Protocol summary

Study aim
The effectiveness of short-term cognitive-behavioral therapy for depressive disorders on academic performance, quality of life, and suicidal ideation of Shiraz University students
Design
The study population in this study is all undergraduate students at Shiraz University. The study sample is 234 people. First, a Beck Depression Inventory is administered and 30 people who meet the depression criteria are randomly selected and divided into two experimental and control groups, 15 people in each group.
Settings and conduct
Study location: Shiraz University; Study population: Students with depressive disorders ; Type of blinding: Blinding is not performed in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of depression based on the Beck Questionnaire; Student at Shiraz University; Completion of the informed consent form. Exclusion criteria: Having a psychotic disorder.
Intervention groups
Intervention group: The intervention will be implemented in this group based on the short-term cognitive-behavioral therapy charter for depressive disorders. After the intervention, they will be post-tested. Control group: they will be post-tested without implementing a short-term cognitive-behavioral therapy protocol for depressive disorders.
Main outcome variables
Academic performance; Quality of life; Suicidal ideation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250616066202N1
Registration date: 2025-09-07, 1404/06/16
Registration timing: prospective

Last update: 2025-09-07, 1404/06/16
Update count: 0
Registration date
2025-09-07, 1404/06/16
Registrant information
Name
Reza davasaz irani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 6919
Email address
reza.davasazirani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-20, 1404/06/29
Expected recruitment end date
2025-10-21, 1404/07/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of short-term cognitive-behavioral therapy of depressive disorders on academic performance, quality of life and suicidal ideation of university students
Public title
The effectiveness of cognitive-behavioral therapy on depressive disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of the disease based on the Beck questionnaire Student of Shiraz University Completing the informed consent form
Exclusion criteria:
Unwillingness to participate in a research study Having a psychotic disorder
Age
From 19 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 234
Randomization (investigator's opinion)
Randomized
Randomization description
Code Assignment: Each of the 30 participants will be assigned a unique identification code (from 1 to 30). Random Sequence Generation: Using the website www.random.org (which is a reputable random number generator service), a random list of numbers from 1 to 30 will be generated. Group Assignment: The first 15 numbers from this random list will be considered the “experimental” group and the next 15 numbers will be considered the “control” group. Implementation: The names of the participants corresponding to the codes selected for each group will be identified and assigned to the corresponding group.
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 Islamic Azad University of Ahvaz Branch
Street address
Islamic Azad University Ahvaz Branch, Farhang Shahr, Golestan Highway, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61349-37333
Approval date
2025-05-15, 1404/02/25
Ethics committee reference number
IR.IAU.AHVAZ.REC.1404.078

Health conditions studied

1

Description of health condition studied
Depressive disorders
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode

Primary outcomes

1

Description
Academic performance
Timepoint
Measurement of academic performance at the beginning of the study (before the start of the intervention, the first week) and immediately after the end of the last intervention session (the fourth week).
Method of measurement
Pham and Taylor Academic Performance Questionnaire

2

Description
Quality of life
Timepoint
Quality of life was measured at the beginning of the study (before the start of the intervention, the first week) and immediately after the end of the last intervention session (the fourth week).
Method of measurement
World Health Organization Short Form Quality of Life Questionnaire

3

Description
Suicidal ideation
Timepoint
Measurement of suicidal ideation at the beginning of the study (before the start of the intervention, the first week) and immediately after the end of the last intervention session (the fourth week).
Method of measurement
Beck Suicidal Ideation Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Subjects in the experimental group will undergo short-term cognitive-behavioral therapy over four 90-minute sessions over a period of one month. In the first session: establishing communication, talking about depressive disorders and the psychologically damaging effects, discussing the importance of lifestyle and its reducing factors, and practicing relaxation; Second session: awareness of the role of cognitive errors in the emergence and intensification of negative thoughts and providing a self-review table; Third session: teaching logical problem-solving skills and writing long-term and short-term goals; Fourth session: Review and practice of the therapeutic techniques taught with an emphasis on depression, determining the time for the relevant post-tests by sending questionnaires, and providing techniques for continuing and maintaining the recovery process will be taught.
Category
Treatment - Other

2

Description
Control group: No intervention is performed in this group.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shiraz University
Full name of responsible person
Mohammad Mozni
Street address
Shiraz University (Abivardi Neighborhood), Intersection of Daneshgah Boulevard, Jomhuri Eslami Boulevard, Eram Boulevard, Shiraz
City
Shiraz
Province
Fars
Postal code
7134846968
Phone
+98 71 3613 4000
Email
pr@shirazu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shahram Lak
Street address
Islamic Azad University Ahvaz Branch, Farhangshahr, Golestan Highway, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۳۴۹-۳۷۳۳۳
Phone
+98 61 3334 8421
Email
info@iauahvaz.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University, Ahvaz Branch
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Reza davasaz irani
Position
guest professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Dpartment of health, fatemi St,amaniyeh
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3314 0000
Email
Reza.davasazirani@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Reza Davasaz Irani
Position
guest professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Department of health, Fatemi Street, Amaniyeh
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3314 0000
Email
Reza.davasazirani@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Reza Davasaz Irani
Position
guest professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Department of health, Fatemi Street, Amaniyeh
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3314 0000
Email
Reza.davasazirani@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
No - There is not 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
All data obtained will be shared.
When the data will become available and for how long
Six months after implementing the independent variable and statistical analysis, access to the data will be available in the form of an article.
To whom data/document is available
Researcher; Supervisor; Professional experts
Under which criteria data/document could be used
For access by other researchers as a study background, as well as the relevant organization, whose results can lead to intervention for the target group.
From where data/document is obtainable
If accepted into a scientific or research journal, the researcher's first and last name will be listed along with an address and email address so that professionals can contact the researcher.
What processes are involved for a request to access data/document
After receiving a data request from a professional and expert in the above field, it is possible to send it with the opinion of the responsible author of the article.
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