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IRCT20210414050967N2 IRCT 2022-03-12 Iran University of Medical Sciences Effect of intervention focused on intolerance of uncertainty in multiple sclerosis The effectiveness of group intervention focused on intolerance of uncertainty on psychological distress and quality of life in multiple sclerosis patients 2020-12-29 anticipated 60 Complete https://irct.ir/trial/59136 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Considering the inclusion and non-inclusion criteria, 60 patients who wished to participate in the study (with written consent) were randomly substituted into three groups of 20 intervention (the group that received routine drug therapy and group intervention focused on intolerance of uncertainty), the first control (group receiving routine drug therapy and cognitive-behavioral group therapy as gold standard) and the second control (group receiving only routine drug therapy) were divided. The method of randomization was that first, codes were assigned to all three groups and then, by drawing lots, the order of the groups was determined as the intervention focused on intolerance of uncertainty, cognitive-behavioral therapy and waiting list. In the next step, the code was assigned to the sample people. In one pot, 60 codes (20 codes for each group) and in another pot, 60 people were sampled. Then, randomly, a piece of paper was taken out of each pot, and based on the code that came out, the patient was placed in the group corresponding to the same code, until the codes were completed. Thus, 20 people were placed in each of the mentioned groups. N/A Multiple Sclerosis. Intervention 1: Intervention group: Group therapy focused on the inability to tolerate uncertainty was based on the protocol of Molton et al., performed in 12 sessions of two hours on a weekly basis. It is designed considering some basic principles of cognitive-behavioral therapy as well as acceptance and commitment therapy. This treatment focuses on recognizing the controllable and uncontrollable aspects of MS, setting personal goals for accepting the disease regardless of uncertainty, as well as mindfulness exercises, and finding ways to live alongside personal values despite uncertainty about the future. Intervention 2: Control group: Cognitive-behavioral group therapy was based on the protocol of Van den Akker et al., performed in 12 sessions of two hours on a weekly basis. This treatment focuses on identifying cognitive distortions associated with MS; challenging cognitive distortions associated with the disease; and cognitive reconstruction of these beliefs, practicing to reduce attention to symptoms through attention distraction techniques, regulating sleep pattern, empowering patients to develop social activities by teaching communication skills and encouraging and supporting patients to increase mental activities such as reading or working with a computer. Intervention 3: Control group: The group that receives only the usual drug treatment in MS patients and does not receive any other intervention. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals. When: Access period starts 6 months after the results are published To whom: The data of this project will be available for researchers working in academic and scientific institutes. Conditions: Any use of data must be done in coordination with the developer. Where to obtain: Iran University of Medical Science How to obtain: Applicants should first correspond with the responsible author by e-mail and if possible, the desired information will be provided. Comments:
public Hani Rahimi
Imam Khomeini Boulevard, 31 Alley
Evaz Iran (Islamic Republic of) 74331-84799 +98 71 5251 7627 hani.psy86@yahoo.com Iran University of Medical Sciences scientific Hani Rahimi
Imam Khomeini Boulevard, 31 Alley
Evaz Iran (Islamic Republic of) 74331-84799 +98 71 5251 7627 hani.psy86@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Definitive diagnosis of the disease by a neurologist Age range 18 to 55 years Have at least a diploma Having a medical record in the MS community Score between 0 and 5 on the Extensive Disability Status Scale (EDSS) Having the necessary facilities for online participation in various stages of research (laptop or Mobile with high-speed Internet connection) 18 years 55 years Both Severe psychiatric disorders (psychotic or bipolar disorders) based on DSM_5 drug use disorder based on DSM-5 the presence of a physical illness that prevented them from attending treatment sessions. G35 Multiple sclerosis Behavior Behavior Treatment - Drugs Intervention group: Group therapy focused on the inability to tolerate uncertainty was based on the protocol of Molton et al., performed in 12 sessions of two hours on a weekly basis. It is designed considering some basic principles of cognitive-behavioral therapy as well as acceptance and commitment therapy. This treatment focuses on recognizing the controllable and uncontrollable aspects of MS, setting personal goals for accepting the disease regardless of uncertainty, as well as mindfulness exercises, and finding ways to live alongside personal values despite uncertainty about the future. Control group: Cognitive-behavioral group therapy was based on the protocol of Van den Akker et al., performed in 12 sessions of two hours on a weekly basis. This treatment focuses on identifying cognitive distortions associated with MS; challenging cognitive distortions associated with the disease; and cognitive reconstruction of these beliefs, practicing to reduce attention to symptoms through attention distraction techniques, regulating sleep pattern, empowering patients to develop social activities by teaching communication skills and encouraging and supporting patients to increase mental activities such as reading or working with a computer. Control group: The group that receives only the usual drug treatment in MS patients and does not receive any other intervention. Psychological distress. Timepoint: Before and after the intervention (pre-test and post-test), Three-month follow-up. Method of measurement: Depression, Anxiety, Stress Questionnaire (DASS-21). Quality of life. Timepoint: Before and after the intervention (pre-test and post-test), Three-month follow-up. Method of measurement: MS Quality of life (MSQoL-54). Iran University of Medical Science Approved 2020-12-27 Ethics committee of Iran University of Medical Sciences Hemmat Highway next to Milad Tower, Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)