Protocol summary

Study aim
The aim of this study was to develop an analytical metacognitive therapy protocol using intervention mapping and its effect on my ability and reduce anxiety and depression of nurses involved with Covid-19 patients.
Design
In the first stage, the intervention protocol is developed using cartography, in the second stage, the impact of the metacognitive analytical treatment protocol components is measured as an intervention for the nurse with the diagnosis of mild, moderate and severe depression.
Settings and conduct
The intervention is done for each person individually at Ali Bin Abi Talib Hospital in Zahedan.
Participants/Inclusion and exclusion criteria
The participant must have at least a nursing degree and at least one year of work experience, be at least 23 and at most 30 years old, not have a severe physical or psychological illness, not receive psychological services from another person, and be female.
Intervention groups
Three people will be selected with a diagnosis of mild, moderate and severe anxiety and depression, and the research objectives will be discussed in detail and the baseline test will be performed until the scores of the dependent variables are stable. Then analytical metacognitive therapy intervention is performed. During the intervention, a test will be performed for each participant after each treatment session (before the start of the next session). After the intervention, the last test will be taken with a maximum interval of one week.
Main outcome variables
Increase ego strenghth-Reduce anxiety-Reduce depression

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180705040356N1
Registration date: 2023-04-19, 1402/01/30
Registration timing: prospective

Last update: 2023-04-19, 1402/01/30
Update count: 0
Registration date
2023-04-19, 1402/01/30
Registrant information
Name
Rahim Shahbakhsh
Name of organization / entity
Tehran University of science and culture
Country
Iran (Islamic Republic of)
Phone
+98 21 4423 8171
Email address
rahimshabakhsh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2023-05-20, 1402/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compiling of metacognitive analytical therapy protocol using intervention mapping and its effect on ego strength and reducing anxiety and depression of nurses involved with covid -19
Public title
Compiling of metacognitive analytical therapy protocol using intervention mapping and its effect on ego strength and reducing anxiety and depression of nurses involved with covid -19
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least a bachelor's degree in nursing Having at least one year of work experience in different departments of Zahedan hospitals Having satisfaction and willingness to cooperate Being at least 23 years old and at most 30 years old Failure to report any other severe physical or psychological illness at the initial screening interview Not using the psychological services of another person at the same time Having a low score and a maximum of 40% of my ability questionnaire score being female
Exclusion criteria:
Anxiety and depression with psychotic features Severe disability in one of the five senses Severe mood swings
Age
From 23 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 3
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
One type of intervention will be conducted on three groups of one person with mild, moderate and severe anxiety and depression

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Royan Research Institute - Academic Jihad
Street address
Royan Research Institute- NO 9- UNIT 10- Royan Alley- Hafez East St-Bani Hashem St- Resalat Highway- Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۶۱۹۶۸۱۵۱
Approval date
2021-04-12, 1400/01/23
Ethics committee reference number
IR.ACECR.ROYAN.REC.1401.010

Health conditions studied

1

Description of health condition studied
Mixed anxiety and depressive disorder
ICD-10 code
F41.2
ICD-10 code description
Mixed anxiety and depressive disorder

Primary outcomes

1

Description
Increase Ego strength score
Timepoint
7، 14، 21، 28، 35، 42، 49، 56، 62، 69، 75
Method of measurement
Makström Ego Strength Questionnaire

2

Description
Decreased anxiety score
Timepoint
7، 14، 21، 28، 35، 42، 49، 56، 62، 69، 75
Method of measurement
Beck anxiety questionnaire

3

Description
Decreasing the depression score
Timepoint
7، 14، 21، 28، 35، 42، 49، 56، 62، 69، 75
Method of measurement
Beck depression questionnaire

Secondary outcomes

1

Description
Increase my strength score
Timepoint
One week after each treatment session and one hour before the next treatment session, measurement will be done, which will be done eleven times in the process of implementing the protocol.
Method of measurement
Makström Ego Strength Questionnaire

2

Description
Decreased anxiety score
Timepoint
One week after each treatment session and one hour before the next treatment session, measurement will be done, which will be done eleven times in the process of implementing the protocol.
Method of measurement
Beck anxiety questionnaire

3

Description
Decreasing the depression score
Timepoint
One week after each treatment session and one hour before the next treatment session, measurement will be done, which will be done eleven times in the process of implementing the protocol.
Method of measurement
Beck depression questionnaire

Intervention groups

1

Description
Intervention group: Three people with the diagnosis of mild, moderate and severe anxiety and depression will be selected and a detailed discussion will be conducted regarding the objectives of the research and a baseline test will be performed until the scores of the dependent variables are stable. Then metacognitive analytic treatment intervention is performed. During the intervention for each participant, after each treatment session (before the start of the next session), the test will be administered. After the end of the intervention, the last test will be taken with a maximum interval of one week.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Zahedan University of Medical Sciences
Full name of responsible person
Rahim Shahbakkhsh
Street address
Unit8- Building 1- Varzesh Residential Complex- Alley 19- Enghelab Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817787787
Phone
+98 54 3337 0801
Email
Rahimshabakhsh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Science and Culture
Full name of responsible person
Musa Itharbakhsh
Street address
Tehran University of Science and Culture- Bahar Street - Shahid Qomoshi Street- Ashrafi Esfahani Boulevard.
City
Tehran
Province
Tehran
Postal code
۱۴۶۱۹۶۸۱۵۱
Phone
+98 21 4423 8171
Email
info@usc.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Science and Culture
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
Tehran University of Science and Culture
Full name of responsible person
Ali Soleimani
Position
Assistant Professor, Department of Psychology, Tehran University of Science and Culture
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Tehran University of Science and Culture- Bahar Street - Shahid Qomoshi Street- Ashrafi Esfahani Boulevard.
City
Tehran
Province
Tehran
Postal code
۱۴۶۱۹۶۸۱۵۱
Phone
+98 21 4423 8171
Email
alisoleimani42@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Science and Culture
Full name of responsible person
Rahim Shahbakhsh
Position
Doctoral student of Clinical Psychology, Tehran University of Science and Culture
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Tehran University of Science and Culture- Bahar Street - Shahid Qomoshi Street- Ashrafi Esfahani Boulevard.
City
Tehran
Province
Tehran
Postal code
۱۴۶۱۹۶۸۱۵۱
Phone
+98 21 4423 8171
Email
rahimshabakhsh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Science and Culture
Full name of responsible person
Rahim Shahbakhsh
Position
Doctoral student of Clinical Psychology, Tehran University of Science and Culture
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Tehran University of Science and Culture- Bahar Street - Shahid Qomoshi Street- Ashrafi Esfahani Boulevard.
City
Tehran
Province
Tehran
Postal code
۱۴۶۱۹۶۸۱۵۱
Phone
+98 21 4423 8171
Email
rahimshabakhsh@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The research results will be available after publication.
When the data will become available and for how long
The data will be available from March 2024
To whom data/document is available
researchers
Under which criteria data/document could be used
For therapeutic and research purposes
From where data/document is obtainable
Science and Culture University Library
What processes are involved for a request to access data/document
By referring to the library of the University of Science and Culture and submitting a request regarding the research results
Comments
Loading...