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IRCT20180909040974N2 IRCT 2020-08-01 Esfahan University of Medical Sciences Mindfulness-Based Stress Reduction in Somatic symptom disorder Title: Effectiveness of Mindfulness-Based Stress Reduction (MBSR) Intervention on Psychological Symptoms, Quality of Life, Symptom Severity in Patients with Somatic Symptoms Disorder 2020-06-06 anticipated 20 Complete https://irct.ir/trial/45247 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: First, eligible patients will be simple randomly selected. Then they will be divided into two groups using random numbers created by computer software (SPSS software). So that, even numbers will be in the intervention group and odd numbers will be in the control group, Blinding description: The data analyst is unaware of the group membership of the participants. N/A somatic symptom disorder. Intervention 1: Intervention group: The intervention group was treated with Venlafaxine, and they participated in eight 2-hour sessions of the Mindfulness Based Stress Reduction (MBSRD) program on a weekly basis. Venlafa xine was prescribed 37.5 to 150 mg daily for 8 weeks (VenabidER®, ABIDI Company, Tehran, Iran). Intervention 2: Control group: the control group was treated with Venlafaxine alone. Venlafaxine was prescribed 37.5 to 150 mg daily for 8 weeks (Venabid ER®, ABIDI Company, Tehran, Iran). Yes - There is a plan to make this available What will be shared: specific participant data sets related to primary outcome measure are to be shared. When: starting 6 months after publication To whom: people working in academic institutions Conditions: Therapists working in hospital clinics Where to obtain: Email: fatemehzargar@gmail.com How to obtain: Having a letter of introduction from work Comments:
public Leila Rahafrouz
Isfahan University of Medical Sciences, Department of Health Psychology, Hezar Jarib St.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 8109 fatemehzargar@gmail.com Esfahan University of Medical Sciences scientific Leila Rahafrouz
Isfahan University of Medical Sciences, Department of Health Psychology, Hezar Jarib St.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 8109 fatemehzargar@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Documented diagnosis of Somatic Symptom Disorder based on Diagnostic and Statistical Manual of psychiatric disorders Educational level more than primary school, Age between 20-50 years, Patient's willingness to participate in this study 20 years 50 years Both Diagnosis of other major psychiatry disorder based on clinical interview and Substance use disorder Participating in another psychotherapy F40.232 Fear of other medical care Behavior Treatment - Drugs Intervention group: The intervention group was treated with Venlafaxine, and they participated in eight 2-hour sessions of the Mindfulness Based Stress Reduction (MBSRD) program on a weekly basis. Venlafa xine was prescribed 37.5 to 150 mg daily for 8 weeks (VenabidER®, ABIDI Company, Tehran, Iran). Control group: the control group was treated with Venlafaxine alone. Venlafaxine was prescribed 37.5 to 150 mg daily for 8 weeks (Venabid ER®, ABIDI Company, Tehran, Iran). Anxiety. Timepoint: Before and 8 weeks after intervention. Method of measurement: Questionnaire of anxiety, depression, stress scale (DASS). Quality of life. Timepoint: Before and 8 weeks after the intervention. Method of measurement: 36-Item Short Form Health Survey. Clinical symptoms. Timepoint: Before and 8 weeks after the intervention. Method of measurement: Patient Health Questionnare 15-item. Esfahan University of Medical Sciences Approved 2018-05-27 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Department of Health Psychology, Hezar Jarib St. Isfahan Isfehan Iran (Islamic Republic of)