Protocol summary
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Study aim
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Comparison of effect of Stress Management, Emotion Regulation, Eye Movement Desensitization and Reprocessing Therapy in Improving Resilience, Repetitive Negative Thoughts, Anxiety and Depression in Patients with Covid 19
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Design
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Clinical trial with parallel groups, not blinded, a sample of 80 patients with Covid_19 disorder will be selected by available sampling and will be randomly assigned to 4 groups. 3 groups will receive treatment and one group will be evaluated as a control group. Generator number random v1.3 software was used for randomization.
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Settings and conduct
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Samples will be referred by a psychiatrist colleague according to the entry criteria and will be included in the test groups if they are not subject to the exit criteria. Then, after obtaining informed consent to participate in the study, the Conner and Davidson Scale Resilience Questionnaire, the Negative Repetitive Thought Questionnaire, and the DASS Depression, Anxiety, and Stress Questionnaire are presented, and we compare the scores obtained from the questionnaire. . Then the stress management treatment program and the treatment of emotion regulation and desensitization with eye movement and reprocessing will be implemented. After performing the interventions of the questionnaires, the score obtained from the questionnaires will be compared again and the mentioned test will be performed again and also 1 month after the end of the intervention in order to follow up the results.
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Participants/Inclusion and exclusion criteria
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Depression and anxiety diagnosed by a psychiatrist and hospitalized in Corona Hospital
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Intervention groups
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3 groups receive intervention, stress management treatment, emotion regulation, eye desensitization and reprocessing, and a control group will receive no treatment.
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Main outcome variables
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Resilience, recurring negative thoughts, anxiety, depression
General information
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Reason for update
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single blind
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210728052006N1
Registration date:
2021-10-04, 1400/07/12
Registration timing:
registered_while_recruiting
Last update:
2024-07-31, 1403/05/10
Update count:
1
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Registration date
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2021-10-04, 1400/07/12
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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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2021-08-23, 1400/06/01
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Expected recruitment end date
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2021-12-21, 1400/09/30
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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 effect of Stress Management, Emotion Regulation, Eye Movement Desensitization and Reprocessing Therapy in Improving Resilience, Repetitive Negative Thoughts, Anxiety and Depression in Patients with Covid 19
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Public title
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The effectiveness of stress management, emotion regulation and desensitization treatments with eye movement and reprocessing on depression and anxiety in patients with Covid 19
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
patients referred to the clinics and hospitals accepting Corona. suffering from depression and anxiety at the diagnosis of a psychiatrist. aged 18 and up to 60 years.
Exclusion criteria:
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Age
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From 18 years old to 60 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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Sample size
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Target sample size:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Random Number Generator v1.3 program will be used to assign sample members to four experimental groups. In this way, the number of sample people is given to this software and this program randomly places each number in a group according to its function.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The evaluator was not aware of the allocation of any of the 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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2021-07-23, 1400/05/01
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Ethics committee reference number
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https://ethics.research.ac.ir/IR.QUMS.REC.1400.186
Health conditions studied
1
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Description of health condition studied
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Covid-19
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ICD-10 code
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U07.2
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ICD-10 code description
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COVID-19, virus not identified
Primary outcomes
1
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Description
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Resilience
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Timepoint
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10 sessions and 1 month
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Method of measurement
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Connor and Davidson scale resilience questionnaire
2
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Description
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Repeated negative thoughts
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Timepoint
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10 sessions and 1 month
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Method of measurement
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Negative Repetitive Thoughts Questionnaire
3
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Description
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Depression
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Timepoint
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10 sessions and 1 month
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Method of measurement
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DASS Depression Inventory
4
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Description
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anxiety
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Timepoint
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10 sessions and 1 month
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Method of measurement
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DASS Anxiety Inventory
Intervention groups
1
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Description
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Intervention group 1: Cognitive-behavioral stress management group intervention sessions, 10 sessions for 1.5 hours and one session per week.
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Category
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Behavior
2
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Description
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Intervention group 2: Emotion regulation group intervention sessions based on Gross regulatory strategies, 10 sessions for 1.5 hours and one session per week.
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Category
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Behavior
3
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Description
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Intervention group 3: Group intervention sessions of desensitization with eye movement and reprocessing, 8 sessions for 1.5 hours and one session per week will be held.
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Category
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Behavior
4
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Description
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Control group: They will not receive any treatment.
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Category
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N/A
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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Qazvin 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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no more information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available