Determining the effectiveness of mindfulness-based cognitive therapy on anxiety of treatment staff in contact with COVID_19. Determining the effectiveness of mindfulness-based cognitive therapy on the components of burnout in medical staff in contact with COVID_19.
Design
The study will be done in two groups, a control group and an experimental group. The subjects will be selected voluntarily but the assignment in the two groups will be done randomly with a lottery table. The total number of subjects will be 40 who will be divided into two groups.
Settings and conduct
Therapy will be done through the Skype program, eight one-hour sessions. All pre-tests and post-tests will be done through the PorsLine link or manual forms.
Participants/Inclusion and exclusion criteria
Admission requirements: conscious satisfaction; obtaining a score above 15 in the Beck Anxiety Questionnaire; optimal physical and mental condition to participate in the study; there is no specific age limit.
Exclusion criteria: simultaneous receipt of other psychological or pharmacological interventions؛ at least two weeks before the start of the intervention; change of the subject's opinion about participating in the study.
Intervention groups
Mindfulness-based cognitive therapy is performed virtually on Skype in eight one-hour sessions one week apart. For the control group, the same treatment will be performed after the end of the study.
Main outcome variables
Anxiety; job burnout
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220203053924N1
Registration date:2022-04-10, 1401/01/21
Registration timing:prospective
Last update:2022-04-10, 1401/01/21
Update count:0
Registration date
2022-04-10, 1401/01/21
Registrant information
Name
Maryam Tahmasbi Abdar
Name of organization / entity
Allameh Tabata'i University
Country
Iran (Islamic Republic of)
Phone
+98 34 3411 3925
Email address
faribatahmasbi2020@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-14, 1401/01/25
Expected recruitment end date
2022-04-20, 1401/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Mindfulness-Based Cognitive Therapy on Anxiety and Burnout of Treatment Staff That Exposed to Covid_19
Public title
Effectiveness of Mindfulness-Based Cognitive Therapy on Anxiety and Burnout of Treatment Staff That Exposed to COVID_19
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Subjects should be medical staff who have been in contact with COVID_19 disease.
A score higher than fifteen in the Beck Anxiety Inventory
Exclusion criteria:
Subjects undergoing psychological treatment or medication to reduce anxiety or burnout will be excluded from the study.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be done voluntarily, but the subjects will be assigned to the experimental and control groups randomly and by drawing lots with a random number table.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The study will be performed with two groups of control and experimental, pre-test will be taken from both groups and then treatment will be performed for the control group. A post-test will be performed after treatment and a post-test will be performed at intervals. At the end of the study, treatment will be performed for the control group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Biomedical Research Allameh Tabatabai University
Street address
Allameh Tabatabai University, Intersection of Olympic Village, The west Shahid Hemmat Highway., Tehran
City
Tehran
Province
Tehran
Postal code
1489684511
Approval date
2022-01-09, 1400/10/19
Ethics committee reference number
IRATU.REC.1400.064
Health conditions studied
1
Description of health condition studied
Covid-19 disease
ICD-10 code
U07.1
ICD-10 code description
covid-19, virus identified
Primary outcomes
1
Description
Beck anxiety score
Timepoint
Before the intervention, immediately after the intervention, two months after the end of the intervention
Method of measurement
Beck Anxiety Questionnaire.
2
Description
Maslach burnout score
Timepoint
Before the intervention, immediately after the intervention, two months after the end of the intervention.
Method of measurement
Maslach Burnout Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Mindfulness-based cognitive therapy, according to Rebecca Crane's instructions, will be performed in eight one-hour sessions (one session per week) in a virtual and group setting. This therapy revolves around mindfulness exercises and being here and now and paying full attention to what is going on inside or outside the person; is. All relevant mindfulness techniques are taught in each session and subjects are asked to apply the techniques to learn properly. Between treatment sessions, subjects are given home exercises that will help stabilize the treatment. All questions and ambiguities of the subjects will be answered in the intervals between sessions. Treatment will take about two months.
Category
Treatment - Other
2
Description
Control group: No treatment is provided in the control group during the study. Only pre-tests and post-tests are taken (one after the intervention of the experimental group and the other two months apart). If the members of the control group wish, after the end of the research, mindfulness-based cognitive therapy will be performed in the same way as the presentation to the intervention group. That is, the treatment will be performed in eight one-hour sessions with home exercises and answering the subjects' questions.
Allameh Tabataba'i University., The intersection of the Olympic Village., The West Shahid Hemmat Highway.
City
Tehran
Province
Tehran
Postal code
1489684511
Phone
+98 21 4839 0000
Email
deghani@atu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Allameh Tabataba'i University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Allameh Tabataba'i University
Full name of responsible person
Maryam Tahmasbi Abdar
Position
Master Student of Clinical Psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Allameh Tabataba'i University, The intersection of the Olympic Village, The West Shahid Hemmat Highway, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1489684511
Phone
+98 21 4839 0000
Email
faribatahmasbi2020@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Allameh Tabata'i University
Full name of responsible person
Maryam Tahmasbi Abdar
Position
Master Student of Clinical Psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Allameh Tabataba'i University, The intersection of the Olympic Village, The West Shahid Hemmat Highway, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1489684511
Phone
+98 21 4839 0000
Fax
Email
faribatahmasbi2020@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Allameh Tabataba'i University
Full name of responsible person
Maryam Tahmasbi Abdar
Position
Master Student of Clinical Psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Allameh Tabataba'i University, The intersection of the Olympic Village, The West Shahid Hemmat Highway, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1489684511
Phone
+98 21 4839 0000
Email
faribatahmasbi2020@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The data file will not be shared, only the results of the research will be published.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Individual data obtained from the subjects will not be published. Only the results of the research will be published in the form of a master's thesis and finally in the form of an article.
When the data will become available and for how long
The results will be available after the thesis is completed and the article is published. From September 2022.
To whom data/document is available
Only research members of Allameh Tabatabai University (if required), supervisor, advisor and researcher will have access to the data.
Under which criteria data/document could be used
A study is an academic study and no individual or organization will have access to the documents except the relevant academic people. The access request will be made only with the approval of the university.
From where data/document is obtainable
Access to the documents will be done with the approval of Allameh Tabatabai University Research Organization.
Seyed Jalal Dehghani Firoozabadi, Assistant of Research organization , Allameh Tabatabai University, 02144737561
What processes are involved for a request to access data/document
Access to the documents will be done with the approval of Allameh Tabatabai University Research Organization.
Seyed Jalal Dehghani Firoozabadi, Assistant of Research organization , Allameh Tabatabai University, 02144737561