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IRCT20250929067413N1 IRCT 2025-10-28 Islamic Azad University Investigating the effect of group psychological therapies on reducing anxiety and improving mental health in women with multiple sclerosis (MS). Comparing the effectiveness of acceptance and commitment group therapy with emotion regulation on the severity of worry, alexithymia, resilience, and psychological well-being of female patients with multiple sclerosis in Ahvaz. 2025-12-21 anticipated 45 Complete https://irct.ir/trial/86532 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization and Allocation Concealment Method and Process The randomization unit in this study was individual; meaning that each participant was independently and separately assigned to one of the two treatment groups. To maintain and balance the number of participants in the groups, a block randomization unit method with a block size of 4 was used. Randomization sequence using a random number tableIt was standardized and manually generated. In this sequence, the numbers 1 and 2 represented the treatment groups, respectively, and the allocation was based on randomly extracted numbers to maintain equal composition between the groups (15 people in each group). The construction of this sequence was done by an individual independent of the research team to avoid possible bias. To conceal allocation, opaque, sealed, and numbered envelopes were used. Each group code was placed inside the envelope, and participants received their respective envelopes in the order they arrived. After registering and obtaining written consent, their respective envelopes wereThe study was open-trial; therefore, after allocation, the treatment group was visible to the participant and therapist, but complete concealment was maintained until the moment of allocation. N/A Multiple sclerosis. Intervention 1: First intervention group: (Acceptance and Commitment Therapy sessions): For members of this group, the acceptance and commitment therapy protocol was implemented in 8 90-minute training sessions, one session per week, with PowerPoint, audio, and short videos. All six components of therapy, including acceptance, faultfinding, self, mindfulness, values ​​clarification, and commitment, will be implemented in the form of metaphors and exercises as homework.The acceptance and commitment treatment intervention was adapted from the Hayes (1999) manual and the acceptance and commitment program for chronic pain by Woolz and Sorrell (2008), which will be implemented in 8 90-minute sessions. The content of the acceptance and commitment treatment intervention has been used and validated in the study of Parvizian, Sharifi, Shekarkan, and Ghazanfari (2019). Below is a brief description of the intervention.The intervention is committed and accepted: First session: welcoming patients, introducing the therapist, introducing group members with the aim of getting to know each other and creating a good relationship in the group, introducing group members to the research topic, brief explanation about MS, patients answering research questionnaires, practicing mindfulness, presenting home exercises. Second session: reviewing the contents of the first session, receiving feedbackFrom patients, familiarization with the concept of resilience and psychological well-being using the brainstorming method, summarizing the discussion, practicing conscious breathing, presenting home exercises. Third session: Reviewing the contents of the previous session and receiving feedback from patients, expressing bus metaphors, 70th birthdayBirthday, Tombstone, and Values ​​Card (The Values ​​Card is a life compass based on the Ross Harris Happiness Trap Card set by Ali Sahebi and Mehdi Eskandari. This set consists of 59 values ​​cards and 13 action cards, which can be used to(The ability to direct the intervention method) Presentation of home practice. Session 4: Reviewing the assignment and reviewing the materials of the previous session, understanding the concept of acceptance in ACT, using the metaphors of the flower garden and the bus, we clarify that acceptance means giving space and creating a place for painful feelings, desires, and emotions without fighting and putting them aside, and clarifying thatThis does not mean loving or wanting them, it is simply creating space for them, mindfulness, providing home practice. Session 5: Reviewing the previous session and receiving feedback from patients, mindfulness practice, examining committed action from the perspective of ACT, which is a value-based action and evokes a wide range of desirable and undesirable thoughts and feelings; therefore, actionCommitted means doing the actions that are necessary to have a worthwhile life, even if they involve pain and suffering. Discussion of resilience and emotional alexithymia and their components, as well as the relationship between their level of influence on committed action. Practice conscious breathing. Presentation of home exercises. Session 6: Review of the previous session and receiving feedback from patients. Explanation of the concept.Fusion (fusion, holding thoughts firmly) and teaching how to break down using metaphors of river leaves, radio, etc., defining the goal in ACT and its difference from value, summarizing the discussions raised in the session, practicing conscious breathing, presenting home exercises. Session 7: Reviewing the previous session and getting feedback from patients, practicing mindfulness and emphasizing being in the moment.Now, examining the values ​​of the group members, discussing internal and external obstacles to achieving values, discussing setting short-term and long-term goals according to life values, practicing conscious breathing. Session 8: A brief review of previous sessions, explaining the nature of ACT training, which is acceptance and commitment to action, value-centeredness of life, and being committed to one's values.Patients' responses to the resilience, alexithymia, anxiety severity, and psychological well-being questionnaires again as a post-test, and thanking the patients for participating in the study. Intervention 2: Intervention group: Intervention Group 2: Content of emotion regulation therapy sessions for experimental group members 2. The emotion regulation therapy protocol will be implemented in 9 90-minute training sessions, one session per week, with PowerPoint, audio, and short videos. This intervention will be implemented with a technical approach based on the Linehan approach (2008) and the emotion regulation techniques of Leahy et al. (2020) after validation.Implemented these interventions in the target population. The following is a brief description of the emotion regulation intervention: Session 1: Administering pre-tests, explaining and providing a general description of the goals and programs of the training course. Session 2: Describing emotions and training in emotion awareness. Session 3: Describing emotion regulation, recognizingCognitive techniques and strategies in regulating positive emotions. Session Four: Strategies of note for changing thinking (re-evaluation) and accepting the situation. Session Five: Training and implementing the technique of confrontational thoughts. Strategies of note for changing thinking (re-evaluation). Session Six: Strategies of note for planning activities and seeing realities as pleasant. Session Seven: Training andImplementing the technique of enhancing emotional awareness. Session 8: Training and implementing the technique of de-catastrophizing. Strategies of interest: relaxation and meditation. Session 9: Strategies of interest: cognitive framing and problem solving. Session 10: Summarizing the training sessions and implementing the post-test. Intervention 3: Control group: No intervention was performed for the control group and the control group remained on the waiting list. Yes - There is a plan to make this available What will be shared: Information on primary and secondary outcomes will be collected using questionnaires. All data will be recorded in standard data collection forms and then imported into SPSS software as an Excel file for statistical analysis. Documents such as informed consent, protocol, etc.Intervention and patient education guides will also be prepared and maintained. To maintain confidentiality, data will be coded and stored anonymously, and only the principal investigator and the statistical analysis team will have access to them. When: Access begins 6 months after completion of data collection and final analysis. To whom: Researchers working in academic and scientific institutions Conditions: Data were collected to investigate the effectiveness of group psychological treatments on psychological parameters of patients with multiple sclerosis. These data may be used in the future for research purposes such as secondary analyses, development of treatment methods, scientific articles, and clinical education. Reuse of data is permitted only with written permission from the principal investigator and approval from the ethics committee. All data will be stored anonymously and no identifying information will be made available to individuals outside the research. Also, use of data in the form of related projects or student theses will be subject to formal approval from the principal investigator and compliance with data confidentiality. Public release of the data is not currently considered. . Where to obtain: Contact researcher Ms. Zahra Mousavi Moghadamz at 9160019095 or mousavimoghadamz@gmail.com How to obtain: Any request for access to data or documentation from this study must be made formally to the researcher via email or written letter. Upon receipt of the request, the subject will be referred to the team.The research will be reviewed and, if necessary, sent to the ethics committee for comment. If approved, the applicant will be required to sign a form for data confidentiality and scientific use.Only anonymous data without identifying information is provided to the applicant. The entire process takes between 2 and 4 weeks. Comments:
public Zahra Mousavi Moghadam
Shahid Danesh Town, No. 49, Farhangian St.
Shoush Iran (Islamic Republic of) 6478175224 +98 916 001 9095 mousavimoghadamz@gmail.com Islamic Azad University scientific Zahra Mousavi Moghadam
Shahid Danesh Town, No. 49, Farhangian St.
Shoush Iran (Islamic Republic of) 6478175224 +98 916 001 9095 mousavimoghadamz@gmail.com Islamic Azad University Iran (Islamic Republic of) Female Definitive diagnosis of multiple sclerosis (MS) Ability to participate regularly in group meetings no limit no limit Female Having a severe psychiatric disorder Participation in other concurrent psychological interventions Unwillingness to continue cooperation Reluctance to fill out questionnaires G35 Multiple sclerosis Lifestyle Lifestyle Lifestyle First intervention group: (Acceptance and Commitment Therapy sessions): For members of this group, the acceptance and commitment therapy protocol was implemented in 8 90-minute training sessions, one session per week, with PowerPoint, audio, and short videos. All six components of therapy, including acceptance, faultfinding, self, mindfulness, values ​​clarification, and commitment, will be implemented in the form of metaphors and exercises as homework.The acceptance and commitment treatment intervention was adapted from the Hayes (1999) manual and the acceptance and commitment program for chronic pain by Woolz and Sorrell (2008), which will be implemented in 8 90-minute sessions. The content of the acceptance and commitment treatment intervention has been used and validated in the study of Parvizian, Sharifi, Shekarkan, and Ghazanfari (2019). Below is a brief description of the intervention.The intervention is committed and accepted: First session: welcoming patients, introducing the therapist, introducing group members with the aim of getting to know each other and creating a good relationship in the group, introducing group members to the research topic, brief explanation about MS, patients answering research questionnaires, practicing mindfulness, presenting home exercises. Second session: reviewing the contents of the first session, receiving feedbackFrom patients, familiarization with the concept of resilience and psychological well-being using the brainstorming method, summarizing the discussion, practicing conscious breathing, presenting home exercises. Third session: Reviewing the contents of the previous session and receiving feedback from patients, expressing bus metaphors, 70th birthdayBirthday, Tombstone, and Values ​​Card (The Values ​​Card is a life compass based on the Ross Harris Happiness Trap Card set by Ali Sahebi and Mehdi Eskandari. This set consists of 59 values ​​cards and 13 action cards, which can be used to(The ability to direct the intervention method) Presentation of home practice. Session 4: Reviewing the assignment and reviewing the materials of the previous session, understanding the concept of acceptance in ACT, using the metaphors of the flower garden and the bus, we clarify that acceptance means giving space and creating a place for painful feelings, desires, and emotions without fighting and putting them aside, and clarifying thatThis does not mean loving or wanting them, it is simply creating space for them, mindfulness, providing home practice. Session 5: Reviewing the previous session and receiving feedback from patients, mindfulness practice, examining committed action from the perspective of ACT, which is a value-based action and evokes a wide range of desirable and undesirable thoughts and feelings; therefore, actionCommitted means doing the actions that are necessary to have a worthwhile life, even if they involve pain and suffering. Discussion of resilience and emotional alexithymia and their components, as well as the relationship between their level of influence on committed action. Practice conscious breathing. Presentation of home exercises. Session 6: Review of the previous session and receiving feedback from patients. Explanation of the concept.Fusion (fusion, holding thoughts firmly) and teaching how to break down using metaphors of river leaves, radio, etc., defining the goal in ACT and its difference from value, summarizing the discussions raised in the session, practicing conscious breathing, presenting home exercises. Session 7: Reviewing the previous session and getting feedback from patients, practicing mindfulness and emphasizing being in the moment.Now, examining the values ​​of the group members, discussing internal and external obstacles to achieving values, discussing setting short-term and long-term goals according to life values, practicing conscious breathing. Session 8: A brief review of previous sessions, explaining the nature of ACT training, which is acceptance and commitment to action, value-centeredness of life, and being committed to one's values.Patients' responses to the resilience, alexithymia, anxiety severity, and psychological well-being questionnaires again as a post-test, and thanking the patients for participating in the study. Intervention group: Intervention Group 2: Content of emotion regulation therapy sessions for experimental group members 2. The emotion regulation therapy protocol will be implemented in 9 90-minute training sessions, one session per week, with PowerPoint, audio, and short videos. This intervention will be implemented with a technical approach based on the Linehan approach (2008) and the emotion regulation techniques of Leahy et al. (2020) after validation.Implemented these interventions in the target population. The following is a brief description of the emotion regulation intervention: Session 1: Administering pre-tests, explaining and providing a general description of the goals and programs of the training course. Session 2: Describing emotions and training in emotion awareness. Session 3: Describing emotion regulation, recognizingCognitive techniques and strategies in regulating positive emotions. Session Four: Strategies of note for changing thinking (re-evaluation) and accepting the situation. Session Five: Training and implementing the technique of confrontational thoughts. Strategies of note for changing thinking (re-evaluation). Session Six: Strategies of note for planning activities and seeing realities as pleasant. Session Seven: Training andImplementing the technique of enhancing emotional awareness. Session 8: Training and implementing the technique of de-catastrophizing. Strategies of interest: relaxation and meditation. Session 9: Strategies of interest: cognitive framing and problem solving. Session 10: Summarizing the training sessions and implementing the post-test. Control group: No intervention was performed for the control group and the control group remained on the waiting list. Resilience: In this study, resilience refers to the score that subjects obtain based on their responses to the Connor and Davidson Resilience Scale (2003). Timepoint: It is measured with a pre-test and post-test before the start of the intervention and 8 weeks after the start of the intervention. Method of measurement: The Connor Davidson Resilience Scale has 25 items that are scored on a Likert scale from zero (completely false) to five (always true). The options on this scale are scored as follows: Complete false = 0 Rarely true = 1 Sometimes true = 2 Often true = 3 Always true = 4 Therefore, the test score range is between 0 and 100. Higher scores indicate greater resilience of the subject. Worry intensity: In this study, worry intensity refers to the score that subjects obtain based on their responses to the Penn State Worry Questionnaire. Timepoint: It is measured with a pre-test and post-test before the start of the intervention and 8 weeks after the start of the intervention. Method of measurement: The Penn State Worry Questionnaire was developed in 1990 by Zinberg and Barlow. It is a self-assessment tool for diagnosing the trait of worry and consists of 16 items.These items are designed to capture dimensions of generality, severity, and uncontrollability of pathological worry. Each item is rated on a 5-point scale (1 = not at all true of me to 5 = very true of me). The standard questionnaire has a scoring range of 16 to 80. In eleven itemsHigher scores indicate more worry. The other five items indicate no problems with worry, and these items are reverse scored. The reverse-scored items include questions 1-3-8-10-11. Scores of 16 to 39 indicate low worry; scores of 40 to 59 indicate moderate worry; and scores of 60 to 80 indicate high worry. Psychological well-being: Psychological well-being refers to the score that each subject obtained from responding to the psychological well-being questionnaire (Ryff Psychological Well-being Scale 1989). Timepoint: It is measured with a pre-test and post-test before the start of the intervention and 8 weeks after the start of the intervention. Method of measurement: Ryff Psychological Well-being Scale (1989) Short Form: This questionnaire has 18 questions and is derived from the original form with 120 questions. This version includes:There are 6 factors: independence (questions 9-12-18), mastery of the environment (questions 1-4-6), personal growth (questions 7-15-17), positive relationship with others factor (3, 11, 13), purpose in life (questions 5-14-16), and self-acceptance (questions 2-8-10). The scoring range of this questionnaire is based on a six-choice Likert scale.In this case, the options are: I completely disagree (1 point), I somewhat disagree (2 points), I slightly disagree (3 points), I slightly agree (4 points), I somewhat agree (5 points), I completely agree (6 points). Of course, this scoring method is reversed for questions 1, 3, 4, 5, 9, 10, 13, 17. The lowest score is 18 and the highest score is 108. Emotional alexithymia: The score that participants obtain on the Toronto Alexithymia Scale-20. Timepoint: It is measured with a pre-test and post-test before the start of the intervention and 8 weeks after the start of the intervention. Method of measurement: In this scale, the construct of alexithymia is assessed in three subscales: difficulty in recognizing emotions, difficulty in describing emotions, and externally oriented thinking. The first subscale consists of 7 items (14-13-9-7-6-3-1) that assess the subject's ability to identify emotions and differentiate between emotions and physical sensations. The second subscale has 5 items.(17-12-11-4-2) which measures a person's ability to express emotions and whether or not they are able to express their feelings in words. The third subscale has 8 items (20-19-18-16-15-10-8-5) and examines the degree to which a person is introspective and deeply involved in their own and others' inner feelings. Islamic Azad University Approved 2025-09-11 Ethics Committee of Islamic Azad University Shahid Danesh Town, No. 49, Farhangian St. Shoush Khouzestan Iran (Islamic Republic of)