Online Multi-component Psychological Intervention for Prevention of Grief Disorder Due to COVID-19
NCT ID: NCT04638842
Last Updated: 2021-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
43 participants
INTERVENTIONAL
2020-12-24
2021-06-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Grief COVID intervention
Participants in this group will receive 12 sessions of a multi-component psychological intervention focused on 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.
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.
Waiting List group
The participants in this group will not receive the treatment, just waiting list. They will be measured one time and then a second time 3 months after. Calculating when 3 months corresponding to 12 sessions will receive the intervention.
No interventions assigned to this group
Interventions
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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
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Inclusion Criteria
* 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 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
18 Years
60 Years
ALL
Yes
Sponsors
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Universidad Nacional Autonoma de Mexico
OTHER
Universidad Autonoma de Ciudad Juarez
OTHER
University of Buenos Aires
OTHER
Universidad Internacional de Valencia
OTHER
Responsible Party
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Principal Investigators
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Sofía Cristina Martínez Luna, MD
Role: STUDY_CHAIR
Universidad Nacional Autonoma de Mexico
Paulina Arenas Landgrave, PhD
Role: STUDY_CHAIR
Universidad Nacional Autonoma de Mexico
Anabel de la Rosa, Gómez
Role: STUDY_CHAIR
Universidad Nacional Autonoma de Mexico
Esteban Eugenio Esquivel Santoveña, PhD
Role: STUDY_CHAIR
Universidad Autónoma de Ciudad Juárez
Rosa Olimpia Castellanos Vargas, MD
Role: STUDY_CHAIR
Universidad Autónoma de Ciudad Juárez
Luis Farfallini, PhD
Role: STUDY_CHAIR
University of Buenos Aires
Locations
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Universidad Autónoma de Ciudad Juárez
Juárez, Chihuahua, Mexico
Countries
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References
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Wallace CL, Wladkowski SP, Gibson A, White P. Grief During the COVID-19 Pandemic: Considerations for Palliative Care Providers. J Pain Symptom Manage. 2020 Jul;60(1):e70-e76. doi: 10.1016/j.jpainsymman.2020.04.012. Epub 2020 Apr 13.
Holland DE, Vanderboom CE, Dose AM, Moore D, Robinson KV, Wild E, Stiles C, Ingram C, Mandrekar J, Borah B, Taylor E, Griffin JM. Death and Grieving for Family Caregivers of Loved Ones With Life-Limiting Illnesses in the Era of COVID-19: Considerations for Case Managers. Prof Case Manag. 2021 Mar-Apr 01;26(2):53-61. doi: 10.1097/NCM.0000000000000485.
Mayland CR, Harding AJE, Preston N, Payne S. Supporting Adults Bereaved Through COVID-19: A Rapid Review of the Impact of Previous Pandemics on Grief and Bereavement. J Pain Symptom Manage. 2020 Aug;60(2):e33-e39. doi: 10.1016/j.jpainsymman.2020.05.012. Epub 2020 May 15.
Boelen PA, Prigerson HG. The influence of symptoms of prolonged grief disorder, depression, and anxiety on quality of life among bereaved adults: a prospective study. Eur Arch Psychiatry Clin Neurosci. 2007 Dec;257(8):444-52. doi: 10.1007/s00406-007-0744-0.
Boelen PA, Smid GE. Disturbed grief: prolonged grief disorder and persistent complex bereavement disorder. BMJ. 2017 May 18;357:j2016. doi: 10.1136/bmj.j2016. No abstract available.
Sauer J, Sonderegger A, Schmutz S. Usability, user experience and accessibility: towards an integrative model. Ergonomics. 2020 Oct;63(10):1207-1220. doi: 10.1080/00140139.2020.1774080. Epub 2020 Jun 12.
Merino MD, Privado J. Positive Psychological Functioning. Evidence for a new construct and its measurement.[Funcionamiento psicológico positivo. Evidencia para un nuevo constructo y su medición]. Anales de Psicología/Annals of Psychology. 2015;31(1):45-54.
Foa EB, Cashman L, Jaycox L, Perry K. The validation of a self-report measure of posttraumatic stress disorder: the Posttraumatic Diagnostic Scale. Psychological assessment. 1997 Dec;9(4):445.
Kersting A, Dolemeyer R, Steinig J, Walter F, Kroker K, Baust K, Wagner B. Brief Internet-based intervention reduces posttraumatic stress and prolonged grief in parents after the loss of a child during pregnancy: a randomized controlled trial. Psychother Psychosom. 2013;82(6):372-81. doi: 10.1159/000348713. Epub 2013 Sep 20.
Hoffmann R, Grosse J, Nagl M, Niederwieser D, Mehnert A, Kersting A. Internet-based grief therapy for bereaved individuals after loss due to Haematological cancer: study protocol of a randomized controlled trial. BMC Psychiatry. 2018 Feb 27;18(1):52. doi: 10.1186/s12888-018-1633-y.
Sogaard Neilsen A, Wilson RL. Combining e-mental health intervention development with human computer interaction (HCI) design to enhance technology-facilitated recovery for people with depression and/or anxiety conditions: An integrative literature review. Int J Ment Health Nurs. 2019 Feb;28(1):22-39. doi: 10.1111/inm.12527. Epub 2018 Aug 22.
Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
Carleton RN, Thibodeau MA, Teale MJ, Welch PG, Abrams MP, Robinson T, Asmundson GJ. The center for epidemiologic studies depression scale: a review with a theoretical and empirical examination of item content and factor structure. PLoS One. 2013;8(3):e58067. doi: 10.1371/journal.pone.0058067. Epub 2013 Mar 1.
Norton PJ. Depression Anxiety and Stress Scales (DASS-21): psychometric analysis across four racial groups. Anxiety Stress Coping. 2007 Sep;20(3):253-65. doi: 10.1080/10615800701309279.
Koslowsky M, Bleich A, Greenspoon A, Wagner B, Apter A, Solomon Z. Assessing the validity of the Plutchik Suicide Risk Scale. J Psychiatr Res. 1991;25(4):155-8. doi: 10.1016/0022-3956(91)90019-7.
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
Beck AT, Weissman A, Lester D, Trexler L. The measurement of pessimism: the hopelessness scale. J Consult Clin Psychol. 1974 Dec;42(6):861-5. doi: 10.1037/h0037562. No abstract available.
Novy DM, Stanley MA, Averill P, Daza P. Psychometric comparability of English- and Spanish-language measures of anxiety and related affective symptoms. Psychol Assess. 2001 Sep;13(3):347-55. doi: 10.1037//1040-3590.13.3.347.
Dominguez-Rodriguez A, Sanz-Gomez S, Gonzalez Ramirez LP, Herdoiza-Arroyo PE, Trevino Garcia LE, de la Rosa-Gomez A, Gonzalez-Cantero JO, Macias-Aguinaga V, Miaja M. The Efficacy and Usability of an Unguided Web-Based Grief Intervention for Adults Who Lost a Loved One During the COVID-19 Pandemic: Randomized Controlled Trial. J Med Internet Res. 2023 Apr 6;25:e43839. doi: 10.2196/43839.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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VIU-Grief-COVID
Identifier Type: -
Identifier Source: org_study_id