CompletedNot Applicable

Online Multi-component Psychological Intervention for Prevention of Grief Disorder Due to COVID-19

Mexico43 participantsStarted 2020-12-24

Plain-language 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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

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

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

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

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

Trial details

NCT IDNCT04638842

SponsorUniversidad Internacional de Valencia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-06-01

View on ClinicalTrials.gov More Grief trials