Official Title
Effectiveness of 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: A Randomized Clinical Trial
Brief Summary

This study evaluates the effectiveness of an online Multi-component psychological intervention, that is focused on providing self-support to the Mexican population for the prevention of complicated grief disorder, by reducing grief and strengthening the capacities of the person to handle losses derived from COVID-19 as well as reducing the symptoms of anxiety, depression, hopelessness, and post-traumatic stress, and increasing the quality of sleep and perception of the quality of life.

Detailed Description

The loss of a loved one is perhaps one of the most shocking events in the life of a person.
Grief is an emotional experience universal human, unique and painful, that can be delimited
in time, which allows the person to adapt to loss and the new reality. In situations, prior
to COVID-19, there was a risk of suffering prolonged grief when going through the death of a
family member hospitalized and unable to say goodbye. The global COVID-19 pandemic is
expected to have a major impact related to the experience of death, dying, and grief, which
will make the grieving process difficult. The confusion, anger, and post-traumatic stress are
some of the negative effects related to quarantine. It is not only difficult to deal with the
loss of the person but at the same time with the interruption of rituals and practices
associated with a death such as funerals and burials, which are postponed and performed
without the presence of family. Given such data, it is necessary to intervene with proposals
that help improve mental health and the management of grief.

To provide treatment in such conditions where face-to-face sessions are not possible, and the
number of patients surpasses the number of available therapists it will be implemented an
online intervention based on Cognitive Behavioral Therapy, Mindfulness, Behavioral Activation
Therapy, and Positive Psychology. The Online Intervention system "Grief COVID" will be
delivered in 12 modules interconnected. The objective of this study is to assess the efficacy
and moderators of change of this intervention for the reduction of symptoms of anxiety,
depression, hopelessness, and post-traumatic stress, and the increase of the quality of sleep
and perception of the quality of life.

The contents of this intervention will be implemented through a responsive web application.
In order to create the most fitted intervention for the real needs of the participants will
be created following the principles of User Experience (UX), with this ensuring that the
design characteristics of the tool will meet the desired requirements to be perceived as easy
to use, attractive and useful. The UX approach refers to the experience that a user has with
a product, with special emphasis on human-product interaction.

This study will have an experimental and control group. The experimental group will receive
the intervention to prevent complicated grief, and the control group will be on the waiting
list. Participants will be randomly assigned to one of the two groups. Participants in the
control group once their data have been collected and the time elapsed after receiving the
intervention in the participants in the experimental group will receive access to the
intervention and will also be evaluated in order to increase the sample level and to be able
to have more results about the effectiveness of the intervention. In both conditions, the
participants will be measured at pre and post moments. The subjective measures will include
the following Psychometrics:

1. Depression scale of the Center for Epidemiological Studies.

2. The abbreviated depression, anxiety, and stress scale (DASS-21).

3. Plutchik Suicide Risk Scale.

4. Pittsburgh Sleep Quality Index.

5. Post-traumatic diagnostic scale.

6. Satisfaction with Life Scale.

7. Beck's Hopelessness Scale.

8. Generalized Anxiety Scale (GAD-7).

9. Opinion on the treatment.

10. System usability scale.

Completed
Grief
Anxiety
Depression
Sleep Disturbance
Quality of Life

Behavioral: Online Intervention Grief COVID-19

The online Intervention Grief COVID-19 aims to provide to the target population a self-applied intervention based on Cognitive Behavioral Therapy, Mindfulness, Behavioral Activation Therapy, and Positive Psychology, aimed at the Psychoeducation regarding the manifestations of normal grief, advice and guidance on how to find emotional relief, with the aim that survivors allow themselves to validate their experience of emotional pain and recognize it as a normal part of their process of adaptation to loss, what does grief deprived of rights consist of, specifically from the contingency of COVID-19, establish self-care measures for people in different areas of their life (physical, emotional, cognitive and spiritual), direct the survivor to relocate the died in his life without his memory causing suffering, in addition to beginning to resume his life project, adjusting according to his needs and goals. The sessions will be delivered in a frequency of one session every three days.

Eligibility Criteria

Inclusion Criteria:

- To have access to a communication device with access to the internet (computer,
tablet, and mobile).

- To have a valid email address.

- To have basic digital skills in the use of an operational system and internet
browsing.

- To understand Spanish since all the contents are in this language.

- Having suffered the loss of a loved one in a period of no less than 3 months and no
longer than 6 months.

- Symptoms of General Anxiety Disorder and/or Depression and/or, grief symptoms.

Exclusion Criteria:

- To have a diagnosis of psychotic disorder

- To be receiving psychological and/or pharmacological treatment during the study

- Moderate to high score on the suicide scale

- Recent attempt of suicide (3 months)

- Symptoms of posttraumatic Stress Disorder

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 60 Years
Countries
Mexico
Locations

Universidad Autónoma de Ciudad Juárez
Juárez, Chihuahua, Mexico

Universidad Internacional de Valencia
NCT Number
MeSH Terms
Dyssomnias
Parasomnias