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

NCT04638842 | Completed DMC

• 1 other identifier: VIU-Grief-COVID
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Grief; Anxiety; Depression; Sleep Disturbance; Quality of Life

Outcome Measures

Primary Outcomes (6)

• Decrease in the scores of the Center for Epidemiologic Studies Depression (CES-D) scale

  Center for Epidemiologic Studies Depression (CES-D) is a structured self-report scale for evaluation depression symptoms. This scale assesses the number of depression symptoms within 2 weeks. The scale consists 20 items and contains 4-point score responses (0 to 3) as the following; rarely or none of the time (less than 1 day); some of a little of the time (1-2 days); occasionally or moderate amount of time (3-4 days) and most or all of the time (5-7 days). The total possible range of scores is from 0 to 60 where \^16 is the cut-off point for this scale, and higher scores indicate more symptoms of depression. It is expected a statistically significant decrease (P \< 0.05) in depression symptoms.

  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)

  The Depression Anxiety Stress Scale-21 is a structured self-report scale that assesses the subscales of anxiety, depression, and stress symptoms over the past last week. Each subscale contains seven items with responses rated on a 4-point scale (0-3) as follows; 0 Did not apply at me at all; 1 Applied to me to a considerable degree or some of the time; 2 Applied to me to a considerable degree or a good part of the time; 3 Applied to me very much or most of the time. Each subscale has a cut-off point for depression (6), anxiety (5), and stress (6). It is expected a statistically significant decrease (P \< 0.05) in depression and anxiety symptoms.

  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.

  This instrument assesses the quality patterns of sleep. It differentiates the "poor" and "good" sleep by measuring seven areas, where the range score of answers are from 0 to 3, the global sum of this scale can be a value between 0 to 60, and the cutoff point is "5" that indicates a "poor" sleep quality. It is expected a statistically significant increase (P \< 0.05) in the Sleep Quality measure.

  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

  The Post-Traumatic Stress Disorder Symptom Scale is a 17-item structured interview. The severity over the last 2 weeks of each item on the PSS is rated by the interviewer using a 4-point scale: 0 = not at all, 1 = a little bit, 2 = somewhat, and 3 = very much. The maximum possible score is 51 (severely affected) and the minimum possible score is 0 (total absence of the symptoms). The total severity score is calculated as the sum of the severity ratings for the 17 items. The diagnosis of the Post-Traumatic Stress Disorder Symptom Scale is made when at least 1 re-experiencing, 3 avoidance, and 2 arousal symptoms are endorsed on the scale by individuals who were traumatized at least one month prior to the assessment. It is expected a statistically significant decrease (P \< 0.05) in the symptoms of Post-Traumatic Stress Disorder in the patients suffering from this disorder.

  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

  This instrument is composed of 5 items in which the participants must indicate how much they agree with each question, with an answer option in Likert format from 1 (totally disagree) to 7 (totally agree), the scores range from a minimum from 5 to a maximum of 35, where the highest scores indicate greater satisfaction with life. This scale has been validated in the Mexican population, obtaining good results of internal consistency (α = 0.74).

  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

  On the Generalized Anxiety Disorder 7-item (GAD-7) scale subjects are asked how often, during the last 2 weeks, they have been bothered by each of the 7 core symptoms of generalized anxiety disorder. Response options are "not at all," "several days," "more than half the days," and "nearly every day," scored as 0, 1, 2, and 3, respectively. Therefore, GAD-7 scores range from 0 to 21, with scores of ≥5, ≥10, and ≥15 represent mild, moderate, and severe anxiety symptom levels, respectively. Is expected a statistically significant decrease (P \< 0.05) in the General Anxiety symptoms.

  1.5 to 2 months, depending on the development of the patient and the completion of the 12 modules

Secondary Outcomes (2)

• Decrease in the Plutchik Suicide Risk Scale

  1.5 to 2 months, depending on the development of the patient and the completion of the 12 modules

• Decrease in Grief symptoms

  1.5 to 2 months, depending on the development of the patient and the completion of the 12 modules

Study Arms (2)

Grief COVID intervention

EXPERIMENTAL

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.

Behavioral: Online Intervention Grief COVID-19

Waiting List group

NO INTERVENTION

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.

Interventions

Online Intervention Grief COVID-19 BEHAVIORAL

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.

Grief COVID intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Internacional de Valencia: lead
• Universidad Nacional Autonoma de Mexico: collaborator
• Universidad Autonoma de Ciudad Juarez: collaborator
• University of Buenos Aires: collaborator

Study Sites (1)

Universidad Autónoma de Ciudad Juárez

Juárez, Chihuahua, 32315, Mexico

Location

Related Publications (19)

• 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.

  PMID: 32298748 BACKGROUND

• 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.

  PMID: 33181608 BACKGROUND

• 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.

  PMID: 32416233 BACKGROUND

• 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.

  PMID: 17629728 BACKGROUND

• 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.

  PMID: 28522468 BACKGROUND

• 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.

  PMID: 32450782 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 24061387 BACKGROUND

• 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.

  PMID: 29482525 BACKGROUND

• 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.

  PMID: 30133096 BACKGROUND

• 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.

  PMID: 2748771 RESULT

• 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.

  PMID: 23469262 RESULT

• 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.

  PMID: 17999228 RESULT

• 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.

  PMID: 1779413 RESULT

• 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.

  PMID: 16717171 RESULT

• 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.

  PMID: 4436473 RESULT

• 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.

  PMID: 11556271 RESULT

• 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.

  PMID: 36877800 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression; Parasomnias

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Sofía Cristina Martínez Luna, MD

  Universidad Nacional Autonoma de Mexico

  STUDY CHAIR

• Paulina Arenas Landgrave, PhD

  Universidad Nacional Autonoma de Mexico

  STUDY CHAIR

• Anabel de la Rosa, Gómez

  Universidad Nacional Autonoma de Mexico

  STUDY CHAIR

• Esteban Eugenio Esquivel Santoveña, PhD

  Universidad Autónoma de Ciudad Juárez

  STUDY CHAIR

• Rosa Olimpia Castellanos Vargas, MD

  Universidad Autónoma de Ciudad Juárez

  STUDY CHAIR

• Luis Farfallini, PhD

  University of Buenos Aires

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patients are not aware that there is an experimental group and a control group, the participants are not related and do not know each other. The conditions of the study are only known by the researcher, the therapists, and the Research Ethics Committee of the Universidad Autónoma de Ciudad Juárez.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: November 20, 2020
• Study Start: December 24, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: October 13, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: This data will be available approximately in April 2021 and it will be permanently available. It will be shared in the databases of the journal where the article(s) will be published.
• Access Criteria: Through the servers of the journal(s) where we will publish the articles.

Locations

ME (1)