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Effectiveness and Cost-Effectiveness of Blended Cognitive Behavioral Therapy in Clinically Depressed Adolescents: Protocol for a Pragmatic Quasi-Experimental Controlled Trial.

ABSTRACT: BACKGROUND:Cognitive behavioral therapy (CBT) is an effective intervention to treat depressive disorders in youth. However, 50% of adolescents still have depressive symptoms after treatment, and 57% drop out during treatment. Online CBT interventions have proven to be effective in reducing depressive symptoms and seem promising as a treatment for depressed adolescents. However, combining online programs with face-to-face sessions seems necessary to increase their effectiveness and monitor for suicide risk. OBJECTIVE:In this study, we examine the effectiveness and cost-effectiveness of a blended CBT treatment protocol, a mixture of online and face-to-face CBT, as a treatment for clinically depressed adolescents. METHODS:A pragmatic quasi-experimental controlled trial will be conducted to study the effectiveness of a blended CBT treatment protocol, in which blended CBT is compared with face-to-face CBT (n=44) and treatment as usual (n=44); the latter two were collected in a previous randomized controlled trial. The same inclusion and exclusion criteria will be used: adolescents aged between 12 and 21 years, with a clinical diagnosis of a depressive disorder, and referred to one of the participating mental health institutions. Assessments will be conducted at the same time points: before the start of the intervention, during the intervention (after 5 and 10 weeks), postintervention, and at 6- and 12-month follow-ups. RESULTS:The primary outcome is the presence of a depression diagnosis at 12-month follow-up. Several secondary outcomes will be measured, such as depressive symptoms, quality of life, and suicide risk. Costs and effects in both conditions will be compared to analyze cost-effectiveness. Further, moderating (age, gender, alcohol and drug use, parental depression, and other psychopathology) and mediating effects (negative automatic thoughts, cognitive emotion regulation, attributional style) will be analyzed. Also, treatment characteristics will be studied, such as characteristics of the therapists, treatment expectancy, and therapeutic alliance. Dropout rates and treatment characteristics will be measured to study the feasibility of blended CBT. CONCLUSIONS:This study will examine the effectiveness and cost-effectiveness of a blended CBT program in which depressed adolescents are treated in mental health care. Results of blended CBT will be compared with face-to-face CBT and treatment as usual, and implications for implementation will be reviewed. TRIAL REGISTRATION:Dutch Trial Register (NTR6759); http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6759. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/13434 RR1-10.2196/12654.

SUBMITTER: Rasing SPA

PROVIDER: S-EPMC6803889 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Effectiveness and Cost-Effectiveness of Blended Cognitive Behavioral Therapy in Clinically Depressed Adolescents: Protocol for a Pragmatic Quasi-Experimental Controlled Trial.

Rasing Sanne P A SPA Stikkelbroek Yvonne A J YAJ Riper Heleen H Dekovic Maja M Nauta Maaike H MH Dirksen Carmen D CD Creemers Daan H M DHM Bodden Denise H M DHM

JMIR research protocols 20191007 10

<h4>Background</h4>Cognitive behavioral therapy (CBT) is an effective intervention to treat depressive disorders in youth. However, 50% of adolescents still have depressive symptoms after treatment, and 57% drop out during treatment. Online CBT interventions have proven to be effective in reducing depressive symptoms and seem promising as a treatment for depressed adolescents. However, combining online programs with face-to-face sessions seems necessary to increase their effectiveness and monito ...[more]

PMID: 31593538

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Project description:BackgroundEthiopia was among the 15 countries that, together accounted for 64% of the world's severe episodes of pneumonia among children below the age of 5 in 2011. To reduce this burden, the 10-valent pneumococcal conjugate vaccine (PCV 10) was introduced into the general childhood national immunization program in Ethiopia in 2011. However, there is little evidence on its cost-effectiveness, and the aim of this study was to estimate the cost-effectiveness of the introduction of PCV 10 vaccination in the Ethiopian setting.MethodsThe cost-effectiveness analysis was carried out based on a quasi-experimental evaluation of implementing PCV 10 at the Butajira rural health program site in Ethiopia. The intervention and the control groups consisted 876 and 1010 children, respectively. Using data from program site's surveillance system database as a framework, health outcome and vaccination data were collected from medical records, immunization registration books and reports. Disability- Adjusted Life Year (DALY) was a main health outcome metric complimented by incidence of acute lower respiratory infection/1000-person years. Vaccination and treatment costs were collected by document review and cross-sectional household survey.ResultsIn the intervention cohort, 626 of 876 (71.5%) children received PCV 10 vaccination. Until the first year of life, the incidence of acute lower respiratory infection was higher in the intervention group. After the first year of life, the incidence rate was 35.2 per 1000-person years in the intervention group compared to 60.4 per 1000-person years in the control group. The incremental cost-effectiveness ratio (ICER) per averted DALY for the intervention group during the total follow-up period was (2013 US$) 394.3 (undiscounted) and 413.8 (discounted). The ICER per averted DALY excluding the first year of life was (2013 US$) 225 (undiscounted) and 292.7 (discounted).ConclusionCompared to the WHO's suggested cost-effectiveness threshold value, the results indicate that the general childhood PCV 10 vaccination was a cost-effective intervention in the Butajira rural health program site.

Project description:BackgroundCognitive behavioral therapy (CBT) is an effective treatment, but access is often restricted due to costs and limited availability of trained therapists. Blending online and face-to-face CBT for depression might improve cost-effectiveness and treatment availability.ObjectiveThis pilot study aimed to examine the costs and effectiveness of blended CBT compared with standard CBT for depressed patients in specialized mental health care to guide further research and development of blended CBT.MethodsPatients were randomly allocated to blended CBT (n=53) or standard CBT (n=49). Blended CBT consisted of 10 weekly face-to-face sessions and 9 Web-based sessions. Standard CBT consisted of 15 to 20 weekly face-to-face sessions. At baseline and 10, 20, and 30 weeks after start of treatment, self-assessed depression severity, quality-adjusted life-years (QALYs), and costs were measured. Clinicians, blinded to treatment allocation, assessed psychopathology at all time points. Data were analyzed using linear mixed models. Uncertainty intervals around cost and effect estimates were estimated with 5000 Monte Carlo simulations.ResultsBlended CBT treatment duration was mean 19.0 (SD 12.6) weeks versus mean 33.2 (SD 23.0) weeks in standard CBT (P<.001). No significant differences were found between groups for depressive episodes (risk difference [RD] 0.06, 95% CI -0.05 to 0.19), response to treatment (RD 0.03, 95% CI -0.10 to 0.15), and QALYs (mean difference 0.01, 95% CI -0.03 to 0.04). Mean societal costs for blended CBT were €1183 higher than standard CBT. This difference was not significant (95% CI -399 to 2765). Blended CBT had a probability of being cost-effective compared with standard CBT of 0.02 per extra QALY and 0.37 for an additional treatment response, at a ceiling ratio of €25,000. For health care providers, mean costs for blended CBT were €176 lower than standard CBT. This difference was not significant (95% CI -659 to 343). At €0 per additional unit of effect, the probability of blended CBT being cost-effective compared with standard CBT was 0.75. The probability increased to 0.88 at a ceiling ratio of €5000 for an added treatment response, and to 0.85 at €10,000 per QALY gained. For avoiding new depressive episodes, blended CBT was deemed not cost-effective compared with standard CBT because the increase in costs was associated with negative effects.ConclusionsThis pilot study shows that blended CBT might be a promising way to engage depressed patients in specialized mental health care. Compared with standard CBT, blended CBT was not considered cost-effective from a societal perspective but had an acceptable probability of being cost-effective from the health care provider perspective. Results should be carefully interpreted due to the small sample size. Further research in larger replication studies focused on optimizing the clinical effects of blended CBT and its budget impact is warranted.Trial registrationNetherlands Trial Register NTR4650; https://www.trialregister.nl/trial/4408.International registered report identifier (irrid)RR2-10.1186/s12888-014-0290-z.

Project description:ObjectivesUK exercise referral schemes (ERSs) have been criticised for focusing too much on exercise prescription and not enough on sustainable physical activity (PA) behaviour change. Previously, a theoretically grounded intervention (coproduced PA referral scheme, Co-PARS) was coproduced to support long-term PA behaviour change in individuals with health conditions. The purpose of this study was to investigate the effectiveness of Co-PARS compared with a usual care ERS and no treatment for increasing cardiorespiratory fitness.DesignA three-arm quasi-experimental trial.SettingTwo leisure centres providing (1) Co-PARS, (2) usual exercise referral care and one no-treatment control.Participants68 adults with lifestyle-related health conditions (eg, cardiovascular, diabetes, depression) were recruited to co-PARS, usual care or no treatment.Intervention16-weeks of PA behaviour change support delivered at 4, 8, 12 and 18 weeks, in addition to the usual care 12-week leisure centre access.Outcome measuresCardiorespiratory fitness, vascular health, PA and mental well-being were measured at baseline, 12 weeks and 6 months (PA and mental well-being only). Fitness centre engagement (co-PARS and usual care) and behaviour change consultation attendance (co-PARS) were assessed. Following an intention-to-treat approach, repeated-measures linear mixed models were used to explore intervention effects.ResultsSignificant improvements in cardiorespiratory fitness (p=0.002) and vascular health (p=0.002) were found in co-PARS compared with usual care and no-treatment at 12 weeks. No significant changes in PA or well-being at 12 weeks or 6 months were noted. Intervention engagement was higher in co-PARS than usual care, though this was not statistically significant.ConclusionA coproduced PA behaviour change intervention led to promising improvements in cardiorespiratory and vascular health at 12 weeks, despite no effect for PA levels at 12 weeks or 6 months.Trial registration numberNCT03490747.

Project description:BackgroundData from primary health care in Spain show a high prevalence of the major depressive disorder. Blended treatment (combination of face-to-face and online components) seems to be a very promising tool for the optimization and dissemination of psychological treatments in a cost-effective form. Although there is growing data that confirm the advantages of blended therapies, few studies have analyzed their application in regular clinical practice. The objective of the present paper is to describe the protocol for a clinical study aimed at exploring the clinical and cost-effectiveness of a blended cognitive behavioral therapy (b-CBT) for depression, compared to treatment as usual (TAU) in a primary health care setting.MethodsA two-arm randomised controlled non-inferiority trial will be carried out, with repeated measures (baseline, 3 months, 6 months, and 12 months) under two conditions: b-CBT and TAU. The b-CBT program will consist in three face-to-face sessions and eight online sessions. The TAU is defined as the routine care delivered by the general practitioner for the treatment of depression in primary care. The primary outcome is a symptomatic change of depressive symptoms on the patient-health questionnaire (PHQ-9). Other secondary outcomes will be considered (e.g., quality of life, treatment preference). All participants must be 18 years of age or older and meet the diagnostic criteria for major depressive disorder according to the Diagnostic and Statistical Manual of Mental disorders 4th edition. 156 participants will be recruited (78 per arm).DiscussionIt is expected that b-CBT is clinically non-inferior when compared to TAU. This is the first study in Spain to use a b-CBT format in primary and specialized care, and this format could be an efficacious and cost-effective therapeutic strategy for the treatment of depression.Trial registrationClinicalTrials.gov NCT02361684. Registered on 8 January 2015. Currently recruiting participants.

Dataset Information

Effectiveness and Cost-Effectiveness of Blended Cognitive Behavioral Therapy in Clinically Depressed Adolescents: Protocol for a Pragmatic Quasi-Experimental Controlled Trial.

Publications

Effectiveness and Cost-Effectiveness of Blended Cognitive Behavioral Therapy in Clinically Depressed Adolescents: Protocol for a Pragmatic Quasi-Experimental Controlled Trial.

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