Protocol summary

Study aim
Determining the Effect of CBGT on Self-esteem and Optimism in Patients with Major Depression
Design
80 Eligible Individuals Were Selected By Convenience Sampling. Samples were selected From Those Admitted to the Wards as Well as from those who Referred to the clinic. Then, using the cards on which 40 of them have the word A (intervention group) and the other 40 words B (control group) are written. These people randomly selected one of these cards and were placed in the control or intervention group. The intervention group was divided into 4 groups of 10. The Questionnaires were filled out in such a way that at the moment when the patients were in the Control Group, they completed the Questionnaires and the people in the Intervention group Coordinated in a Previous Session. The test Completed the Questionnaires.
Settings and conduct
Group Therapy in Addition to Routine Interventions (Drug Therapy, Electro-shock therapy) for Each Intervention Group was Held in 8 sessions of 90 minutes with a Frequency of two Sessions Per Week in the Hospital Amphitheater. The control group received only routine interventions (drug therapy, Electroconvulsive Therapy).
Participants/Inclusion and exclusion criteria
Entry Requirements: 1) Having Major Depression 2) Satisfaction to Participate In Research 3) Do not Use Other psychotherapy and Counseling services During the Sessions 4) Have a Minimum of Literacy Tips
Intervention groups
The individuals in the intervention group attended 8 sessions of 90 minutes in the hospital amphitheater and participated sessions of cognitive-behavioral group therapy (in addition to receiving routine treatments). The control group received only routine therapies
Main outcome variables
1. Cognitive-Behavioral GroupTherapy 2. Self esteem 3. Optimism 4. Ages 5. Gender 6. Levels of Education 7. Length of Admission 8. period of Illness 9. Employment Status 10. Marital Status

General information

Reason for update
Acronym
CBT
IRCT registration information
IRCT registration number: IRCT20140212016564N15
Registration date: 2021-09-20, 1400/06/29
Registration timing: retrospective

Last update: 2021-09-20, 1400/06/29
Update count: 0
Registration date
2021-09-20, 1400/06/29
Registrant information
Name
Molood Radfar
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 1275 4961
Email address
radfar.m@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-01, 1397/05/10
Expected recruitment end date
2018-09-05, 1397/06/14
Actual recruitment start date
2018-08-01, 1397/05/10
Actual recruitment end date
2018-10-12, 1397/07/20
Trial completion date
2018-10-12, 1397/07/20
Scientific title
The Effect Of Cognitive-Behavioral Group Therapy On Self-esteem And Optimism Of Patient With Major Depression
Public title
The Effect Of Cognitive-Behavioral Group Therapy On Self-esteem And Optimism Of Patient With Major Depression
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction to Attend Research Not Using Other Mental Health Services And Counseling During Meetings Not participating In The Same previous Study Have a Minimum Of Literacy Tips Stable Patients According to Psychiatrist
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Actual sample size reached: 64
Randomization (investigator's opinion)
Randomized
Randomization description
From the study population, 80 eligible individuals were selected by convenience sampling. Using cards with 40 words A (intervention group) and 40 words B (control group) written on them, the samples randomly selected one of these cards and were placed in the control or intervention group. . The intervention group was divided into 4 groups of 10. The questionnaires were filled out in such a way that at the moment when the patients were in the control and intervention groups, they filled in the questionnaires during coordination in a pre-test session.
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
Ethic committee of Urmia University of Medical Sciences
Street address
Pardis Nazlou, 11 km of Nazlou Road,Urmia,Iran
City
Urmia
Province
West Azarbaijan
Postal code
57561-15335
Approval date
2018-04-05, 1397/01/16
Ethics committee reference number
IR.UMSU.REC.1397.116

Health conditions studied

1

Description of health condition studied
Major Depression
ICD-10 code
F32.4
ICD-10 code description
Major depressive disorder, single episode, in partial remission

Primary outcomes

1

Description
Self-esteem
Timepoint
Before Intervention,Immediately After Intervention, Three Months After Intervention And Six Months After Intervention.
Method of measurement
Completion Of Rosenberg Self-Esteem Questionnaire Before The Intervention, Immediately After The Intervention, Three And Six Months After The Intervention By the Research Units

Secondary outcomes

1

Description
Optimisim
Timepoint
Before Intervention,Immediately After Intervention, Three Months After Intervention And Six Months After Intervention.
Method of measurement
Completion Of Schier and Carver Optimism Questionnaire Before The Intervention, Immediately After The Intervention, Three And Six Months After The Intervention By The Research Units.

2

Description
Optimism
Timepoint
Immediately after the intervention, 3 and 6 months after the intervention
Method of measurement
schier and carver optimism questionnaire

Intervention groups

1

Description
Intervention Group: The Intervention Group Was Divided In To 4 Groups Of 10 People. In addition to routine interventions (Pharmacotherapy), each intervention group received cognitive-behavioral therapy in 8 sessions of 90 minutes with a frequency of two sessions per week. Each session consisted of four stages, (1) reviewing the content of the previous session, (2) presenting a new topic, (3) group discussion about the new topic, (4) summarizing the content with patients and catering.
Category
Behavior

2

Description
Control Group: The Control Group Received only routine (Pharmacotherapy) Interventions.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Medical Education Center, Urmia
Full name of responsible person
moloud radfar
Street address
Pardis Nazlou, 11 km of Nazlou Road,Urmia,Iran
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3275 4961
Fax
+98 44 3222 9059
Email
mradfar1343@gmail.com
Web page address
http://www.umsu.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Moloud Radfar
Street address
Pardis Nazlou, 11 km of Nazlou Road,Urmia
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+98 44 3275 4961
Fax
+98 44 3222 9059
Email
mradfar1343@gmail.com
Web page address
http://www.umsu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Urmia 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
Oroumia University of Medical Sciences
Full name of responsible person
Moloud Radfar
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Pardis Nazlou, 11 km of Nazlou Road,Urmia,Iran
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+98 44 3275 4961
Fax
+98 44 3222 9059
Email
mradfar1343@gmail.com
Web page address
http://www.umsu.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Moloud Radfar
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Pardis Nazlou, 11 km of Nazlou Road,Urmia,Iran
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3275 4961
Fax
+98 44 3222 9059
Email
mradfar1343@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Saeed Yavari
Position
Master of Psychiatric Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hazratpour St.-Zarrin St. -16 Meters first Sana Building 3 Unit 1
City
urmia
Province
West Azarbaijan
Postal code
5715169987
Phone
+98 44 4633 5618
Fax
+98 44 3275 4921
Email
saeedyavari044@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
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The section on the consequences of study (self-esteem and optimism) will be shared.
When the data will become available and for how long
6 months after publishing the results as an article
To whom data/document is available
for research project and article reviewer
Under which criteria data/document could be used
Other people cannot access the data.
From where data/document is obtainable
Moloud Radfra e-mail: mradfar1343@gmail.com
What processes are involved for a request to access data/document
Request through the Vice Chancellor for Research
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