scholarly journals Effectiveness and Cost-Effectiveness of Blended Cognitive Behavioral Therapy in Clinically Depressed Adolescents: Protocol for a Pragmatic Quasi-Experimental Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Sanne P A Rasing ◽  
Yvonne A J Stikkelbroek ◽  
Heleen Riper ◽  
Maja Dekovic ◽  
Maaike H Nauta ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Cost Effectiveness ◽  
Suicide Risk ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Treatment As Usual ◽  
Face To Face ◽  
Clinically Depressed ◽  
Quasi Experimental

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. CLINICALTRIAL Dutch Trial Register (NTR6759); http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6759

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

10.2196/13434 ◽  
2019 ◽  
Vol 8 (10) ◽  
pp. e13434 ◽  
Author(s):  
Sanne P A Rasing ◽  
Yvonne A J Stikkelbroek ◽  
Heleen Riper ◽  
Maja Dekovic ◽  
Maaike H Nauta ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Cost Effectiveness ◽  
Suicide Risk ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Treatment As Usual ◽  
Face To Face ◽  
Clinically Depressed ◽  
Quasi Experimental

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

scholarly journals Pragmatic Quasi-Experimental Controlled Trial Evaluating the Outcomes of Blended CBT Compared to Face-to-Face CBT and Treatment as Usual for Adolescents with Depressive Disorders

2021 ◽  
Vol 18 (6) ◽  
pp. 3102
Author(s):  
Sanne P.A. Rasing ◽  
Yvonne A.J. Stikkelbroek ◽  
Wouter den Hollander ◽  
Heleen Riper ◽  
Maja Deković ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Depressive Disorders ◽  
Controlled Trial ◽  
Post Intervention ◽  
Global Functioning ◽  
Treatment As Usual ◽  
Face To Face ◽  
Quasi Experimental ◽  
Secondary Outcomes

Depression is a major problem in youth mental health. Current treatment is on average effective, but adolescents are hesitant to seek help. Blended treatment could lower the barriers to seeking treatment. Evidence on effectiveness is, however, scarce. The present pragmatic quasi-experimental controlled trial aimed to compare the outcomes of blended cognitive behavioral therapy (CBT) to face-to-face CBT and treatment as usual. A total of 129 adolescents with clinical depression (82.2% female), aged 13–22 (M = 16.60, SD = 2.03) received blended CBT, face-to-face CBT or treatment as usual. Clinical diagnosis, depressive symptoms, and secondary outcomes were assessed at baseline, post-intervention, and six-months follow-up. Participants receiving blended CBT were, compared to participants receiving face-to-face CBT and treatment as usual, evenly likely to be in remission from their depressive disorder at post-intervention and at six-month follow-up. Depressive symptoms decreased significantly over time in all three conditions, and changes were not significantly different between conditions. Other secondary outcomes (suicide risk, internalizing and externalizing symptoms, severity of depression, and global functioning) did not differ between treatment conditions at post-intervention and six-month follow-up. Since there was no evidence for favorable outcomes for face-to-face therapies above blended CBT, blended CBT may also be an effective treatment format in clinical practice.

scholarly journals Effectiveness and moderators of individual cognitive behavioral therapy versus treatment as usual in clinically depressed adolescents: a randomized controlled trial

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Yvonne Stikkelbroek ◽  
Gerko Vink ◽  
Maaike H. Nauta ◽  
Marco A. Bottelier ◽  
Leonieke J. J. Vet ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Cognitive Behavioral Therapy ◽  
Behavioral Therapy ◽  
Post Treatment ◽  
Multiple Informants ◽  
Cognitive Behavioral ◽  
Dysthymic Disorder ◽  
Treatment As Usual ◽  
Randomized Controlled ◽  
Clinically Depressed

Abstract We examined if manualized cognitive behavioral therapy (CBT) was more effective than Treatment As Usual (TAU) for clinically depressed adolescents within routine care. This multisite Randomized controlled trail included 88 clinically depressed adolescents (aged 12–21 years) randomly assigned to CBT or TAU. Multiple assessments (pre-, post treatment and six-month follow-up) were done using semi-structured interviews, questionnaires and ratings and multiple informants. The primary outcome was depressive or dysthymic disorder based on the KSADS. Completers, CBT (n = 19) and TAU (n = 26), showed a significant reduction of affective diagnoses at post treatment (76% versus 76%) and after six months (90% versus 79%). Intention-to-treat analyses on depressive symptoms showed that 41.6% within CBT and 31.8% within the TAU condition was below clinical cut-off at post treatment and after six-months, respectively 61.4% and 47.7%. No significant differences in self-reported depressive symptoms between CBT and TAU were found. No prediction or moderation effects were found for age, gender, child/parent educational level, suicidal criteria, comorbidity, and severity of depression. We conclude that CBT did not outperform TAU in clinical practice in the Netherlands. Both treatments were found to be suitable to treat clinically referred depressed adolescents. CBT needs further improvement to decrease symptom levels below the clinical cut-off at post treatment.

scholarly journals SUGAR-DIP trial: oral medication strategy versus insulin for diabetes in pregnancy, study protocol for a multicentre, open-label, non-inferiority, randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e029808 ◽  
Author(s):  
Leon de Wit ◽  
Doortje Rademaker ◽  
Daphne N Voormolen ◽  
Bettina M C Akerboom ◽  
Rosalie M Kiewiet-Kemper ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Glycaemic Control ◽  
Study Protocol ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Large For Gestational Age ◽  
Secondary Outcome ◽  
Oral Glucose ◽  
Open Label ◽  
Randomised Controlled

IntroductionIn women with gestational diabetes mellitus (GDM) requiring pharmacotherapy, insulin was the established first-line treatment. More recently, oral glucose lowering drugs (OGLDs) have gained popularity as a patient-friendly, less expensive and safe alternative. Monotherapy with metformin or glibenclamide (glyburide) is incorporated in several international guidelines. In women who do not reach sufficient glucose control with OGLD monotherapy, usually insulin is added, either with or without continuation of OGLDs. No reliable data from clinical trials, however, are available on the effectiveness of a treatment strategy using all three agents, metformin, glibenclamide and insulin, in a stepwise approach, compared with insulin-only therapy for improving pregnancy outcomes. In this trial, we aim to assess the clinical effectiveness, cost-effectiveness and patient experience of a stepwise combined OGLD treatment protocol, compared with conventional insulin-based therapy for GDM.MethodsThe SUGAR-DIP trial is an open-label, multicentre randomised controlled non-inferiority trial. Participants are women with GDM who do not reach target glycaemic control with modification of diet, between 16 and 34 weeks of gestation. Participants will be randomised to either treatment with OGLDs, starting with metformin and supplemented as needed with glibenclamide, or randomised to treatment with insulin. In women who do not reach target glycaemic control with combined metformin and glibenclamide, glibenclamide will be substituted with insulin, while continuing metformin. The primary outcome will be the incidence of large-for-gestational-age infants (birth weight >90th percentile). Secondary outcome measures are maternal diabetes-related endpoints, obstetric complications, neonatal complications and cost-effectiveness analysis. Outcomes will be analysed according to the intention-to-treat principle.Ethics and disseminationThe study protocol was approved by the Ethics Committee of the Utrecht University Medical Centre. Approval by the boards of management for all participating hospitals will be obtained. Trial results will be submitted for publication in peer-reviewed journals.Trial registration numberNTR6134; Pre-results.

scholarly journals A protocol for a multicentre, parallel-group, pragmatic randomised controlled trial to evaluate the NEVERMIND system in preventing and treating depression in patients with severe somatic conditions

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Vladimir Carli ◽  
Danuta Wasserman ◽  
Gergö Hadlaczky ◽  
Nuhamin Gebrewold Petros ◽  
Sara Carletto ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Well Being ◽  
Physiological Data ◽  
Control Group ◽  
Evidence Based ◽  
Treatment As Usual ◽  
Randomised Controlled ◽  
Pragmatic Randomised Controlled Trial

Abstract Background Depressive symptoms are common in individuals suffering from severe somatic conditions. There is a lack of interventions and evidence-based interventions aiming to reduce depressive symptoms in patients with severe somatic conditions. The aim of the NEVERMIND project is to address these issues and provide evidence by testing the NEVERMIND system, designed to reduce and prevent depressive symptoms in comparison to treatment as usual. Methods The NEVERMIND study is a parallel-groups, pragmatic randomised controlled trial to assess the effectiveness of the NEVERMIND system in reducing depressive symptoms among individuals with severe somatic conditions. The NEVERMIND system comprises a smart shirt and a user interface, in the form of a mobile application. The system is a real-time decision support system, aiming to predict the severity and onset of depressive symptoms by modelling the well-being condition of patients based on physiological data, body movement, and the recurrence of social interactions. The study includes 330 patients who have a diagnosis of myocardial infarction, breast cancer, prostate cancer, kidney failure, or lower limb amputation. Participants are randomised in blocks of ten to either the NEVERMIND intervention or treatment as usual as the control group. Clinical interviews and structured questionnaires are administered at baseline, at 12 weeks, and 24 weeks to assess whether the NEVERMIND system is superior to treatment as usual. The endpoint of primary interest is Beck Depression Inventory II (BDI-II) at 12 weeks defined as (i) the severity of depressive symptoms as measured by the BDI-II. Secondary outcomes include prevention of the onset of depressive symptoms, changes in quality of life, perceived stigma, and self-efficacy. Discussion There is a lack of evidence-based interventions aiming to reduce and prevent depressive symptoms in patients with severe somatic conditions. If the NEVERMIND system is effective, it will provide healthcare systems with a novel and innovative method to attend to depressive symptoms in patients with severe somatic conditions. Trial registration DRKS00013391. Registered 23 November 2017.

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