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Protocol for a randomized controlled dismantling study of an internet-based intervention for depressive symptoms: exploring the contribution of behavioral activation and positive psychotherapy strategies

BACKGROUND: There are evidence-based interventions for depression that include different components. However, the efficacy of their therapeutic components is unknown. Another important issue related to depression interventions is that, up to now, their therapeutic components have only focused on red...

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Autores principales: Mira, Adriana, Díaz-García, Amanda, Castilla, Diana, Campos, Daniel, Romero, Sonia, Bretón-López, Juana, García-Palacios, Azucena, Baños, Rosa, Botella, Cristina
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6500058/
https://www.ncbi.nlm.nih.gov/pubmed/31053067
http://dx.doi.org/10.1186/s12888-019-2099-2
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author Mira, Adriana
Díaz-García, Amanda
Castilla, Diana
Campos, Daniel
Romero, Sonia
Bretón-López, Juana
García-Palacios, Azucena
Baños, Rosa
Botella, Cristina
author_facet Mira, Adriana
Díaz-García, Amanda
Castilla, Diana
Campos, Daniel
Romero, Sonia
Bretón-López, Juana
García-Palacios, Azucena
Baños, Rosa
Botella, Cristina
author_sort Mira, Adriana
collection PubMed
description BACKGROUND: There are evidence-based interventions for depression that include different components. However, the efficacy of their therapeutic components is unknown. Another important issue related to depression interventions is that, up to now, their therapeutic components have only focused on reducing negative symptoms rather than on improving positive affect and well-being. Because the low levels of positive affect are more strongly linked to depression than to other emotional disorders, it is important to include this variable as an important treatment target. Positive psychotherapeutic strategies (PPs) could help in this issue. The results obtained so far are consistent and promising, showing that Internet-based interventions are effective in treating depression. However, most of them are also multi-component, and it is important to make progress in investigating what each component contributes to the intervention. METHODS: The current study will be a three-armed, simple-blinded, randomized controlled clinical trial with a dismantling design. 192 participants will be randomly assigned to: a) an Internet-based Global Protocol condition, which includes traditional therapeutic components of evidence-based treatments for depression (Motivation for change, Psychoeducation, Cognitive Therapy, Behavioral Activation (BA), Relapse Prevention) and PPs component, offering strategies to enhance positive mood and promote psychological strengths; b) an Internet-based BA Protocol condition (without the PPs component), and c) an Internet-based PPs Protocol condition (without the BA component). Primary outcome measures will be the BDI-II and PANAS. Secondary outcomes will include other variables such as depression, anxiety and stress, quality of life, resilience, and wellbeing related measures. Treatment acceptance and usability will also be measured. Participants will be assessed at pre-, post-treatment, 3-, 6- and 12- month follow- ups. The data will be analyzed based on the Intention-to-treat principle. Per protocol analyses will also be performed. DISCUSSION: To the best of our knowledge, this is the first randomized dismantling intervention study for depression with the aim of exploring the contribution of a PPs component and the BA component in an Internet-based intervention. The three protocols are online interventions, helping to reach many people who need psychological treatments and otherwise would not have access to them. TRIAL REGISTRATION: Clinicalstrials.gov as NCT03159715. Registered 19 May 2017.
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spelling pubmed-65000582019-05-09 Protocol for a randomized controlled dismantling study of an internet-based intervention for depressive symptoms: exploring the contribution of behavioral activation and positive psychotherapy strategies Mira, Adriana Díaz-García, Amanda Castilla, Diana Campos, Daniel Romero, Sonia Bretón-López, Juana García-Palacios, Azucena Baños, Rosa Botella, Cristina BMC Psychiatry Study Protocol BACKGROUND: There are evidence-based interventions for depression that include different components. However, the efficacy of their therapeutic components is unknown. Another important issue related to depression interventions is that, up to now, their therapeutic components have only focused on reducing negative symptoms rather than on improving positive affect and well-being. Because the low levels of positive affect are more strongly linked to depression than to other emotional disorders, it is important to include this variable as an important treatment target. Positive psychotherapeutic strategies (PPs) could help in this issue. The results obtained so far are consistent and promising, showing that Internet-based interventions are effective in treating depression. However, most of them are also multi-component, and it is important to make progress in investigating what each component contributes to the intervention. METHODS: The current study will be a three-armed, simple-blinded, randomized controlled clinical trial with a dismantling design. 192 participants will be randomly assigned to: a) an Internet-based Global Protocol condition, which includes traditional therapeutic components of evidence-based treatments for depression (Motivation for change, Psychoeducation, Cognitive Therapy, Behavioral Activation (BA), Relapse Prevention) and PPs component, offering strategies to enhance positive mood and promote psychological strengths; b) an Internet-based BA Protocol condition (without the PPs component), and c) an Internet-based PPs Protocol condition (without the BA component). Primary outcome measures will be the BDI-II and PANAS. Secondary outcomes will include other variables such as depression, anxiety and stress, quality of life, resilience, and wellbeing related measures. Treatment acceptance and usability will also be measured. Participants will be assessed at pre-, post-treatment, 3-, 6- and 12- month follow- ups. The data will be analyzed based on the Intention-to-treat principle. Per protocol analyses will also be performed. DISCUSSION: To the best of our knowledge, this is the first randomized dismantling intervention study for depression with the aim of exploring the contribution of a PPs component and the BA component in an Internet-based intervention. The three protocols are online interventions, helping to reach many people who need psychological treatments and otherwise would not have access to them. TRIAL REGISTRATION: Clinicalstrials.gov as NCT03159715. Registered 19 May 2017. BioMed Central 2019-05-03 /pmc/articles/PMC6500058/ /pubmed/31053067 http://dx.doi.org/10.1186/s12888-019-2099-2 Text en © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. 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.
spellingShingle Study Protocol
Mira, Adriana
Díaz-García, Amanda
Castilla, Diana
Campos, Daniel
Romero, Sonia
Bretón-López, Juana
García-Palacios, Azucena
Baños, Rosa
Botella, Cristina
Protocol for a randomized controlled dismantling study of an internet-based intervention for depressive symptoms: exploring the contribution of behavioral activation and positive psychotherapy strategies
title Protocol for a randomized controlled dismantling study of an internet-based intervention for depressive symptoms: exploring the contribution of behavioral activation and positive psychotherapy strategies
title_full Protocol for a randomized controlled dismantling study of an internet-based intervention for depressive symptoms: exploring the contribution of behavioral activation and positive psychotherapy strategies
title_fullStr Protocol for a randomized controlled dismantling study of an internet-based intervention for depressive symptoms: exploring the contribution of behavioral activation and positive psychotherapy strategies
title_full_unstemmed Protocol for a randomized controlled dismantling study of an internet-based intervention for depressive symptoms: exploring the contribution of behavioral activation and positive psychotherapy strategies
title_short Protocol for a randomized controlled dismantling study of an internet-based intervention for depressive symptoms: exploring the contribution of behavioral activation and positive psychotherapy strategies
title_sort protocol for a randomized controlled dismantling study of an internet-based intervention for depressive symptoms: exploring the contribution of behavioral activation and positive psychotherapy strategies
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6500058/
https://www.ncbi.nlm.nih.gov/pubmed/31053067
http://dx.doi.org/10.1186/s12888-019-2099-2
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