Value of gym-based group exercise versus usual care for young adults receiving antipsychotic medication: study protocol for the multicenter randomized controlled Vega trial.

BACKGROUND: Exercise is recommended to protect physical health among people with severe mental illness and holds the potential to facilitate long-term recovery. An inclusive exercise community provides an opportunity for life skill training and social connectedness and may reduce the experience of loneliness and internalized stigmatization which together may improve personal recovery. Using a pragmatic randomized design, we aim to examine the effectiveness of a gym-based exercise intervention tailored to young adults in antipsychotic treatment (i.e., Vega Exercise Community) compared to usual care. It is hypothesized that the Vega Exercise Community will be superior to usual care for personal recovery at four months. METHODS: The trial will be conducted at four sites in Denmark from which 400 participants, aged 18 to 35 years, who are in current treatment with antipsychotic medications for the management of schizophrenia spectrum or affective disorders, will be recruited. Participants will be randomized (2:1) to Vega Exercise Community or usual care. Vega Exercise Community includes three weekly group-based exercise sessions hosted in commercial functional training centers delivered by certified Vega instructors. After four months, participants in Vega Exercise Community will be randomized (1:1) to minimal versus extended support with regards to sustained physical activity. Data will be collected at baseline, four, six and 12 months. The primary outcome is personal recovery assessed by Questionnaire about the Process of Recovery at four months. Behavioral symptoms, health-related quality of life, metabolic health, and program costs will be evaluated to further determine the effectiveness and cost-effectiveness of the Vega Exercise Community. Finally, the quality of life and physical and mental health of the participants' primary relative will be evaluated. DISCUSSION: The results of this trial may have important implications for health, sustained physical activity, and recovery for individuals in treatment with antipsychotics. Given the pragmatic design, positive results may readily be implemented by mental health care professionals to promote exercise as an integrated part of treatment of severe mental illness. TRIAL REGISTRATION: Clinical Trials.gov (NCT05461885, initial registration June 29th, 2022). WHO Universal Trial Number (UTN): U1111-1271-9928.

Effect modification of an effective transdiagnostic cognitive behavioral psychotherapy in youths with common mental health problems: Secondary analyses of the randomized mind-my-mind trial.

Mind My Mind (MMM) cognitive behavioral therapy (CBT) manualized treatment is effective in the management of common emotional and behavioral mental health problems in youth, yet not all individuals respond satisfactorily to treatment. This study explored potential effect modifiers, i.e., baseline factors associated with a differential treatment effect. We conducted secondary effect modifier analyses with MMM trial data, which involved randomization of 396 youths aged 6-16 years to either MMM CBT treatment (9-13 sessions) or management as usual in local community settings. We examined sociodemographic- (sex, age, family composition, ethnicity, parental education, and income) and clinical variables (mental disorders and duration of mental health problems) as potential effect modifiers of the a) change in parent-rated impact of mental health problems measured by the Strengths and Difficulties Questionnaire (SDQ) or b) response (reduction of ≥1 on SDQ-impact). In intention-to-treat analyses, superior treatment (net) benefits from the MMM intervention were found among youths who met criteria for any mental disorder at baseline (-1.25 [95%CI: -1.67;-0.82]) compared to youths that did not meet diagnostic criteria (-0.22 [95%CI:-1.09;0.65]). Comorbidity vs no comorbidity (-1.84 [95%CI:-2.58;-1.10] vs -0.72 [95%CI:-1.15;-0.29]) and longer duration of untreated mental health problems, i.e., more vs less than 6 months (-1.16 [95%CI:-1.55;-0.78] vs 0.43 [95%CI:-1.01;1.86]) were also associated with superior treatment benefits. The sociodemographic factors were not associated with differential treatment effects in the intention-to-treat analyses. These findings suggest that community-based programs like the MMM are well-suited for youths with substantial mental health problems. Clinical Trials Identifier: NCT03535805.

Cost-effectiveness of a transdiagnostic psychotherapy program for youth with common mental health problems.

OBJECTIVES: Our objective was to evaluate the cost-effectiveness of the transdiagnostic psychotherapy program Mind My Mind (MMM) for youth with common mental health problems using a cost-utility analysis (CUA) framework and data from a randomized controlled trial. Furthermore, we analyzed the impact of the choice of informant for both quality-of-life reporting and preference weights on the Incremental Cost-Effectiveness Ratio (ICER). METHODS: A total of 396 school-aged (6-16 years) youth took part in the 6-month trial carried out in Denmark. CUAs were carried out for the trial period and four one-year extrapolation scenarios. Costs were based on a combination of budget and self-reported costs. Youths and parents were asked to report on the youth's quality-of-life three times during the trial using the Child Health Utility 9D (CHU9D). Parental-reported CHU9D was used in the base case together with preference weights of a youth population. Analyses using self-reported CHU9D and preference weights of an adult population were also carried out. RESULTS: The analysis of the trial period resulted in an ICER of €170,465. The analyses of the one-year scenarios resulted in ICERs between €23,653 and €50,480. The ICER increased by 24% and 71% compared to the base case when using self-reported CHU9D and adult preference weights, respectively. CONCLUSION: The MMM intervention has the potential to be cost-effective, but the ICER is dependent on the duration of the treatment effects. Results varied significantly with the choice of informant and the choice of preference weights indicating that both factors should be considered when assessing CUA involving youth.

Systematic identification and stratification of help-seeking school-aged youth with mental health problems: a novel approach to stage-based stepped-care.

We investigated whether a novel visitation model for school-aged youth with mental health problems based on a stage-based stepped-care approach facilitated a systematic identification and stratification process without problems with equity in access. The visitation model was developed within the context of evaluating a new transdiagnostic early treatment for youth with anxiety, depressive symptoms, and/or behavioural problems. The model aimed to identify youth with mental health problems requiring an intervention, and to stratify the youth into three groups with increasing severity of problems. This was accomplished using a two-phase stratification process involving a web-based assessment and a semi-structured psychopathological interview of the youth and parents. To assess problems with inequity in access, individual-level socioeconomic data were obtained from national registers with data on both the youth participating in the visitation and the background population. Altogether, 573 youth and their parents took part in the visitation process. Seventy-five (13%) youth had mental health problems below the intervention threshold, 396 (69%) were deemed eligible for the early treatment, and 52 (9%) had symptoms of severe mental health problems. Fifty (9%) youth were excluded for other reasons. Eighty percent of the 396 youth eligible for early treatment fulfilled criteria of a mental disorder. The severity of mental health problems highlights the urgent need for a systematic approach. Potential problems in reaching youth of less resourceful parents, and older youth were identified. These findings can help ensure that actions are taken to avoid equity problems in future mental health care implementations.

The longitudinal validity of proxy-reported CHU9D.

OBJECTIVES: The Child Health Utility 9D (CHU9D) currently represents the only preference-based health-related quality-of-life instrument designed exclusively from its inception for application with children. The objective of this study was to examine the construct validity and responsiveness of the proxy-reported (parent) CHU9D in a mental health setting using utility weights derived from an adult and adolescent population, respectively. METHODS: The discriminant validity and convergent validity were examined using the mental health-specific 'The Strengths and Difficulties Questionnaire' (SDQ) and the generic KIDSCREEN-27. Responsiveness was assessed by examining the floor-ceiling effects, the magnitude of change over time, and the ability to differentiate between improvement and no improvement. RESULTS: The study included 396 children with mental health problems. CHU9D showed good construct validity, with correlation coefficients ranging between 0.329 and 0.571 for SDQ Impact score and KIDSCREEN-27 Psychological Well-being. CHU9D was able to distinguish between groups of children with different levels of mental health problems (p < 0.001). The absolute magnitudes of the group mean differences were larger using adolescent weights. No evidence of a floor/ceiling effect was found at the baseline. A standardized response mean of 0.634-0.654 was found for the children who experienced clinically significant improvements. CHU9D was able to discriminate between children who experienced positive and no health improvements (p < 0.001). CONCLUSION: This study provides the first evidence on responsiveness for CHU9D in a mental health context. The findings demonstrate that CHU9D is an appropriate HRQOL measure for use in mental health trials. Furthermore, the results show that the preference weights generated from an adolescent population resulted in the larger mean differences between groups.

Effectiveness of Transdiagnostic Cognitive-Behavioral Psychotherapy Compared With Management as Usual for Youth With Common Mental Health Problems: A Randomized Clinical Trial.

Importance: Behavioral therapy and cognitive-behavioral therapy (CBT) programs targeting a single class of problems have not been widely implemented. The population of youths with common mental health problems is markedly undertreated. Objective: To determine the effectiveness of a new transdiagnostic CBT program (Mind My Mind [MMM]) compared with management as usual (MAU) in youths with emotional and behavioral problems below the threshold for referral to mental health care. Design, Setting, and Participants: This pragmatic, multisite, randomized clinical trial of MMM vs MAU was conducted from September 7, 2017, to August 28, 2019, including 8 weeks of postintervention follow-up, in 4 municipalities in Denmark. Consecutive help-seeking youths were randomized (1:1) to the MMM or the MAU group. Main inclusion criteria were age 6 to 16 years and anxiety, depressive symptoms, and/or behavioral disturbances as a primary problem. Data were analyzed from August 12 to October 25, 2019. Interventions: The MMM intervention consisted of 9 to 13 weekly, individually adapted sessions of manualized CBT delivered by local psychologists. The MAU group received 2 care coordination visits to enhance usual care. Main Outcomes and Measures: The primary outcome was change in mental health problems reported by parents at week 18, using the Strengths and Difficulties Questionnaire (SDQ) Impact scale (range, 0-10 points, with higher scores indicating greater severity of distress and impairment). Primary and secondary outcomes were assessed in the intention-to-treat population at week 18. Maintenance effects were assessed at week 26. Results: A total of 396 youths (mean [SD] age, 10.3 [2.4] years; 206 [52.0%] boys) were randomized to MMM (n = 197) or MAU (n = 199), with primary outcome data available in 177 (89.8%) and 167 (83.9%), respectively, at 18 weeks. The SDQ Impact score decreased by 2.34 points with MMM and 1.23 with MAU, from initial scores of 4.12 and 4.21, respectively (between-group difference, 1.10 [95% CI, 0.75-1.45]; P < .001; Cohen d = 0.60). Number of responders (≥1-point reduction in SDQ Impact score) was greater with MMM than with MAU (144 of 197 [73.1%] vs 93 of 199 [46.7%]; number needed to treat, 4 [95% CI, 3-6]). Secondary outcomes indicated statistically significant benefits in parent-reported changes of anxiety, depressive symptoms, daily functioning, school attendance, and the principal problem. All benefits were maintained at week 26 except for school attendance. Conclusions and Relevance: In this randomized clinical trial, the scalable transdiagnostic cognitive-behavioral intervention MMM outperformed MAU in a community setting on multiple, clinically relevant domains in youth with emotional and behavioral problems. Trial Registration: ClinicalTrials.gov Identifier: NCT03535805.

Healthcare Costs, School Performance, and Health-related Quality of Life in Adolescence Following Psychotic Experiences in Preadolescence: A Longitudinal Cohort Study.

Psychotic experiences (PEs) are common in the general population in preadolescence. The implications of PEs on socioeconomic outcomes, including educational attainment, are scarcely described. We aimed to estimate how preadolescent PEs were associated with later healthcare costs, school performance, and health-related quality of life (HRQoL) in adolescence. A total of 1607 preadolescents from the general population Copenhagen Child Cohort 2000 were assessed for PEs at age 11-12 years and followed up over 5 years using register-based data on mental and somatic healthcare costs, and school performance at age 16. Furthermore, HRQoL was assessed for a subsample of the children at age 16-17. We adjusted for perinatal and family sociodemographic adversities, prior parental mental illness and healthcare use, child IQ-estimate at age 11-12, and parent-rated general psychopathology of their child. PEs were associated with slightly poorer school performance. However, preadolescents with PEs more often reported HRQoL within the lowest 10th percentile (OR = 2.74 [95% CI 1.71-4.37]). Preadolescents who reported PEs had higher average total healthcare costs over the following 5 years. The costs for individuals with PEs were higher for mental healthcare services across primary to tertiary care, but not for somatic care. After adjustments, PEs remained independently associated with higher costs and poorer HRQoL, but not with poorer school performance. In conclusion, PEs are important in mental health screening of preadolescents and identify a group of young people with increased healthcare service-use throughout adolescence and who report poorer HRQoL in adolescence, over and above parent-rated general psychopathology of their child.

Cost-effectiveness analysis of systematic fast-track transition from oncological treatment to specialised palliative care at home for patients and their caregivers: the DOMUS trial.

BACKGROUND: While hospitals remain the most common place of death in many western countries, specialised palliative care (SPC) at home is an alternative to improve the quality of life for patients with incurable cancer. We evaluated the cost-effectiveness of a systematic fast-track transition process from oncological treatment to SPC enriched with a psychological intervention at home for patients with incurable cancer and their caregivers. METHODS: A full economic evaluation with a time horizon of six months was performed from a societal perspective within a randomised controlled trial, the DOMUS trial ( Clinicaltrials.gov : NCT01885637). The primary outcome of the health economic analysis was a incremental cost-effectiveness ratio (ICER), which is obtained by comparing costs required per gain in Quality-Adjusted Life Years (QALY). The costs included primary and secondary healthcare costs, cost of intervention and informal care from caregivers. Public transfers were analysed in seperate analysis. QALYs were measured using EORTC QLQ-C30 for patients and SF-36 for caregivers. Bootstrap simulations were performed to obtain the ICER estimate. RESULTS: In total, 321 patients (162 in intervention group, 159 in control group) and 235 caregivers (126 in intervention group, 109 in control group) completed the study. The intervention resulted in significantly higher QALYs for patients when compared to usual care (p-value = 0.026), while being more expensive as well. In the 6 months observation period, the average incremental cost of intervention compared to usual care was €2015 per patient (p value < 0.000). The mean incremental gain was 0.01678 QALY (p-value = 0.026). Thereby, the ICER was €118,292/QALY when adjusting for baseline costs and quality of life. For the caregivers, we found no significant differences in QALYs between the intervention and control group (p-value = 0.630). At a willingness to pay of €80,000 per QALY, the probability that the intervention is cost-effective lies at 15% in the base case scenario. CONCLUSION: This model of fast-track SPC enriched with a psychological intervention yields better QALYs than usual care with a large increase in costs. TRIAL REGISTRATION: The trial was prospectively registered 25.6.2013. Clinicaltrials.gov Identifier: NCT01885637 .

Mental Health Service Use and Psychopharmacological Treatment Following Psychotic Experiences in Preadolescence.

OBJECTIVE: Psychotic experiences affect more than 10% of children and often co-occur with nonpsychotic mental disorders. However, longitudinal studies of the outcome of psychotic experiences based on unbiased information on mental health service use and psychotropic medications are scarce. The authors investigated whether psychotic experiences at ages 11-12 predicted a psychiatric diagnosis or treatment with psychotropic medications by ages 16-17. METHODS: In a longitudinal register-based follow-up study of the Copenhagen Child Cohort 2000, a total of 1,632 children ages 11-12 were assessed for psychotic experiences in face-to-face interviews. The children were also assessed for mental disorders and IQ. National registries provided information on perinatal and sociodemographic characteristics, on psychiatric disorders diagnosed at child and adolescent mental health services, and on prescribed psychotropic medications through ages 16-17. RESULTS: Among children who had not been previously diagnosed, and after adjustment for sociodemographic and perinatal adversities and IQ, psychotic experiences at ages 11-12 predicted receiving a psychiatric diagnosis in child and adolescent mental health services before ages 16-17 (adjusted hazard ratio=3.13, 95% CI=1.93, 5.07). The risk was increased if the child met criteria for a co-occurring mental disorder (not diagnosed in mental health settings) at baseline compared with no psychotic experiences or diagnosis at baseline (adjusted hazard ratio=7.85, 95% CI=3.94, 15.63), but having psychotic experiences alone still marked a significantly increased risk of later psychiatric diagnoses (adjusted hazard ratio=2.76, 95% CI=1.48, 5.13). Similar patterns were found for treatment with psychotropic medications. CONCLUSIONS: Psychotic experiences in childhood predict mental health service use and use of psychotropic medications during adolescence. The study findings provide strong evidence that psychotic experiences in preadolescence index a transdiagnostic vulnerability for diagnosed psychopathology in adolescence.

Evaluation of a screening algorithm using the Strengths and Difficulties Questionnaire to identify children with mental health problems: A five-year register-based follow-up on school performance and healthcare use.

BACKGROUND: Treatment of mental health problems (MHP) is often delayed or absent due to the lack of systematic detection and early intervention. This study evaluates the potential of a new screening algorithm to identify children with MHP. METHODS: The study population comprises 2,015 children from the Copenhagen Child Cohort 2000 whose mental health was assessed at age 11-12 years and who had no prior use of specialised mental health services. A new algorithm based on the Strengths and Difficulties Questionnaire (SDQ) is utilised to identify MHP by combining parent-reported scores of emotional and behavioural problems and functional impairments. The screening is done on historical data, implying that neither parents, teachers nor health care professionals received any feedback on the screening status. The screening status and results of an IQ-test were linked to individual-level data from national registries. These national registers include records of each child's school performance at the end of compulsory schooling, their health care utilisation, as well as their parents' socio-economic status and health care utilisation. RESULTS: 10% of the children screen positive for MHP. The children with MHP achieve a significantly lower Grade Point Average on their exams, independently of their IQ-score, perinatal factors and parental characteristics. On average, the children with MHP also carry higher health care costs over a five-year follow-up period. The higher health care costs are only attributed to 23% of these children, while the remaining children with MHP also show poorer school performance but receive no additional health care. CONCLUSIONS: The results demonstrate that children with MHP and a poor prognosis can be identified by the use of the brief standardised questionnaire SDQ combined with a screening algorithm.

Costs associated with adverse events among acute patients.

BACKGROUND: The aim of this study was to analyse the additional treatment costs of acute patients admitted to a Danish hospital who suffered an adverse event (AE) during in-hospital treatment. METHODS: A matched case-control design was utilised. Using a combination of trigger words and patient record reviews 91 patients exposed to AEs were identified. Controls were identified among patients admitted to the same department during the same 20-month period. The matching was based on age, gender, and main diagnosis. Cost data was extracted from the Danish National Cost Database for four different periods after beginning of the admission. RESULTS: Patients exposed to an AE were associated with higher mean cost of EUR 9505 during their index admission (p = 0.014). For the period of 6 months from the beginning of the admission minus the admission itself they were associated with higher mean cost of EUR 4968 (p = 0.016). For the period from the 7th month until the end of the 12th month there was no statistically significant difference (p = 0.104). For the total period of 12 month, patients exposed to an AE were associated with statistically significant higher mean cost of EUR 13,930 (p = 0.001). CONCLUSIONS: AEs are associated with significant hospital costs. Our findings suggest that a follow-up period of 6 months is necessary when investigating the costs associated with AEs among acute patients. Further research of specific types of AEs and the costs of preventing these types of AEs would improve the understanding of the relationship between adverse events and costs.