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Internet-based psychodynamic versus cognitive behaviour therapy for adolescents with depression: study protocol for a non-inferiority randomized controlled trial (the ERiCA study)

BACKGROUND: Adolescent depression is a common mental health problem and there is an urgent need for effective and accessible treatments. Internet-based interventions solve many obstacles for seeking and receiving treatment, thus increasing access to effective treatments. Internet-based cognitive beh...

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Autores principales: Mechler, Jakob, Lindqvist, Karin, Carlbring, Per, Lilliengren, Peter, Falkenström, Fredrik, Andersson, Gerhard, Topooco, Naira, Johansson, Robert, Midgley, Nick, Edbrooke-Childs, Julian, J. Dahl, Hanne-Sofie, Sandell, Rolf, Thorén, Agneta, Ulberg, Randi, Lindert Bergsten, Katja, Philips, Björn
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7322832/
https://www.ncbi.nlm.nih.gov/pubmed/32600400
http://dx.doi.org/10.1186/s13063-020-04491-z
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author Mechler, Jakob
Lindqvist, Karin
Carlbring, Per
Lilliengren, Peter
Falkenström, Fredrik
Andersson, Gerhard
Topooco, Naira
Johansson, Robert
Midgley, Nick
Edbrooke-Childs, Julian
J. Dahl, Hanne-Sofie
Sandell, Rolf
Thorén, Agneta
Ulberg, Randi
Lindert Bergsten, Katja
Philips, Björn
author_facet Mechler, Jakob
Lindqvist, Karin
Carlbring, Per
Lilliengren, Peter
Falkenström, Fredrik
Andersson, Gerhard
Topooco, Naira
Johansson, Robert
Midgley, Nick
Edbrooke-Childs, Julian
J. Dahl, Hanne-Sofie
Sandell, Rolf
Thorén, Agneta
Ulberg, Randi
Lindert Bergsten, Katja
Philips, Björn
author_sort Mechler, Jakob
collection PubMed
description BACKGROUND: Adolescent depression is a common mental health problem and there is an urgent need for effective and accessible treatments. Internet-based interventions solve many obstacles for seeking and receiving treatment, thus increasing access to effective treatments. Internet-based cognitive behavioural therapy (ICBT) for adolescent depression has demonstrated efficacy in previous trials. In order to broaden the range of evidence-based treatments for young people, we evaluated a newly developed affect-focused Internet-based psychodynamic treatment (IPDT) in a previous study with promising results. The purpose of the planned study is to evaluate the efficacy of IPDT for adolescent depression in a non-inferiority trial, comparing it to ICBT. METHODS: The study will employ a parallel randomized non-inferiority design (ratio 1:1; n = 270). Eligible participants are adolescents 15–19 years suffering from depression. The primary hypothesis is that IPDT will be non-inferior to ICBT in reducing depressive symptoms from pre-treatment to end of treatment. Secondary research questions include comparing outcomes of IPDT and ICBT regarding anxiety symptoms, emotion regulation and self-compassion. Additional data will be collected to evaluate cost-effectiveness as well as investigating predictors, moderators and mediators of outcome. In addition, we will examine long-term outcome up to 1 year after end of treatment. Diagnostic interviews with MINI 7.0 will be used to establish primary diagnosis of depression as well as ruling out any exclusion criteria. Both treatments consist of eight modules over 10 weeks, complemented with therapist support through text messages and weekly chat sessions. Primary outcome measure is the Quick Inventory of Depressive Symptomatology in Adolescents Self-Rated (QIDS-A17-SR). Primary outcome will be analysed using data from all participants entering the study using a multilevel growth curve strategy based on the weekly measurements of QIDS-A17-SR. The non-inferiority margin is defined as d = 0.30. DISCUSSION: This trial will demonstrate whether IPDT is non-inferior to ICBT in the treatment of adolescent depression. The study might therefore broaden the range of evidence-based treatment alternatives for young people struggling with depression. Further analyses of data from this trial may increase our knowledge about “what works for whom” and the pathways of change for two distinct types of interventions. TRIAL REGISTRATION: ISRCTN12552584, Registered on 13 August 2019.
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spelling pubmed-73228322020-06-29 Internet-based psychodynamic versus cognitive behaviour therapy for adolescents with depression: study protocol for a non-inferiority randomized controlled trial (the ERiCA study) Mechler, Jakob Lindqvist, Karin Carlbring, Per Lilliengren, Peter Falkenström, Fredrik Andersson, Gerhard Topooco, Naira Johansson, Robert Midgley, Nick Edbrooke-Childs, Julian J. Dahl, Hanne-Sofie Sandell, Rolf Thorén, Agneta Ulberg, Randi Lindert Bergsten, Katja Philips, Björn Trials Study Protocol BACKGROUND: Adolescent depression is a common mental health problem and there is an urgent need for effective and accessible treatments. Internet-based interventions solve many obstacles for seeking and receiving treatment, thus increasing access to effective treatments. Internet-based cognitive behavioural therapy (ICBT) for adolescent depression has demonstrated efficacy in previous trials. In order to broaden the range of evidence-based treatments for young people, we evaluated a newly developed affect-focused Internet-based psychodynamic treatment (IPDT) in a previous study with promising results. The purpose of the planned study is to evaluate the efficacy of IPDT for adolescent depression in a non-inferiority trial, comparing it to ICBT. METHODS: The study will employ a parallel randomized non-inferiority design (ratio 1:1; n = 270). Eligible participants are adolescents 15–19 years suffering from depression. The primary hypothesis is that IPDT will be non-inferior to ICBT in reducing depressive symptoms from pre-treatment to end of treatment. Secondary research questions include comparing outcomes of IPDT and ICBT regarding anxiety symptoms, emotion regulation and self-compassion. Additional data will be collected to evaluate cost-effectiveness as well as investigating predictors, moderators and mediators of outcome. In addition, we will examine long-term outcome up to 1 year after end of treatment. Diagnostic interviews with MINI 7.0 will be used to establish primary diagnosis of depression as well as ruling out any exclusion criteria. Both treatments consist of eight modules over 10 weeks, complemented with therapist support through text messages and weekly chat sessions. Primary outcome measure is the Quick Inventory of Depressive Symptomatology in Adolescents Self-Rated (QIDS-A17-SR). Primary outcome will be analysed using data from all participants entering the study using a multilevel growth curve strategy based on the weekly measurements of QIDS-A17-SR. The non-inferiority margin is defined as d = 0.30. DISCUSSION: This trial will demonstrate whether IPDT is non-inferior to ICBT in the treatment of adolescent depression. The study might therefore broaden the range of evidence-based treatment alternatives for young people struggling with depression. Further analyses of data from this trial may increase our knowledge about “what works for whom” and the pathways of change for two distinct types of interventions. TRIAL REGISTRATION: ISRCTN12552584, Registered on 13 August 2019. BioMed Central 2020-06-29 /pmc/articles/PMC7322832/ /pubmed/32600400 http://dx.doi.org/10.1186/s13063-020-04491-z Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Mechler, Jakob
Lindqvist, Karin
Carlbring, Per
Lilliengren, Peter
Falkenström, Fredrik
Andersson, Gerhard
Topooco, Naira
Johansson, Robert
Midgley, Nick
Edbrooke-Childs, Julian
J. Dahl, Hanne-Sofie
Sandell, Rolf
Thorén, Agneta
Ulberg, Randi
Lindert Bergsten, Katja
Philips, Björn
Internet-based psychodynamic versus cognitive behaviour therapy for adolescents with depression: study protocol for a non-inferiority randomized controlled trial (the ERiCA study)
title Internet-based psychodynamic versus cognitive behaviour therapy for adolescents with depression: study protocol for a non-inferiority randomized controlled trial (the ERiCA study)
title_full Internet-based psychodynamic versus cognitive behaviour therapy for adolescents with depression: study protocol for a non-inferiority randomized controlled trial (the ERiCA study)
title_fullStr Internet-based psychodynamic versus cognitive behaviour therapy for adolescents with depression: study protocol for a non-inferiority randomized controlled trial (the ERiCA study)
title_full_unstemmed Internet-based psychodynamic versus cognitive behaviour therapy for adolescents with depression: study protocol for a non-inferiority randomized controlled trial (the ERiCA study)
title_short Internet-based psychodynamic versus cognitive behaviour therapy for adolescents with depression: study protocol for a non-inferiority randomized controlled trial (the ERiCA study)
title_sort internet-based psychodynamic versus cognitive behaviour therapy for adolescents with depression: study protocol for a non-inferiority randomized controlled trial (the erica study)
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7322832/
https://www.ncbi.nlm.nih.gov/pubmed/32600400
http://dx.doi.org/10.1186/s13063-020-04491-z
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