Protocol summary
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Study aim
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Study the effect of one shot cognitive behavioral therapy on insomnia and heart rate variability of health care workers at the time of Covid-19 pandemic
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Design
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Clinical trial, with parallel groups, for 70 patients, randomized using a random string, double-blind, the outcome evaluator and data analyzer will be blinded,
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Settings and conduct
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This study is being performed on health care workers at Al-Zahra and Khorshid Hospitals in Isfahan. 70 healthcare workers will randomly divide into two groups and the intervention group underwent a one-shot cognitive behavioral therapy intervention. Blinding is done by assigning a unique code to patients and the outcome assessor and the data analyzer are unaware of the groups.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria: Healthcare workers who work in ALzahra hospital, insomnia score of 8 and higher based on Insomnia Severity Index, age 18 years old and above; Exclusion criteria: History of cardiovascular disease, history of seizure, manic depressive disorder, narcolepsy, and parasomnia, using beta-adrenergic blockade or antiarrhythmic medications
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Intervention groups
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Intervention group: The sleep diary sheets are given to participants to be completed by them within the next 2 weeks. Then participants are divided into groups of 2-3 people and each group will come for a group meeting (for one-shot cognitive behavioral therapy) at a specific time. An ECG will be recorded for 5 minutes before the start of the session to assess changes in basal heart rate. After a month, the consequences are reviewed. Control group: includes hospital health staff for whom no intervention is performed and only at similar times in the intervention group, heart rate changes and insomnia severity are evaluated for them.
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Main outcome variables
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insomnia, heart rate variability
General information
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Reason for update
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This study is carried on healthcare workers. During the recruitment, they were involved with the 4th wave of the Covid-19 pandemic. Hence, we had to change the protocol.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20171219037964N4
Registration date:
2021-03-20, 1399/12/30
Registration timing:
prospective
Last update:
2021-12-18, 1400/09/27
Update count:
1
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Registration date
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2021-03-20, 1399/12/30
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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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2021-04-09, 1400/01/20
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Expected recruitment end date
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2021-07-22, 1400/04/31
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Actual recruitment start date
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2021-04-21, 1400/02/01
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Actual recruitment end date
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2021-07-22, 1400/04/31
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Trial completion date
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2021-09-22, 1400/06/31
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Scientific title
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study the effect of one shot cognitive behavioral therapy on insomnia and heart rate variability of healthcare workers at the time of covid-19
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Public title
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study the effect of cognitive therapy on insomnia and heart rate variability of health care workers
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Healthcare workers who work in ALzahra and Khorshid hospital
Insomnia score of 8 and higher based on insomnia severity index
age over 18 years old
Exclusion criteria:
History of cardiovascular disease
History of seizure, manic depressive disorder, narcolepsy and parasomnia
Using beta adrenergic blockade or anti arrhythmic medications
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Age
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From 18 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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- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
70
Actual sample size reached:
57
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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A random sequence for 70 numbers is made using randomization.com and is available to the research assistant. Each person is given a code (from one to 70). The research assistant places the person in the relevant groups by matching the person's code with a random sequence.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Each person is given a unique code and these codes are given to the research assistant. The person in charge of data analysis and the person in charge of follow-up are unaware of their allocation to study groups and study codes.
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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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2021-03-15, 1399/12/25
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Ethics committee reference number
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IR.MUI.MED.REC.1399.1153
Health conditions studied
1
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Description of health condition studied
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Insomnia
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ICD-10 code
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F51.01
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ICD-10 code description
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Primary insomnia
Primary outcomes
1
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Description
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insomnia
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Timepoint
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at baseline, after one month
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Method of measurement
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Insomnia Severity Index
2
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Description
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Heart rate variability
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Timepoint
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at baseline, after one month
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Method of measurement
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heart monitoring
Intervention groups
1
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Description
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Intervention group: This group first completes sleep dairy for two weeks and then receives a group session (in groups of 2-3) of a one-session cognitive behavioral intervention based on their sleep status and sleep habits.
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Category
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Treatment - Other
2
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Description
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Control group: Routine treatments
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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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Esfahan 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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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Participants data will be Shared after being unidentified
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When the data will become available and for how long
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Six months after the publication of the results
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To whom data/document is available
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All researchers are allowed to have access to data
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Under which criteria data/document could be used
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In order to use in Meta-analysis studies
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From where data/document is obtainable
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A request should be sent to the Chancellery of Research of Isfahan University of Medical Sciences
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What processes are involved for a request to access data/document
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The request will be reviewed in the Chancellery of Research and the Ethics Committee of Isfahan University of Medical Sciences; Data will be delivered upon approval.
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Comments
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