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Randomization process of the “Grief COVID” (Duelo COVID) intervention.

Randomization process of the “Grief COVID” (Duelo COVID) intervention.

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Article
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Background: COVID-19 has taken many lives worldwide and due to this, millions of persons are in grief. When the grief process lasts longer than 6 months, the person is in risk of developing Complicated Grief Disorder (CGD). The CGD is related to serious health consequences. To reduce the probability of developing CGD a preventive intervention could...

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... Participation was voluntary, and all participants provided written informed consent to take part in this study and to use their data for research purposes. The study protocol is available at Dominguez-Rodriguez et al. (2021). ...
... Subsequently, a series of short psychoeducational videos were shown. The program also included experiential activities utilizing relaxation, mindfulness, and problem-solving techniques to recognize emotions, set goals, practice self-care, build support networks, and prevent relapses (Dominguez-Rodriguez et al., 2021). At the end of each module, the participants received a questionnaire with 5 multiple-choice questions to assess their understanding of the material. ...
... The platform where the intervention was delivered was created using User Experience (UX) design principles (Tullis & Albert, 2013). A detailed description of the intervention can be found in Dominguez-Rodriguez et al. (2021). ...
Article
The COVID-19 pandemic amplified the emotional impact of losing a loved one, deteriorating well-being, and increasing dysphoric symptoms in mourners. This study evaluated the efficacy of COVID Grief, a self-applied online cognitive-behavioral intervention for Mexican adults facing grief during the pandemic. We conducted a randomized clinical trial, enrolling 1,109 participants, 45 of whom completed the full intervention, and 69 of whom completed the waiting list control (WLC). Between-subject analysis showed that intervention group (IG) participants reported significantly higher satisfaction with life and quality of life and a reduction in depression, anxiety and stress levels compared to those in the WLC. Within-subjects analysis showed that IG presented no significant changes in satisfaction with life, whereas the quality of life was increased, and levels of depression, anxiety, and stress were reduced after treatment. For WLC, satisfaction with life and quality of life were significantly decreased, and symptoms of depression and anxiety -but not stress symptoms- increased after the waitlist. Completer’s opinions of the treatment were highly positive, although they only represent 5% of participants who accessed the intervention. High dropout rates should be addressed in future studies.
... In addition, another situation to consider is that web-based psychological interventions, particularly those of a self-guided type, remain relatively unknown in Latin American countries because these interventions are often offered to the population as therapeutic alternatives for a short time. Furthermore, few web-based interventions have been delivered in Mexico, free of charge for the user (eg, Grief COVID; [97]). Privacy and security of the users' data should be explicitly warranted to increase trust among potential users of web-based resources [98]. ...
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Background: The COVID-19 pandemic has had an impact on mental health worldwide. Low- and middle-income countries were largely affected by it. Mexico was one of the most affected countries. Extended periods of lockdowns, isolation, and social distancing, among other factors, highlighted the need to introduce web-based psychological interventions to the Mexican population. In this context, Mental Health COVID-19 emerged as a self-guided web-based intervention (SGWI) aimed at adults to improve mental health during the COVID-19 pandemic. Objective: This study aims to assess the efficacy of 2 modalities of a self-guided intervention (with and without chat support) in reducing depression symptoms, generalized anxiety, community posttraumatic stress, widespread fear, anxiety, sleep quality, physiological and affective coping, and suicide ideation. In addition, it aimed to compare the moderating role of coping strategies, acceptance, and satisfaction in participants’ symptom reduction. We hypothesize that the self-guided, chat-supported modality will show higher efficacy than the modality without chat support in achieving clinical change and better performance as a moderator of depression symptoms, generalized anxiety, community posttraumatic stress, widespread fear, anxiety, sleep quality, physiological and affective coping, and suicide ideation, as well as an increase in participants’ satisfaction and acceptability. Methods: A randomized controlled trial was conducted. Data were collected from May 2020 to June 2022. We performed intrasubject measures at 4 evaluation periods: pretest, posttest, and follow-up measurements at 3 and 6 months. Differences between intervention groups were assessed through the Mann-Whitney U test for continuous variables and the chi-square test for categorical variables. Changes due to intervention were analyzed using Wilcoxon W test. Moderated regression analysis was performed to test the hypothesized moderating role of coping strategies, usability, and opinion about treatment on clinical change. Results: A total of 36 participants completed the intervention; of these, 5 (14%) were part of the SGWI group, and 31 (86%) were on the SGWI plus chat support (SGWI+C) group, which included a chat service with therapists. The perceived high complexity of the system for the SGWI group had a moderating effect associated with a lack of efficacy of the intervention regarding depression, but not when controlled for sociodemographic variables. A perception of lower helpfulness of the intervention was associated with poorer outcomes. Coping strategies did not show moderating effects. Conclusions: Enhancing the utility of web-based interventions for reducing clinical symptoms by incorporating a support chat to boost treatment adherence seemed to improve the perception of the intervention’s usefulness. Web-based interventions face several challenges, such as eliminating complexities in platform use and increasing the users’ perceived utility of the intervention, among other issues identified in the study. Trial Registration: ClinicalTrials.gov NCT04468893; https://clinicaltrials.gov/study/NCT04468893?tab=results International Registered Report Identifier (IRRID): RR2-10.2196/23117 JMIR Form Res 2024;8:e53767
... We then tried to confirm and extend these findings using simulations based on real data from a similar previous study conducted by Dominguez-Rodriguez et al. (2021, 2023. The data included the results of 114 participants, 45 on the treatment condition and 69 on the control condition, which after finishing a waiting period of 36 days, were assigned to the treatment condition. ...
Article
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Background Online psychological interventions have emerged as a treatment alternative because they are accessible, flexible, personalized, and available to large populations. The number of Internet interventions in Latin America is limited, as are Randomized Controlled Trials (RCTs) of their effectiveness and a few studies comparing their effectiveness in multiple countries at the same time. We have developed an online intervention, Well-being Online, which will be available to the public free of charge in 7 countries: Mexico, Ecuador, Peru, Chile, Brazil, Spain, and the Netherlands. We expect a reduction in depression and anxiety symptoms and an increase in well-being of the participants. Methods A multi-country, randomized controlled trial will be conducted. The intervention is multicomponent (Cognitive Behavioral Therapy, Behavioral Activation Therapy, Mindfulness, Acceptance and Commitment Therapy, and Positive Psychology), with 10 sessions. In each country, eligible participants will be randomized to one of three groups: Enriched Intervention (interactive web design with videos, infographics, text, audio, and forum), Text Intervention (text on the website), and Wait List (control group). Repeated measures will be obtained at 5-time points. Our primary outcomes will be anxiety symptomatology, depressive symptomatology, and mental well-being. MANOVA analysis will be used for our main analysis. Discussion This protocol describes the design of a randomized trial to evaluate the efficacy of a web-based intervention to reduce anxiety and depression symptomatology and increase subjective well-being. The intervention will be made available in four languages (Spanish, Portuguese, Dutch, and English). Its results will contribute to the evidence of effectiveness in terms of randomized trials and Internet interventions, mainly in Latin America and Europe.
... We then tried to confirm and extend these findings using simulations based on real data from a similar previous study conducted by Dominguez-Rodriguez et al. (2021, 2023. The data included the results of 114 participants, 45 on the treatment condition and 69 on the control condition, which after finishing a waiting period of 36 days, were assigned to the treatment condition. ...
Article
Background: Online psychological interventions have emerged as a treatment alternative because they are accessible, flexible, personalized, and available to large populations. The number of Internet interventions in Latin America is limited, as are Randomized Controlled Trials (RCTs) of their effectiveness and a few studies comparing their effectiveness in multiple countries at the same time. We have developed an online intervention, Well-being Online, which will be available to the public free of charge in 7 countries: Mexico, Ecuador, Peru, Chile, Brazil, Spain, and the Netherlands. We expect a reduction in depression and anxiety symptoms and an increase in well-being of the participants. Methods: A multi-country, randomized controlled trial will be conducted. The intervention is multicomponent (Cognitive Behavioral Therapy, Behavioral Activation Therapy, Mindfulness, Acceptance and Commitment Therapy, and Positive Psychology), with 10 sessions. In each country, eligible participants will be randomized to one of three groups: Enriched Intervention (interactive web design with videos, infographics, text, audio, and forum), Text Intervention (text on the website), and Wait List (control group). Repeated measures will be obtained at 5-time points. Our primary outcomes will be anxiety symptomatology, depressive symptomatology, and mental well-being. MANOVA analysis will be used for our main analysis. Discussion: This protocol describes the design of a randomized trial to evaluate the efficacy of a web-based intervention to reduce anxiety and depression symptomatology and increase subjective well-being. The intervention will be made available in four languages (Spanish, Portuguese, Dutch, and English). Its results will contribute to the evidence of effectiveness in terms of randomized trials and Internet interventions, mainly in Latin America and Europe
... These contacts provided a supportive environment for expressing grief-related emotions, mobilizing internal psycho-emotional resources, and making referrals for more severe symptoms. Additionally, Dominguez-Rodriguez et al. (2021) launched an online service in Mexico to enhance the quality of life during the COVID-19 outbreak with offering self-applied cognitive behavioral therapy (CBT) interventions. ...
Preprint
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As the COVID-19 pandemic has created complex conditions and the horrific loss of numerous lives, grieving the loss of loved ones in close families can be extremely difficult. To reduce the suffering of the loss and prevent the development of complicated grief, it is necessary to provide bereavement care as soon as possible. Therefore, we quickly developed a complete online program that included supportive psycho-therapeutic interventions and psychiatric counseling. The structure of all services is the main emphasis of the study, which also emphasizes the quantitative components and the unique characteristics of the interventions. Based on the lesson learned, we discussed the difficulties experienced in putting into practice an internet-based preventive service.
... The present cross-sectional study was part of a larger research/intervention project exploring multiple clinical factors of Mexican people who accessed a free online platform devised to provide emotional support for people experiencing grief during the COVID-19 pandemic (Dominguez-Rodriguez et al., 2021), conducted between December 2020 and April 2021. ...
Article
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Introducción: La satisfacción con la vida ha demostrado ser un indicador importante de bienestar físico y mental en las personas, y puede verse afectada por eventos vitales tales como la pérdida de un ser querido. Por consiguiente, el presente estudio tuvo como objetivo analizar la relación entre un conjunto de variables sociodemográficas y la satisfacción con la vida en población mexicana que perdió un ser querido durante la pandemia por COVID-19. Método: Se realizó un estudio de tipo transversal, en el cual se aplicó la Escala de satisfacción con la vida a una muestra total de 4875 participantes de México. Resultados: Los hallazgos confirmaron que, a mayor edad, tener un trabajo y educación superior se asociaron con una mayor satisfacción con la vida. Por otra parte, el uso de medicación psiquiátrica y un mayor tiempo transcurrido desde la pérdida se relacionaron con menor satisfacción con la vida. Conclusiones: El estudio respalda la necesidad de construir redes de apoyo entre la población y los servicios de salud mental, con especial énfasis en algunas subpoblaciones de mayor vulnerabilidad.
... So far, most measures used to assess PGD have been developed in the US and their validity is yet to be established across cultures. For example, the Inventory of Complicated Grief, the measure that has been most used to assess pathological grief, has been validated in eight languages, including Hebrew (Lifshitz et al., 2020), Korean (Han et al., 2016), Polish (Ludwikowska-Świeboda and Lachowska, 2019), Italian (Carmassi et al., 2014), and Spanish (Spanish version [Limonero et al., 2009], Colombian-Spanish version [Gamba-Collazos et al., 2017], Mexican-Spanish version [Dominguez-Rodriguez et al., 2021]). However, it is based on older diagnostic criteria for PGD. ...
Article
Full-text available
The death of a loved one – bereavement – is a universal experience that marks the human mental health condition. Grief – the cognitive, emotional, and behavioral responses to bereavement – is thus experienced by virtually everyone at some point in life, while mourning is a process through which grievers come to term with the loss envisioning life without the deceased. Although distress subsides over time among most bereaved individuals, a minority will develop a condition recently identified as Prolonged Grief Disorder (PGD). The present review provides a global perspective on bereavement, grief reactions, and PGD. Although the loss of a loved one and grief reactions are in general experienced consistently across different cultures, differences and variations in their expression may exist across cultures. Especially within specific populations that may be more at risk for PGD, possibly due to risk factors associated with the mechanisms of loss (e.g., refugees, migrants, and conflict survivors). The diagnostic criteria for PGD are mostly based on Western grieving populations and cultural adaptations of PGD treatments are limited. Therefore, cross-cultural development and validation of PGD screening/assessment is critical to support future research of grief reactions and PGD, especially in non-Western contexts, and concerning the potential future global changes and challenges that appear to have a major impact on PGD. More transcultural research on PGD is needed to contextualize and will lead to culture-bound symptom identification of PGD, and the adaptation of current treatment protocols, which may ultimately improve health at the individual level, and health care systems.
... To the authors' best knowledge, in Latin America, no web-based interventions have been developed before our study to support individuals going through a grieving process. Clinical symptoms and variables of well-being were assessed as proposed in the Grief COVID protocol article [11]. The results have been organized into 2 manuscripts that include different variables. ...
... After 36 days, the participants in the CG received an email notifying them that they would now have access to the treatment after responding to another assessment. More details can be found in a study by Dominguez-Rodriguez et al [11]. ...
... Participants were recommended to progress through 2 modules per week or 1 every 3 days. A detailed description of the intervention is available in the protocol article [11]. The web-based intervention can be accessed on the website [33]. ...
Article
Full-text available
Background: The death of a loved one was a challenge many people faced during the COVID-19 pandemic within the context of extraordinary circumstances and great uncertainty. Grief is an unavoidable part of life, and for most people, feelings of grief decrease naturally over time. However, for some people, grieving can become a particularly painful process with clinical symptoms that may require professional help to resolve. To provide psychological support to people who had lost a loved one during the COVID-19 pandemic, an unguided web-based psychological intervention was developed. Objective: The main objective of this study was to evaluate the efficacy of the web-based treatment, Grief COVID (Duelo COVID in Spanish; ITLAB), in reducing clinical symptoms of complicated grief, depression, posttraumatic stress, hopelessness, anxiety, and suicidal risk in adults. The secondary aim was to validate the usability of the self-applied intervention system. Methods: We used a randomized controlled trial with an intervention group (IG) and a waitlist control group (CG). The groups were assessed 3 times (before beginning the intervention, upon completing the intervention, and 3 months after the intervention). The intervention was delivered on the web in an asynchronous format through the Duelo COVID web page. Participants created an account that could be used on their computers, smartphones, or tablets. The evaluation process was automated as part of the intervention. Results: A total of 114 participants were randomly assigned to the IG or CG and met criteria for inclusion in the study (n=45, 39.5% completed the intervention and n=69, 60.5% completed the waitlist period). Most participants (103/114, 90.4%) were women. The results indicated that the treatment significantly reduced baseline clinical symptoms in the IG for all variables (P<.001 to P=.006), with larger effect sizes for depression, hopelessness, grief, anxiety, and risk of suicide (all effect sizes ≥0.5). The follow-up evaluation showed that symptom reduction was maintained at 3 months after the intervention. The results from the CG showed that participants experienced significantly decreased levels of hopelessness after completing the time on the waitlist (P<.001), but their suicidal risk scores increased. Regarding the usability of the self-applied intervention system, the results indicated a high level of satisfaction with the Grief COVID. Conclusions: The self-applied web-based intervention Grief COVID was effective in reducing symptoms of anxiety, depression, hopelessness, risk of suicide risk, posttraumatic stress disorder, and complicated grief disorder. Grief COVID was evaluated by the participants, who reported that the system was easy to use. These results affirm the importance of developing additional web-based psychological tools to help reduce clinical symptoms in people experiencing grief because of the loss of a loved one during a pandemic. Trial Registration: ClinicalTrials.gov NCT04638842; https://clinicaltrials.gov/ct2/show/NCT04638842
... To the authors' best knowledge, in Latin America, no web-based interventions have been developed before our study to support individuals going through a grieving process. Clinical symptoms and variables of well-being were assessed as proposed in the Grief COVID protocol article [11]. The results have been organized into 2 manuscripts that include different variables. ...
... After 36 days, the participants in the CG received an email notifying them that they would now have access to the treatment after responding to another assessment. More details can be found in a study by Dominguez-Rodriguez et al [11]. ...
... Participants were recommended to progress through 2 modules per week or 1 every 3 days. A detailed description of the intervention is available in the protocol article [11]. The web-based intervention can be accessed on the website [33]. ...
Preprint
BACKGROUND The death of loved ones during the COVID-19 pandemic was a challenge people faced in this historical period. Although grief for most people is a natural process that resolves itself, for some, it becomes a painful process with clinical correlates that may require professional help for its resolution. We developed an unguided online psychological intervention to provide psychological support to people who lost a loved one during the COVID-19 pandemic. OBJECTIVE The main objective of this study was to evaluate the efficacy of online treatment in reducing clinical symptoms of complicated grief, depression, post-traumatic stress, hopelessness, anxiety, and suicidal risk in adults. METHODS We used a randomized controlled trial with an intervention group and a waiting list control group. The groups were assessed three times (before entering, after finishing the intervention, and three months later). As a secondary aim, we evaluated the usability of the system. RESULTS For the intervention group, the results indicated that treatment significantly reduced baseline clinical symptoms for all variables, with larger effect sizes for depression, hopelessness, grief, anxiety, and risk of suicide (all effect sizes ≥ 0.5). The participants in the control group significantly decreased hopelessness levels after the waiting list but increased their suicidal risk scores. The follow-up evaluation showed that symptom reduction was maintained. Participants rated the intervention as a highly usability system. CONCLUSIONS These results show the importance of developing online psychological tools to reduce clinical symptoms in people going through a grief process derived from the loss of a loved one in times of pandemic. CLINICALTRIAL Trial Registration: The study is registered in Clinical trials (NCT04638842).
... In this sense, in the context of healthcare workers facing COVID-19, these comparisons between modalities have not been explored. Despite the above, in Mexico, psychological digital interventions have been a good option in the current pandemic, since the users are not exposed to the risk of contagion [36]. Another relevant aspect is the cost efficacy of online interventions, especially in low-and middle-income countries where the available budget is scarce for mental health treatments. ...
... Voluntary healthcare workers will participate in the intervention. The total sample will be at least composed of 49 participants (24 in active control group and 25 in experimental group), based on previous interventions administered online [36], as well as on the potency analysis (1 − β = 0.95, α = 0.05, Cohen's d = 0.80), considering that values equal or greater than 0.80 in Cohen's d are considered large effect sizes [40]. The above analysis was done with GPower and revealed the need to consider at least 36 participants. ...
Article
Full-text available
(1) Background: Healthcare workers have been affected by the COVID-19 pandemic. Digital interventions have been carried out that have been effective with this population; however, few have been reported in Latin America. Our aim is to describe the components and methods to evaluate the feasibility and utility of an online multi-component psychological intervention for healthcare workers in Mexico during COVID-19. (2) Methods: This study is a randomized clinical trial with two arms: (1) self-applied intervention and (2) intervention delivered online by therapists. The participants are randomly assigned to one arm, receiving the same treatment contents in both groups. The “Personal COVID” intervention consists of an internet platform containing 9 nuclear and 3 complementary modules. The objectives of the intervention are: (1) to reduce anxiety, depressive symptoms, burnout, and compassion fatigue, and (2) to increase the quality of life, sleep quality, self-care, and their skills to give bad news. The protocol has been registered on ClinicalTrials.gov (identifier: NCT04890665). (3) Discussion: This protocol is designed according to the highest scientific standards following the SPIRIT guidelines. The “Personal COVID” intervention is expected to be of high efficacy in treating the emotional distress of healthcare workers and promoting their health during the COVID-19 pandemic.