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IRCT20250708066412N1 IRCT 2025-11-01 Zanjan University of Medical Sciences The comparison of the effectiveness of online group therapy and in-person therapy on depression and anxiety in patients with MS (Multiple Sclerosis). Effectiveness of Online vs. In-Person Unified Protocol Group Therapy on Transdiagnostic Components in Patients with Multiple Sclerosis Comorbid with Depression and Anxiety 2025-07-30 anticipated 40 Complete https://irct.ir/trial/85158 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Based on the selection criteria, a sample size of 40 individuals has been determined, all of whom are members of the MS Association in Zanjan. The sample will be selected using a convenience sampling method according to the inclusion criteria and will be randomly assigned to two groups: virtual intervention and online intervention. Each of these groups will be further divided into two subgroups of ten individuals. The two intervention groups will receive in-person and online therapy, respectively. Each group will consist of 20 individuals, Blinding description: In this trial, due to the nature of the interventions (online therapy versus in-person therapy), blinding of the participants and therapists was not feasible. The participants and therapists are naturally aware of the type of intervention they are receiving or delivering. However, to minimize bias in the outcome assessment and data analysis, a method of "outcome assessor and data analyst blinding" was employed. Outcome assessors, who were responsible for collecting primary outcome data (such as scores on psychological questionnaires, functional assessments, etc.), were kept unaware of the participants' group allocation. The individual or team who performed the final statistical analyses were unaware of the identity of the groups (i.e., which statistical code corresponded to the "online" group and which to the "in-person" group). The data provided to the analysts were labeled with neutral codes (e.g., "Group A" and "Group B"). The linkage between these codes and the actual group identities was only revealed after the completion of the primary statistical analyses, for the purpose of drafting the results. N/A Multiple Sclerosis. Intervention 1: Intervention group: In-Person Transdiagnostic Cognitive-Behavioral Therapy (Unified Protocol)** The intervention will be delivered in person using the Transdiagnostic Cognitive-Behavioral Therapy (Unified Protocol) for adults. This protocol consists of eight modules to be implemented over a minimum of 12 sessions. The modules include: (1) goal setting and maintaining motivation, (2) understanding emotions, (3) emotional mindfulness, (4) cognitive flexibility, (5) emotional behavior, (6) understanding and confronting bodily sensations, (7) emotion exposure, and (8) reviewing skills while progressing toward goals and maintaining achievements. The protocol primarily focuses on emotions and their three fundamental components: thoughts, bodily sensations, and behaviors. Within the thought component, emphasis is placed on identifying cognitive errors and cognitive restructuring. The bodily sensation component incorporates techniques to enhance awareness of physical sensations. For the behavior component, participants learn about emotional triggers and opposite action strategies. The intervention culminates with techniques for confronting situational emotions and conducting behavioral experiments. All modules will be delivered across 12 weekly sessions, each lasting 45 minutes, spanning approximately 12 weeks. Intervention 2: Intervention group: Online Transdiagnostic Cognitive-Behavioral Therapy (Unified Protocol)The intervention will be delivered online using the Transdiagnostic Cognitive-Behavioral Therapy (Unified Protocol) for adults. This protocol consists of eight modules to be implemented over 12 sessions. The modules include: (1) goal setting and maintaining motivation, (2) understanding emotions, (3) emotional mindfulness, (4) cognitive flexibility, (5) emotional behavior, (6) understanding and confronting bodily sensations, (7) emotion exposure, and (8) reviewing skills while progressing toward goals and maintaining achievements.The protocol primarily focuses on emotions and their three fundamental components: thoughts, bodily sensations, and behaviors. Within the thought component, emphasis is placed on identifying cognitive errors and cognitive restructuring. The bodily sensation component incorporates techniques to enhance awareness of physical sensations. For the behavior component, participants learn about emotional triggers and opposite action strategies. The intervention culminates with techniques for confronting situational emotions and conducting behavioral experiments. All modules will be delivered across 12 sessions, each lasting 45 minutes, spanning approximately 6 weeks with twice-weekly sessions. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Elahe karami
Dr. Beheshti Hospital, Darvazeh Ark
Zanjan Iran (Islamic Republic of) 1331713161 +98 992 061 7285 eliikaramiii@gmail.com Zanjan University of Medical Sciences scientific Elahe karami
Dr. Beheshti Hospital, Darvazeh Ark
Zanjan Iran (Islamic Republic of) 1331713161 +98 992 061 7285 eliikaramiii@gmail.com Zanjan University of Medical Sciences Iran (Islamic Republic of) Diagnosis of Multiple Sclerosis Minimum literacy level (at least middle school education) No history of addiction No other psychological treatments received during the study Age between 20 and 40 years No acute psychiatric disorders No severe physical disability, such as dependence on a wheelchair Score between 0 and 16 on the BDI-II (Beck Depression Inventory-II) Score between 0 and 25 on the BAI (Beck Anxiety Inventory) 20 years 40 years Both Development of severe psychiatric disorders Relapse of the disease or severe physical disability Development of severe physical disability (such as wheelchair dependence) during the study Absence from more than two sessions Recent experience of an acute psychological crisis Score higher than 16 on the BDI-II Score higher than 25 on the BAI G35 Multiple Sclerosis Treatment - Other Treatment - Other Intervention group: In-Person Transdiagnostic Cognitive-Behavioral Therapy (Unified Protocol)** The intervention will be delivered in person using the Transdiagnostic Cognitive-Behavioral Therapy (Unified Protocol) for adults. This protocol consists of eight modules to be implemented over a minimum of 12 sessions. The modules include: (1) goal setting and maintaining motivation, (2) understanding emotions, (3) emotional mindfulness, (4) cognitive flexibility, (5) emotional behavior, (6) understanding and confronting bodily sensations, (7) emotion exposure, and (8) reviewing skills while progressing toward goals and maintaining achievements. The protocol primarily focuses on emotions and their three fundamental components: thoughts, bodily sensations, and behaviors. Within the thought component, emphasis is placed on identifying cognitive errors and cognitive restructuring. The bodily sensation component incorporates techniques to enhance awareness of physical sensations. For the behavior component, participants learn about emotional triggers and opposite action strategies. The intervention culminates with techniques for confronting situational emotions and conducting behavioral experiments. All modules will be delivered across 12 weekly sessions, each lasting 45 minutes, spanning approximately 12 weeks. Intervention group: Online Transdiagnostic Cognitive-Behavioral Therapy (Unified Protocol)The intervention will be delivered online using the Transdiagnostic Cognitive-Behavioral Therapy (Unified Protocol) for adults. This protocol consists of eight modules to be implemented over 12 sessions. The modules include: (1) goal setting and maintaining motivation, (2) understanding emotions, (3) emotional mindfulness, (4) cognitive flexibility, (5) emotional behavior, (6) understanding and confronting bodily sensations, (7) emotion exposure, and (8) reviewing skills while progressing toward goals and maintaining achievements.The protocol primarily focuses on emotions and their three fundamental components: thoughts, bodily sensations, and behaviors. Within the thought component, emphasis is placed on identifying cognitive errors and cognitive restructuring. The bodily sensation component incorporates techniques to enhance awareness of physical sensations. For the behavior component, participants learn about emotional triggers and opposite action strategies. The intervention culminates with techniques for confronting situational emotions and conducting behavioral experiments. All modules will be delivered across 12 sessions, each lasting 45 minutes, spanning approximately 6 weeks with twice-weekly sessions. Fear of Disease Progression. Timepoint: Measurements will be conducted at three time points: before the intervention (baseline), immediately after the intervention completion (post-treatment), and three months after the intervention completion (3-month follow-up). Method of measurement: The individual's score on the Fear of Disease Progression Questionnaire (FoP-Q). Perceived Stress. Timepoint: Measurements will be conducted at three time points: before the intervention (baseline), immediately after the intervention completion (post-treatment), and three months after the intervention completion (3-month follow-up). Method of measurement: The participant's score on the Cohen Perceived Stress Scale (PSS). Intolerance of Uncertainty. Timepoint: Measurements will be conducted at three time points: before the intervention (baseline), immediately after the intervention completion (post-treatment), and three months after the intervention completion (3-month follow-up). Method of measurement: The respondent's Intolerance of Uncertainty Scale (IUS) score. Depresion. Timepoint: Measurements will be conducted at three time points: before the intervention (baseline), immediately after the intervention completion (post-treatment), and three months after the intervention completion (3-month follow-up). Method of measurement: BDI Questionnaire score. Anxiety. Timepoint: Measurements will be conducted at three time points: before the intervention (baseline), immediately after the intervention completion (post-treatment), and three months after the intervention completion (3-month follow-up). Method of measurement: BAI Questionnaire score. Zanjan University of Medical Sciences Approved 2025-01-20 Zanjan University of Medical Sciences Zanjan University of Medical Sciences Mahdavi Street Karmandan Town Zanjan, Iran Zanjan Zanjan Iran (Islamic Republic of)