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IRCT20201128049518N1 IRCT 2020-12-05 Shahid Beheshti University of Medical Sciences Unified Trans diagnostic Treatment The Efficacy of Unified Trans diagnostic Treatment on Cognitive Mechanisms of Emotion Regulation, Sleep Disorder and Symptoms Remission of Premenstrual Syndrome (PMS) 2021-01-04 anticipated 40 Complete https://irct.ir/trial/52721 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method is a simple randomization method. The unit of randomization is individual. Using the table of random numbers, patients are randomly divided into two groups: experimental and control. Even numbers are considered for the experimental group and odd numbers are for the control group. Random allocation is done by the researcher and the clinical caregiver and data analyzer are not aware of the allocation of patients, Blinding description: Treatment allocation was concealed from the psychiatrist and the data analyzer who rated patients by using successively numbered, opaque, and sealed envelopes. In fact, participants pick up envelopes inside the box randomly which are in an unspecified wrapper. They are aware which experimental group they were assigned to. N/A Premenstrual syndrome. Intervention 1: Intervention group:The first group was treated with Unified Trans diagnostic Treatment: The first group participates in Unified Trans diagnostic Treatment session for 8 weeks (One session per week). Intervention 2: Control group: The control group does not receive any treatment. Yes - There is a plan to make this available What will be shared: Only part of the data, such as information related to main outcome or like that , can be share. When: Start of access, 6 months after publishing the results To whom: Only people working in academic institutions could apply. Conditions: People who are conducting clinical trials in this field could apply. Where to obtain: By referring to the electronic address: drahangari@sbmu.ac.ir How to obtain: The applicant can receive information by registering the exact personal details. Comments:
public Saba Hasanvandi
Lorestan University of Medical Sciences, Kilometer 5 Road of Tehran-Khorram Abad, Khorram Abad, Lorestan, Iran.
Khorram Abad Iran (Islamic Republic of) 6813833946 +98 66 3324 2643 s.hasanvandi@alzahra.ac.ir Khoram-Abad University of Medical Sciences scientific Nazanin Ahangari
Taleghani hospital, Yemen street, Shahid Chamran road, Shahid Beheshti University of Medical Science, Tehran, Iran
Tehran Iran (Islamic Republic of) 1985717443 +98 21 23871 drahangari@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Diagnosis of premenstrual syndrome based on diagnostic and Statistical Manual of Mental Disorders (DSM) Lack of mental retardation No use of psychiatric drugs before the study 17 years 45 years Female Dissatisfaction to participate in study Psychiatric comorbidity Drug allergy N94.3 Premenstrual tension syndrome Treatment - Other Placebo Intervention group:The first group was treated with Unified Trans diagnostic Treatment: The first group participates in Unified Trans diagnostic Treatment session for 8 weeks (One session per week). Control group: The control group does not receive any treatment. Symptoms of Premenstrual. Timepoint: At the first of study (before the intervention), 4 and 8 week after starting psychotherapy sessions in experimental and control group premenstrual symptoms are evaluated. Method of measurement: Premenstrual Syndrome Screening (PSST). Quality of sleep. Timepoint: At the first of study (before the intervention), 4 and 8 week after starting psychotherapy sessions in experimental and control group quality of sleep is evaluated. Method of measurement: Iowa Sleep Disturbances Inventory (ISDI). تنظیم شناختی هیجان. Timepoint: At the first of study (before the intervention), 4 and 8 week after starting psychotherapy sessions in experimental and control group cognitive emotion regulation is evaluated. Method of measurement: Cognitive Emotion Regulation Questionnaire (CERQ). Shahid Beheshti University of Medical Sciences Approved 2019-09-24 کمیته اخلاق دانشگاه علوم پزشکی شهید بهشتی Taleghani hospital, Yemen street, Shahid Chamran road, Shahid Beheshti University of Medical Science, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)