Clinical trial NCT04638842: Online Multi-component Psychological Intervention for Prevention of Grief Disorder Due to COVID-19
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Grief
Anxiety
Depression
Sleep Disturbance
Quality of Life
Lead sponsor: Universidad Internacional de Valencia
Sponsor class: OTHER
Collaborators: name: Universidad Nacional Autonoma de Mexico
name: Universidad Autonoma de Ciudad Juarez
name: University of Buenos Aires
First posted: 2020-11-20
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study has two arms, one is the experimental group that receives the treatment and the other is the comparison group that will receive treatment after the 12 sessions of the experimental group finished. The patients in both groups will be evaluated pre and post/treatment. The participants are assigned randomly to the intervention or comparison group.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Decrease in the scores of the Center for Epidemiologic Studies Depression (CES-D) scale
timeFrame: 1.5 to 2 months, depending on the development of the patient and the completion of the 12 modules
measure: Change in the score of Anxiety Symptoms in the Depression Anxiety Stress Scale (DASS-21)
timeFrame: 1.5 to 2 months, depending on the development of the patient and the completion of the 12 modules
measure: Decrease in the score of The Pittsburgh Sleep Quality Index.
timeFrame: 1.5 to 2 months, depending on the development of the patient and the completion of the 12 modules
measure: Decrease in the scores of the Post-Traumatic Stress Disorder Symptom Scale
timeFrame: 1.5 to 2 months, depending on the development of the patient and the completion of the 12 modules
measure: Increase in Satisfaction with Life Scale
timeFrame: 1.5 to 2 months, depending on the development of the patient and the completion of the 12 modules
measure: Decrease in the symptoms of General Anxiety Disorder
timeFrame: 1.5 to 2 months, depending on the development of the patient and the completion of the 12 modules
Secondary outcomes:
measure: Decrease in the Plutchik Suicide Risk Scale
timeFrame: 1.5 to 2 months, depending on the development of the patient and the completion of the 12 modules
measure: Decrease in Grief symptoms
timeFrame: 1.5 to 2 months, depending on the development of the patient and the completion of the 12 modules
Other outcomes:
Locations:
city: Juárez
country: Mexico
facility: Universidad Autónoma de Ciudad Juárez
state: Chihuahua
Study officials:
affiliation: Universidad Nacional Autonoma de Mexico
name: Sofía Cristina Martínez Luna, MD
role: STUDY_CHAIR
affiliation: Universidad Nacional Autonoma de Mexico
name: Paulina Arenas Landgrave, PhD
role: STUDY_CHAIR
affiliation: Universidad Nacional Autonoma de Mexico
name: Anabel de la Rosa, Gómez
role: STUDY_CHAIR
affiliation: Universidad Autónoma de Ciudad Juárez
name: Esteban Eugenio Esquivel Santoveña, PhD
role: STUDY_CHAIR
affiliation: Universidad Autónoma de Ciudad Juárez
name: Rosa Olimpia Castellanos Vargas, MD
role: STUDY_CHAIR
affiliation: University of Buenos Aires
name: Luis Farfallini, PhD
role: STUDY_CHAIR
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