBT. BPDSI decreased significantly in both groups, with the improvement leveling off at the end of treatment. While step-down DBT was more effective in increasing quality of life, it also cost significantly more. The extra costs per gained QALY exceeded the €80,000 threshold that is considered acceptable for severely ill patients in the Netherlands. __Conclusions:__ A pragmatic randomized controlled trial in the Netherlands showed that 9 months of step-down DBT is an effective treatment for people suffering from severe levels of BPD. However, step-down DBT is not more effective than 12 months of outpatient DBT, nor is it more cost-effective. These findings should be considered tentative because of high noncompliance with the treatment assignment in outpatient DBT. Furthermore, the longterm effectiveness of step-down DBT, and moderators of treatment response, remain to be evaluated

De effectiviteit van re-integratietraining versus boostersessies na kortdurende klinische psychotherapie: een gerandomiseerd klinisch onderzoek

Abstract BACKGROUND: Standardised evaluation studies performed in the Netherlands in a large number of inpatient and day-treatment hospitals providing psychotherapy have shown significant symptomatic improvements in patients between the date of entry to the studies and follow-up after one year. However, the work situation of ex-patients hardly changed and a large number of patients were still receiving psychotherapy. AIM: To examine the effectiveness of a specifically designed course of re-integration training. METHOD: A group of 128 patients were assigned randomly either to a re-integration training course aimed at improved functioning at work and improved relationships, or to booster sessions. Outcome measures were symptom level, work status, absence from work, and further psychotherapy. results After two years the number of patients in paid employment remained the same (76%) in the re-integration training course and increased from 67 to 87% in the booster sessions. Attendance was significantly higher in the booster sessions than in the re-integration training. There were no differences in the other outcome measures. CONCLUSION: We conclude that re-integration training was no more effective than the booster sessions. Our hypothesis is that continuity of care (therapists plus programme) explains the favourable result of the booster sessions

Cost-effectiveness of blended vs. face-to-face cognitive behavioural therapy for severe anxiety disorders: study protocol of a randomized controlled trial

Background: Anxiety disorders are among the most prevalent psychiatric conditions, and are associated with poor quality of life and substantial economic burden. Cognitive behavioural therapy is an effective treatment to reduce anxiety symptoms, but is also costly and labour intensive. Cost-effectiveness could possibly be improved by delivering cognitive behavioural therapy in a blended format, where face-to-face sessions are partially replaced by online sessions. The aim of this trial is to determine the cost-effectiveness of blended cognitive behavioural therapy for adults with anxiety disorders, i.e. panic disorder, social phobia or generalized anxiety disorder, in specialized mental health care settings compared to face-to-face cognitive behavioural therapy. In this paper, we present the study protocol. It is hypothesized that blended cognitive behavioural therapy for anxiety disorders is clinically as effective as face-to-face cognitive behavioural therapy, but that intervention costs may be reduced. We thus hypothesize that blended cognitive behavioural therapy is more cost-effective than face-to-face cognitive behavioural therapy. Methods/design: In a randomised controlled equivalence trial 156 patients will be included (n = 78 in blended cognitive behavioural therapy, n = 78 in face-to-face cognitive behavioural therapy) based on a power of 0.80, calculated by using a formula to estimate the power of a cost-effectiveness analysis: $n = \frac{2(z_\alpha + z_\beta)^2(sd^2 + (W^2sd^2) - (2Wpsd_csd_q))}{(WE-C)^2}$ Measurements will take place at baseline, midway treatment (7 weeks), immediately after treatment (15 weeks) and 12-month follow-up. At baseline a diagnostic interview will be administered. Primary clinical outcomes are changes in anxiety symptom severity as measured with the Beck Anxiety Inventory. An incremental cost-effectiveness ratio will be calculated to obtain the costs per quality-adjusted life years (QALYs) measured by the EQ-5D (5-level version). Health-economic outcomes will be explored from a societal and health care perspective. Discussion: This trial will be one of the first to provide information on the cost-effectiveness of blended cognitive behavioural therapy for anxiety disorders in routine specialized mental health care settings, both from a societal and a health care perspective

Cost-utility of a visiting service for older widowed individuals: Randomised trial

Background. Despite a growing understanding of the effectiveness of bereavement interventions and the groups that benefit most from them, we know little about the cost-effectiveness of bereavement interventions. Methods. We conducted a cost-utility analysis alongside a randomized clinical trial on a visiting service for older widowed individuals (n = 110) versus care as usual (CAU; n = 106). The visiting service is a selective bereavement intervention that offers social support to lonely widows and widowers by a trained volunteer. Participants were contacted 6-9 months post-loss. Eleven percent of all contacted persons responded and eight percent participated in the trial. The primary outcome measure was quality adjusted life years (QALYs) gained (assessed with the EQ-5D), which is a generic measure of health status. Costs were calculated from a societal perspective excluding costs arising from productivity losses. Using the bootstrap method, we obtained the incremental cost utility ratio (ICUR), projected these on a cost-utility plane and presented as an acceptability curve. Results. Overall, the experimental group demonstrated slightly better results against slightly higher costs. Whether the visiting service is acceptable depends on the willingness to pay: at a willingness to pay equal to zero per QALY gained, the visiting service has a probability of 31% of being acceptable; beyond €20,000, the visiting service has a probability of 70% of being more acceptable than CAU. Conclusion. Selective bereavement interventions like the visiting service will not produce large benefits from the health economic point of view, when targeted towards the entire population of all widowed individuals. We recommend that in depth analyses are conducted to identify who benefits most from this kind of interventions, and in what subgroups the incremental cost-utility is best. In the future bereavement interventions are then best directed to these groups. Trial registration. Controlled trials ISRCTN17508307. © 2008 Onrust et al; licensee BioMed Central Ltd

Cross-Sectional Study into the Costs and Impact on Family Functioning of 4-Year-Old Children with Aggressive Behavior

Early-onset aggressive behavior is known for its negative developmental consequences, and the associated high costs for families, the health care system and wider society. Although the origins of aggressive behavior are to be found in early childhood, the costs incurred by aggressive behavior of young children have not been studied extensively. The present study aimed to investigate whether preschool children with a high level of aggressive behavior already differ in the generated amount of costs and impact on family functioning from children with lower levels of aggressive behavior. A population-based sample of 317 preschool children was divided into four groups with different levels of aggression (moderate, borderline, clinical). Parents filled out questionnaires to assess service use (lifetime and past 3 months) and impact on family functioning. Over the past 3 months as well as over the first 4 years of life, children with a clinical level of aggression were more costly than children with a low level of aggression (mean total costs over the past 3 months: low = €167,05 versus clinical € = 1034,83 and mean lifetime costs: low € = 817,37 versus clinical € = 1433,04), due to higher costs of services used by the child. In addition, families of children with a borderline or clinical level of aggressive behavior reported more impairment in their daily functioning than families of children with lower levels of aggression. The findings demonstrate that a high level of aggressive behavior results in high costs and impaired family functioning in the preschool years already

A microcosting study of microsurgery, LINAC radiosurgery, and gamma knife radiosurgery in meningioma patients

The aim of the present study is to determine and compare initial treatment costs of microsurgery, linear accelerator (LINAC) radiosurgery, and gamma knife radiosurgery in meningioma patients. Additionally, the follow-up costs in the first year after initial treatment were assessed. Cost analyses were performed at two neurosurgical departments in The Netherlands from the healthcare providers’ perspective. A total of 59 patients were included, of whom 18 underwent microsurgery, 15 underwent LINAC radiosurgery, and 26 underwent gamma knife radiosurgery. A standardized microcosting methodology was employed to ensure that the identified cost differences would reflect only actual cost differences. Initial treatment costs, using equipment costs per fraction, were €12,288 for microsurgery, €1,547 for LINAC radiosurgery, and €2,412 for gamma knife radiosurgery. Higher initial treatment costs for microsurgery were predominantly due to inpatient stay (€5,321) and indirect costs (€4,350). LINAC and gamma knife radiosurgery were equally expensive when equipment was valued per treatment (€2,198 and €2,412, respectively). Follow-up costs were slightly, but not significantly, higher for microsurgery compared with LINAC and gamma knife radiosurgery. Even though initial treatment costs were over five times higher for microsurgery compared with both radiosurgical treatments, our study gives indications that the relative cost difference may decrease when follow-up costs occurring during the first year after initial treatment are incorporated. This reinforces the need to consider follow-up costs after initial treatment when examining the relative costs of alternative treatments

The effectiveness of a web-based self-help intervention to reduce suicidal thoughts: A randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>Suicide, attempted suicide and suicidal thoughts are major public health problems worldwide. Effective face-to-face treatments are Cognitive Behavioural Therapy (CBT), Dialectical Behavioural Therapy (DBT) and Problem Solving Treatment (PST). However, about two-thirds of persons who die by suicide have not been in contact with mental health care services in the preceding year, and many have never been treated. Furthermore, many patients do not disclose their suicidal thoughts to their care provider. This may be out of shame, due to fear of stigma or due to lack of trust in (mental) health care. Since many suicidal individuals seek information online, the internet provides an opportunity to reach suicidal individuals who would not be contacted otherwise. By providing a self-help intervention online, persons can anonymously learn to gain control over their suicidal thoughts. There is convincing evidence that self-help is effective for a number of mental disorders. In this study the effectiveness for suicidal thoughts is examined.</p> <p>Methods/Design</p> <p>In this study, a recently developed self-help intervention will be evaluated in a Randomized Controlled Trial. The intervention is based on Cognitive Behavioural Therapy and is aimed at subjects who experience mild to moderate suicidal thoughts. This is defined as a score between 1 and 26 on the Beck Scale for Suicidal Ideation (BSS). Higher and lower scores are excluded. In addition, severely depressed subjects are excluded. In total, 260 subjects will be randomly allocated to the intervention-condition (N = 130) or to the information-control condition (N = 130). Self-report questionnaires will be filled out at baseline, 6 weeks after baseline and 18 weeks after baseline. Primary outcome measure is the reduction in frequency and intensity of suicidal thoughts. Secondary outcome measures are the reduction of hopelessness, anxiety and depression, sleeplessness, worry and quality of life measures.</p> <p>Discussion</p> <p>This study is the first to evaluate the effectiveness of a web-based self-help intervention for suicidal thoughts. Several limitations and strengths of the design are discussed.</p> <p>Trial Registration</p> <p>Netherlands Trial Register, NTR1689</p