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STUDY PROTOCOL
published: 29 March 2021
doi: 10.3389/fpsyg.2021.644782
Frontiers in Psychology | www.frontiersin.org 1March 2021 | Volume 12 | Article 644782
Edited by:
Ioana Roxana Podina,
University of Bucharest, Romania
Reviewed by:
Liviu Andrei Fodor,
Babe ¸s-Bolyai University, Romania
Andreea Iuliana Luca,
University of Bucharest, Romania
Ana Toma,
University of Bucharest, Romania
*Correspondence:
Alejandro Dominguez-Rodriguez
alejandro.dominguez.r@campusviu.es
Specialty section:
This article was submitted to
Psychology for Clinical Settings,
a section of the journal
Frontiers in Psychology
Received: 21 December 2020
Accepted: 01 March 2021
Published: 29 March 2021
Citation:
Dominguez-Rodriguez A,
Martínez-Luna SC, Hernández
Jiménez MJ, De La Rosa-Gómez A,
Arenas-Landgrave P, Esquivel
Santoveña EE, Arzola-Sánchez C,
Alvarez Silva J, Solis Nicolas AM,
Colmenero Guadián AM,
Ramírez-Martínez FR and Vargas ROC
(2021) A Self-Applied
Multi-Component Psychological
Online Intervention Based on UX, for
the Prevention of Complicated Grief
Disorder in the Mexican Population
During the COVID-19 Outbreak:
Protocol of a Randomized Clinical
Trial. Front. Psychol. 12:644782.
doi: 10.3389/fpsyg.2021.644782
A Self-Applied Multi-Component
Psychological Online Intervention
Based on UX, for the Prevention of
Complicated Grief Disorder in the
Mexican Population During the
COVID-19 Outbreak: Protocol of a
Randomized Clinical Trial
Alejandro Dominguez-Rodriguez 1
*, Sofia Cristina Martínez-Luna 2,
María Jesús Hernández Jiménez 1, Anabel De La Rosa-Gómez 3,
Paulina Arenas-Landgrave 2, Esteban Eugenio Esquivel Santoveña 4,
Carlos Arzola-Sánchez 4, Joabián Alvarez Silva 5, Arantza Mariel Solis Nicolas 6,
Ana Marisa Colmenero Guadián 5, Flor Rocio Ramírez-Martínez 4and
Rosa Olimpia Castellanos Vargas 4
1Health Sciences Area, Valencian International University, Valencia, Spain, 2Facultad de Psicología, Universidad Nacional
Autónoma de México, Mexico City, Mexico, 3Iztacala College of Higher Education, National Autonomous University of
Mexico, Mexico City, Mexico, 4Department of Social Sciences, Universidad Autónoma de Ciudad Juárez, Ciudad Juárez,
Mexico, 5Independent Researcher, Ciudad Juárez, Mexico, 6Independent Researcher, Tijuana, Mexico
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 be applied. In developing countries like Mexico, the psychological services are
scarce, self-applied interventions could provide support to solve this problem and reduce
the health impact even after the pandemic has already finished.
Aims: To design and implement a self-applied intervention composed of 12 modules
focused on the decrease of the risk of developing CGD, and increasing the life quality,
and as a secondary objective to reduce the symptomatology of anxiety, depression,
and increase of sleep quality. The Intervention Duelo COVID (Grief COVID) follows the
principles of User Experience (UX) and is designed according to the needs and desires
of a sample of the objective participants, to increase the adherence to the self-applied
intervention, considered one of the main weaknesses of online interventions.
Methods: A Randomized Controlled Trial will be conducted from the 22nd of December
of 2020 to the first of June 2021. The participants will be assigned to an intervention
with elements of Cognitive Behavioral Therapy, Acceptance and Commitment Therapy,
Mindfulness and Positive Psychology. The control group will be a wait-list condition, that
will receive the intervention 1.5–2 months after the pre-measurement were taken. The
Power Size Calculation conducted through G∗Power indicated the need for a total of 42
Dominguez-Rodriguez et al. COVID Grief Online Self-Applied Intervention
participants, which will be divided by 21 participants in each group. The platform will be
delivered through responsive design assuring with this that the intervention will adapt to
the screen size of cellphones, tablets, and computers.
Ethics and Dissemination: The study counts with the approval of the Research Ethics
Committee of the Autonomous University of Ciudad Juárez, México, and it is registered
in Clinical Trials (NCT04638842). The article is sent and registered in clinical trials before
the recruitment started. The results will be reported in future conferences, scientific
publications, and media.
Keywords: grief, COVID-19, online intervention, user experience, randomized controlled (clinical) trial
INTRODUCTION
Background
The Coronavirus disease 2019 (COVID-19) pandemic continues
indefinitely, and the number of cases is growing exponentially
worldwide. Even though more about this virus is being learned
every day, there are still several questions about how the disease
behaves and why one of its consequences is the high mortality
that it causes, mainly in people over 60 years old (Serra Valdes,
2020). It has been proven that advanced age, the presence of
diabetes mellitus, hypertension and obesity significantly increases
the risk of hospitalization and death in patients with COVID-19
(Muniyappa and Gubbi, 2020).
According to the World Health Organization (WHO), the
number of infected people and deaths caused by this virus as
of December 19, 2020 has risen to 74,299,042 and 1,669,982,
respectively (World Health Organization, 2020).
The pandemic has caused psychological consequences (Li
et al., 2020), among which fear, anxiety, post-traumatic stress
disorder, depression, suicidal or addictive behaviors stand out, as
well as domestic violence as a collateral effect of the confinement
(Mengin et al., 2020). Also, financial difficulties could reduce the
access to receive mental health treatment (Sher, 2020).
In addition, among the psychological consequences, the grief
due to the loss of loved ones cannot be ignored, and it should
also be noted the importance of the suffering derived from the
mandatory physical separation of family members who are sick
with COVID-19 (Singer et al., 2020).
The grieving process has been studied and analyzed by various
authors, the psychiatrist Kübler-Ross stands out among the
experts on this topic, who defined the five phases in which
a person transits during grief: denial, anger, pact/negotiation,
depression, and acceptance (Miaja Ávila and Moral De La
Rubia, 2013). A person can go through these phases in different
ways, therefore, there is no correct way to grieve, since each
Abbreviations: 2019-nCoV, Novel Coronavirus; BAT, Behavioral Activation
Therapy; CBT, Cognitive Behavioral Therapy; CES-D, Center for Epidemiologic
Studies Depression Scale; COVID-19, Coronavirus disease 2019; DASS-21,
Depression Anxiety Stress Scale; GAD-7, Generalized Anxiety Disorder 7-item; PP,
Positive Psychology; WHO, World Health Organization; WHOQoL, World Health
Organization Quality of Life; UX, User Experience.
experience is unique, individual, and requires necessary and
adequate support in each particular situation.
Grief is a common human response to loss (Archer, 2003;
Weir, 2020). Most people adapt to the death of their loved ones
and the changes that occur in their lives (Goveas and Shear,
2020). At the present time, grief is being experienced in different
ways, on the one hand there is some uncertainty in the face of
daily losses, such as social distancing, economic losses, health
losses and the lack of contact with family and friends. On the
other hand, there is anticipatory grief, usually is the normal grief
that appears when the death of a relative or of oneself is feared
(Shore et al., 2016), and it can be experienced in the form of high
concern for other people who may be affected due to the disease
(Wallace et al., 2020).
As the pandemic progresses and with it the large number
of deaths, as well as the lack of preparation for the imminent
death of close relatives, the recommended restrictions to reduce
the infection and transmission of the virus, the physical, mental,
and social consequences of distancing, such as not being able to
say goodbye to loved ones, and therefore to not celebrate the
traditional social and cultural rituals of grief (Goveas and Shear,
2020; Morris et al., 2020), sometimes necessary to heal the wound
caused by the death of the loved person, the pathological or
chronic grief may appear complicated (Lobb et al., 2010; Wallace
et al., 2020).
Complicated grief is characterized by intense emotional
distress that can last longer than socially expected and that causes
a disability in the person’s daily functioning, endangers their
health and well-being, and can last for years and even become
indefinitely chronic (Barreto et al., 2012). There are other factors
that can contribute to increase it, such as sudden or traumatic
death, which results in the lack of preparation for it and the lack
of social support at the time of the event (Burke and Neimeyer,
2014). These are factors present at this moment with COVID-
19 and they may have a significant impact on the individual and
on the social experience of death and grief due to the measures
of social isolation and the lack of the usual support structures
(Mayland et al., 2020).
Recognizing the uniqueness of each individual with respect
to their process of loss and pain will provide opportunities
to develop personalized strategies that facilitate psychological
flexibility (Hayes et al., 2015) and functional adaptation to the
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Dominguez-Rodriguez et al. COVID Grief Online Self-Applied Intervention
loss, which will promote mental health and well-being in this
crisis (Zhai and Du, 2020).
It is therefore clear that grief is inevitable and
multidimensional for people with losses. The loss of a loved
one is perhaps one of the most shocking events that occur in
a person’s life (Zhai and Du, 2020). In few periods of human
history, grief and pain have been as present in people’s lives as
they are today (Goveas and Shear, 2020).
It should be noted, considering the reviewed bibliography,
that grief will not always need a psychotherapeutic approach,
since most people who experience the loss of a loved one
cope with their grief in a natural way and without emotional
discomfort implying a deterioration in their daily functioning,
managing over time to continue with their lives and their
activities (Neimeyer et al., 2002; Neimeyer, 2014).
On the other hand, survivors experience a series of
consequences in their health (physical and mental) and social
interaction that make it difficult for them to continue with their
daily lives and lead to considerable wear and tear that triggers
the development of complicated grief (Prigerson, 2004), or a
mental disorder, such as depression (Boelen and Prigerson, 2007)
or post-traumatic stress disorder (Payás, 2010; Christiansen
et al., 2013), and in more severe cases, suicidal behavior
(Szanto et al., 2006).
In this sense, Litz et al. (2014), suggest that it is possible
to prevent complicated grief by intervening in the early stages
for people who present significant preclinical symptoms after
the loss, reducing the possibility of developing a considerable
deterioration in their loss during the following months,
functioning on the daily basis and allowing to alleviate emotional
suffering gradually.
Regarding the evidence of effective psychological
interventions that could be implemented to provide support to
the population that suffered a loss, it is important to start with
Cognitive Behavioral Therapy (CBT). The CBT proposes that the
way we think affects the way we feel and behave (Litz et al., 2014).
Thus, helping people to learn how to evaluate their thinking and
generate more realistic or accurate thought patterns improves
both their emotional and behavioral state (Beck, 2006). The
cognitive model provides a framework to identify and challenge
inappropriate thoughts or beliefs that can lead to feelings of guilt,
anger, or rage (Bayés, 2006). Yahya and Khawaja (2020) study
found that internet-based CBT is effective in a series of small
randomized controlled trials.
In addition, CBT can be nourished by the practice of
Mindfulness. Jon Kabat-Zinn is recognized for being, mainly,
one of the first authors who introduced Mindfulness within the
field of Western psychology, developing the Mindfulness-Based
Stress Reduction Program (MBSR). Mindfulness has become an
allied technique of psychotherapy, more focused on acceptance
than on change (Simón, 2010). According to Hayes et al. (2006),
the component of acceptance of cognitions and sensations in
Mindfulness would decrease emotional reactance and would
allow a healthier and more effective coping in patients subjected
to some type of trauma, such as grief. In relation to mindfulness-
based treatments that have been highly investigated in recent
years, a systematic review published by Goldberg et al. (2017),
corroborated that Mindfulness-Based Interventions (or MBI) are
effective for depression, grief, and pain conditions, smoking, and
other addictions. The basis of these programs is not to change
the patient’s experience, promoting psychological acceptance by
giving importance to the values of the patient or the therapist. It
allows patients to learn skills, reduce worry, ruminant thoughts,
and emotional cognitive reactivity. They are programs that are
carried out in a group mode and can improve the quality of life
of patients in a broad sense (Segal et al., 2004).
Other effects of bereavement include loss of pleasure and
interest in activities (Craske et al., 2019). Focused attention on the
meaning of the loss, positive reinforcement for the actions taken
(Bartone et al., 2019), behavioral activation techniques, such as
activities, reinforcement of self-care and contact and support
among the peer group (Lacasta and Aguirre, 2020) and the
performance of rituals, attention to spirituality and the need for
a farewell are presented as the central axis to avoid complicated
grief (Barbero et al., 2014).
It should be noted that although Psychotherapy in Mexico is
mainly carried out in private practice, it is expanding to public
institutions, like hospitals and ambulatory clinics (Sánchez-
Sosa, 2007), however mental health services are still insufficient
(Martinez et al., 2017).
Zhang et al. (2006), proposed that clinical interventions
can focus on the following elements: (a) differentiate
between expected grief reactions and those of complicated
grief; (b) detect the risk factors that make people more
vulnerable to develop complications in grief; and (c) establish
intervention actions to prevent maladaptive responses
to loss.
Taking into account the reduction in the availability of
carrying out psychological interventions, it has been selected to
provide psychological support at a distance through different
communication networks and platforms (Eisma et al., 2020).
These interventions can be applied if the pandemic continues
for longer periods. During the last decades, an increase in the
implementation of online interventions has been observed due to
the advantages that this entails, such as having greater flexibility
and anonymity, in addition to having demonstrated positive
effects comparable to face-to-face therapy (Wagner et al., 2014;
Hoffmann et al., 2018).
On other hand, self-applied interventions appear as an option
to arrive at a great number of participants. To make a self-
applied intervention effective, tools are included to communicate
skills that help to externalize the problem and set realistic
goals, as recommended by Malkinson (2010), with the cross-
cutting objective of reducing anxiety symptoms and exploring
emotions (Aoun et al., 2020; Morris et al., 2020). Along the
same lines, previous research has shown the effectiveness of
online tools in grief support that help improve the adaptive
adjustment of people in grief (Dominick et al., 2010). There
is evidence of the efficacy of online interventions applied
to patients suffering from abnormal grief. For example, in
studies where an online intervention was carried out in
which the patient has to write a letter to the deceased
person, the researchers concluded that this activity alone was
efficient in reducing emotional loneliness and increasing the
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Dominguez-Rodriguez et al. COVID Grief Online Self-Applied Intervention
state of positive mood, as well as its effect on rumination;
however, no effects were observed in terms of grief and
depression symptoms (Van der Houwen et al., 2010), indicating
that an online intervention aimed at this population should
be multicomponent.
In the study by Kersting et al. (2013) a brief 5-week
intervention based on CBT, was implemented for parents who
lost a child during pregnancy. The contents of the intervention
were delivered through a web platform focused on three central
axes: (a) self-confrontation, (b) cognitive reappraisal, and (c)
social sharing. This study had 228 participants divided into two
groups (intervention and on the waiting list). The participants in
the intervention group reduced the symptoms of post-traumatic
stress, prolonged grief, depression, and anxiety, with statistically
significant changes (Kersting et al., 2013).
Another study focused on relatives of patients who died from
hematological cancer, in which the participants were similarly
divided into two conditions, the intervention group and the
control group. The intervention group received the contents
of the intervention similar to the Kersting study: (a) self-
confrontation (patients describe their experience of loss, with
a special emphasis on emotional and cognitive processes), (b)
cognitive reassessment (the purpose of this phase is to work on
a change of perspective to help participants develop realistic and
useful coping strategies), and (c) social sharing (in this phase
patients have to write a letter for people affected by the death
of a loved one, including themselves, and a letter to the person
who passed away). The Internet-based grief therapy is assumed
to have at least moderate effects regarding Prolonged Grief and
other bereavement-related mental health outcomes (Hoffmann
et al., 2018). Also, there is wide evidence of the effectiveness of
psychological interventions in terms of maintaining the results
on the follow-ups, such as 3 months for a self-help online
intervention for suicidal thoughts (Van Spijker et al., 2015) and
a Meta-Analysis of Cowpertwait and Clarke (2013), identified
that web-based interventions for depression where the effects
are maintained for 3–6 months, and even the results have
been observed to maintain in a 12 months follow-up in a self-
help intervention for parents of children on cancer treatment
(Cernvall et al., 2017), to mention a few examples.
Along similar lines, online interventions for patients with
abnormal grief are supported by studies that have demonstrated
their efficacy. However, one of the main problems that have
been observed in terms of online interventions aimed at treating
depression and anxiety symptoms is the broad description
of the theoretical content, and the poor description of the
relevant characteristics of the human-computer interaction
design (Søgaard and Wilson, 2019). For example, a study
published in 2017, identified that there is a lack of research
offering qualitative data about the subjective User Experience
(UX) of young people using interventions for depression, such
as social network based (Santesteban-Echarri et al., 2017). In
this sense, in the intervention of this research we have to take
this into account and assume that in some cases an impediment
may be encountered, such as the user’s lack of experience
in the use of ICTs or the need for more human contact.
It is also important to note that the duration of the entire
intervention without time spaces in which to receive feedback
on improvement or emotional stability may lead to abandoning
of the therapy, or lack of adherence to treatment. It is hoped
that results can be seen throughout each module, but there may
always be someone with an urgent need for instant feedback
on improvement.
Likewise, there is available evidence that online interventions
have good adherence to treatment in weekly sessions of 50 min,
and with work between sessions. However, this structure is not
recommended for groups that are not clinical, for example, for
prevention and/or for people with mild problems, since the
time they dedicate to the interventions is reduced, or if they
do it only once, or if it is unlikely that they will return and
finish (Cavanagh, 2010). Also when it comes to interventions of
longer periods, there is the risk of losing motivation to continue
(Melville et al., 2010), therefore, it is proposed to use short-time
videos and to have at least two sessions per week (every other
day) in order to increase adherence and probability of completing
the intervention.
Among the aspects of human-computer interaction design,
the concept of universal design aims to design interactions
with digital tools which are aesthetically pleasing, and at the
same time ensures that the tool can be used by all participants,
regardless of their age, ability, or status (Søgaard and Wilson,
2019). It is relevant to note that older adults are interested in
using technology to take care of their mental health and this
form of intervention is feasible and reliable for them (Figueroa
and Aguilera, 2020). According to these same authors, these
interventions are specifically aimed at this vulnerable group and
are adapted to their specific needs. It includes easy-to-use design
options and uses a vocabulary adapted to the general population.
In addition, its infrastructure ensures confidentiality, without
violation of privacy and minimizes the risk of data leaks.
Other online interventions are known to mitigate the impact
of COVID-19 on health, in which psychological well-being
is promoted in health professionals (Blake et al., 2020). It is
particularly vital to stimulate the development and dissemination
of Internet-based treatments for grief, and it is also a question to
ask if they should implement this type of intervention in health
care systems. Due to the current circumstances, it is relevant to
provide an online intervention to aid the population suffering of
Grief due to the loss of a loved one, due to COVID or during the
most part of this year, where the measures are strict, and funerals
are unrecommended.
The intervention protocol through the platform presented
in this research is focused to contribute to the reduction
of the development of Complicated Grief Disorder (CGD)
after experiencing the traumatic situation of loss, in this case
specifically from the contingency of COVID-19 with a self-
applied intervention based on CBT, Mindfulness, Behavioral
Activation Therapy (BAT), and Positive Psychology (PP) and an
increase in the quality of life. Other aims are the reduction of
anxiety/depression symptoms and the increase of sleep quality. In
this way the survivors will be able to establish self-care measures
in different areas of their life (physical, emotional, cognitive, and
spiritual), and the risk of the appearance of complicated grief is
diminished (Greenberg et al., 2008).
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Dominguez-Rodriguez et al. COVID Grief Online Self-Applied Intervention
FIGURE 1 | Flow chart of the study design of the “Grief COVID” (Duelo COVID) intervention.
Aims
The online Intervention Grief COVID (Duelo COVID), aims
to provide a self-applied intervention composed of 12 sessions
based on CBT, Mindfulness, BAT, and PP, aimed at the decrease
of the risk of developing Complicated Grief Disorder (CGD)
specifically from the contingency of COVID-19, and increasing
the quality of life. And as a secondary objective, to reduce
the symptomatology of anxiety, depression, and to increase
sleep quality. With the objective that the survivors are be able
to establish self-care measures in different areas of their life
(physical, emotional, cognitive, and spiritual).
HYPOTHESES
Primary Hypothesis
The self-applied multi-component psychological online
intervention for the prevention of complicated grief disorder will
show greater improvement in the quality of life and perception
of the satisfaction of life than a waitlist control group.
Secondary Hypothesis
Participants in the self-applied multi-component psychological
online intervention will report better indicators of change in
reduction of symptoms of anxiety, depression, and greater sleep
quality compared to the waiting list group; and the changes will
be maintained for 3 and 6 months after completing the treatment.
METHODS AND ANALYSIS
Study Design
A randomized controlled clinical superiority trial with two
independent groups will be used, with intrasubject measures at
four evaluation periods: pretest, post-test, follow-up at 3 months,
and follow-up at 6 months (Solomon et al., 2009). Participants
will be randomly assigned to one of two groups:
(1) Grief COVID-19 intervention, participants in this group
will receive 12 sessions of a multi-component psychological
intervention focused on the decrease of the risk of
developing CGD, increasing the life quality, reduction
of symptoms of anxiety/depression and increase of sleep
quality. Each session will be administered every third day
to give time to do the tasks, and not too long to reduce the
chance of abandoning the treatment.
(2) Waiting List group, the participants in this group will not
receive the treatment immediately. They will be measured
one time and then a second time 1.5–2 months later
than the intervention group when it is calculated that
the first group has carried out 12 sessions. The post-
measures and follow up will be applied to all the participants
to analyze the effectiveness of the intervention (see
Figure 1).
Randomization Process
This will be a randomized controlled efficacy trial comparing
an intervention for grief within control. The randomization
procedure will use a permuted blocks algorithm via the
Study Randomizer software (Study Randomizer, 2020), where a
researcher in the team will obtain the location for the participants
before they join the intervention. The process will consist on
that once the participant creates an account on the platform, and
fulfills the inclusion criteria, and does not fulfill any point of the
exclusion criteria, he/she will be assigned to the corresponding
condition (see Figure 2).
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Dominguez-Rodriguez et al. COVID Grief Online Self-Applied Intervention
FIGURE 2 | Randomization process of the “Grief COVID” (Duelo COVID) intervention.
Sample
A total of 49 Spanish-speaking male and/or female users meeting
the inclusion criteria are expected to be recruited via the online
Grief COVID platform. The intervention is aimed at participants
aged 18 or older.
Participant Criteria
Inclusion Criteria:
1. To have a communication device with access to the Internet
(computer, tablet, or mobile).
2. To have a valid e-mail address.
3. To have basic digital skills in the use of an operational system
and Internet browsing.
4. To be fluent in Spanish, since the complete intervention is in
such language.
5. To have symptoms of Depression, State Anxiety and/or Acute
Stress Disorder grief symptoms.
Exclusion Criteria:
1. To have a diagnosis of psychotic disorder.
2. To have more than 6 months passed since the death of the
loved person.
3. To receive psychological and/or pharmacological treatment
during the study.
4. To have a moderate to a high score in the suicide scale.
5. To have a recent attempt of suicide (3 months).
6. To have a diagnosis of Post-traumatic Stress Disorder.
The participants need to meet all the five points of the inclusion
criteria to access the intervention and to not meet any of the six
points of the exclusion criteria.
Psychological Measures
Center for Epidemiologic Studies Depression Scale
(CES-D)
Depression levels will be assessed by the CESD-D, a self-report
scale that assesses symptoms of depression in the past 2 weeks.
This scale consists of 20 questions and contains four possible
answers: rarely or never (<1 day), sometime or rarely (1–2 days),
occasionally or a good part of the time (3–4 days) and most of
the time (5–7 days). This instrument has been constantly used
in health research and its psychometric properties prove to be
a valid scale in Mexican population (Cronbach’s alpha >0.90),
according to González-Forteza et al. (2011), and among different
populations, such as young people and adults (Cuijpers et al.,
2007).
Depression Anxiety Stress Scale (DASS-21)
The DASS-21 is a self-report scale that assesses the depression,
anxiety, and stress subscales during the past week. Each subscale
contains seven questions with four possible answers (0–3) as
follows: does not apply to me (0), it applies to me to some degree,
or sometimes (1), they applied to me to a considerable degree or
a good part of the time (2), they applied to me a lot or most of the
time (3). All scores must be multiplied by two to obtain the final
score, where each subscale has a cut-off score for each severity
condition (normal, moderate, and severe), the cut-off point for
moderate levels is 14–20 for depression, 10–14 for anxiety, and
19–25 for stress, where any previous score is considered severe or
extremely severe (Lovibond and Lovibond, 1995). This scale has
been validated in the Mexican population obtaining a reliability
for global (α=0.86) and for each subscale; depression (α=0.81),
anxiety (α=0.76), and stress (α=0.79) (Gurrola et al., 2006).
The Pittsburgh Sleep Quality Index
The quality of sleep scores will be evaluated using the Pittsburgh
Sleep Quality Index. This instrument assesses sleep quality
patterns, differentiating people who have poor sleep quality from
those who have good sleep quality. For this, seven areas are
evaluated, where the response ranges go from 0 to 3 with a total
sum that goes from 0 to 60, where the cut-off point is a score of 5,
which indicates a poor quality of sleep (Buysse et al., 1989). The
evaluation in the Mexican population has shown solid criteria of
reliability (α=0.78) (Jiménez-Genchi et al., 2008).
Post-traumatic Stress Disorder Symptom Scale
It is a 17-item structured interview. The severity over the last 2
weeks of each item on the PSS is rated by the interviewer using
a 4-point scale: 0 =not at all, 1 =a little bit, 2 =somewhat,
and 3 =very much. The maximum possible score is 51 (severely
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affected) and the minimum possible score is 0 (total absence of
the symptoms). The total severity score is calculated as the sum
of the severity ratings for the 17 items. The diagnosis is made
when one symptom of re-experience, three of avoidance and two
of activation are observed (Foa et al., 1997). For this study, the
validated version in Spanish will be used (Novy et al., 2001).
Satisfaction With Life Scale
This instrument consists of five items in which the participants
must indicate how much they agree with each question, with
an answer option in Likert format from 1 (totally disagree) to
7 (totally agree), the scores range from a minimum or 5 to
a maximum of 35, where the highest scores indicate greater
satisfaction with life (Vázquez et al., 2013). This scale has been
validated in the Mexican population, obtaining good results of
internal consistency (α=0.74) (López-Ortega et al., 2016).
Beck’s Hopelessness Scale
This scale is composed of 20 items with a false or true answer
option, the score ranges from 0 to 20 with higher scores
indicating a higher level of hopelessness (Beck et al., 1974).
It is a widely validated and used scale, and for this study the
version validated in the Mexican population will be applied
(Osnaya and Pérez, 2012).
Generalized Anxiety Disorder 7-Item (GAD-7)
The Generalized Anxiety Disorder 7-Item (GAD-7) scale. This is
a brief scale consisting of 7 items designed to measure the severity
of symptoms of generalized anxiety disorder. The answers are
based on the symptoms perceived during the last week. The
questions in this scale are answered in a Likert format with scores
from 0 to 3, where the maximum total score is 21. A score
between 0 and 4 points indicates that anxiety is not perceived,
and a score between 15 and 21 is an indicator of perceived
severe anxiety (Spitzer et al., 2006). The version in Spanish by
García-Campayo et al. (2010), will be used for this study.
Inventory of Complicated Grief
It is composed of 19 items, with a five Likert-type scale ranging
from 0 to 4, where: 0 “never,” 1 “rarely,” 2 “sometimes,” 3
“often,” and 4 “always.” The items assess the frequency of the
explored symptoms type (emotional, cognitive, or behavioral).
For its evaluation, the points of each item are added, and the
scores fluctuate between 0 and 76 points. Scores above 25 are an
indicator of complicated grief. The properties of the adaptation
of the scale to Spanish have good results of internal consistency
(α=0.88). The version of Limonero et al. (2009), will be used for
this study.
World Health Organization Quality of Life
(WHOQoL)-BREF Spanish Version
This instrument is composed of 26 items, two global questions
(global quality of life and general health), and 24 questions
that provide a profile on the responders’ life quality in
four dimensions: (1) Physical health, (2) Psychological health,
(3) Social relationships, and (4) Environment. It focuses on
the degree of satisfaction that the person has with various
situations in their daily life. Each item has 5 Likert-type
response options (1–5). The scale was validated in the
Mexican population showing wide validity in clinical settings
(Acosta-Quiroz et al., 2013).
Plutchik Suicide Risk Scale
This questionnaire assesses the risk of suicide through questions
posed in a dichotomous way (yes/no), where the history of suicide
attempts, suicidal ideation and suicide are considered plans. This
scale establishes a cut-off point of >6 that differentiates people
at risk from those who are not at risk of suicide (Plutchik and
Van Praag, 1994). The properties of this scale have shown good
reliability (α=0.74), based on these findings, it is established
that it is an appropriate questionnaire to assess the risk of suicide.
This scale has been used in previous studies with the Mexican
population (Alderete-Aguilar et al., 2017).
SECONDARY MEASURES
Acceptance/Satisfaction/Usability
Measures
Opinion on the Treatment
This questionnaire is made up of four questions that report
the level of satisfaction with the treatment, if the users would
recommend the treatment to a friend or relative, if the patient
considers the treatment useful, and if they think the treatment
was difficult to handle or was aversive. The items are answered
on a scale from 1 (not at all) to 10 (a lot) (Botella et al., 2009).
System Usability Scale
It is an instrument designed to validate the usability of a system,
it is composed of 10 items, which are answered on a 5-point
Likert-type scale with respect to the degree of conformity of the
product (1 =totally disagree to 5 =completely agree). To obtain
the global score of this scale, all the values obtained must be
added and multiplied by 2.5, and this will result in a number
between 0 and 100, which will be the global value of this scale
(Brooke, 1996).
Study Period
Pre-intervention screening and the intervention process itself
shall start on December 22nd and it is expected to conclude by
June 1st. By then, the targeted sample is expected to be recruited.
Prospective 3- and 6-month follow up assessments on outcome
variables will be conducted to ascertain the intervention’s
effectiveness. The detailed description of the plan of the steps and
instruments that will follow this study can be found on Table 1.
Outcomes
•Improved perceived satisfaction with life and quality of life is
expected upon completion of the intervention.
•A reduction of anxiety and depression symptoms, as well as
an increase of sleep quality are expected upon completion of
the intervention. Such changes are expected to be maintained
3 and 6 months after the end of the intervention process.
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Dominguez-Rodriguez et al. COVID Grief Online Self-Applied Intervention
TABLE 1 | SPIRIT figure to display the study’s schedule of enrolment, interventions, and assessments.
Study period
Enrolment Allocation Post-allocation
Timepoint t0 0 t1: PRE t2: Post t3: Follow-up 1 t4: Follow-up 2
ENROLMENT
Eligibility criteria X
Informed consent X
Allocation X
INTERVENTIONS
1) Grief COVID-19 intervention
2) Waiting List group
ASSESSMENTS
Primary outcome measure
Center for Epidemiologic Studies Depression Scale (CES-D) X X X X
Depression Anxiety Stress Scale (DASS-21) X X X X
The Pittsburgh Sleep Quality Index X X X X
Satisfaction with Life Scale X X X X
Beck’s Hopelessness Scale X X X X
Inventory of Complicated Grief X X X X
World Health Organization Quality of Life (WHOQoL)-BREF X X X X
Plutchik Suicide Risk Scale X
Post-Traumatic Stress Disorder Symptom Scale X
Generalized Anxiety Disorder 7-item (GAD-7) X
Secondary further outcome measures
Opinion treatment X
System Usability Scale X
Description of the UX Process for the
Design of the Grief COVID Platform
This intervention was created following the principles of UX,
ensuring that the design characteristics of the tool will meet the
desirable requirements to be perceived as easy to use, attractive
and useful by the participants. The UX approach refers to the
experience that a user has with a product, with special emphasis
on human-product interaction (Hassenzahl, 2008; Tullis and
Albert, 2013). The UX process was conducted by the main author
who is a certified UX designer.
The first step was to review similar interventions, but there
was none found that fulfilled the goals of the COVID Grief
intervention. Afterwards, six interviews were conducted through
Zoom with six objective users (persons that lost someone due
to COVID or during the COVID outbreak) through interviews
with a duration of 30–40 min where they shared what contents
they would like on the platform. The interviews were recorded
with the informed signed consent of the participants in order to
evaluate with more details the information of the intervention.
After analyzing the recordings of the interviews, affinity
mappings were conducted to find similar requests, needs or
suggestions from the participants toward the intervention. From
the results User Personas were created, these are fictional
characters based on the overall results of the participants
interviews (Adlin et al., 2006). Afterwards User Journey Maps
and User Flows were also created, along with a site map proposal
with four main sections: (1) Sessions, (2) Talk with a Psychologist,
(3) Technical Support, and (4) My Profile.
Furthermore, a card sorting test was distributed online
through Optimal Workshop (2020), and 13 participants
completed the task. Also, the site map was redefined to three
sections where the options “Talk with a Psychologist” and
“Technical Support” were fitted into the “Help center” section.
Afterwards, wireframes with the first proposal of the platform
were drawn, followed by the creation of a low-fidelity prototype
in Balsamiq (2020), followed by the creation of a mid-fidelity
prototype in Figma (2020), a collaborative web design tool based
in a web browser. The mid-fidelity prototype was validated
with five objective participants individually through remote
testing through zoom, they were also recorded, consent of the
participants was obtained, and the usability of the platform was
measured with a subjective scale reported by the scale from 0
not usable at all, to 10, totally usable without complications. The
evaluated sections were: (1) create an account, (2) the onboarding
process, (3) Section where the sessions of the treatment are and
to navigate through the first section, (4) Help Center, and (5) My
profile. While analyzing the recordings with the results obtained,
another affinity map was conducted: The Observations, Positive
Quotes, Negative Quotes, Errors, Suggestions and Metrics.
Following the Jakob Nielsen Scale (Nielsen, 1994), where: 0 =I
don’t agree that this is a usability problem at all, 1 =Cosmetic
problem only: need not be fixed unless extra time is available
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Dominguez-Rodriguez et al. COVID Grief Online Self-Applied Intervention
FIGURE 3 | High Fidelity Prototype in Figma of the main page of the “Grief COVID” (Duelo COVID) intervention.
on project, 2 =Minor usability problem: fixing this should be
given low priority, 3 =Major usability problem: important to fix,
so should be given high priority and 4 =Usability catastrophe:
imperative to fix this before the product can be released. All the
sections with scores from 4 to 1 were modified in that order
of priority.
Also, the logo is important to feel connected to the
intervention, therefore three options were offered in an online
A/B testing distributed thorough Usability Hub (2020), 25
persons participated and 12 chose the logo on Figure 3.
Finally, a high-fidelity clickable prototype was designed in
Figma with the previous design inputs by the users. This
prototype and their archives were delivered to the Engineer for
the development of the platform. The full detail on each step
can be found on Domínguez-Rodríguez (2020). The contents
of this intervention will be implemented through a responsive
web application. The characteristics of this type of system can
adapt to different screen sizes and resolutions, from the largest
to the smallest screen sizes, such as computers, tablets, and
cellphones. This type of tool adapts the page design, resizes
images or cuts them proportionally (Baturay and Birtane, 2013).
The intervention can be accessed on www.duelocovid.com.
Structure of the COVID Grief Platform
The platform is designed to be the most usable and simplest
possible by every type of user, with or without a wide ability and
experience with web platforms or cell phone applications (see
Figure 3).
To create an account on the web page, the participant needs to
read and accept the informed consent. Afterwards, the platform
just requests an email and password. In order to protect the
most possible information of the participant, non-sensible data
is requested, such as their name (see Figure 4).
Once the participant has created an account, he/she will need
to answer the psychometrics, and once finished, he/she can
start to use the platform that will begin with an onboarding
process, where the platform will explain how it is composed and
the sections that are included. Once the onboarding process is
finished the participant can find the main menu with the options
from left to right: (1) Interventions sessions, (2) Help center, and
(3) My profile (Figure 5).
The topics of the sessions are presented to the participants
from the onboarding process, and then they are explained. To
go from one session to the next the participant needs to see the
contents, then wait from one session to the next for at least 3
days in order to process the received contents, do the requested
tasks, and answer a quiz of five multiple-answer questions
(see Figure 6). Once this is done the system will activate the
following session.
The process for the design of the contents of the platform
was the following: a group of expert clinicians designed the
sessions and then they were provided to the coordinator of these
projects. After the evaluation, and correcting when necessary,
these sessions were provided to a narrator that audio recorded the
sessions, and to a team of seven designers that created the draft,
illustrations, and animation of the videos, editing the audios and
introducing them into the videos.
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Dominguez-Rodriguez et al. COVID Grief Online Self-Applied Intervention
FIGURE 4 | High Fidelity Prototype in Figma of the login/create an account page of the “Grief COVID” (Duelo COVID) intervention.
FIGURE 5 | High Fidelity Prototype in Figma of the main menu page of the “Grief COVID” (Duelo COVID) intervention.
The platform will be delivered considering the principles
of responsive design, in order to see the intervention
in any device, such as a desktop, or a mobile device
(Nebeling and Norrie, 2013).
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Dominguez-Rodriguez et al. COVID Grief Online Self-Applied Intervention
FIGURE 6 | High Fidelity Prototype in Figma of the available and pending sessions page of the “Grief COVID” (Duelo COVID) intervention.
In order to increase the adherence to the intervention the
platform will send email reminders, a tool that has shown to
be effective for this purpose (Horsch et al., 2017). Therefore, an
email will be sent to the participant to notify them when the new
session is open, and if the participant is absent from the platform
for more than 4 days.
Description of the Intervention
The current protocol article describes the proposal and
development of a UX-based self-administered online
intervention for the prevention of complicated grief disorder
with Mexican population who have lost someone due to or
during the COVID-19 pandemic. This intervention will consist
of 12 sessions; the purpose is to identify and resolve conflicts that
contribute to the risk of developing CGD, like anxiety disorders,
which are an exclusion criterion, and to improve well-being in
different areas of their life (physical, emotional, cognitive and
spiritual). The intervention is based on CBT, BAT, Mindfulness,
and PP. Through this intervention, is expected that the quality
of life and perception of life satisfaction will get improve. As
well, it will be looked at as a reduction of anxiety and depression
symptoms and the increase of sleep quality.
Through 12 sessions, it is expected to guide the participant
to continue their own process of natural adaptation to the
loss with their own coping strategies, by obtaining greater
knowledge about the expected manifestations, while preventing
the appearance of symptoms that lead to the complication of the
grief process.
Session 1, psychoeducation, will be carried out regarding the
manifestations of normal grief and its phases, with the objective
that participants are able to work on the emotions experienced
from the loss and that they begin to adapt to the situation.
Sessions 2–4 will mainly focus on the search for emotional
relief, that is, helping the person to manage the pain of loss,
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TABLE 2 | Detailed description of the main objective and the theoretical model of each of the sessions of the COVID grief self-applied intervention.
Module Theory Principal objective
Grief phases Cognitive behavioral therapy To carry out psychoeducation about the grief process and manifestations (Neimeyer, 2014).
To explain myths about grief and grief phases (Klüber-Ross, 1969; Klüber-Ross and David,
2005).
To identify emotions and attend
needs
Cognitive behavioral therapy and
mindfulness
To accept negative impacts and search for emotional consequences to approach them.
To identify needs, difficulties, preoccupations, and emotions (Neimeyer, 2014).
To feel and face the pain Cognitive behavioral therapy and
mindfulness and positive
psychology
To normalize positive emotions, expressions, and to exculpate for experimenting them
(Neimeyer, 2014).
Evaluation of pre-occupations Cognitive behavioral therapy and
mindfulness
To explore resources and possibilities of coping with difficulties.
To recognize signs of each emotion (Neimeyer, 2014).
Rights deprived grief for COVID-19 Cognitive behavioral therapy To orientate on how to identify characteristics of rights deprived deaths.
To evaluate the emotional impact of deaths during the pandemic (Worden, 2008; Payás, 2010;
Kokou-Kpolou et al., 2020).
Parting strategies Cognitive behavioral therapy To guide in alternative parting rituals application when it is not possible to say goodbye.
To allow for emotional expression during parting rituals (World Health Organization, 2016; Osiris
et al., 2020).
Self-care Cognitive behavioral therapy and
behavioral activation
To promote actions of self-care in the different spheres of life (physical, emotional, cognitive,
and spiritual) (Díaz et al., 2014; Neimeyer, 2014).
Take back daily activities Behavioral activation To help a person gradually come back to his/her daily activities from the simpler to the
increasingly difficult ones (Díaz et al., 2014; Osiris et al., 2020).
To stimulate facing the new reality, resulting from loss, and to promote developing the
necessary practice tasks (Barreto and Soler, 2007).
Contact with a support network Cognitive behavioral therapy To highlight the importance of having a social support network to express the emotional, as
well as the consequences of avoiding isolation, and recognizing the importance of having
lonely moments (World Health Organization, 2016; Osiris et al., 2020).
Relocate to the deceased person Cognitive behavioral therapy To guide the person to continue with their life without an unbearable pain related to memories
of their loved one.
Establishment of goals Behavioral activation To take back to short and medium lapse, which get adjusted to personal needs, considering
the scope and possible obstacles (World Health Organization, 2016; Osiris et al., 2020).
Relapse prevention plan Cognitive behavioral therapy and
behavioral activation
To elaborate a personalized relapse prevention plan.
recognizing, and accepting the pain experienced, therefore, it is
expected that they learn to elaborate and regulate their emotions
to feel them, and finally, to face the duel. The person will develop
the ability to name their emotions, which will allow them to
stop perceiving them as something threatening, likewise, they
will enhance personal resources, as well as strengths and virtues.
Finally, the participants will receive resources to detect those
current situations that are being difficult to handle, and they will
learn how to handle the emergence of emotions and thoughts that
are unpleasant in the face of such events.
Sessions 5 and 6 are focused on how losses are experienced
during the COVID-19 outbreak, it will help to identify the
characteristics of deaths deprived of rights, what is the emotional
impact that losses have during the pandemic, and it will allow
survivors to find a way to say goodbye to their loved one when
they were not able to do so. In addition, it will allow the
experience of pain to normalize, by recognizing thoughts that
accompany their emotions, generating alternative thoughts that
reduce emotional discomfort and make it more tolerable.
Sessions 7–9 are aimed at acceptance and adaptation to
loss, through these, the establishment of self-care measures
is promoted in the different areas of people’s lives, in order
to influence their gradual recovery of daily activities and to
reconnect with support networks. To achieve this, they will learn
to prioritize their activities and carry them out depending on the
degree of difficulty that these imply for the bereaved, going from
the simplest to the most complex.
Finally, sessions 10–12 are designed to work on the
readjustment and recovery, that is, helping the bereaved to
reposition the deceased in their life without causing suffering,
encouraging him or her to resume his or her life project and
life goals at the person’s own pace and to establish a plan
relapse prevention based on the knowledge acquired through the
sessions. On Table 2, it is located the description of the main
objective and the theoretical model of each of the sessions that
make up the platform.
This intervention contains communication skills tools to
help externalize the problem and set realistic goals (Malkinson,
2010). Among them, guiding and reassuring the person to
reduce anxiety symptoms and explore emotions (Aoun et al.,
2020; Morris et al., 2020); transmitting therapeutic support to
process information and recognize emotion (Neimeyer, 2014);
paying attention to self-care; maintenance of social relationships
through the internet, mobile, etc.; help to restructure thinking;
expressing and identifying emotions; recognizing positive
emotions (Lyubomirsky, 2008).
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Each of the 12 sessions is composed by the following
structure: first, a mindfulness exercise is presented so that
users are located in the present moment and participate with
full awareness of the session and the experiential activities;
Subsequently, a series of short psychoeducational videos are
shown, of ∼5 min, through which an explanation of the topics
addressed in each of the sessions is given (see Table 2). In
turn, it contains 2–3 experiential activities that participants
are proposed to carry out based on what has been explained,
using relaxation techniques, visualization, mindfulness, and/or
orientation, as well as strategies to learn to name and recognize
emotions, solution of problems, setting short, medium, and long-
term goals, self-care, scheduling activities, activating a support
network, tolerance to discomfort and prevention of relapses,
depending on the content of each session. It is advisable to take
3 days between each session so that the participant can process
what was addressed in each one. At the end of the session again, a
mindfulness exercise is presented to the participant to close what
was worked on during it. Similarly, the information contained in
the sessions is available in written format for those who prefer to
read the content instead of watching the videos.
Possible Negative Effects and Strategies to
Reduce the Risk or Damage for the
Participants
The main objective of this study is to aid the persons that lost
someone due to COVID-19 or during the pandemic, therefore
producing a benefit, and not a harm. However, it has been
recorded that in previous studies, negative effects had been
found on internet-based interventions. For example, on the
study of Boettcher et al. (2014), it was identified that from 133
participants receiving a 11-week guided treatment for Social
Anxiety Treatment, that out of 19 participants, in detail from
the total of participants, 5% reported the emergence of new
symptoms, 4% noted a deterioration of targeted symptoms. Other
side effects, less frequent, were negative well-being lack of clear
treatment results, non-compliance with the treatment followed
by changes in the work situation, and fear of being stigmatized.
In the same line, Rozental et al. (2015) in a review from four
clinical trials with a total sample of 558 participants identified
that 9.3% of the participants indicated a negative effect. Among
the main ones are deterioration of the targeted conditions, and
new symptoms.
Due to this data, and in order to protect at all times
the participants of the COVID grief self-applied intervention,
the implemented controls will start from the moment they
answer the questionnaires, and with how the inclusion and
exclusion criteria are established, where, with strict filters,
the participants need to fulfill 5 inclusion criteria points
and not fulfill none of the six points of the exclusion
criteria. With this, ensuring that the participants with a
more serious condition would not have access to the self-
applied intervention and would be directed to specialized
phone numbers and email addresses where they could contact
a therapist of one of the institutions in México that is
offering free of charge psychological treatment via phone or
video call.
Also, it will be added on the platform an option to indicate if
the participants that identify that they would need more support,
or for whom the self-applied intervention is not sufficient, a
special email address will be indicated where the participants can
write an email and they will be contacted and redirected to the
same phone numbers that the excluded participants would have
access to. In this sense all the participants will be protected at
all times from the possible negative effects that could be related
directly or indirectly to the intervention. The participants that
use this option will be removed from the intervention and the
data will not be included in the statistical analysis.
Finally, an open question will be added on the post-evaluation,
where the participant can indicate if, even though he or she did
not contact the special email address, but felt that at some point
during the intervention the symptomatology worsened, and in
which sense. This will provide qualitative data that could increase
the knowledge about the possible negative effects related to a
self-applied online interventions.
Proposed Analyses
To test hypotheses, the Statistical Package for Social Sciences
(SPSS) will be used. To examine whether a telepsychology
intervention will improve quality of life and perception
of the satisfaction of life, and also reduce adverse mental
health indicators previously associated to grief/bereavement
(e.g., depressive and anxiety symptoms), multiple (4) mixed
between-within subjects ANOVA tests (Howell, 1999) will be
conducted (within group comparisons; Time 1 [T1]—Pre-test,
Time 2 [T2]—Post-intervention, Time 3 [T3]−3-month follow-
up, Time 4 [T4]−6-month follow-up) with planned post-hoc
tests (Tukey HSD, Gravetter and Wallnau, 2013) and between-
group comparisons with experimental and control groups carried
out from Time 1 to Time 4. Only complete questionnaire
submissions from T1 to T4 will be considered for the proposed
statistical analyses. Incomplete questionnaire submissions will
not be considered for statistical analyses due to risk of bias and
power reduction associated with multiple imputation methods
(Field, 2009).
One-tailed analysis in this experiment means the strength
of the effect is expected to be higher between T1 and T2 than
between T1 and T4. That is, we expect a stronger effect during
the intervention compared to the post-intervention follow-up
phase. It also means the experimental group is expected to
outperform the control group in terms of experiencing lower
levels of adverse mental health related to bereavement, and higher
levels of well-being from T2 to T4.
Power Size Calculation
A total of 49 participants will be recruited online for this study.
The number of participants and expected power size needed
is based on previous internet-based interventions focused on
grief and associated adverse mental health (e.g., Kersting et al.,
2013), and an a priori power analysis using G∗Power software
(Mixed between-within groups ANOVA tests, 1 – β=0.95, α=
0.05, Cohen’s d=0.8) (Cohen, 1973), which revealed that the
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Dominguez-Rodriguez et al. COVID Grief Online Self-Applied Intervention
study would require a total sample size of N=36. According
to Cohen (1988), a value of 0.80 is considered a large effect
size. An additional 13 participants have been added to this
estimated sample size to account for an assumed 36% dropout
rate, considering Linardon and Fuller-Tyszkiewicz’s (2019) mean
meta-analytic attrition rate found at longer-term follow up
assessments in randomized controlled trials for smartphone-
delivered interventions.
DISCUSSION
Due to the COVID-19 pandemic, a large number of deaths
have occurred throughout the world and in Mexico, which has
generated multiple consequences at a psychological level related
to the suffering caused by the mandatory physical separation of
relatives infected with COVID-19 (Singer et al., 2020). Among
the main side effects of the confinement are anxiety, post-
traumatic stress, depression, suicidal behavior, addictions, and
domestic violence (Mengin et al., 2020). In addition to this,
due to the constant losses that people face, such as not being
able to say goodbye to their loved ones or being limited to
performing traditional social and cultural rituals (Goveas and
Shear, 2020; Morris et al., 2020), this can lead to a complicated
grief, characterized by intense emotional discomfort, which in
turn could generate a disability in people’s daily functioning,
compromising their health with an undefined duration (Barreto
et al., 2012). In this way, the need arises to give timely attention to
the psychological consequences due to the COVID-19 pandemic,
however, we are facing a reduction in the availability to carry
out these interventions in person, so it has been opted to
provide psychological support at a distance through different
communication platforms (Eisma et al., 2020), that help to
mitigate the impact of the COVID-19 pandemic on the mental
health of the population (Blake et al., 2020).
In order to respond to the needs of the Mexican population,
the objective of this study is to prevent complicated grief
through a self-applied online intervention to influence the early
stages of the grief process (Litz et al., 2014). Related to this,
Zhang et al. (2006), proposed that clinical interventions should
focus on differentiating between expected grief reactions and
complicated grief reactions, detecting the risk factors that make
people more vulnerable to develop grief complications and
establish measures to anticipate loss-maladjustment behavior.
For this reason, this work proposes the design, development
and validation of a self-applied intervention based on Cognitive
Behavioral Therapy, Behavioral Activation Therapy, Positive
Psychology and Mindfulness.
The online modality is chosen based on the advantages
that some authors have found, such as greater flexibility and
anonymity compared to face-to-face therapy (Wagner et al.,
2014; Hoffmann et al., 2018). Another advantage of the
implementation of online interventions has to do with reaching
the vulnerable and low-income population, who find it difficult
to have access to a psychotherapeutic service, which is why
these types of interventions are profitable and accessible (Barak
and Grohol, 2011). Another self-applied intervention has been
designed and implemented by the authors of this manuscript
for the Mexican population in order to reduce the symptoms of
anxiety and depression, and increase positive emotions and sleep
quality, during and after the COVID-19 outbreak (Dominguez-
Rodriguez et al., 2020).
Another advantage of the proposed intervention is the novelty
of designing it following the principles of UX design, similar
to the industry where tools, such as Figma (2020) and Usability
Hub (2020) are applied. The UX methodology has the potential
to increase the adherence of the users of the interventions,
due to its design in terms of how they would want to receive
this intervention. In spite of the relevance of the UX steps
in order to improve online interventions, this has not been
widely reported. However, few exceptions, such as the study of
Wozney et al. (2015), where five clinicians and four adolescents
aged <20 years old evaluated the platform before identifying
learnability, technical errors and efficiency, user satisfaction, site
aesthetics, among other contents, but stating the importance
of evaluating the UX of the participants objective in order to
determine if their program was easy to understand, efficient
with relevant content, and satisfactory. However, we went a step
ahead, and we evaluated the proposal of the idea of the Covid
Grief platform before it existed, from when it was an idea until
it became a prototype of the product. With this we reduced
greatly the costs of modifying a platform with the input of the
users. In low and middle-income countries where usual care
for mental health problems is scarce (Fu et al., 2020), the UX
approach is cost wise. Also, along with the study of Wozney
et al. (2015), considering the UX can help to create a positive
experience toward using the platform, therefore increasing the
probability of meeting the objectives in our study, and decreasing
the probability of developing Complicated Grief Disorder.
Regarding the limitations of this study, the first limitation is
that a wait list control group is proposed, instead of another
intervention, or instead of providing the treatment directly to all
the participants that meet the inclusion criteria and that do not
have any points of the exclusion criteria. With respect to these
points, other options, such as face to face treatment, would not be
recommended due to the safety measures needed to avoid more
infections of COVID-19. Neither therapist assisted intervention
would be possible due to the broad amount of participants that
we would like to offer an online open intervention without any
cost to all the Mexican population. Due to this, and since this
intervention is an exploratory study, due to the fact that we
do not have knowledge that there is another freely available,
completely self-applied intervention, based on UX principles, for
the prevention of complicated grief disorder, before or during
the COVID-19 pandemic. Therefore, we have set a control group
comparison of this randomized controlled trial, that 36 days after
completing the initial evaluation, will receive the intervention
and also preventive measures considered to prevent damage to
the participants and previously provide explanations. Finally,
regarding this limitation, articles with well-designed studies were
also considered, as well as recent articles published in prestigious
journals that included a wait list control group for Online
or presential Psychological Interventions (Eckert et al., 2018;
Hjemdal et al., 2019; Stächele et al., 2020).
Frontiers in Psychology | www.frontiersin.org 14 March 2021 | Volume 12 | Article 644782
Dominguez-Rodriguez et al. COVID Grief Online Self-Applied Intervention
The following limitation is related to the self-report
instruments, where it would be of higher reliability when the
measures are applied by a trained clinician. However, due
to the reach of this self-applied intervention, this would not
be possible with the current resources and with not having
a sufficient number of therapists to apply all the measures
to the participants. Therefore, this study is supported on the
benefits that it provides a self-applied intervention where the
participants can answer the instruments whenever they want.
Regarding this limitation, the participants will answer very
similar instruments before starting the intervention and after
receiving the intervention, that could affect the response on the
second time they answer the instruments, as previously indicated,
once the participants finish the intervention they will also be
requested to fill the scales Opinion on the treatment (Botella
et al., 2009), and the System Usability Scale (Brooke, 1996).
However, in order to fulfill the reliability of this study it would
be needed to perform the evaluation with the same instruments.
A solution in future studies could be to count with a controlled
number of participants and with the necessary budget to be
able to have an in person or an online evaluation done by a
trained psychologist.
Regarding the confounding variables that could influence the
results, among the main ones is the gender. As widely studied,
in general, men are more reticent to search for psychological
support compared to women (Liddon et al., 2018; Seidler et al.,
2018), and also when they are receiving online treatment, there
is a bigger dropout of men than women, however the results
are still inconclusive and further research needs to be conducted
(Melville et al., 2010). Therefore, it is probable that in our study
most of the participants could also be women, and that the results
cannot be generalized for both genders. However, in order to
reduce the probability that this could happen, we will actively
work on the advertisement of the intervention for everyone, and
that men could also get benefits out of this intervention, making
emphasis on the anonymity that the intervention provides, since
it is not necessary to provide name, telephone number, address
or economic status. The participant can feel safe that his or her
identity will not be identified. Also, the proper statistical analysis
would be applied in case that the participants are considerably
more women than men, to try to reduce the impact of this
difference. Another confounding variable that could influence
on the results is the educational level of the participants, where
participants with a higher educational level engage more with
online interventions and have lower drop-out rates compared
to lower educated persons. The reasons could be related to the
fact that lower educated people tend to use more written health
information, invest less time online seeking health information,
and it is possible that they lose interest in the intervention
sooner (Reinwand et al., 2015). In order to solve this, on the
section “Description of the UX process for the design of the
Grief COVID Platform” it was described that the platform has
been designed with the highest standards of usability testing,
giving as a result a platform easy to use, and therefore making
it more attractive and without a struggle platform to be used. The
results of the intervention would provide information regarding
UX as a methodology that could be implemented to improve
adherence, and attractiveness to the interventions. Also, email
reminders will be sent for the open sessions and to try to “rescue”
when the participants disconnect from the intervention for more
than 5 days.
With respect to the unintended effects that could appear due
to this treatment, they are considered and tried to be controlled
on the possible side effects and controls to reduce the risk or
damage for the participants section of this manuscript. Where
it is explained that the platform will have several filters to grant
access to the treatment, and if any of these filters is not fulfilled the
participant will be directed to a list of free of charge psychological
services offered by diverse institutions in México due to the
pandemic. Also, in case that the participant crosses these filters
but he or she feels that the intervention is not helping him or her
and is feeling worse, an emergency email will be included inside
the platform to reach the researchers in this project, and also the
same list of institutions will be provided as excluded participants
received. Once it is registered by the contact of the participant
to the clinical team, the participant data will be automatically
removed from the platform and will be indicated on the following
reports of articles with the results of the intervention.
This intervention design is expected to improve quality
of life and perception of life satisfaction, depression, anxiety,
hopelessness and stress symptoms, among others, and greater
sleep quality, thus coinciding with the studies by Lotzin
et al. (2020) and Riva et al. (2020). The contents of Grief
COVID intervention will be implemented through a responsive
web application. At the time of writing this manuscript, the
participants have not been evaluated nor assigned to any
group (intervention or control), but the evaluation of the first
proposal of the platform and the usability test have been
conducted with a sample of a representative of the participants.
If this research shows evidence of effectiveness, then it could
be implemented in other Latin American countries with the
respective cultural adaptation.
ETHICS STATEMENT
This study will be carried out protecting the participants integrity
and information. The protocol was approved by the Research
Ethics Committee of the Autonomous University of Ciudad
Juárez, México. All the participants will have access to the written
informed consent in accordance with the Declaration of Helsinki.
AUTHOR CONTRIBUTIONS
AD-R conceived the original idea, did the User Experience
process, and supervised the graphic designers’ team and all the
project steps. AD-R, SM-L, MH, AD, PA-L, EE, CA-S, and AS
designed the study and the original protocol. SM-L and MH
wrote the scripts for the 12 intervention sessions. JA and AD-R
developed the COVID Grief platform. AD-R, SM-L, MH, AD,
PA-L, EE, CA-S, AS, RV, and FR-M wrote the paper. AC narrated
and audio recorded the 12 sessions. FR-M obtained the funding
for the platform. All the authors contributed to the article and
approved the submitted version.
Frontiers in Psychology | www.frontiersin.org 15 March 2021 | Volume 12 | Article 644782