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IRCT20250807066781N1 IRCT 2025-09-02 Islamic Azad University Comparison Of The Effectiveness Of Acceptance And Commitment Based Therapy With Schema Therapy On Depression, Health Anxiety, Adaptive Behavior And Psychological Hardiness In Patients With MS In Isfahan During The Covid-19 Epidemic. Comparison Of The Effectiveness Of Acceptance And Commitment Based Therapy With Schema Therapy On Depression, Health Anxiety, Adaptive Behavior And Psychological Hardiness In Patients With MS In Isfahan During The Covid-19 Epidemic 2025-09-23 anticipated 60 Complete https://irct.ir/trial/85880 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants were randomly assigned to one of three groups—Acceptance and Commitment Therapy (ACT), Schema Therapy, or Waitlist Control—in a 1:1:1 ratio. To ensure balance and control for potential confounders, randomization was stratified by gender (male/female) and disease severity (EDSS < 3.5 vs. ≥ 3.5). Within each stratum, variable block sizes (3, 6, and 9) were used to generate the allocation sequence. The random sequence was generated by an independent researcher using computer-based random number generation with a fixed seed to allow reproducibility. Allocation concealment was achieved through the use of sequentially numbered, opaque, sealed envelopes (SNOSE), prepared for each stratum. After informed consent was obtained and baseline assessment (T1) was completed, the study coordinator opened the next envelope corresponding to the participant’s stratum to determine group assignment. Outcome assessors at post-test (T2) and follow-up (T3) were blinded to participants’ group allocation to reduce bias. Data analysis followed the intention-to-treat principle, and participant flow through each stage of the study was documented using a CONSORT flow diagram, Blinding description: Due to the nature of psychological interventions, it was not possible to blind the participants to the type of treatment they received. However, to minimize bias, the study was conducted in a single-blind manner. Specifically, the outcome assessor who was responsible for data collection and analysis was blinded to the group allocation (Acceptance and Commitment Therapy vs. Schema Therapy). This procedure was implemented to enhance the accuracy of assessments and reduce the influence of researcher or participant expectations on the study outcomes. N/A multiple sclerosis. Intervention 1: Intervention group: Acceptance and Commitment Therapy (ACT) group:Participants in this group will attend structured group sessions based on the ACT approach. The intervention focuses on enhancing acceptance of internal experiences, fostering present-moment awareness, clarifying personal values, and promoting commitment to adaptive behaviors. Intervention 2: Intervention group: Schema Therapy group:Participants in this group will attend group sessions based on Young’s schema therapy model. The intervention emphasizes identifying and modifying early maladaptive schemas and supporting patients in developing healthier emotional and behavioral patterns. Intervention 3: Control group: Participants in the control group received only their routine medical care throughout the study period and did not attend any of the psychological intervention sessions (Acceptance and Commitment Therapy or Schema Therapy). To address ethical considerations, access to similar therapeutic services was provided to these participants after the completion of the study. Yes - There is a plan to make this available What will be shared: "Study results along with anonymized participant data" When: "From the time of publication until one year thereafter" To whom: "All researchers and clinical specialists" Conditions: "For clinical and research purposes" Where to obtain: Formal request to the corresponding author How to obtain: Initially discussed within the research team, and ultimately, the data will be shared upon approval Comments:
public Lotfollah Saberian
Zahedan
Zahedan Iran (Islamic Republic of) 9816743545 +98 913 591 1725 lotfollahsaberian@gmail.com Islamic Azad University scientific Lotfollah Saberian
Zahedan
Zahedan Iran (Islamic Republic of) 9816743545 +98 913 591 1725 lotfollahsaberian@gmail.com Islamic Azad University Iran (Islamic Republic of) Definitive diagnosis of MS based on medical records or neurologist criteria. Age: 18 to 60 years. Education level: Minimum literacy (to complete questionnaires). Clinical status: Mild to moderate depression (based on standard questionnaire) Written consent: Informed willingness to participate in research. 18 years 60 years Both Having severe psychiatric disorders Changing psychiatric or neurological medications during the study Concurrent participation in other psychological treatments Missing more than two therapy sessions Unwillingness to continue cooperation or withdrawal of consent Having a serious physical illness that prevents you from continuing your sessions G35 Multiple sclerosis Treatment - Other Treatment - Other Other Intervention group: Acceptance and Commitment Therapy (ACT) group:Participants in this group will attend structured group sessions based on the ACT approach. The intervention focuses on enhancing acceptance of internal experiences, fostering present-moment awareness, clarifying personal values, and promoting commitment to adaptive behaviors. Intervention group: Schema Therapy group:Participants in this group will attend group sessions based on Young’s schema therapy model. The intervention emphasizes identifying and modifying early maladaptive schemas and supporting patients in developing healthier emotional and behavioral patterns. Control group: Participants in the control group received only their routine medical care throughout the study period and did not attend any of the psychological intervention sessions (Acceptance and Commitment Therapy or Schema Therapy). To address ethical considerations, access to similar therapeutic services was provided to these participants after the completion of the study. Depression. Timepoint: pre and post interventions. Method of measurement: Beck depression questionaire. Anxiety. Timepoint: pre and post intervention. Method of measurement: Beck Anxiety Inventory. Adaptive Behavior. Timepoint: pre and post intervention. Method of measurement: Lambert Adaptive Behavior Scale. Hardiness. Timepoint: pre and post intervention. Method of measurement: Long & Goulet hardiness questionaire. Islamic Azad University Approved 2025-07-26 Ethics Committee Islamic Azad University Zahedan Branch Islamic Azad University, Zahedan Branch Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)