The effectiveness and safety of dialectical behavior therapy for suicidal ideation and behavior in autistic adults: a pragmatic randomized controlled trial.

BACKGROUNDS: Many autistic people in mental health are suicidal. This study evaluated the effectiveness of dialectical behavior therapy (DBT) v. treatment as usual (TAU) in reducing suicidal ideation and suicide attempts. METHODS: At six Dutch mental health centers, 123 outpatients (18-65 years) with DSM-5 diagnosed autism spectrum disorder (ASD) and suicidal behavior were randomly assigned to the DBT intervention group (n = 63) or TAU control group (n = 60). Assessments were conducted at baseline, post-treatment at 6 months and 12-month follow-up. The primary outcomes were severity of suicidal ideation and frequency of suicide attempts. The severity of depression and social anxiety were secondary outcomes. RESULTS: At end-of-treatment, DBT significantly reduced both suicidal ideation (z = -2.24; p = 0.025; b = -4.41; s.e. = 197.0) and suicide attempts (z = -3.15; p = 0.002; IRR = 0.046; s.e. = 0.045) compared to TAU, but lost statistical significance at the 12-month follow-up. Depression severity significantly decreased with DBT (z = -1.99; p = 0.046: b = -2.74; s.e. = 1.37) remaining so at 12 months (z = -2.46; p = 0.014; b = -3.37; s.e. = 1.37). No effects were observed on social anxiety. Severe adverse events included two suicides in the TAU condition. CONCLUSIONS: DBT is an acceptable, safe, and short-term effective intervention to reduce suicidal ideation and suicide attempts in autistic adults with suicidal behavior.

Health-Economic Evaluation of Psychological Interventions for Anxiety Prevention: A Systematic Review.

OBJECTIVE: Although evidence supports the effectiveness of psychological interventions for prevention of anxiety, little is known about their cost-effectiveness. The aim of this study was to conduct a systematic review of health-economic evaluations of psychological interventions for anxiety prevention. METHODS: PubMed, PsycInfo, Web of Science, Embase, Cochrane Central Register of Controlled Trials, EconLit, National Health Service (NHS) Economic Evaluations Database, NHS Health Technology Assessment, and OpenGrey databases were searched electronically on December 23, 2022. Included studies focused on economic evaluations based on randomized controlled trials of psychological interventions to prevent anxiety. Study data were extracted, and the quality of the selected studies was assessed by using the Consensus on Health Economic Criteria and the Cochrane risk-of-bias tool. RESULTS: All included studies (N=5) had economic evaluations that were considered to be of good quality. In two studies, the interventions showed favorable cost-effectiveness compared with usual care groups. In one study, the intervention was not cost-effective. Findings from another study cast doubt on the cost-effectiveness of the intervention, and the cost-effectiveness of the intervention in the remaining study could not be established. CONCLUSIONS: Although the findings suggest some preliminary evidence of cost-effectiveness of psychological interventions for preventing anxiety, they were limited by the small number of included studies. Additional research on the cost-effectiveness of psychological interventions for anxiety in different countries and populations is required.

Psychotic-like experiences and multimorbid psychopathology: The relationship between the 16-item prodromal questionnaire and DSM-IV classifications in a help-seeking population.

AIM: Identifying multimorbid psychopathology is necessary to offer more adequate treatment and ultimately reduce the prevalence of persistent mental illnesses. Psychotic symptoms are increasingly seen as a transdiagnostic indicator of multimorbidity, severity and complexity of non-psychotic psychopathology. This study aims to investigate whether psychotic-like experiences and subclinical psychotic symptoms as measured by the 16-item Prodromal Questionnaire are also associated with multimorbid psychopathology. METHODS: Participants were help-seeking individuals from outpatient mental healthcare settings and intensive home-treatment teams, aged 17-35. Assessment included the 16-item Prodromal Questionnaire to measure psychotic-like experiences, the Structured Clinical Interview for DSM-IV Axis I, and three sections of the Structured Clinical Interview for DSM-IV Axis II Disorders to determine DSM-IV-TR classifications. The final sample comprised of 160 participants who scored above a cutoff of 6 items on the 16-item Prodromal Questionnaire (HIGH-score) and 60 participants who scored below cutoff (LOW-score). A Poisson Regression was executed to determine the association between the PQ-16 and DSM-IV-TR classifications. RESULTS: The HIGH-score group had a mean of 2.76 multimorbid disorders (range 0-7), while the LOW-score group had a mean of 1.45 disorders (range 0-3). Participants with four to seven disorders scored high on the 16-item Prodromal Questionnaire. CONCLUSIONS: Our results suggest that psychotic-like experiences are associated with multimorbidity and severity of psychopathology. Screening for psychotic-like experiences via the PQ-16 in a help-seeking population may help prevent under-diagnosis and under-treatment of comorbid psychopathology.

The economic burden of mental disorders: results from the Netherlands mental health survey and incidence study-2.

OBJECTIVE: Currently, there is a paucity of up-to-date estimates of the economic burden caused by mental disorders. Such information could provide vital insight into one of the most serious and costly-yet to some extent preventable-health challenges facing the world today. METHOD: Data from a national psychiatric-epidemiological cohort study (NEMESIS-2, N = 6506) were used to provide reliable, relevant, and up-to-date cost estimates (in 2019 Euro) regarding healthcare costs, productivity losses, and patient and family costs associated with DSM-IV mental disorders both at individual level, but also in the general population and in the workforce of the Netherlands (per 1 million population). RESULTS: In the general population, the costs of mood disorders, specifically depression, are substantial and rank above those from the anxiety disorders, whilst costs of anxiety disorders are more substantial than those stemming from substance use disorders, even when the per-person costs of drug abuse appear highest of all. In the workforce, specific and social phobias are leading causes of excess costs. The workforce has lower healthcare costs but higher productivity costs than general population. DISCUSSION: The findings suggest that (preventive) healthcare interventions targeting the workforce are likely to become cost-effective and underscore the importance for employers to create healthy work environments. Overall, the results highlight the need to strengthen the role of mental health promotion and prevention of mental disorders in the social domain before people require treatment to reduce the staggering and costly burden caused by mental disorders to individuals and society.

Evaluating Effect Moderators in Cognitive Versus Behavioral Based CBT-Modules and Sequences Towards Preventing Adolescent Depression.

OBJECTIVE: The aim of this study was to investigate age group, gender, and baseline depressive symptom severity as possible effect moderators in (1) cognitive versus behavioral based CBT-modules and (2) sequences of modules that started either with cognitive or behavioral modules in indicated depression prevention in adolescents. METHOD: We conducted a pragmatic cluster-randomized trial under four parallel conditions. Each condition consisted of four CBT-modules of three sessions (cognitive restructuring, problem solving, behavioral activation, relaxation), but the sequencing of modules differed. The CBT-modules and sequences were clustered into more cognitive versus more behavioral based approaches. The sample involved 282 Dutch adolescents with elevated depressive symptoms (Mage = 13.8; 55.7% girls, 92.9% Dutch). Assessments were conducted at baseline, after three sessions, at post-intervention and 6-month follow-up with self-reported depressive symptoms as the primary outcome. RESULTS: We found no evidence for substantial moderation effects. Age group, gender, and depressive symptom severity level at baseline did not moderate the effects of cognitive versus behavioral modules after three sessions. No evidence was also found that these characteristics moderated the effectiveness of sequences of modules that started either with cognitive or behavioral modules at post-intervention and 6-month follow-up. CONCLUSION: Cognitive and behavioral based modules and sequences in the prevention of depression in adolescents might apply to a relatively wide range of adolescents in terms of age group, gender, and severity levels of depressive symptoms.Abbreviation: CDI-2:F: Children's Depression Inventory-2 Full-length version; CDI-2:S: Children's Depression Inventory-2 Short version; STARr: Solve, Think, Act, Relax, and repeat.

Exposure-based treatments for childhood abuse-related post-traumatic stress disorder in adults: a health-economic evaluation.

Background: Prolonged exposure (PE) is an effective treatment for post-traumatic stress disorder (PTSD).Objective: This study aimed to analyse the cost-effectiveness of three exposure-based treatments in patients with childhood abuse-related PTSD.Method: A net-benefit analysis was conducted alongside a pragmatic randomized controlled trial with participants (N = 149) randomized to three conditions: PE (n = 48), intensified PE (i-PE, n = 51), and phase-based PE [Skills Training in Affective and Interpersonal Regulation (STAIR) + PE, n = 50]. Assessments took place at baseline (T0), post-treatment (T3), 6 month follow-up (T4), and 12 month follow-up (T5). Costs stemming from healthcare utilization and productivity losses were estimated using the Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness. Quality-adjusted life-years (QALYs) were based on the 5-level EuroQoL 5 Dimensions (EQ-5D-5L) using the Dutch tariff. Missing values of costs and utilities were multiply imputed. To compare i-PE to PE and STAIR + PE to PE, pair-wise unequal-variance t-tests were conducted. Net-benefit analysis was used to relate costs to QALYs and to draw acceptability curves.Results: Intervention costs did not differ across the three treatment conditions. Total medical costs, productivity losses, total societal costs, and EQ-5D-5L-based QALYs did not differ between treatment conditions either (all p > .10). At the relevant €50,000/QALY threshold, the probability of one treatment being more cost-effective than another was 32%, 28%, and 40% for PE, i-PE, and STAIR-PE, respectively.Conclusion: Three equally effective treatments were compared and no differences in cost-effectiveness between treatments were found. Therefore, we advocate the implementation and adoption of any of the treatments and endorse shared decision making.

This is the first study to compare cost-effectiveness of three exposure-based treatments in patients with CA-PTSD alongside a randomized controlled clinical trial (N = 149).The three exposure-based treatments did not differ in terms of outcomes and costs.Findings underline that any of these treatments can be implemented, and we endorse shared decision making to meet patient treatment preference.

Relative Effectiveness of CBT-Components and Sequencing in Indicated Depression Prevention for Adolescents: A Cluster-Randomized Microtrial.

OBJECTIVE: Cognitive Behavioral Therapy (CBT) was dismantled into four modules of three sessions each: cognitive restructuring (Think), behavioral activation (Act), problem solving (Solve) and relaxation (Relax). We investigated the modules' relative effectiveness in indicated depression prevention for adolescents and examined variations in sequencing of these modules. METHOD: We performed a pragmatic cluster-randomized microtrial with four parallel conditions: (1) Think-Act-Relax-Solve (n = 14 clusters, n = 81 participants); (2) Act-Think-Relax-Solve (n = 13, n = 69); (3) Solve-Act-Think-Relax (n = 13, n = 77); and (4) Relax-Solve-Act-Think (n = 12, n = 55). The sample consisted of 282 Dutch adolescents with elevated depressive symptoms (Mage = 13.8; 55.7% girls, 92.9% Dutch). In total 52 treatment groups were randomized as a cluster. Assessments were conducted at baseline, after each module and at 6-month follow-up with depressive symptoms as primary outcome. RESULTS: None of the modules (Think, Act, Solve, Relax) was associated with a significant decrease in depressive symptoms after three sessions and no significant differences in effectiveness were found between the modules. All sequences of modules were associated with a significant decrease in depressive symptoms at post-intervention, except the sequence Relax-Solve-Act-Think. At 6-month follow-up, all sequences showed a significant decrease in depressive symptoms. No significant differences in effectiveness were found between the sequences at post-intervention and 6-month follow-up. CONCLUSIONS: Regardless of the CBT technique provided, one module of three sessions may not be sufficient to reduce depressive symptoms. The sequence in which the CBT components cognitive restructuring, behavioral activation, problem solving and relaxation are offered, does not appear to significantly influence outcomes at post- intervention or 6-month follow-up. ABBREVIATIONS: CDI-2:F: Children's Depression Inventory-2 Full-length version; CDI-2:S: Children's Depression Inventory-2 Short version; STARr: Solve, Think, Act, Relax and repeat.

Longitudinal clinical and functional outcome in distinct cognitive subgroups of first-episode psychosis: a cluster analysis.

BACKGROUND: Cognitive deficits may be characteristic for only a subgroup of first-episode psychosis (FEP) and the link with clinical and functional outcomes is less profound than previously thought. This study aimed to identify cognitive subgroups in a large sample of FEP using a clustering approach with healthy controls as a reference group, subsequently linking cognitive subgroups to clinical and functional outcomes. METHODS: 204 FEP patients were included. Hierarchical cluster analysis was performed using baseline brief assessment of cognition in schizophrenia (BACS). Cognitive subgroups were compared to 40 controls and linked to longitudinal clinical and functional outcomes (PANSS, GAF, self-reported WHODAS 2.0) up to 12-month follow-up. RESULTS: Three distinct cognitive clusters emerged: relative to controls, we found one cluster with preserved cognition (n = 76), one moderately impaired cluster (n = 74) and one severely impaired cluster (n = 54). Patients with severely impaired cognition had more severe clinical symptoms at baseline, 6- and 12-month follow-up as compared to patients with preserved cognition. General functioning (GAF) in the severely impaired cluster was significantly lower than in those with preserved cognition at baseline and showed trend-level effects at 6- and 12-month follow-up. No significant differences in self-reported functional outcome (WHODAS 2.0) were present. CONCLUSIONS: Current results demonstrate the existence of three distinct cognitive subgroups, corresponding with clinical outcome at baseline, 6- and 12-month follow-up. Importantly, the cognitively preserved subgroup was larger than the severely impaired group. Early identification of discrete cognitive profiles can offer valuable information about the clinical outcome but may not be relevant in predicting self-reported functional outcomes.

Systematic review of economic evaluations for internet- and mobile-based interventions for mental health problems.

In view of the staggering disease and economic burden of mental disorders, internet and mobile-based interventions (IMIs) targeting mental disorders have often been touted to be cost-effective; however, available evidence is inconclusive and outdated. This review aimed to provide an overview of the cost-effectiveness of IMIs for mental disorders and symptoms. A systematic search was conducted for trial-based economic evaluations published before 10th May 2021. Electronic databases (including MEDLINE, PsycINFO, CENTRAL, PSYNDEX, and NHS Economic Evaluations Database) were searched for randomized controlled trials examining IMIs targeting mental disorders and symptoms and conducting a full health economic evaluation. Methodological quality and risk of bias were assessed. Cost-effectiveness was assumed at or below £30,000 per quality-adjusted life year gained. Of the 4044 studies, 36 economic evaluations were reviewed. Guided IMIs were likely to be cost-effective in depression and anxiety. The quality of most evaluations was good, albeit with some risks of bias. Heterogeneity across studies was high because of factors such as different costing methods, design, comparison groups, and outcomes used. IMIs for anxiety and depression have potential to be cost-effective. However, more research is needed into unguided (preventive) IMIs with active control conditions (e.g., treatment as usual) and longer time horizon across a wider range of disorders.Trial registration: PROSPERO Registration No. CRD42018093808.

Smart Continence Care for People With Profound Intellectual and Multiple Disabilities: Protocol for a Cluster Randomized Trial and Trial-Based Economic Evaluation.

BACKGROUND: People with profound intellectual and multiple disabilities (PIMD) cannot communicate the need to change their incontinence products. The smart continence care (SCC) product Abena Nova signals caregivers when change is needed. This provides the opportunity for more person-centered care, increased quality of life, and a decreased number of leakages. However, there is a need for evidence of the effectiveness and cost-effectiveness of such technology compared with regular continence care (RCC) for people with PIMD. OBJECTIVE: This paper presents the research protocol for an effectiveness and cost-effectiveness study with people with PIMD living in long-term care facilities in the Netherlands. METHODS: A cluster randomized trial will be conducted in 3 consecutive waves across 6 long-term care providers for people with disabilities and 160 participants with PIMD. Long-term care providers are randomized at a 1:1 ratio, resulting in an intervention group and a group continuing RCC. The intervention group will receive implementation guidance and use SCC for 3 months; the other group will continue their RCC as usual and then switch to SCC. This study consists of three components: effectiveness study, economic evaluation, and process evaluation. The primary outcome will be a change in the number of leakages. The secondary outcomes are quality of life, the difference in the number of changes, the work perception of caregivers, cost-effectiveness, and cost utility. Data collection will occur at T0 (baseline), T1 (6 weeks), T2 (12 weeks), and T3 (9-month follow-up) for the first 2 intervention groups. An intention-to-treat analysis will be performed. The economic evaluation will be conducted alongside the trial from the societal and long-term care provider perspectives. Qualitative data collection through interviews and field notes will complement these quantitative results and provide input for the process evaluation. RESULTS: This research was funded in December 2019 by ZonMw, the Netherlands Organization for Health Research and Development. As of June 2022, we enrolled 118 of the 160 participants. The enrollment of participants will continue in the third and fourth quarters of 2022. CONCLUSIONS: This study will provide insights into the effectiveness and cost-effectiveness of SCC for people with PIMD, allowing long-term care providers to make informed decisions about implementing such a technology. This is the first time that such a large-scale study is being conducted for people with PIMD. TRIAL REGISTRATION: ClinicalTrials.gov NCT05481840; https://clinicaltrials.gov/ct2/show/NCT05481840. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/42555.

The association between sample and treatment characteristics and the efficacy of repetitive transcranial magnetic stimulation in depression: A meta-analysis and meta-regression of sham-controlled trials.

BACKGROUND: Repetitive transcranial magnetic stimulation (rTMS) is a form of non-invasive neuromodulation that is increasingly used to treat major depressive disorder (MDD). However, treatment with rTMS could be optimized by identifying optimal treatment parameters or characteristics of patients that are most likely to benefit. This meta-analysis and meta-regression aims to identify sample and treatment characteristics that are associated with change in depressive symptom level, treatment response and remission. METHODS: The databases PubMed, Embase, Web of Science and Cochrane library were searched for randomized controlled trials (RCTs) reporting on the therapeutic efficacy of high-frequent, low-frequent, or bilateral rTMS for MDD compared to sham. Study and sample characteristics as well as rTMS parameters and outcome variables were extracted. Effect sizes were calculated for change in depression score and risk ratios for response and remission. RESULTS: Sixty-five RCTs with a total of 2982 subjects were included in this meta-analysis. Active rTMS resulted in a larger depressive symptom reduction than sham protocol (Hedges' g = -0.791 95% CI -0.977; -0.605). Risk ratios for response and remission were 2.378 (95% CI 1.882; 3.005) and 2.450 (95% CI 1.779; 3.375), respectively. We found no significant association between sample and treatment parameters and rTMS efficacy. CONCLUSIONS: rTMS is an efficacious treatment for MDD. No associations between sample or treatment characteristics and efficacy were found, for which we caution that publication bias, heterogeneity and lack of consistency in the definition of remission might bias these latter null findings. Our results are clinically relevant and support the use of rTMS as a non-invasive and effective treatment option for depression.

Comparing a ses-sensitive and an all-ses implementation strategy to improve participation rates of patients with a lower socioeconomic background in a web-based intervention for depressive complaints: a cluster randomised trial in primary care.

BACKGROUND: Depression is a major public health concern, which is most pronounced in population segments with a lower social-economic status (SES). E-health interventions for depressive complaints are proven to be effective, but their reach needs to be improved, especially among people with a lower socioeconomic status (SES). Implementing e-health interventions in the primary care setting with SES-sensitive guidance from General Practice nurses (GP nurses) may be a useful strategy to increase the reach of e-health in lower SES groups. We implemented an evidence-based online intervention that targets depressive complaints in primary care. METHODS: A pragmatic cluster-randomised trial was conducted in two parallel groups where a SES sensitive (SES-sens) implementation strategy with additional face-to-face guidance by GP nurses was compared to an all-SES implementation strategy. The primary outcome was the percentage of lower SES participants in either condition. Participation was defined as completing at least 1 face-to-face session and 2 online exercises. Participation rates were evaluated using logistic mixed modelling. RESULTS: In both conditions, the participation rates of lower SES participants were quite high, but were notably lower in the SES-sens implementation condition (44%) than in the all-SES implementation condition (58%). This unexpected outcome remained statistically significant even after adjusting for potential confounders between the conditions (Odds Ratio 0.43, 95%-CI 0.22 to 0.81). Less guidance was provided by the GP nurses in the SES-sens group, contrary to the implementation instructions. CONCLUSIONS: From a public health point of view, it is good news that a substantial number of primary care patients with a lower SES level used the implemented e-health intervention. It is also positive that an all-SES implementation strategy performed well, and even outperformed a SES-sensitive strategy. However, this was an unexpected finding, warranting further research into tailoring implementation strategies of e-health interventions towards specific target groups in the primary care setting. TRIAL REGISTRATION: Netherlands Trial Register, identifier: NL6595 , registered on 12 November 2017.

Adolescent anxiety and depression: burden of disease study in 53,894 secondary school pupils in the Netherlands.

BACKGROUND: Prevalence rates of anxiety and depression in adolescence are rising markedly in early adolescence. It is important to quantify the non-fatal disease burden of anxiety and depression, such that early interventions can be well targeted, and resources can be allocated in a just and optimal way. This study aimed to estimate the non-fatal disease burden of anxiety and depression with and without suicidal ideation in girls and boys aged 13, 14, and 15 years. METHODS: Participants were 53,894 secondary school pupils who completed health questionnaires between September 2018 and July 2019. A design-based approach was used for complex survey data with post-stratification weights and taking clustering at school-level into account. At individual level, disability weights (DWs) were calculated for each disorder. At population level, DWs were multiplied by the point-prevalence per one thousand population of the respective disorders to compute years lived with disability (YLD). DWs and YLD of anxiety and depression were calculated with and without adjustment for comorbid eating disorders, substance use disorders and somatic illnesses. RESULTS: The unadjusted DW of depression with suicidal ideation (0.30) was greater than without suicidal ideation (0.26), and both were greater than the DW of anxiety (0.24). A similar ranking was obtained after adjusting for comorbidities. At population level, where the prevalence of the disorders come into play, the YLD disease burden was greatest for anxiety, followed by depression with suicidal ideation and depression without suicidal ideation with 17.40, 9.85, and 5.28 YLD per one thousand population, unadjusted for comorbidities. This pattern was the same after adjustment, but then the total YLD of depression with and without suicidal ideation was similar to the YLD of anxiety (12.47 and 12.46, respectively). Girls showed a significantly greater YLD burden of anxiety and depression than boys, but no differences were found between different age groups. CONCLUSIONS: From an individual clinical perspective, depression, especially when accompanied by suicidal ideation, was identified as a major health concern, especially in girls. From a public health perspective, both anxiety and depression, especially when accompanied by suicidal ideation, were identified as major drivers of disease burden, again most notably in girls.

Effectiveness, Cost-effectiveness, and Cost-Utility of a Digital Smoking Cessation Intervention for Cancer Survivors: Health Economic Evaluation and Outcomes of a Pragmatic Randomized Controlled Trial.

BACKGROUND: Smoking cessation (SC) interventions may contribute to better treatment outcomes and the general well-being of cancer survivors. OBJECTIVE: This study aims to evaluate the effectiveness, cost-effectiveness, and cost-utility of a digital interactive SC intervention compared with a noninteractive web-based information brochure for cancer survivors. METHODS: A health economic evaluation alongside a pragmatic 2-arm parallel-group randomized controlled trial was conducted with follow-ups at 3, 6, and 12 months. The study was conducted in the Netherlands over the internet from November 2016 to September 2019. The participants were Dutch adult smoking cancer survivors with the intention to quit smoking. In total, 165 participants were included and analyzed: 83 (50.3%) in the MyCourse group and 82 (49.7%) in the control group. In the intervention group, participants had access to a newly developed, digital, minimally guided SC intervention (MyCourse-Quit Smoking). Control group participants received a noninteractive web-based information brochure on SC. Both groups received unrestricted access to usual care. The primary outcome was self-reported 7-day smoking abstinence at the 6-month follow-up. Secondary outcomes were quality-adjusted life years gained, number of cigarettes smoked, nicotine dependence, and treatment satisfaction. For the health economic evaluation, intervention costs, health care costs, and costs stemming from productivity losses were assessed over a 12-month horizon. RESULTS: At the 6-month follow-up, the quit rates were 28% (23/83) and 26% (21/82) in the MyCourse and control groups, respectively (odds ratio 0.47, 95% CI 0.03-7.86; P=.60). In both groups, nicotine dependence scores were reduced at 12 months, and the number of smoked cigarettes was reduced by approximately half. The number of cigarettes decreased more over time, and the MyCourse group demonstrated a significantly greater reduction at the 12-month follow-up (incidence rate ratio 0.87; 95% CI 0.76-1.00; P=.04). Intervention costs were estimated at US $193 per participant for the MyCourse group and US $74 for the control group. The mean per-participant societal costs were US $25,329 (SD US $29,137) and US $21,836 (SD US $25,792), respectively. In the cost-utility analysis, MyCourse was not preferred over the control group from a societal perspective. With smoking behavior as the outcome, the MyCourse group led to marginally better results per reduced pack-year against higher societal costs, with a mean incremental cost-effectiveness ratio of US $52,067 (95% CI US $32,515-US $81,346). CONCLUSIONS: At 6 months, there was no evidence of a differential effect on cessation rates; in both groups, approximately a quarter of the cancer survivors quit smoking and their number of cigarettes smoked was reduced by half. At 12 months, the MyCourse intervention led to a greater reduction in the number of smoked cigarettes, albeit at higher costs than for the control group. No evidence was found for a differential effect on quality-adjusted life years. TRIAL REGISTRATION: The Netherlands Trial Register NTR6011; https://www.trialregister.nl/trial/5434. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12885-018-4206-z.

rTMS combined with CBT as a next step in antidepressant non-responders: a study protocol for a randomized comparison with current antidepressant treatment approaches.

BACKGROUND: Major depressive disorder (MDD) is one of the most common psychiatric disorders, however, current treatment options are insufficiently effective for about 35% of patients, resulting in treatment-resistant depression (TRD). Repetitive transcranial magnetic stimulation (rTMS) is a form of non-invasive neuromodulation that is effective in treating TRD. Not much is known about the comparative efficacy of rTMS and other treatments and their timing within the treatment algorithm, making it difficult for the treating physician to establish when rTMS is best offered as a treatment option. This study aims to investigate the (cost-)effectiveness of rTMS (in combination with cognitive behavioral therapy (CBT) and continued antidepressant medication), compared to the next step in the treatment algorithm. This will be done in a sample of patients with treatment resistant non-psychotic unipolar depression. METHODS: In this pragmatic multicenter randomized controlled trial 132 patients with MDD are randomized to either rTMS or the next pharmacological step within the current treatment protocol (a switch to a tricyclic antidepressant or augmentation with lithium or a second-generation antipsychotic). Both groups also receive CBT. The trial consists of 8 weeks of unblinded treatment followed by follow-up of the cohort at four and 6 months. A subgroup of patients (n = 92) will have an extended follow-up at nine and 12 months to assess effect decay or retention. We expect that rTMS is more (cost-)effective than medication in reducing depressive symptoms in patients with TRD. We will also explore the effects of both treatments on symptoms associated with depression, e.g. anhedonia and rumination, as well as the effect of expectations regarding the treatments on its effectiveness. DISCUSSION: The present trial aims to inform clinical decision making about whether rTMS should be considered as a treatment option in patients with TRD. The results may improve treatment outcomes in patients with TRD and may facilitate adoption of rTMS in the treatment algorithm for depression and its implementation in clinical practice. TRIAL REGISTRATION: This trial is registered within the Netherlands Trial Register (code: NL7628 , date: March 29th 2019).

Cost-effectiveness and cost-utility of an Acceptance and Commitment Therapy intervention vs. a Cognitive Behavioral Therapy intervention for older adults with anxiety symptoms: A randomized controlled trial.

BACKGROUND: A previous randomized controlled trial in older adults with anxiety symptoms found no differences between a brief blended Acceptance and Commitment Therapy (ACT) intervention and brief face-to-face Cognitive Behavior Therapy (CBT) regarding anxiety symptom severity at posttreatment and 12-month follow-up. A health-economic evaluation comparing these interventions has not yet been conducted. OBJECTIVE: This study examined the one-year cost-effectiveness and cost-utility of blended ACT compared to face-to-face CBT for older adults with anxiety symptoms. METHODS: The economic evaluation was embedded in a randomized controlled trial comparing blended ACT to CBT in 314 older adults with mild to moderately severe anxiety symptoms. Data were collected at baseline and 3, 6 and 12 months post baseline. For the cost-effectiveness analysis, treatment response was defined as a reliable improvement in anxiety symptom severity (measured with the Generalized Anxiety Disorder-7) between baseline and 12-month follow-up. To assess cost-utility, quality-adjusted life years (QALYs) were computed using EuroQol-5 Dimensions-5 Levels-5 utility scores. Analyses took the societal perspective, including both healthcare costs and productivity costs. Incremental cost-effectiveness ratios were calculated using 2500 bootstraps of seemingly unrelated regression equations of costs and effects. Sensitivity analyses were performed to assess the robustness of the findings. RESULTS: Differences between the blended ACT group and CBT group in treatment response and QALYs were statistically insignificant and clinically irrelevant. The ACT intervention was associated with an average per-participant cost reduction of €466 ($593) compared to CBT, which resulted from lower productivity costs in the blended ACT group. From a healthcare perspective, the ACT intervention was associated with higher costs (by €71 ($90)) than CBT. CONCLUSIONS: The results do not indicate that from a health-economic perspective blended ACT should be preferred over CBT in the treatment of older adults with anxiety symptoms. The findings support a model of shared decision making, where clinicians and patients collaboratively decide on the preferred intervention, based on ethical-medical, practical and personal considerations. TRIAL REGISTRATION: Netherlands Trial Register: TRIAL NL6131 (NTR6270); https://www.trialregister.nl/trial/6131.

Effectiveness of school-based preventive programs in suicidal thoughts and behaviors: A meta-analysis.

BACKGROUND: Suicidal thoughts and behaviors (STBs) among adolescents have hardly decreased despite preventative efforts. School-based prevention programs could have a great reach, yet suicide prevention is not an easy topic to address. To increase acceptability of school-based suicide prevention, it is important to evaluate whether programs that target known risk factors of STBs, such as depression, could be equally effective. METHODS: We conducted a systematic literature search in major electronic databases. Outcomes were suicidal ideation and behaviors. Multivariate random effects meta-regression-analyses were conducted. RESULTS: Eleven primary studies met the inclusion criteria, totalling 23,230 participants. The post-test effect size was small for both suicidal ideation (g = 0.15) and suicidal behaviors (g = 0.30). Meta-regression indicated that targeting known risk factors of STBs was not a significant modifier of effect size for ideation, indicating equal effectiveness. However, it was significant modifier of effect for behaviors, but only one intervention targeted know risk factors. Effects at follow-up (3-12 months) were also significant but small for both outcomes. LIMITATIONS: Substantial heterogeneity between studies was noted. Only few and small sample size studies could be included that targeted known risk factors of STBs. Therefore, these results should be interpreted with caution. CONCLUSIONS: School-based prevention of STBs shows some promise within three months post-test assessments, and potentially also have effects that are sustained over time. More studies are needed to make conclusions regarding school-based interventions that target risk factors of STBs.

Reducing problematic alcohol use in employees: economic evaluation of guided and unguided web-based interventions alongside a three-arm randomized controlled trial.

AIMS: To perform an economic evaluation of guided and unguided internet-based interventions to reduce problematic alcohol consumption in employees compared with a waiting-list control condition (WLC) with unrestricted access to treatment-as-usual. DESIGN: A cost-effectiveness analysis (CEA) and cost-utility analysis (CUA) from a societal and a cost-benefit analysis from the employer's perspective with a 6-month time horizon. SETTING: Open recruitment in the German working population. PARTICIPANTS: Employees (178 males, 256 females, mean age 47 years) consuming at least 14 (women) or 21 (men) standard units of alcohol (SUAs) per week and scoring ≥ 8 (men) or 6 (women) on the Alcohol Use Disorders Identification Test. MEASUREMENTS: On-line questionnaires administered to assess SUAs and assess quality of life (AQoL-8D) and resource use. Outcome measure was responder (≤ 14/≤ 21 SUAs) for the CEA and quality-adjusted life years (QALYs) for the CUA. Net benefit regression was used to estimate cost-effectiveness for each study arm. Bootstrapping and sensitivity analyses were performed to account for uncertainty. INTERVENTIONS: Five weekly modules including personalized normative feedback, motivational interviewing, goal setting, problem-solving and emotion regulation, provided with adherence-focused guidance [n = 142; responders: n = 73 (51.4%); QALYs = 0.364, standard error (SE) = 0.006] or without guidance [n = 146; n = 66 (45.2%); 0.359, 0.007]. Controls were on a waiting-list [n = 144; n = 38 (26.4%); 0.342, 0.007]. FINDINGS: From a societal perspective, the guided intervention had a probability of 55% (54%) of being the most efficient strategy at a willingness-to-pay (WTP) of €0 per responder (QALY) gained, compared with the unguided intervention and the control condition. At a WTP of €20 000 per QALY gained, the probability was 78%. From an employer's perspective, the guided intervention had a higher probability of a positive return on investment (81%) compared with the unguided intervention (58%). CONCLUSION: A guided internet-based intervention to reduce problematic alcohol consumption in employees appears to be both cost-beneficial and cost-effective.

Assessment of Quality of Life 8-Dimension (AQoL-8D): translation, validation, and application in two Dutch trials in patients with epilepsy and schizophrenia.

BACKGROUND: To translate and linguistically validate the Assessment of Quality of Life 8-dimensions (AQoL-8D) for use in the Netherlands and to compare the psychometric properties of AQoL-8D with the EuroQol 5-dimensions 5-levels (EQ-5D-5L) in two patient samples. METHODS: AQoL-8D was translated from English into Dutch. The translated AQoL-8D was then administered alongside the EQ-5D-5L at baseline and follow-up of two Dutch randomized controlled trials among patients with epilepsy and schizophrenia. These data were subjected to a post-hoc analysis assessing the psychometric properties of AQol-8D vis-à-vis EQ-5D-5L in terms of known-groups construct validity, responsiveness, and floor/ceiling effects. RESULTS: In total, 103 epilepsy patients and 99 schizophrenia patients were included in this study. In both datasets, the two instruments discriminated between known-groups, but in schizophrenia, AQoL-8D showed higher responsiveness than EQ-5D-5L, while both instruments showed equal responsiveness in epilepsy. Ceiling effects were only found for EQ-5D-5L in both epilepsy (26.6%) and schizophrenia (6.1%). CONCLUSION: Our results have shown that, among other things, AQoL-8D presents better ability to discriminate between known-groups and shows no ceiling effect. Based on our results, we would recommend the use of AQoL-8D in addition to EQ-5D-5L in trials assessing patient's quality of life in patients with epilepsy or schizophrenia.