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IRCT20221230056986N1 IRCT 2023-06-17 Shahid Beheshti University of Medical Sciences Effectiveness of transdiagnostic treatment on psychological parameters in multiple sclerosis Effectiveness of unified protocol of transdiagnostic treatment on psychological symptoms, fatigue, emotion regulation, health anxiety, sleep quality, and sexual satisfaction in patients with multiple sclerosis 2023-08-23 anticipated 48 Complete https://irct.ir/trial/68461 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The process of random allocation of study participants to two groups; intervention group and control group included both creating a random sequence and concealing the random allocation. Firstly, using the random sequence rule, 48 papers for participants of the intervention and control groups (which are marked with A and B and are not defined to avoid bias) were thrown into a lottery container and then the papers were removed from the lottery container -without replacement- and the created sequence is recorded Then, using the snooze method, 48 envelopes were prepared and each of the random sequences created is recorded on a card and placed in the envelopes in order, and the envelopes were also numbered. Then, the envelopes were given to the participants based on the order of entering the study, so the grouping of each was determined, Blinding description: Patients referring to Moheb Mehr Hospital Neurology Clinic, Tehran, Iran are chosen as the participants of the study. In this single-blind study, sealed opaque envelopes will be used to conceal the sequencing. Intervention group will receive 12 sessions of online psychotherapy based on unified protocol of transdiagnostic treatment and control group will not receive the treatment intervention. The responsible for data collection is blind to group allocation and the type of intervention. 2-3 Multiple Sclerosis. Intervention 1: Intervention group: 12 sessions of online psychotherapy based on unified protocol of transdiagnostic treatment. Intervention 2: Control group: Not receiving treatment intervention. Yes - There is a plan to make this available What will be shared: SPSS file of participants data, treatment protocol of study, and informed consent form will be available if necessary. When: After execution of study To whom: Editor in chief of scientific journals Conditions: At request of editor in chief of scientific journals Where to obtain: By email: amir.katani.1993@gmail.com How to obtain: Data will be sent by email after request. Comments:
public Amir Mahdi Katani
No 11, west Eram alley, south Bahar St, west Ferdows Blvd.
Tehran Iran (Islamic Republic of) 1484647366 +98 21 4411 6678 amir.katani.1993@gmail.com Shahid Beheshti University of Medical Sciences scientific Amir Mahdi Katani
No 11, west Eram alley, south Bahar St, west Ferdows Blvd.
Tehran Iran (Islamic Republic of) 1484647366 +98 21 4411 6678 amir.katani.1993@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Confirmation of relapsing-remitting multiple sclerosis diagnosis by neurologist Age least 20 years Being sexually active Mastery in Persian language and reading and writing literacy Fixed dosage of medicine from 3 months before beginning the treatment Being physically able to participate in weekly sessions Not being diagnosed with severe psychiatric disorders Not being diagnosed with another serious or chronic physical illness Not having the history of receiving psychological treatments 20 years no limit Both G35 Multiple sclerosis Treatment - Other Treatment - Other Intervention group: 12 sessions of online psychotherapy based on unified protocol of transdiagnostic treatment Control group: Not receiving treatment intervention Psychological symptoms. Timepoint: Before intervention, after intervention, three month after intervention. Method of measurement: Depression, Anxiety, Stress Scale (DASS-21). Fatigue. Timepoint: Before intervention, after intervention, three month after intervention. Method of measurement: Fatigue Severity Scale (FSS). Quality of sleep. Timepoint: Before intervention, after intervention, three month after intervention. Method of measurement: Pittsburgh Sleep Quality Index (PSQI). Sexual Satisfaction. Timepoint: Before intervention, after intervention, three month after intervention. Method of measurement: Larson Sexual Satisfaction Questionnaire (LSSQ). Emotion regulation. Timepoint: Before intervention, after intervention, three month after intervention. Method of measurement: Cognitive Emotion Regulation Questionnaire (SERQ). Health anxiety. Timepoint: Before intervention, after intervention, three month after intervention. Method of measurement: Health Anxiety Questionnaire (HAQ). Shahid Beheshti University of Medical Sciences Approved 2019-09-24 Ethics committee of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences, Yaman St. Velenjak Tehran Tehran Iran (Islamic Republic of)