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Effectiveness Analysis of Web-Based Cognitive Behavioral Therapy on Cognitive Processing and Regulation in Depression and Anxiety

Protocol summary

Study aim
To study the effectiveness of web-based cognitive behavioral intervention on reducing depression and anxiety in students; to evaluate the cognitive-emotional network’s role in enhancing cognitive processing and regulation (including thought suppression, cognitive avoidance, cognitive insight, and negative metacognition); to assess self-stigma’s role in effectiveness; to check effect durability at 1- and 3-month follow-ups
Design
Quasi-experimental trial with pre-test/post-test design; simple random allocation of eligible students; no blinding; sample size 40 (30 main, 10 reserves for dropout)
Settings and conduct
Study conducted online at Maragheh University; MOODGYM intervention with weekly 15-minute phone/online sessions for progress tracking; no blinding
Participants/Inclusion and exclusion criteria
Maragheh University students; CES-D score 7-40 and K10 score 9-29; age 18-30; internet access and web program ability; B1 English proficiency (min. 10/15 on Test of English Proficiency); informed consent; no concurrent therapy or psychotropic drugs; excluded for severe disorders, unwillingness, or incomplete participation
Intervention groups
Intervention group receives web-based cognitive behavioral therapy via MOODGYM for 5 weeks with weekly 15-minute phone/online sessions for progress monitoring; control group receives no intervention and acts as a comparison group
Main outcome variables
Outcome variables include depression scores (Beck Depression Inventory and CES-D), anxiety scores (Beck Anxiety Inventory and K10), cognitive processing indicators (thought suppression and cognitive avoidance), cognitive regulation indicators (cognitive insight and negative metacognitions), and follow-up assessments at 1- and 3-month intervals.

General information

Reason for update
Acronym
IOTMDA
IRCT registration information
IRCT registration number: IRCT20250521065839N1
Registration date: 2025-10-22, 1404/07/30
Registration timing: retrospective

Last update: 2025-10-22, 1404/07/30
Update count: 0
Registration date
2025-10-22, 1404/07/30
Registrant information
Name
Alireza Abdi
Name of organization / entity
The University of Maragheh
Country
Iran (Islamic Republic of)
Phone
+98 41 3439 2146
Email address
alirezaabdiinvkr@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-06-14, 1404/03/24
Expected recruitment end date
2025-07-15, 1404/04/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness Analysis of Web-Based Cognitive Behavioral Therapy on Cognitive Processing and Regulation in Depression and Anxiety
Public title
Impact of Online Therapy with MOODGYM on Depression and Anxiety
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Score between 9 and 29 on the K10 Score between 7 and 40 on the CES-D Not receiving concurrent psychological treatments Not using psychotropic medications Willingness and signed informed consent form Proficiency in English at B1 level or higher Be a student at the University of Maragheh Have access to the internet and the ability to use web-based programs
Exclusion criteria:
Diagnosis of severe psychiatric disorders such as schizophrenia or bipolar disorder Use of psychotropic medications that may affect intervention outcomes
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
This study used simple randomization The unit of randomization was individuals Gender balancing was applied with 2 males assigned to the intervention group and 2 males to the control group The randomization tool was a random number table The random sequence was generated by dividing 30 participants into two groups of 15 using a random number table Allocation concealment will be implemented using group coding
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This quasi-experimental study employed a pre-test/post-test control group design. Participants were randomly allocated with gender balancing (two males per group). The intervention group received the web-based MoodGYM program, while the control group was placed on a waiting list. Initial screening was conducted to identify eligible participants before recruitment began.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees Certificate
Street address
University of Tabriz, East Azerbaijan Province, Tabriz، 29 Bahman Boulevard
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2025-07-23, 1404/05/01
Ethics committee reference number
IR.TABRIZU.REC.1404.073

Health conditions studied

1

Description of health condition studied
Depression
ICD-10 code
F32.1
ICD-10 code description
Major depressive disorder, single episode, moderate

2

Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder

Primary outcomes

1

Description
Severity of depression symptoms
Timepoint
Measurement at baseline (before intervention), at the end of week 6 (post-intervention), and at 1-month and 3-month follow-ups
Method of measurement
Center for Epidemiologic Studies Depression Scale

2

Description
Severity of anxiety symptoms
Timepoint
Measurement at baseline (before intervention), at the end of week 6 (post-intervention), and at 1-month and 3-month follow-ups
Method of measurement
Beck Anxiety Inventory

Secondary outcomes

1

Description
Thought suppression level
Timepoint
Measurement at baseline (before intervention), at the end of week 6 (post-intervention), and at 1-month and 3-month follow-ups
Method of measurement
Wegner Thought Suppression Inventory

2

Description
Cognitive avoidance level
Timepoint
Measurement at baseline (before intervention), at the end of week 6 (post-intervention), and at 1-month and 3-month follow-ups
Method of measurement
Cognitive Avoidance Questionnaire

3

Description
cognitive insight
Timepoint
Measurement at baseline (before intervention), at the end of week 6 (post-intervention), and at 1-month and 3-month follow-ups
Method of measurement
Beck Cognitive Insight Scale

4

Description
negative metacognitions
Timepoint
Measurement at baseline (before intervention), at the end of week 6 (post-intervention), and at 1-month and 3-month follow-ups
Method of measurement
Metacognitions Questionnaire

5

Description
Level of emotion regulation strategies
Timepoint
Measurement at baseline (before intervention), at the end of week 6 (post-intervention), and at 1-month and 3-month follow-ups
Method of measurement
Emotion Regulation Questionnaire

6

Description
Level of perceived social stigma due to depression
Timepoint
Measurement at baseline (before intervention), at the end of week 6 (post-intervention), and at 1-month and 3-month follow-ups
Method of measurement
Depression Stigma Scale ( SSDS )

Intervention groups

1

Description
Intervention group: Intervention group: Participants receive a 5-week Internet-based Cognitive Behavioral Therapy (ICBT) intervention using the MoodGYM program, consisting of one module per week. Additionally, they participate in weekly 10-15 minute telephone follow-up sessions conducted by a trained facilitator to monitor progress and provide support.
Category
Behavior

2

Description
Control group: Control group: Participants are placed on a waitlist and receive no intervention during the 5-week study period. They will be offered access to the ICBT intervention with MoodGYM after the study completion.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
University of Maragheh
Full name of responsible person
Alireza Abdi
Street address
Daneshgah Boulevard , Madar Square , Maragheh University ,Maragheh , East Azarbaijan , Iran
City
Maragheh
Province
East Azarbaijan
Postal code
۵۵۱۸۷۷۹۸۴۰ - ۵۵۱۸۷۷۹
Phone
+98 41 3727 6060
Email
info@maragheh.ac.ir
Web page address
https://www.maragheh.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Maragheh
Full name of responsible person
Dr. Ali Afshari
Street address
Daneshgah Boulevard , Madar Square , Maragheh University ,Maragheh , East Azarbaijan , Iran
City
Maragheh
Province
East Azarbaijan
Postal code
۵۵۱۸۷۷۹۸۴۰ - ۵۵۱۸۷۷۹
Phone
+98 41 3727 8001
Email
info@maragheh.ac.ir
Web page address
https://www.maragheh.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Maragheh
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
University of Maragheh
Full name of responsible person
Alireza Abdi
Position
Research Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Daneshgah Boulevard , Madar Square , Maragheh University ,Maragheh , East Azarbaijan , Iran
City
Maragheh
Province
East Azarbaijan
Postal code
۵۵۱۸۷۷۹۸۴۰ - ۵۵۱۸۷۷۹
Phone
+98 41 3727 8001
Email
info@maragheh.ac.ir
Web page address
https://www.maragheh.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Maragheh
Full name of responsible person
Dr. Ali Afshari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Daneshgah Boulevard , Madar Square , Maragheh University ,Maragheh , East Azarbaijan , Iran
City
Maragheh
Province
East Azarbaijan
Postal code
۵۵۱۸۷۷۹۸۴۰ - ۵۵۱۸۷۷۹
Phone
+98 41 3727 8001
Fax
Email
afshari@maragheh.ac.ir
Web page address
https://www.maragheh.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
University of Maragheh
Full name of responsible person
Alireza Abdi
Position
Research Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Daneshgah Boulevard , Madar Square , Maragheh University ,Maragheh , East Azarbaijan , Iran
City
Maragheh
Province
East Azarbaijan
Postal code
۵۵۱۸۷۷۹۸۴۰ - ۵۵۱۸۷۷۹
Phone
+98 41 3727 8001
Email
alirezaabdiinvkr@gmail.com
Web page address
https://www.maragheh.ac.ir/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Individual participant data (IPD) will not be shared to protect participant confidentiality and comply with ethical guidelines set by the University of Tabriz Biomedical Ethics Committee, from which the ethical approval was obtained. Aggregated, de-identified data will be available instead.
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
No - There is not 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
No - There is not a plan to make this available
Title and more details about the data/document
Study Protocol: Detailed document outlining the study design, methodology, and procedures for the web-based cognitive-behavioral therapy trial.
When the data will become available and for how long
Access will begin approximately 1 month after study completion and receipt of the trial registration code (expected post-September 2025), with a possible extension to 3 months, and will last for 5 years.
To whom data/document is available
Access is granted to academic researchers affiliated with recognized academic institutions.
Under which criteria data/document could be used
Data is intended for academic research purposes only, requiring a written request detailing the research objectives, submitted to the University of Tabriz Biomedical Ethics Committee for approval.
From where data/document is obtainable
Requests should be submitted to the University of Tabriz Biomedical Ethics Committee. Contact details to be confirmed with the university (tentative email: tabrizubioethics@gmail.com, subject to verification).
What processes are involved for a request to access data/document
Requests will be reviewed within 30 days by the University of Tabriz Biomedical Ethics Committee, with approval notification sent via email, followed by data access within 15 days of approval.
Comments
The study population was not specified in the title to align with the approved protocol by the University of Tabriz Biomedical Ethics Committee.
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