Protocol summary
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Study aim
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Comparison of the efficacy of three versus five sessions of grief counseling on general health, quality of life and severity of grief in family members of the COVID-19 victims
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Design
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The study will be a multi-center randomized controlled trial with parallel groups and double-blind on 120 family members of the COVID-19 victims in the 10 medical sciences universities. The Balanced Block Randomization, stratified by center, will be used with the RANDBETWEEN command in Excel software.
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Settings and conduct
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This study will be conducted in selected health care centers of Tehran, Iran, Shiraz, Mashhad, Kerman, Tabriz, Ahvaz, Gilan, Golestan and Arak Universities of Medical Sciences. Face-to-face counseling sessions will be held individually by the mental health experts, in full compliance with the health guidelines and social distance in a suitable environment located in the comprehensive health care centers.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: the first-degree relatives of COVID-19 victim; the age between 15 and 64 years old; have literacy and be able to understand and speak Persian; provide written consent to enter the study.
Exclusion criteria: receiving any other grief interventions and psychological or pharmacological treatments before or at the same time as the research; severe physical or mental disorders (delusions, hallucinations, lack of awareness of time and place) that make intervention impossible; suicidal ideation or self-harm; alcohol and drug use.
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Intervention groups
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Participants will be randomly divided into two equal groups, one will receive 5 grief counselling sessions and the other will receive 3 sessions.
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Main outcome variables
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The primary outcome of this study is the intensity of grief and the secondary outcomes are general health and quality of life in family members of the COVID- 19 victims.
General information
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Reason for update
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Displacement of the primary and secondary outcome variables
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200505047305N1
Registration date:
2020-06-30, 1399/04/10
Registration timing:
registered_while_recruiting
Last update:
2022-12-11, 1401/09/20
Update count:
1
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Registration date
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2020-06-30, 1399/04/10
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-06-06, 1399/03/17
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Expected recruitment end date
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2020-10-06, 1399/07/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of the efficacy of three versus five sessions of grief counseling on general health, quality of life and intensity of grief in family members of the COVID-19 victims: A multi-center randomized controlled trial
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Public title
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Grief counseling in family members of the COVID-19 victims
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
The first-degree relatives of COVID-19 victim
The age between 15 and 64 years old
Have literacy and be able to understand and speak Persian.
Provide written consent to enter the study.
Exclusion criteria:
Receiving any other grief interventions and psychological or pharmacological treatments before or at the same time as the research.
Severe physical or mental disorders (delusions, hallucinations, lack of awareness of time and place) that make intervention impossible.
Suicidal ideation or self-harm
Alcohol and drug use
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Age
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From 15 years old to 64 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
120
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this study, in order to randomly assignment of 120 participants from 10 universities into two study groups, Stratified Balanced Block Randomization, will be used. Randomization will be done separately for each University of Medical Sciences. Out of a maximum of 20 forms for the six size blocks, including three members of the intervention group A: five-session grief counseling and three members of the intervention group B: three-session grief counseling, using the RANDBETWEEN(1,20) command in Excel software, 2 blocks will be randomly selected for each university and a random sequence will be created. According to the random sequence created, participants will be divided equally into two groups. The randomization will be done by the study's head office and will be announced to the universities.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Because of the type of study, it is not possible to blind the participants about intervention. The outcome evaluators will not be one of the consultants and will be blind about the belonging of individuals to the intervention groups. The data analyst will not be aware of the coding nature of the study groups.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-05-31, 1399/03/11
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Ethics committee reference number
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IR.IUMS.REC.1399.272
Health conditions studied
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Description of health condition studied
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Greif
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ICD-10 code
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F43.20
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ICD-10 code description
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Adjustment disorder, unspecified
Primary outcomes
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Description
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The primary outcome of this study is the intensity of grief score of the family members of the COVID-19 victims measured with the Grief Intensity Scale (GIS).
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Timepoint
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Assessments will take place three times, including before the intervention begins, one month and three months after the end of the last counseling session.
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Method of measurement
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The Grief Intensity Scale (GIS): The GIS is a scale proposed by Prigerson et al. and is consisted of 12 questions measuring the thoughts, emotions, and behaviors of individuals who have recently lost an important person. This scale represents the severity of reactions of the bereaving individual. It facilitates clinicians to be able to assess the risk of an individual being later diagnosed with prolonged grief disorder after the loss of a loved one. The first two questions of this scale question the time elapsed since the death of a loved one and the decline in performance. The sum of the scores of the next 10 Likert-scale questions, each of which is answered with never, at least once a month, once a week, once a day, and several times a day, is analyzed as a grief intensity score. Each item receives a score of 1-5. A higher score represents a higher intensity in grief symptoms. We conducted a pilot study to investigate the validity and reliability of the Persian version of GIS and estimate the mean and standard deviation of the grief intensity score of the bereaved persons due to Covid-19. The face and content validity of the questionnaire was confirmed by the expert panel. The Cronbach's alpha of 0.92 and intraclass correlation coefficient of 0.87 indicated the good internal consistency and test-retest reliability of the Persian version of GIS.
Secondary outcomes
1
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Description
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The quality of life score in physical and mental performance of family members of the COVID-19 victims measured with the Short Form Quality of Life Questionnaire (SF-12)
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Timepoint
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Assessments will take place three times, including before the intervention begins, one month and three months after the end of the last counseling session.
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Method of measurement
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Short Form-12 Quality of Life (SF-12): This questionnaire is the short version of SF-36 that has two general components of physical and mental performance with 12 questions and 8 sub-scales of physical functioning (2 questions), bodily pain (2 questions), role limitation due to physical problems (1 question), general health (1 question), Energy and vitality (1 question), social functioning (1 question), role limitation due to mental health problems (2 questions) and perceived mental health (2 questions). After performing the necessary calculations, the overall score of each person is obtained in two components: physical performance and mental performance. After translation for the Iranian population, the validity and the reliability of this questionnaire has been confirmed and standardized by Montazeri et al. with Cronbach's alpha of 0.72.
2
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Description
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The general health score of family members of the COVID-19 victims measured with the General Health Questionnaire (GHQ-28)
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Timepoint
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Assessments will take place three times, including before the intervention begins, one month and three months after the end of the last counseling session.
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Method of measurement
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General Health Questionnaire (GHQ-28): This questionnaire was developed for screening the psychiatric disorders and has been commonly used in research in various countries. It includes 4 sub-scales of somatic symptoms, anxiety and insomnia, social dysfunction and depressive symptoms. The 28-item Persian version of GHQ was validated in a study by Noorbala et al. on Tehran population (aged 15 and more) and it showed a good reliability and validity for epidemiological studies. The 28-item version of the GHQ consists of four-choice questions, ranges from a 'better than normal' option, through a 'same as usual' and a 'more than usual' to a 'much worse than usual' option, and is scored on a 0-1-2-3 Likert scale. A higher score indicates poorer general health and the maximum score is 84.
Intervention groups
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Description
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First intervention group: In five-session grief counseling group, the order and type of sessions are as following: 1. Preliminary session: Preliminary evaluation and consultation 2. The first session: Flexible evaluation of event and increasing understanding of loss 3. The second session: coping with grief and finding the meaning 4. The third session: recovery, adaptation to life without the deceased 5. Fourth session: Assessing the grief process, returning to life without the deceased • Sessions will be held weekly and will be followed up and evaluated in person in one and three months after the last session. The intervention of grief counseling will be held according to the protocol by trained mental health experts, individually and in person at the health center.
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Category
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Other
2
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Description
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Second intervention group: In three-session grief counseling group, the order and type of sessions are as following: 1. Preliminary session: Preliminary evaluation and consultation 2. The first session: Flexible evaluation of event and increasing understanding of loss, coping with grief and finding the meaning 3. The second session: recovery, adaptation to life without the deceased, Assessing the grief process, returning to life without the deceased • The two sessions followed by the preliminary's will be held once every two weeks and will be followed up and evaluated in person one and three months after the last session. The intervention of grief counseling will be held according to the protocol by trained mental health experts, individually and in person at the health center.
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available