Protocol summary

Study aim
1. Determine the average professional ethics score of medical students during the psychology internship before and after (immediately and one month later) digital cognitive behavioral training. 2. Compare the average professional ethics score of medical students during the psychology internship before and after (immediately and one month later) digital cognitive behavioral training
Design
All 32 eligible participants will be divided into two separate blocks based on their academic field, including nursing and emergency department students. Then, the random assignment process to two intervention and control groups will be carried out separately within each block. A Intervention (receiving the usual training of the psychiatric ward internship (such as psychiatric interview - learning about medications and giving them, nursing diagnosis and preparing the nursing process in the psychiatric ward) and digital CBT training) B Control (receiving the usual training of the psychiatric ward internship (such as psychiatric interview - learning about medications and giving them, nursing diagnosis and preparing the nursing process in the psychiatric ward) and not receiving digital CBT training)
Settings and conduct
Saveh Faculty of Medical Sciences - Psychiatric Department, Shahid Modarres Saveh Hospital. It will be double-blind
Participants/Inclusion and exclusion criteria
1. Students' willingness to participate in the study 2. Students' access to the digital learning program and channel via mobile phone
Intervention groups
Intervention (receiving standard training during the psychiatric ward internship (such as psychiatric interviewing - learning about medications and giving medications, nursing diagnosis and preparing the nursing process in the psychiatric ward) and digital CBT training)
Main outcome variables
Promoting professional ethics by considering psychosocial criteria

General information

Reason for update
Acronym
CBT
IRCT registration information
IRCT registration number: IRCT20260720070267N1
Registration date: 2026-10-13, 1405/07/21
Registration timing: registered_while_recruiting

Last update: 2026-10-13, 1405/07/21
Update count: 0
Registration date
2026-10-13, 1405/07/21
Registrant information
Name
zeynab pirallahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 919 052 1377
Email address
zeynabpirallahi@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-10-12, 1405/07/20
Expected recruitment end date
2026-12-21, 1405/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of digital cognitive behavioral training on the professional ethics of medical students during their psychology internship (an interventional study)
Public title
Investigating the effect of digital cognitive behavioral training on the professional ethics
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study Students' access to the digital education program and channel via mobile phone
Exclusion criteria:
Failure to fully participate in training sessions Unwillingness to continue participating in any phase of the study The occurrence of illness or special circumstances (personal or professional) that prevent continued participation in the study Previous experience in formal or specialized training in mental health management within the last six months Simultaneous participation in similar educational courses or related research
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 38
Randomization (investigator's opinion)
Randomized
Randomization description
Given that academic semester and field of study can affect the results of the study as a confounding variable, block randomization will be used to randomly assign participants. For this purpose, first, all 32 eligible participants are divided into two separate blocks based on their field of study, including nursing and emergency medicine students. Then, the random assignment process to the intervention and control groups is carried out separately within each block. In each block, each participant is assigned a unique identification code (from 1 to the number of people in that block). Using a random number table and starting from a random point, the numbers are read in order. If the number is even, the person is assigned to the intervention group and if it is odd, the person is assigned to the control group. This process continues until all people in that block are assigned.Finally, in each block, an approximately equal number of students (half to the intervention and half to the control) will be assigned, and a total of two intervention and control groups will be formed with an identical structure in terms of semester and field of study.Coding of intervention and control groups: There will be two intervention and control groups in this study, each of which will also be coded for random assignment: : A Intervention (receiving the usual training of the psychiatric ward internship (such as psychiatric interview, learning about medications and giving medications, nursing diagnosis, and preparing the nursing process in the psychiatric ward) and digital CBT training) : B Control (receiving the usual training of the psychiatric ward internship (such as psychiatric interview, learning about medications and giving medications, nursing diagnosis, and preparing the nursing process in the psychiatric ward) and not receiving digital CBT training) To ensure allocation concealment, the process of generating and maintaining the final allocation list will be carried out by an independent colleague who has no role in the intervention and evaluation stages. The implementation of the training will be carried out after the group of training sessions is determined according to the predetermined protocols for the intervention group.All participants in the intervention group will enter the group and educational channel via a link and receive digital cognitive behavioral training, and student movement between groups will be prevented to minimize the risk of educational contamination. Evaluation schedule: The assessment of the professional ethics variable will be conducted in 3 stages: Pre-test: before the start of the educational intervention Post-test: after the complete completion of the educational sessions and follow-up will be held one month after the last educational session. In order to comply with ethical issues and the absence of discrimination between the intervention and control groups, relevant training and educational materials will also be provided to the control group after taking the follow-up test
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants do not know whether they are in the intervention or control group. The analyst receives the data in numerical, encrypted form and does not know the information about each group
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Student Research Committee, Saveh University of Medical Sciences, Saveh, Iran
Street address
کمیته تحقیقات دانشجویی، دانشگاه علوم پزشکی ساوه، ساوه، ایران
City
saveh
Province
Markazi
Postal code
3914794881
Approval date
2026-08-18, 1405/05/27
Ethics committee reference number
IR.SAVEHUMS.REC.1405.020

Health conditions studied

1

Description of health condition studied
professional ethics
ICD-10 code
XXI
ICD-10 code description
XXI

Primary outcomes

1

Description
professional ethics
Timepoint
Before training - Immediately after the last training session - One month after the last training session
Method of measurement
Professional ethics questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: (Receiving standard training for psychiatric internships (such as psychiatric interviews, learning about medications and giving medications, nursing diagnosis, and preparing nursing processes in the psychiatric ward) and digital CBT training)
Category
Behavior

2

Description
Control group: (Receiving the usual training of the psychiatric ward internship (such as psychiatric interview - learning about medications and giving medications, nursing diagnosis and preparing the nursing process in the psychiatric ward) and not receiving digital CBT training)
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
دانشکده علوم پزشکی ساوه
Full name of responsible person
زینب پیراللهی
Street address
Alavi Town, Ghaem Street, Alley 4
City
saveh
Province
Markazi
Postal code
3914794881
Phone
+98 919 052 1377
Email
zeynabpirallahi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Saveh University of Medical Sciences
Full name of responsible person
زینب پیراللهی
Street address
Alavi Town, Ghaem Street, Alley 4
City
saveh
Province
Markazi
Postal code
3914794881
Phone
+98 919 052 1377
Email
zeynabpirallahi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Saveh 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
Saveh University of Medical Sciences
Full name of responsible person
زینب پیراللهی
Position
Faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Alavi Town, Ghaem Street, Alley 4
City
saveh
Province
Markazi
Postal code
3914794881
Phone
+98 86 4248 3166
Email
zeynabpirallahi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Saveh University of Medical Sciences
Full name of responsible person
زینب پیراللهی
Position
factuly
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Alavi Town, Ghaem Street, Alley 4
City
saveh
Province
Markazi
Postal code
3914794881
Phone
+98 86 4248 3166
Email
zeynabpirallahi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Saveh University of Medical Sciences
Full name of responsible person
زینب پیراللهی
Position
Faculty trainer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Alavi Town, Ghaem Street, Alley 4
City
saveh
Province
Markazi
Postal code
3914794881
Phone
+98 86 4248 3166
Email
zeynabpirallahi@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 data is provided anonymously and without any mention of it
When the data will become available and for how long
Access period begins 6 months after results are published
To whom data/document is available
For researchers working in academic and scientific institutions, submit an application via
Under which criteria data/document could be used
Submit a request via email
From where data/document is obtainable
Email
What processes are involved for a request to access data/document
Email will be responded to immediately upon request
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