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IRCT20220920055998N1 IRCT 2023-02-12 Iran University of Medical Sciences evaluate the effectiveness of Emotion-Focused therapy in PMDD PMDD evaluate the effectiveness of Emotion-Focused therapy on outcome treatment in premenstrual dysphoric disorder 2022-04-21 anticipated 48 Complete https://irct.ir/trial/67772 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: People are assigned to the Emotion-Focused therapy group and the control group by block randomization method. For this purpose, 4 blocks will be used, which will be designed using a random number table, and the allocation of people to the control and intervention groups will be done based on the sequence of the randomization table, which the statistical consultant and the interventionist are aware of, Blinding description: The evaluator and statistical analyst are blind to the research process, but the researcher and the participants are not blind to the research. N/A Premenstrual Dysphoric Disorder. Intervention 1: Intervention group: In this research, Emotion-Focused Therapy was done individually. To start the Emotion-Focused Therapy, first in a meeting, we talked about the objectives of the research, the principles of secrecy and confidentiality of the participants' information, possible side effects, and the rules of participation in the research. Then, explanations were provided about Pre Menstrual Dysphoric Disorder, available treatments for it and their differences, types of interventions for this disorder, Emotion-Focused Therapy and its effectiveness, duration of sessions, number of sessions, and how to end them. Before the first session, the participants completed the research questionnaires as a pre-test and then entered the treatment.16 treatment sessions, each session 45 minutes, were held weekly. The treatment had three main stages.The first phase refers to an initial stage of treatment, which is focused onestablishing a therapeutic bond and promoting client awareness. This is centered onbuilding a safe and empathic therapeutic alliance and relationship, as well as setting ashared focus for the process, which allows clients to shift their attention inwards andbecome more aware of their experiences.In the second phase, focused on theevocation and exploration of core difficulties of emotional processing, the main goalis to help clients experience their core vulnerabilities by attending, arousing and exploring their maladaptive schemes. Gradual exploration of these experiences allowsreaching to the core experiences of vulnerability. In this phase, therapist and clientwork together in order to access and process the “core pain”.The third and final phase, focused on emotion transformation, involves theconstruction of alternatives by producing new emotions and building new alternativesand meanings. Intervention 2: Control group: In the control group, the waiting list method was used to comply with ethical principles. After completing the treatment, the questionnaires were given again to the people of both groups, and the follow-up will be done after three months. Then, Emotion-Focused Therapy will be done individually by the researcher for the subjects of the control group who are willing to participate in the treatment. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The study has not been completed.
public Saeideh Izadi Dehnavi
shahid Mansouri Sreet, Niyayesh Sreet, Satarkhan Avenue
Tehran Iran (Islamic Republic of) 1145613111 +98 21 6655 5516 s.izadipsy@gmail.com Iran University of Medical Sciences scientific Saeideh Izadi Dehnavi
Shahid Mansouri Sreet, Niyayesh Sreet, Satarkhan Avenue
Tehran Iran (Islamic Republic of) 1445613111 0982166555516 S.izadipsy@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Diagnosis of PMDD disorder based on SCID-5 Regular menstrual cycle (25 to 32 days) Minimum education is diploma 18 years 44 years Female Pregnancy (within the last 6 months) Breastfeeding (during the last 6 months) Menopause Having certain medical diseases (cardiac, respiratory, neurological diseases, high blood pressure, migraine, hormonal problems) according to the subject's self-report. Having any psychiatric disorder for which a person takes medicine Use of hormonal contraceptive methods Drug abuse F38.8 Other specified mood [affective] disorders Treatment - Other Treatment - Other Intervention group: In this research, Emotion-Focused Therapy was done individually. To start the Emotion-Focused Therapy, first in a meeting, we talked about the objectives of the research, the principles of secrecy and confidentiality of the participants' information, possible side effects, and the rules of participation in the research. Then, explanations were provided about Pre Menstrual Dysphoric Disorder, available treatments for it and their differences, types of interventions for this disorder, Emotion-Focused Therapy and its effectiveness, duration of sessions, number of sessions, and how to end them. Before the first session, the participants completed the research questionnaires as a pre-test and then entered the treatment.16 treatment sessions, each session 45 minutes, were held weekly. The treatment had three main stages.The first phase refers to an initial stage of treatment, which is focused onestablishing a therapeutic bond and promoting client awareness. This is centered onbuilding a safe and empathic therapeutic alliance and relationship, as well as setting ashared focus for the process, which allows clients to shift their attention inwards andbecome more aware of their experiences.In the second phase, focused on theevocation and exploration of core difficulties of emotional processing, the main goalis to help clients experience their core vulnerabilities by attending, arousing and exploring their maladaptive schemes. Gradual exploration of these experiences allowsreaching to the core experiences of vulnerability. In this phase, therapist and clientwork together in order to access and process the “core pain”.The third and final phase, focused on emotion transformation, involves theconstruction of alternatives by producing new emotions and building new alternativesand meanings. Control group: In the control group, the waiting list method was used to comply with ethical principles. After completing the treatment, the questionnaires were given again to the people of both groups, and the follow-up will be done after three months. Then, Emotion-Focused Therapy will be done individually by the researcher for the subjects of the control group who are willing to participate in the treatment. Severity of symptoms in Premenstrual Dysphoric Disorder. Timepoint: Before the intervention, the last session, 3 months after the intervention. Method of measurement: Premenstrual Symptoms Screening Tool-PSST. Difficulties in Emotion Regulation. Timepoint: Before the intervention, the last session, 3 months after the intervention. Method of measurement: Difficulties in Emotion Regulation Scale (DERS). Severity of symptoms of anxiety, depression, stress. Timepoint: Before the intervention, the last session, 3 months after the intervention. Method of measurement: Depression, Anxiety, Stress Scale-21 (DASS-21). Iran University of Medical Sciences Approved 2022-01-26 Ethic committee of Iran University of Medical Sciences Iran University of Medical Sciences ,fifth floor Tehran Tehran Iran (Islamic Republic of)