Protocol summary

Study aim
To investigate the effect of cognitive-behavioral group training on the depression levels of nurses working in teaching hospitals of Birjand
Design
In this randomized controlled field trial, 40 eligible nurses from the teaching hospitals affiliated with Birjand University of Medical Sciences were included by convenience sampling method. First, the Beck Depression Inventory was completed by nurses and those with a score range from 13 to 32 on the inventory were included. Afterwards, the nurses were randomly assigned into the intervention (n=20) and control (n=20) groups.
Settings and conduct
As a non-blinded study, the trial was conducted at the nursing research center of Birjand University of Medical Sciences. At first, the participants completed Beck's Depression Inventory. The intervention group members received eight 1.5-hour sessions of cognitive-behavioral group training on coping with depression on a weekly basis. Nurses in the control group did not receive any interventions. After the 8th session and two months later, the members of both groups completed the inventory.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Earning score 13 or above on the Beck Depression Inventory; working in one of the teaching hospitals affiliated to Birjand University of Medical Sciences for a minimum of one year; and informed consent to participate in the study. Exclusion criterion: Suffering from other mental and physical disorders.
Intervention groups
Intervention group (cognitive-behavioral): The intervention group members received eight 1.5-hour sessions of cognitive-behavioral group training on coping with depression on a weekly basis. Control group: They received no training.
Main outcome variables
depression

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170316033099N5
Registration date: 2018-12-23, 1397/10/02
Registration timing: retrospective

Last update: 2018-12-23, 1397/10/02
Update count: 0
Registration date
2018-12-23, 1397/10/02
Registrant information
Name
Mohammad Bagher Roozgar
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5680
Email address
roozgar@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-05-10, 1396/02/20
Actual recruitment start date
2017-04-21, 1396/02/01
Actual recruitment end date
2017-05-10, 1396/02/20
Trial completion date
2017-09-11, 1396/06/20
Scientific title
A clinical trial comparing the effects of cognitive-behavioral group training and lack of training on depression of nurses
Public title
Effect of cognitive-behavioral group training on depression
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Earning the score of 13 or above on the Beck Depression Inventory Working in one of the teaching hospitals affiliated to Birjand University of Medical Sciences for a minimum of one year Informed consent to participate in the study Age range from 23 to 45 years Having bachelor’s degree or higher
Exclusion criteria:
Having other mental and physical disorders
Age
From 23 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Actual sample size reached: 80
Randomization (investigator's opinion)
Randomized
Randomization description
A total of 80 participants who met the inclusion criteria were incorporated using convenience sampling method. Each eligible participant was assigned a code. Using the table of random numbers, the participants were allocated to the intervention or control groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2017-04-19, 1396/01/30
Ethics committee reference number
IR.bums.REC.1396.21

Health conditions studied

1

Description of health condition studied
depression
ICD-10 code
f32.9
ICD-10 code description
Depressive episode, unspecified

Primary outcomes

1

Description
Depression
Timepoint
Before training, immediately after training, two months after training
Method of measurement
Beck Depression Inventory

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group (cognitive-behavioral): The intervention group members received eight 1.5-hour sessions of cognitive-behavioral group training on coping with depression on a weekly basis. In brief, topics of the sessions included the nature of depression, cognitive model, cognitive errors, identification of negative thoughts according to the form of the thoughts, cognitive restructuring using the positive self-reflection technique, depression triggers and the standard dual technique, coping skills and problem solving.
Category
Treatment - Other

2

Description
Control group: They received no training.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Nursing Research Center of Birjand University of Medical Sciences
Full name of responsible person
Feridoon Keramatinia
Street address
Moallem Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5000
Email
Feridoon.keramati@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Tooba Kazemi
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1200
Email
drtooba.kazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences
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
Birjand University of Medical Sciences
Full name of responsible person
Feridoon Keramatinia
Position
MSc Student of Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5641
Email
Feridoon.keramati@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Feridoon Keramatinia
Position
MSc Student of Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5641
Email
Feridoon.keramati@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Bagher Roozgar
Position
Translator
Latest degree
Master
Other areas of specialty/work
Others
Street address
Ghaffari St.,
City
Birjand,
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5680
Fax
+98 56 3242 0447
Email
roozgar@bums.ac.ir

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
Not applicable
Title and more details about the data/document
Deidentified Individual Participant Data Set
When the data will become available and for how long
After the paper extracted from the research project is published and for 6 months
To whom data/document is available
to readers of the paper
Under which criteria data/document could be used
for research purposes
From where data/document is obtainable
personal correspondence with the corresponding author
What processes are involved for a request to access data/document
email
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