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IRCT20200521047537N1 IRCT 2020-06-26 University of social welfare and rehabilitation sciences Effect of Mindfulness-Based Cognitive Therapy on swallowing in Multiple Sclerosis Comparing the effectiveness of Mindfulness-Based Cognitive Therapy with Diet Modification on swallowing function in patients with Multiple Sclerosis 2020-06-09 anticipated 44 Complete https://irct.ir/trial/48415 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomizing will be accomplished using block randomization method. Sequence allocation will be determined through a web portal site (https://www.sealedenvelope.com/simple-randomiser/v1/lists). Concealment will be achieved by sequentially numbered, opaque, sealed envelopes, Blinding description: Patients with MS are randomly allocated into one of two intervention or control groups. In this study the assessor are not aware of the groups each patient belongs to. N/A Multiple Sclerosis. Intervention 1: Intervention group (Combined treatment): Patients in this group will receive Mindfulness-Based Cognitive Therapy (MBCT) with a conventional dysphagia treatment. We use the protocol of MBCT was developed by Segal in 2002. The patients undergo a 8 weekly one-hour sessions with additional all-day exercise and one-hour homework. Also, patients will receive a 30-minute session per week for diet modification as a conventional dysphagia treatment. Intervention 2: Active control group: The control group will receive diet modification. Recommendations for changing the food texture are based on the International Dysphagia Diet Standardisation Committee (IDDSI). The patients undergo a 30-minute session per week for food texture modification. Yes - There is a plan to make this available What will be shared: All patient documentation, including participants' demographic and clinical information, will be shared after making individuals unidentifiable, and also the outcomes can be provided. When: Access started in 1399 To whom: The data will be available to researchers working in academic and scientific institutions Conditions: The information will be made available to researchers who want to continue to plan or compare results with other treatments. Where to obtain: Department of Speech Therapy University of Social Welfare and Rehabilitation Sciences Dr. Zahra Sadat Ghoreishi za.ghoreyshi@uswr.ac.ir How to obtain: Visit to department of Speech Therapy of University of Social Welfare and Rehabilitation Sciences. The applicant was provided with information for about a week Comments:
public Zahra Sadeghi
Koodakyar Avenue, Velenjac
Tehran Iran (Islamic Republic of) ۱۹۸۵۷۱۳۸۳۴ +98 21 2218 0043 za.sadeghi@uswr.ac.ir University of social welfare and rehabilitation sciences scientific Zahra Sadeghi
Koodakyar Avenue, Velenjac
Tehran Iran (Islamic Republic of) ۱۹۸۵۷۱۳۸۳۴ +98 21 2218 0043 za.sadeghi@uswr.ac.ir University of social welfare and rehabilitation sciences Iran (Islamic Republic of) Diagnosed MS and MRI confirmation of disease Patients who are 20-60 years of age range Dysphagia diagnosis based on MASA examination 20 years 60 years Both Do not want to participate in the study Have a score below 23 on the Mini Mental State Examination (MMSE) Have relapse of disease in the previous month Have a history of dysphagia prior to MS symptom onset Have severe depression or another known psychiatric diagnosis (were taking antidepressant and/or anxiolytic drugs) G35 Multiple sclerosis Rehabilitation Rehabilitation Intervention group (Combined treatment): Patients in this group will receive Mindfulness-Based Cognitive Therapy (MBCT) with a conventional dysphagia treatment. We use the protocol of MBCT was developed by Segal in 2002. The patients undergo a 8 weekly one-hour sessions with additional all-day exercise and one-hour homework. Also, patients will receive a 30-minute session per week for diet modification as a conventional dysphagia treatment. Active control group: The control group will receive diet modification. Recommendations for changing the food texture are based on the International Dysphagia Diet Standardisation Committee (IDDSI). The patients undergo a 30-minute session per week for food texture modification. Swallowing function. Timepoint: Before and after the treatment. Method of measurement: Mann Assessment of Swallowing Ability (MASA) examination. Depression. Timepoint: Pre and post treatment. Method of measurement: Depression subscale of Depression, Anxiety and Stress scale (DASS)-21. Emotion regulation. Timepoint: Pre and post treatment. Method of measurement: Emotion Regulation Questionnaire. Anxiety. Timepoint: Pre and post treatment. Method of measurement: Anxiety subscale of Depression, Anxiety and Stress scale (DASS)-21. Stress. Timepoint: Pre and post treatment. Method of measurement: Stress subscale of Depression, Anxiety and Stress scale (DASS)-21. University of social welfare and rehabilitation sciences Approved 2019-07-07 University of Social Welfare and Rehabilitation Science Koodakyar close-end alley, Daneshjoo boulevard, Evin Tehran Tehran Iran (Islamic Republic of)