Determining the effectiveness of Emotion-Focused therapy (EFT) on the outcome of treatment of women with Premenstrual dysphoric disorder (PMDD)
Design
A clinical trial with a control group, one-sided blind, block randomized. It is done with 48 samples, 24 of whom are the experimental group and 24 are the control group.The rand function of Excel software was used for randomization.
Settings and conduct
Sampling was done in the form of online research notices. The implementation took place in a private clinic. The evaluator and statistical analyst are blind to the research process, but the researcher and the participants are not blind to the research.
Participants/Inclusion and exclusion criteria
Inclusion criteria: woman with PMDD based on SCID-5; age range of 18 to 44 years old; regular menstrual cycle; at least diploma education. Exclusion criteria: pregnancy; breastfeeding (within the last 6 months); menopause; having certain medical diseases; having any psychiatric disorder that the person is prescribed for she uses medicine; use of hormonal birth control methods; use of drugs.
Intervention groups
The implementation of the treatment is individual and was done during 16 weekly treatment sessions. After taking the pre-test, the treatment begins. The treatment consists of three stages.1-therapeutic bond and promoting client awareness2-evocation and exploration 3- focused on emotion transformation.Then the post-test is performed.
The waiting list method was used in the control group. After completing the treatment, follow-up will be done after three months.Then, treatment will be done individually by the researcher for the subjects of the control group who are willing to participate in the treatment.
Main outcome variables
Difficulties in Emotion Regulation; severity of symptoms of PMDD; severity of depression symptoms; severity of anxiety symptoms; severity of stress symptoms
General information
Reason for update
Acronym
PMDD
IRCT registration information
IRCT registration number:IRCT20220920055998N1
Registration date:2023-02-12, 1401/11/23
Registration timing:retrospective
Last update:2023-02-12, 1401/11/23
Update count:0
Registration date
2023-02-12, 1401/11/23
Registrant information
Name
Saeideh Izadi Dehnavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5566 5516
Email address
izadidehnavi.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2022-06-22, 1401/04/01
Actual recruitment start date
2022-04-21, 1401/02/01
Actual recruitment end date
2022-06-22, 1401/04/01
Trial completion date
2022-12-26, 1401/10/05
Scientific title
evaluate the effectiveness of Emotion-Focused therapy on outcome treatment in premenstrual dysphoric disorder
Public title
evaluate the effectiveness of Emotion-Focused therapy in PMDD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of PMDD disorder based on SCID-5
Regular menstrual cycle (25 to 32 days)
Minimum education is diploma
Exclusion criteria:
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
Age
From 18 years old to 44 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
48
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences ,fifth floor
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2022-01-26, 1400/11/06
Ethics committee reference number
IR.IUMS.REC.1400.964
Health conditions studied
1
Description of health condition studied
Premenstrual Dysphoric Disorder
ICD-10 code
F38.8
ICD-10 code description
Other specified mood [affective] disorders
Primary outcomes
1
Description
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
Secondary outcomes
1
Description
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)
2
Description
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)
Intervention groups
1
Description
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.
Category
Treatment - Other
2
Description
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.