Online Multi-component Psychological Intervention for Prevention of Grief Disorder Due to COVID-19
Condition: Grief; Anxiety; Depression; Sleep Disturbance; Quality of Life
MeSH terms: Dyssomnias; Parasomnias
Study type: Interventional

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.
    

Intervention name(s): Online Intervention Grief COVID-19
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Single (Participant)
Primary purpose: Treatment