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Supporting People Who Have Lost a Close Person by Bereavement or Separation: Protocol of a Randomized Controlled Trial Comparing Two French-Language Internet-Based Interventions

BACKGROUND: Internet-based interventions (IBIs) are as efficient as face-to-face psychotherapy for a variety of mental health disorders, including complicated grief. Most evidence stems from guided IBIs. However, recent research indicates that the benefit of guidance is lower in more interactive IBI...

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Autores principales: Debrot, Anik, Kheyar, Maya, Efinger, Liliane, Berthoud, Laurent, Pomini, Valentino
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9264124/
https://www.ncbi.nlm.nih.gov/pubmed/35737454
http://dx.doi.org/10.2196/39026
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author Debrot, Anik
Kheyar, Maya
Efinger, Liliane
Berthoud, Laurent
Pomini, Valentino
author_facet Debrot, Anik
Kheyar, Maya
Efinger, Liliane
Berthoud, Laurent
Pomini, Valentino
author_sort Debrot, Anik
collection PubMed
description BACKGROUND: Internet-based interventions (IBIs) are as efficient as face-to-face psychotherapy for a variety of mental health disorders, including complicated grief. Most evidence stems from guided IBIs. However, recent research indicates that the benefit of guidance is lower in more interactive IBIs. As such, providing guidance only to people requiring it (guidance on demand) appears a cost-effective solution. This is particularly important to develop given the recent rise in grief symptoms in the context of the COVID-19 pandemic. This paper presents the protocol of a randomized controlled trial comparing the efficacy and adherence rate of 2 IBIs for grief-related symptoms after the loss a close one following death or romantic separation, using a guidance on demand framework. LIVIA 2.0 was developed based on theoretical and empirical findings on grief processes and IBIs, and it will be compared to LIVIA 1 that has already demonstrated its efficacy. OBJECTIVE: Our main hypotheses are that LIVIA 1 (control condition) and LIVIA 2.0 (experimental condition) increase participants’ well-being and decrease their distress at posttest and at follow-up, that LIVIA 2.0 is more efficient than LIVIA 1 for all outcomes, and that LIVIA 2.0 has less dropouts than LIVIA 1. METHODS: Outcomes will be assessed at pretest, posttest (12 weeks later), and follow-up (24 weeks later). We will recruit 234 participants through a variety of means, including social media and contacts with the press. Primary outcomes are grief symptoms, depressive symptoms, and eudemonic well-being. Secondary outcomes are anxiety symptoms, grief coping strategies, aspects related to self-identity reorganization, and program satisfaction. LIVIA 2.0 participants will additionally undergo a weekly mood and grief symptom monitoring, allowing us to explore the short-term efficacy of the sessions. RESULTS: The creation and development of the content of LIVIA 2.0 was completed during the first phase of the project. Participant recruitment will begin in May 2022 and will last until January 2023. CONCLUSIONS: This study will emphasize the relevance of the innovations included in LIVIA 2.0 regarding the efficacy and dropout rate of IBIs for grief symptoms and will allow investigations on how these changes impact the demand for guidance. In the current postpandemic times, developing and assessing IBIs targeting grief symptoms are particularly critical given the rise in grief-related symptoms. TRIAL REGISTRATION: clinicaltrials.gov NCT05219760; https://tinyurl.com/3dzztjts INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/39026
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spelling pubmed-92641242022-07-09 Supporting People Who Have Lost a Close Person by Bereavement or Separation: Protocol of a Randomized Controlled Trial Comparing Two French-Language Internet-Based Interventions Debrot, Anik Kheyar, Maya Efinger, Liliane Berthoud, Laurent Pomini, Valentino JMIR Res Protoc Protocol BACKGROUND: Internet-based interventions (IBIs) are as efficient as face-to-face psychotherapy for a variety of mental health disorders, including complicated grief. Most evidence stems from guided IBIs. However, recent research indicates that the benefit of guidance is lower in more interactive IBIs. As such, providing guidance only to people requiring it (guidance on demand) appears a cost-effective solution. This is particularly important to develop given the recent rise in grief symptoms in the context of the COVID-19 pandemic. This paper presents the protocol of a randomized controlled trial comparing the efficacy and adherence rate of 2 IBIs for grief-related symptoms after the loss a close one following death or romantic separation, using a guidance on demand framework. LIVIA 2.0 was developed based on theoretical and empirical findings on grief processes and IBIs, and it will be compared to LIVIA 1 that has already demonstrated its efficacy. OBJECTIVE: Our main hypotheses are that LIVIA 1 (control condition) and LIVIA 2.0 (experimental condition) increase participants’ well-being and decrease their distress at posttest and at follow-up, that LIVIA 2.0 is more efficient than LIVIA 1 for all outcomes, and that LIVIA 2.0 has less dropouts than LIVIA 1. METHODS: Outcomes will be assessed at pretest, posttest (12 weeks later), and follow-up (24 weeks later). We will recruit 234 participants through a variety of means, including social media and contacts with the press. Primary outcomes are grief symptoms, depressive symptoms, and eudemonic well-being. Secondary outcomes are anxiety symptoms, grief coping strategies, aspects related to self-identity reorganization, and program satisfaction. LIVIA 2.0 participants will additionally undergo a weekly mood and grief symptom monitoring, allowing us to explore the short-term efficacy of the sessions. RESULTS: The creation and development of the content of LIVIA 2.0 was completed during the first phase of the project. Participant recruitment will begin in May 2022 and will last until January 2023. CONCLUSIONS: This study will emphasize the relevance of the innovations included in LIVIA 2.0 regarding the efficacy and dropout rate of IBIs for grief symptoms and will allow investigations on how these changes impact the demand for guidance. In the current postpandemic times, developing and assessing IBIs targeting grief symptoms are particularly critical given the rise in grief-related symptoms. TRIAL REGISTRATION: clinicaltrials.gov NCT05219760; https://tinyurl.com/3dzztjts INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/39026 JMIR Publications 2022-06-23 /pmc/articles/PMC9264124/ /pubmed/35737454 http://dx.doi.org/10.2196/39026 Text en ©Anik Debrot, Maya Kheyar, Liliane Efinger, Laurent Berthoud, Valentino Pomini. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 23.06.2022. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.
spellingShingle Protocol
Debrot, Anik
Kheyar, Maya
Efinger, Liliane
Berthoud, Laurent
Pomini, Valentino
Supporting People Who Have Lost a Close Person by Bereavement or Separation: Protocol of a Randomized Controlled Trial Comparing Two French-Language Internet-Based Interventions
title Supporting People Who Have Lost a Close Person by Bereavement or Separation: Protocol of a Randomized Controlled Trial Comparing Two French-Language Internet-Based Interventions
title_full Supporting People Who Have Lost a Close Person by Bereavement or Separation: Protocol of a Randomized Controlled Trial Comparing Two French-Language Internet-Based Interventions
title_fullStr Supporting People Who Have Lost a Close Person by Bereavement or Separation: Protocol of a Randomized Controlled Trial Comparing Two French-Language Internet-Based Interventions
title_full_unstemmed Supporting People Who Have Lost a Close Person by Bereavement or Separation: Protocol of a Randomized Controlled Trial Comparing Two French-Language Internet-Based Interventions
title_short Supporting People Who Have Lost a Close Person by Bereavement or Separation: Protocol of a Randomized Controlled Trial Comparing Two French-Language Internet-Based Interventions
title_sort supporting people who have lost a close person by bereavement or separation: protocol of a randomized controlled trial comparing two french-language internet-based interventions
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9264124/
https://www.ncbi.nlm.nih.gov/pubmed/35737454
http://dx.doi.org/10.2196/39026
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