]>
IRCT20250521065839N1 IRCT 2025-10-22 University of Maragheh Impact of Online Therapy with MOODGYM on Depression and Anxiety IOTMDA Effectiveness Analysis of Web-Based Cognitive Behavioral Therapy on Cognitive Processing and Regulation in Depression and Anxiety 2025-06-14 anticipated 40 Complete https://irct.ir/trial/83934 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, 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, 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. N/A Condition 1: Depression. Condition 2: Anxiety. Intervention 1: 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. Intervention 2: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is 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.
public Alireza Abdi
Daneshgah Boulevard , Madar Square , Maragheh University ,Maragheh , East Azarbaijan , Iran
Maragheh Iran (Islamic Republic of) ۵۵۱۸۷۷۹۸۴۰ - ۵۵۱۸۷۷۹ +98 41 3727 8001 info@maragheh.ac.ir University of Maragheh scientific Dr. Ali Afshari
Daneshgah Boulevard , Madar Square , Maragheh University ,Maragheh , East Azarbaijan , Iran
Maragheh Iran (Islamic Republic of) ۵۵۱۸۷۷۹۸۴۰ - ۵۵۱۸۷۷۹ +98 41 3727 8001 afshari@maragheh.ac.ir University of Maragheh Iran (Islamic Republic of) 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 18 years no limit Both Diagnosis of severe psychiatric disorders such as schizophrenia or bipolar disorder Use of psychotropic medications that may affect intervention outcomes F32.1 F41.1 Major depressive disorder, single episode, moderate Generalized anxiety disorder Behavior Other 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. 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. 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. 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. 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. 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. 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. 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. 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. 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 ). University of Maragheh Approved 2025-07-23 Research Ethics Committees Certificate University of Tabriz, East Azerbaijan Province, Tabriz، 29 Bahman Boulevard Tabriz East Azarbaijan Iran (Islamic Republic of)