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This study examined the impact of clinical severity on treatment outcome in two programs that differ markedly in treatment intensity: day hospital mentalization‐based treatment (MBT‐DH) and intensive outpatient mentalization‐based treatment (MBT‐IOP) for borderline personality disorder (BPD). A multicenter randomized controlled trial was conducted. Participants include the full intention‐to‐treat sample of the original trial of N = 114 randomized BPD patients (MBT‐DH n = 70, MBT‐IOP n = 44), who were assessed at baseline and subsequently every 6 up to 36 months after start of treatment. Outcomes were general symptom severity, borderline features, and interpersonal functioning. Clinical severity was examined in terms of severity of BPD, general symptom severity, comorbid symptom disorders, comorbid personality disorders, and cluster C personality features. None of the severity measures was related to treatment outcome or differentially predicted treatment outcome in MBT‐DH and MBT‐IOP, with the exception of a single moderating effect of co morbid symptom disorders on outcome in terms of BPD features, indicating less improvement in MBT‐DH for patients with more symptom disorders. Overall, patients with varying levels of clinical severity benefited equally from MBT‐DH and MBT‐IOP, indicating that clinical severity may not be a useful criterion to differentiate in treatment intensity. [ABSTRACT FROM AUTHOR]

Introduction: The aim is to perform an economic evaluation alongside a randomized controlled trial comparing guided self‐help cognitive behavioral therapy‐enhanced (CBT‐E) for binge‐eating disorder (BED) to a waiting list control condition. Methods: BED patients (N = 212) were randomly assigned to guided self‐help CBT‐E or the 3‐month waiting list. Measurements took place at baseline and the end‐of‐treatment. The cost‐effectiveness analysis was performed using the number of binge‐eating episodes during the last 28 days as an outcome indicator according to the eating disorder examination. A cost‐utility analysis was performed using the EuroQol‐5D. Results: The difference in societal costs over the 3 months of the intervention between both conditions was €679 (confidence interval [CI] 50–1330). The incremental costs associated with one incremental binge eating episode prevented in the guided self‐help condition was approximately €18 (CI 1–41). From a societal perspective there was a 96% likelihood that guided self‐help CBT‐E led to a greater number of binge‐eating episodes prevented, but at higher costs. Each additional quality‐adjusted life year (QALY) gained was associated with incremental costs of €34,000 (CI 2494–154,530). With a 95% likelihood guided self‐help CBT‐E led to greater QALY gain at higher costs compared to waiting for treatment. Based on the National Institute for Health and Clinical Excellence willingness‐to‐pay threshold of €35,000 per QALY, guided self‐help CBT‐E can be considered cost‐effective with a likelihood of 95% from a societal perspective. Discussion: Guided self‐help CBT‐E is likely a cost‐effective treatment for BED in the short‐term (3‐month course of treatment). Comparison to treatment‐as‐usual is recommended for future research, as it enables an economic evaluation with a longer time horizon. Public Significance: Offering treatment remotely has several benefits for patients suffering from binge‐eating disorders. Guided self‐help CBT‐E is an efficacious and likely cost‐effective treatment, reducing binge eating and improving quality‐of‐life, albeit at higher societal costs. [ABSTRACT FROM AUTHOR]

Background: Two types of mentalization-based treatment (MBT), day hospital MBT (MBT-DH) and intensive outpatient MBT (MBT-IOP), have been shown to be effective in treating patients with borderline personality disorder (BPD). This study evaluated trajectories of change in a multi-site trial of MBT-DH and MBT-IOP at 36 months after the start of treatment. Methods: All 114 patients (MBT-DH n = 70, MBT-IOP n = 44) from the original multicentre trial were assessed at 24, 30 and 36 months after the start of treatment. The primary outcome was symptom severity measured with the Brief Symptom Inventory. Secondary outcome measures included borderline symptomatology, personality and interpersonal functioning, quality of life and self-harm. Data were analysed using multilevel modelling and the intention-to-treat principle. Results: Patients in both MBT-DH and MBT-IOP maintained the substantial improvements made during the intensive treatment phase and showed further gains during follow-up. Across both conditions, 83% of patients improved in terms of symptom severity, and 97% improved on borderline symptomatology. No significant differences were found between MBT-DH and MBT-IOP at 36 months after the start of treatment. However, trajectories of change were different. Whereas patients in MBT-DH showed greater improvement during the intensive treatment phase, patients in MBT-IOP showed greater continuing improvement during follow-up. Conclusions: Patients in both conditions showed similar large improvements over the course of 36 months, despite large differences in treatment intensity. MBT-DH and MBT-IOP were associated with different trajectories of change. Cost-effectiveness considerations and predictors of differential treatment outcome may further inform optimal treatment selection. [ABSTRACT FROM AUTHOR]

Background: Alcohol moderation (AM) interventions may contribute to better treatment outcomes and the general well-being of cancer survivors.Objective: This study evaluates the effectiveness, cost-effectiveness, and cost-utility of MyCourse, a digital AM intervention, compared with a noninteractive digital 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 after randomization. The study was conducted on the web in the Netherlands from 2016 to 2019. Participants were adult 10-year cancer survivors drinking over the Dutch-recommended drinking guidelines (≤7 standard units [10 g of alcohol] per week) with the intention to moderate or quit drinking. Overall, 103 participants were randomized and analyzed: 53 (51.5%) in the MyCourse group and 50 (48.5%) in the control group. In the MyCourse group, participants had access to a newly developed, digital, minimally guided AM intervention, MyCourse-Moderate Drinking. The primary outcome was the self-reported number of standard drinks (10 g of ethanol) consumed in the past 7 days at the 6-month follow-up. The secondary outcome measures were alcohol-related problems as measured by the Alcohol Use Disorders Identification Test (AUDIT) and treatment satisfaction. For the health economic evaluation, health care costs, costs because of productivity losses, and intervention costs were assessed over a 12-month horizon.Results: Alcohol use at the 6-month follow-up decreased by 38% in the MyCourse group and by 33% in the control group. No difference in 7-day alcohol use was found between the groups (B=2.1, 95% CI -7.6 to 3.1; P=.22) at any of the follow-ups. AUDIT scores for alcohol-related problems decreased over time in both groups, showing no significant difference between the groups (Cohen d=0.3, 95% CI -0.1 to 0.6; P=.21). Intervention costs per participant were estimated at US $279 for the MyCourse group and US $74 for the control group. The mean societal costs were US $18,092 (SD 25,662) and US $23,496 (SD 34,327), respectively. The MyCourse group led to fewer gained quality-adjusted life years at lower societal costs in the cost-utility analysis. In the cost-effectiveness analysis, the MyCourse group led to a larger reduction in drinking units over time at lower societal costs (incremental cost-effectiveness ratio per reduced drink: US $ -1158, 95% CI -1609 to -781).Conclusions: At 6 months, alcohol use was reduced by approximately one-third in both groups, with no significant differences between the digital intervention MyCourse and a noninteractive web-based brochure. At 12 months, cost-effectiveness analyses showed that MyCourse led to a larger reduction in drinking units over time, at lower societal costs. The MyCourse group led to marginally fewer gained quality-adjusted life years, also at lower societal costs.Trial Registration: Netherlands Trial Register NTR6010; https://www.trialregister.nl/trial/5433.International Registered Report Identifier (irrid): RR2-10.1186/s12885-018-4206-z. [ABSTRACT FROM AUTHOR]

Background: Patients with substance use disorder (SUD) or Attention Deficit Hyperactivity Disorder (ADHD) have a high risk of drop out from treatment. Few studies have investigated predictors of therapy drop out and outcome in SUD patients with comorbid ADHD. Recently, integrated cognitive behavioral therapy (CBT/Integrated) was shown to be more effective than standard CBT (CBT/SUD) in the treatment of SUD + ADHD.Objective: To investigate the association of demographic, clinical and neurocognitive variables with drop-out and treatment outcome, and to examine which of these variables are suitable for patient-treatment matching.Methods: We performed an RCT in which 119 patients were allocated to CBT/Integrated (n = 60) or CBT/SUD (n = 59). In addition, 55 patients had dropped out before randomization. Demographic variables, clinical characteristics and measures of cognitive functioning (Stroop, Tower of London (ToL) and Balloon Analogue Risk Task (BART)) were included as predictors. Outcome measures were: early treatment drop-out, ADHD symptom severity, and substance use severity at end of treatment and follow up.Results: Primary substance of abuse (drugs as opposed to alcohol only) and lower accuracy scores on the ToL were significant predictors of early treatment drop-out. Having more depression and anxiety symptoms and using ADHD medication at baseline significantly predicted more ADHD symptoms at end of treatment, and higher accuracy scores on the ToL significantly predicted higher substance use at end of treatment. No significant predictor-by-treatment interactions were found.Conclusion: The results add to the existing realization that also relatively mild cognitive deficits are a risk factor for treatment drop-out in these patients. [ABSTRACT FROM AUTHOR]

The aim of this study was to test the effectiveness of a brief motivational enhancing intervention (MEI) as an add-on to supervision-as-usual (SAU) in reducing time to treatment initiation in offenders with substance use disorders (SUDs) under probation supervision. We also tested the effectiveness in enhancing treatment retention and abstinence of primary substance rates. The study was designed as a multi-site, cluster randomized trial (CRT) in six addiction probation offices. We randomized 73 probation officers (37 to intervention, 36 to control) and followed 220 substance-abusing repeat offenders during their supervision (111 intervention, 109 control). Individualized SAU was compared with supervision with MEI. We report time to treatment initiation, treatment retention rate during the 12 months follow-up, and primary substance abstinence rate in the 30 days before follow-up. Results show that time to treatment initiation (χ2(1) = 1.817, p = .178), and the proportion of treatment retention (OR = 1.980, p = .213) and primary substance abstinence (OR = 0.945, p = .886) did not significantly differ between offenders that received SAU plus MEI and those that received SAU at 12 months follow-up. Our findings provide no evidence that supervision plus a brief manual-base MEI is more effective than SAU. [ABSTRACT FROM AUTHOR]

Background: Antidepressant trials are criticized due to potential methodological flaws. Root causes of failing methodology can be found in insufficient inter-rater reliability (IRR) and training practices, leading to higher placebo response and reduced study-power. However, it is unknown to what extent reliability estimates or training procedures are currently included in antidepressant reports. Therefore, we aimed to determine the proportion of publications concerning double-blind randomized controlled antidepressant trials that report on IRR coefficients and training procedures.Methods: We extracted all double-blind randomized clinical trials (RCTs) from the meta-analysis of Cipriani et al. (2018) concerning the period from 2000 until January 2016. Further, we conducted a Medline-search for double-blind RCTs from January 2016 until January 2020 for additional reports. We identified IRR coefficients and training procedures in these publications.Results: In total we identified 179 double-blind RCTs. Only 4.5% reported an IRR coefficient whereas 27.9% reported training procedures.Limitations: We did not contact individual authors for additional information regarding implementation of training procedures or inter-rater reliability assessment.Conclusions: There is a substantial lack of reporting IRR coefficients and training procedures in RCTs with antidepressant medication. Considering the large implications of insufficient reliability, we urge researchers to conduct and report training procedures and reliability estimations. [ABSTRACT FROM AUTHOR]

Background: Depression and harmful alcohol use are two of the top five leading causes of years of life lost to disability in high-income countries. Integrated treatment targeting both at the same time is often considered more complicated and difficult and, therefore, more expensive. Consequently, integrated internet-based interventions could be a valuable addition to traditional care.Methods: A three-arm randomized controlled trial was conducted comparing the effectiveness of (1) an integrated, minimal-guidance, adherence-focused self-help intervention designed to reduce both alcohol use and depression symptoms (AFGE-AD); (2) a similar intervention designed to reduce alcohol use only (AFGE-AO), and (3) internet access as usual (IAU) as a control condition, in at least moderately depressed alcohol misusers from February 2016-March 2020. We recruited 689 alcohol misusers (51.6 % males, mean age = 42.8 years) with at least moderate depression symptoms not otherwise in treatment from the general population. Six months after baseline, 288 subjects (41.8 %) were reachable for the final assessment.Results: All interventions yielded reduced alcohol-use after six months (AFGE-AD: -16.6; AFGE-AO: -19.8; IAU: -13.2). Those who undertook active-interventions reported significantly fewer standard drinks than controls (AFGE-AD: p = .048, d=0.10; AFGE-AO: p = .004, d=0.20). The two active-intervention groups also reported significantly less severe depression symptoms than controls (AFGE-AD: p = .006, d=0.41; AFGE-AO: p = .008, d=0.43). Testing revealed noninferiority between the two interventions.Conclusions: This study documented sustained effectiveness of the first integrated, fully internet-based self-help intervention developed for the reduction of both alcohol use and depression symptoms in at least moderately depressed adult alcohol misusers recruited from the general population. [ABSTRACT FROM AUTHOR]