Efficacy and cost-effectiveness of guided and unguided internet- and mobile-based indicated transdiagnostic prevention of depression and anxiety (ICare Prevent): A three-armed randomized controlled trial in four European countries

Kiona K. Weisel, Anna Carlotta Zarski, Thomas Berger, Tobias Krieger, Michael P. Schaub, Christian T. Moser, Matthias Berking, Michelle Dey, Cristina Botella, Rosa Ma Baños, Rocío Herrero, Ernestina Etchemendy, Heleen Riper, Pim Cuijpers, F. Bolinski, A.M. Kleiboer, D. Görlich, J Beecham, Corinna Jacobi, David D. Ebert

Research output: Contribution to JournalArticleAcademicpeer-review

Abstract

Background
Depression and anxiety are highly prevalent and often co-occur. Several studies indicate the potential of disorder-specific psychological interventions for the prevention each of these disorders. To treat comorbidity, transdiagnostic treatment concepts seem to be a promising approach, however, evidence for transdiagnostic concepts of prevention remains inconclusive. Internet- and mobile-based interventions (IMIs) may be an effective means to deliver psychological interventions on a large scale for the prevention of common mental disorders (CMDs) such as depression and anxiety. IMIs have been shown to be effective in treating CMDs, e.g. in reducing symptoms of depression and anxiety. However, there is a lack of studies examining the efficacy of interventions reducing the incidence of CMDs. Moreover, the comparative cost-effectiveness of guided versus unguided IMIs for the prevention of depression and anxiety has not been studied yet. Hence, this study aims at investigating the (cost-)effectiveness of guided and unguided internet and mobile-based transdiagnostic individually tailored indicated prevention of depression and anxiety.

Methods
A multi-country three-armed randomized controlled trial will be conducted to compare a guided and unguided intervention to treatment as usual (TAU). Both active conditions are based on the same intervention, ICare Prevent, and differ only with regard to guidance format. Altogether, 954 individuals with subclinical symptoms of depression (CES-D ≥ 16) and anxiety (GAD-7 ≥ 5) who do not have a full-blown disorder will be recruited in Germany, Switzerland, Spain and the Netherlands, and randomized to one of three conditions (guided intervention, unguided intervention, or TAU). The TAU arm will receive access to the training after a 12-month waiting period. The primary outcome will be time to CMD onset (any depression / anxiety disorder) within a follow-up period of 12 months after baseline. Secondary outcomes will include disorder-specific symptom severity (depression / anxiety) assessed by diagnostic raters blinded to intervention condition at post-intervention, self-reports, acceptability, health related quality of life, and psychosocial variables associated with developing a CMD. Assessments will take place at baseline, mid-intervention (5 weeks into the intervention), post-intervention (8 weeks after randomization) and follow-up (6 and 12 months after randomization). Data will be analyzed on an intention-to-treat basis and per protocol. Cost-effectiveness will be evaluated from a public health and a societal perspective, including both direct and indirect costs.

Discussion
The present study will further enhance the evidence-base for transdiagnostic preventive interventions and provide valuable information about optimal trade-off between treatment outcome and costs.
LanguageEnglish
Pages52-64
Number of pages13
JournalInternet Interventions
Volume16
DOIs
Publication statusPublished - 2019

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Internet
Cost-Benefit Analysis
Anxiety
Randomized Controlled Trials
Depression
Mental Disorders
Random Allocation
Psychology
Anxiety Disorders
Switzerland
Health Care Costs
Netherlands
Spain
Self Report
Germany
Comorbidity
Public Health
Quality of Life
Costs and Cost Analysis
Incidence

Cite this

Weisel, Kiona K. ; Zarski, Anna Carlotta ; Berger, Thomas ; Krieger, Tobias ; Schaub, Michael P. ; Moser, Christian T. ; Berking, Matthias ; Dey, Michelle ; Botella, Cristina ; Baños, Rosa Ma ; Herrero, Rocío ; Etchemendy, Ernestina ; Riper, Heleen ; Cuijpers, Pim ; Bolinski, F. ; Kleiboer, A.M. ; Görlich, D. ; Beecham, J ; Jacobi, Corinna ; Ebert, David D. / Efficacy and cost-effectiveness of guided and unguided internet- and mobile-based indicated transdiagnostic prevention of depression and anxiety (ICare Prevent): A three-armed randomized controlled trial in four European countries. In: Internet Interventions. 2019 ; Vol. 16. pp. 52-64.
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title = "Efficacy and cost-effectiveness of guided and unguided internet- and mobile-based indicated transdiagnostic prevention of depression and anxiety (ICare Prevent): A three-armed randomized controlled trial in four European countries",
abstract = "BackgroundDepression and anxiety are highly prevalent and often co-occur. Several studies indicate the potential of disorder-specific psychological interventions for the prevention each of these disorders. To treat comorbidity, transdiagnostic treatment concepts seem to be a promising approach, however, evidence for transdiagnostic concepts of prevention remains inconclusive. Internet- and mobile-based interventions (IMIs) may be an effective means to deliver psychological interventions on a large scale for the prevention of common mental disorders (CMDs) such as depression and anxiety. IMIs have been shown to be effective in treating CMDs, e.g. in reducing symptoms of depression and anxiety. However, there is a lack of studies examining the efficacy of interventions reducing the incidence of CMDs. Moreover, the comparative cost-effectiveness of guided versus unguided IMIs for the prevention of depression and anxiety has not been studied yet. Hence, this study aims at investigating the (cost-)effectiveness of guided and unguided internet and mobile-based transdiagnostic individually tailored indicated prevention of depression and anxiety.MethodsA multi-country three-armed randomized controlled trial will be conducted to compare a guided and unguided intervention to treatment as usual (TAU). Both active conditions are based on the same intervention, ICare Prevent, and differ only with regard to guidance format. Altogether, 954 individuals with subclinical symptoms of depression (CES-D ≥ 16) and anxiety (GAD-7 ≥ 5) who do not have a full-blown disorder will be recruited in Germany, Switzerland, Spain and the Netherlands, and randomized to one of three conditions (guided intervention, unguided intervention, or TAU). The TAU arm will receive access to the training after a 12-month waiting period. The primary outcome will be time to CMD onset (any depression / anxiety disorder) within a follow-up period of 12 months after baseline. Secondary outcomes will include disorder-specific symptom severity (depression / anxiety) assessed by diagnostic raters blinded to intervention condition at post-intervention, self-reports, acceptability, health related quality of life, and psychosocial variables associated with developing a CMD. Assessments will take place at baseline, mid-intervention (5 weeks into the intervention), post-intervention (8 weeks after randomization) and follow-up (6 and 12 months after randomization). Data will be analyzed on an intention-to-treat basis and per protocol. Cost-effectiveness will be evaluated from a public health and a societal perspective, including both direct and indirect costs.DiscussionThe present study will further enhance the evidence-base for transdiagnostic preventive interventions and provide valuable information about optimal trade-off between treatment outcome and costs.",
author = "Weisel, {Kiona K.} and Zarski, {Anna Carlotta} and Thomas Berger and Tobias Krieger and Schaub, {Michael P.} and Moser, {Christian T.} and Matthias Berking and Michelle Dey and Cristina Botella and Ba{\~n}os, {Rosa Ma} and Roc{\'i}o Herrero and Ernestina Etchemendy and Heleen Riper and Pim Cuijpers and F. Bolinski and A.M. Kleiboer and D. G{\"o}rlich and J Beecham and Corinna Jacobi and Ebert, {David D.}",
year = "2019",
doi = "10.1016/j.invent.2018.04.002",
language = "English",
volume = "16",
pages = "52--64",
journal = "Internet Interventions",
issn = "2214-7829",
publisher = "Elsevier BV",

}

Weisel, KK, Zarski, AC, Berger, T, Krieger, T, Schaub, MP, Moser, CT, Berking, M, Dey, M, Botella, C, Baños, RM, Herrero, R, Etchemendy, E, Riper, H, Cuijpers, P, Bolinski, F, Kleiboer, AM, Görlich, D, Beecham, J, Jacobi, C & Ebert, DD 2019, 'Efficacy and cost-effectiveness of guided and unguided internet- and mobile-based indicated transdiagnostic prevention of depression and anxiety (ICare Prevent): A three-armed randomized controlled trial in four European countries', Internet Interventions, vol. 16, pp. 52-64. https://doi.org/10.1016/j.invent.2018.04.002

Efficacy and cost-effectiveness of guided and unguided internet- and mobile-based indicated transdiagnostic prevention of depression and anxiety (ICare Prevent): A three-armed randomized controlled trial in four European countries. / Weisel, Kiona K.; Zarski, Anna Carlotta; Berger, Thomas; Krieger, Tobias; Schaub, Michael P.; Moser, Christian T.; Berking, Matthias; Dey, Michelle; Botella, Cristina; Baños, Rosa Ma; Herrero, Rocío; Etchemendy, Ernestina; Riper, Heleen; Cuijpers, Pim; Bolinski, F.; Kleiboer, A.M.; Görlich, D.; Beecham, J; Jacobi, Corinna; Ebert, David D.

In: Internet Interventions, Vol. 16, 2019, p. 52-64.

Research output: Contribution to JournalArticleAcademicpeer-review

TY - JOUR

T1 - Efficacy and cost-effectiveness of guided and unguided internet- and mobile-based indicated transdiagnostic prevention of depression and anxiety (ICare Prevent): A three-armed randomized controlled trial in four European countries

AU - Weisel, Kiona K.

AU - Zarski, Anna Carlotta

AU - Berger, Thomas

AU - Krieger, Tobias

AU - Schaub, Michael P.

AU - Moser, Christian T.

AU - Berking, Matthias

AU - Dey, Michelle

AU - Botella, Cristina

AU - Baños, Rosa Ma

AU - Herrero, Rocío

AU - Etchemendy, Ernestina

AU - Riper, Heleen

AU - Cuijpers, Pim

AU - Bolinski, F.

AU - Kleiboer, A.M.

AU - Görlich, D.

AU - Beecham, J

AU - Jacobi, Corinna

AU - Ebert, David D.

PY - 2019

Y1 - 2019

N2 - BackgroundDepression and anxiety are highly prevalent and often co-occur. Several studies indicate the potential of disorder-specific psychological interventions for the prevention each of these disorders. To treat comorbidity, transdiagnostic treatment concepts seem to be a promising approach, however, evidence for transdiagnostic concepts of prevention remains inconclusive. Internet- and mobile-based interventions (IMIs) may be an effective means to deliver psychological interventions on a large scale for the prevention of common mental disorders (CMDs) such as depression and anxiety. IMIs have been shown to be effective in treating CMDs, e.g. in reducing symptoms of depression and anxiety. However, there is a lack of studies examining the efficacy of interventions reducing the incidence of CMDs. Moreover, the comparative cost-effectiveness of guided versus unguided IMIs for the prevention of depression and anxiety has not been studied yet. Hence, this study aims at investigating the (cost-)effectiveness of guided and unguided internet and mobile-based transdiagnostic individually tailored indicated prevention of depression and anxiety.MethodsA multi-country three-armed randomized controlled trial will be conducted to compare a guided and unguided intervention to treatment as usual (TAU). Both active conditions are based on the same intervention, ICare Prevent, and differ only with regard to guidance format. Altogether, 954 individuals with subclinical symptoms of depression (CES-D ≥ 16) and anxiety (GAD-7 ≥ 5) who do not have a full-blown disorder will be recruited in Germany, Switzerland, Spain and the Netherlands, and randomized to one of three conditions (guided intervention, unguided intervention, or TAU). The TAU arm will receive access to the training after a 12-month waiting period. The primary outcome will be time to CMD onset (any depression / anxiety disorder) within a follow-up period of 12 months after baseline. Secondary outcomes will include disorder-specific symptom severity (depression / anxiety) assessed by diagnostic raters blinded to intervention condition at post-intervention, self-reports, acceptability, health related quality of life, and psychosocial variables associated with developing a CMD. Assessments will take place at baseline, mid-intervention (5 weeks into the intervention), post-intervention (8 weeks after randomization) and follow-up (6 and 12 months after randomization). Data will be analyzed on an intention-to-treat basis and per protocol. Cost-effectiveness will be evaluated from a public health and a societal perspective, including both direct and indirect costs.DiscussionThe present study will further enhance the evidence-base for transdiagnostic preventive interventions and provide valuable information about optimal trade-off between treatment outcome and costs.

AB - BackgroundDepression and anxiety are highly prevalent and often co-occur. Several studies indicate the potential of disorder-specific psychological interventions for the prevention each of these disorders. To treat comorbidity, transdiagnostic treatment concepts seem to be a promising approach, however, evidence for transdiagnostic concepts of prevention remains inconclusive. Internet- and mobile-based interventions (IMIs) may be an effective means to deliver psychological interventions on a large scale for the prevention of common mental disorders (CMDs) such as depression and anxiety. IMIs have been shown to be effective in treating CMDs, e.g. in reducing symptoms of depression and anxiety. However, there is a lack of studies examining the efficacy of interventions reducing the incidence of CMDs. Moreover, the comparative cost-effectiveness of guided versus unguided IMIs for the prevention of depression and anxiety has not been studied yet. Hence, this study aims at investigating the (cost-)effectiveness of guided and unguided internet and mobile-based transdiagnostic individually tailored indicated prevention of depression and anxiety.MethodsA multi-country three-armed randomized controlled trial will be conducted to compare a guided and unguided intervention to treatment as usual (TAU). Both active conditions are based on the same intervention, ICare Prevent, and differ only with regard to guidance format. Altogether, 954 individuals with subclinical symptoms of depression (CES-D ≥ 16) and anxiety (GAD-7 ≥ 5) who do not have a full-blown disorder will be recruited in Germany, Switzerland, Spain and the Netherlands, and randomized to one of three conditions (guided intervention, unguided intervention, or TAU). The TAU arm will receive access to the training after a 12-month waiting period. The primary outcome will be time to CMD onset (any depression / anxiety disorder) within a follow-up period of 12 months after baseline. Secondary outcomes will include disorder-specific symptom severity (depression / anxiety) assessed by diagnostic raters blinded to intervention condition at post-intervention, self-reports, acceptability, health related quality of life, and psychosocial variables associated with developing a CMD. Assessments will take place at baseline, mid-intervention (5 weeks into the intervention), post-intervention (8 weeks after randomization) and follow-up (6 and 12 months after randomization). Data will be analyzed on an intention-to-treat basis and per protocol. Cost-effectiveness will be evaluated from a public health and a societal perspective, including both direct and indirect costs.DiscussionThe present study will further enhance the evidence-base for transdiagnostic preventive interventions and provide valuable information about optimal trade-off between treatment outcome and costs.

U2 - 10.1016/j.invent.2018.04.002

DO - 10.1016/j.invent.2018.04.002

M3 - Article

VL - 16

SP - 52

EP - 64

JO - Internet Interventions

T2 - Internet Interventions

JF - Internet Interventions

SN - 2214-7829

ER -