Protocol summary

Study aim
A Comparative Study on the Efficacy of a Positive Cognitive-Behavioral therapy and a Cognitive Behavioral Therapy, in depression
Design
Among of people that received the diagnosis according to the criteria for entry and exit, a list was prepared, and accidentally selected 60 of them, and accidentally splited into three groups. One of the groups as a witness, second group as a the experimental group 1 (Positive cognitive behavioral therapy), and Third group as a experimental group 2 (cognitive behavioral therapy), Were tested.
Settings and conduct
First, five school selected among The first middle school boys in Mayamey and shahrood cities. Then, The beck depression scale was implemented, and were choosen those who are above cutting score. Then, Psychiatric interview was presented
Participants/Inclusion and exclusion criteria
Entry criterions: 1- Having mild to moderate depression criteria 6- Age range from 13 to 16 years Exit criterions: 1- having criteria for severe depression or any other psychiatric disorder 2- having a chronic and severe physical illness 3- taking any psychoactive drug 4- having cognitive states such as low levels of mental disability 5- Parents are separated 6- having Family problems
Intervention groups
1- Intervention description: 10 sessions of one and a half hours of cognitive-behavioral therapy Classification: behavioral 2- Intervention description: 10 sessions of one and a half hours of positive cognitive-behavioral therapy Classification: behavioral 3- Intervention description: nonintervention
Main outcome variables
depression, subjective well-being, resiliency, self-efficacy , self-esteem

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171231038158N1
Registration date: 2018-01-11, 1396/10/21
Registration timing: retrospective

Last update: 2018-01-11, 1396/10/21
Update count: 0
Registration date
2018-01-11, 1396/10/21
Registrant information
Name
Ali Beygi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3263 6889
Email address
ali.beygi@semnan.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-12, 1396/09/21
Expected recruitment end date
2017-12-24, 1396/10/03
Actual recruitment start date
2017-12-12, 1396/09/21
Actual recruitment end date
2017-12-26, 1396/10/05
Trial completion date
empty
Scientific title
A Comparative Study on the Efficacy of a Positive Cognitive-Behavioral therapy and a Cognitive Behavioral Therapy, in depression, subjective well-being, resiliency, self-efficacy and self-esteem for adolescences with depression signs.
Public title
A Comparative Study on the Efficacy of a Positive Cognitive-Behavioral therapy and a Cognitive Behavioral Therapy, in depression.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
having depression symptom according to Beck Depression Scale and Diagnostic Interview age: 13- 16
Exclusion criteria:
having criteria for severe depression or any other psychiatric disorder having a chronic and severe physical illness taking any psychoactive drug having cognitive states such as low levels of mental disability
Age
From 13 years old to 16 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Actual sample size reached: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: clustered randomization Randomization unit:Cluster randomization Randomization layers: not having Randomization tools: drawing creation a random sequence: First, five school selected among The first middle school boys in Mayamey and shahrood cities. Then, The beck depression scale was implemented. Among of people that received the diagnosis according to the criteria for entry and exit, a list was prepared, and accidentally selected 60 of them, and accidentally splited into three groups. One of the groups as a witness, second group as a the experimental group 1 (Positive cognitive behavioral therapy), and Third group as a experimental group 2 (cognitive behavioral therapy), Were tested.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
کمیته اخلاق دانشگاه علوم پزشکی سمنان
Secondary trial Id
IR.SEMUMS.REC.1396.169
Registration date
2017-12-12, 1396/09/21

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committe of Semnan university of medical science
Street address
Headquarters of Semnan University of Medical Sciences- Basij Boulevard
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2017-12-12, 1396/09/21
Ethics committee reference number
IR.SEMUMS.REC.1396,169

Health conditions studied

1

Description of health condition studied
Mild and moderate depression
ICD-10 code
F32.0
ICD-10 code description
Major depressive disorder, single episode, mild

Primary outcomes

1

Description
Depression
Timepoint
Before intervention - Immediately after intervention - one month after the intervention
Method of measurement
Beck Depression Scale

Secondary outcomes

1

Description
Well-Being
Timepoint
Pre-test at the beginning of the study - Post-test after intervention - Follow up one month after the intervention
Method of measurement
Adolescent Well-Being scale

2

Description
Resiliency
Timepoint
Pre-test at the beginning of the study - Post-test after intervention - Follow up one month after the intervention
Method of measurement
Connor and Devidson resiliency scale

3

Description
Self-esteem
Timepoint
Pre-test at the beginning of the study - Post-test after intervention - Follow up one month after the intervention.
Method of measurement
Rosenberg Self-Esteem Scale

4

Description
Self efficacy
Timepoint
Pre-test at the beginning of the study - Post-test after intervention - Follow up one month after the intervention.
Method of measurement
Schwartz and Jerosselm Self-efficacy Scale

Intervention groups

1

Description
Intervention group 1:10 sessions one and a half hours Cognitive behavioral therapy
Category
Behavior

2

Description
Intervention group 2 : 10 sessions one and a half hours Positive cognitive behavioral therapy
Category
Behavior

3

Description
Control group: nonintervention
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Miami Education Bureau
Full name of responsible person
Saemi Abbas
Street address
Emam Avenue - Education Bureau
City
Mayamey
Province
Semnan
Postal code
3638141459
Phone
+98 23 3262 2502
Email
ali.beygi@yahoo.com
Web page address
http://mayamei.semnan.medu.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Assistant at Semnan University
Full name of responsible person
Mahmood Najafi
Street address
School of Psychology and Educational Sciences - Mehdishahr - ُSemnan
City
Semnan
Province
Semnan
Postal code
3564111156
Phone
+98 23 3362 3300
Email
M_najafi2005@yahoo.com
Web page address
http://psy.semnan.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Assistant at Semnan 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
semnan university
Full name of responsible person
Mahmmood Najafi
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
School of Psychology and Educational Sciences - Mehdishahr- Semnan
City
Mahdishahr
Province
Semnan
Postal code
3564111156
Phone
+98 23 3362 4250
Email
m_najafi2005@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan university
Full name of responsible person
Ali Beygi
Position
student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
School of Psychology and Educational Sciences - Mahdishahr - Semnan
City
Semnan
Province
Semnan
Postal code
3638141459
Phone
+98 23 3263 6889
Email
Ali.beygi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan university
Full name of responsible person
Ali Beygi
Position
student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
School of Psychology and Educational Sciences - Mahdishahr - Semnan
City
Semnan
Province
Semnan
Postal code
36381414590912873164
Phone
+98 23 3263 6889
Email
Ali.beygi@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Not applicable
Title and more details about the data/document
Scientific journals and ISI
When the data will become available and for how long
On line
To whom data/document is available
Psychologists and psychiatrists
Under which criteria data/document could be used
Research and treatment and education
From where data/document is obtainable
Scientific journals, Iran Scientific Documents Database and Email: Ali.beygi@yahoo.com
What processes are involved for a request to access data/document
Message to email address
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