Study design and participants
The present randomized controlled trial was approved by the ethics committee of the University of Medical Sciences, Tabriz with the approval code IR.TBZMED.REC.1398.014 and was prospectively registered in the Iranian Register of Clinical Trials with the registration code IRCT20100414003706N34. The recruitment of participants was then carried out. We followed the CONSORT guidelines.
The inclusion criteria were healthy university students aged 18-35 who lived in the residences of the University of Medical Sciences of Tabriz (4 residences with approximately 1200 students) who had regular periods, cycle length 25-35 days in the past 6 months had moderate to severe PMS diagnosed using the Daily Problem Severity Record (DRSP) for two cycles menstrual period prior to inclusion in the study, and has not used any treatment for PMS or premenstrual dysphoric disorder (PMDD) currently.
The exclusion criteria were as follows: being a professional athlete, pregnancy, breastfeeding, history of childbirth within the last year, major depression at the time of the study, history of major psychiatric disorders (psychosis, bipolar disorder, of the diet, and severe depression), taking particular drugs (antidepressants, benzodiazepines, anticancer drugs, oral contraceptives or hormones) during the last three months, suffering from particular diseases (epilepsy or gastrointestinal, cardiovascular, renal and endocrine) at the time of the study, having experienced a very stressful event (parental divorce or death of a first-degree family member) in the past 6 months, current or previous gynecological problems (previous hysterectomy, oophorectomy, gynecological cancer , polycystic ovary syndrome, endometriosis and infertility), no access to internet and cell phones the, and a history of drug, alcohol or hookah use in the past two years.
Patients were assessed for major depression using the Beck questionnaire and the DRSP, while other exclusion criteria were applied based on participants’ self-report. In addition, we have tried to include a few students from two private residences (with a total population of 225 students). However, the officials did not cooperate with us. Therefore, we were unable to register any participants from the private residences.
Considering the PMS scores of a previous study conducted in a similar study setting (M1 = 163.6, SD1 = 89.5) , an estimated 35% reduction in mean PMS score due to the intervention (M2 = 106.3, SD2 = SD1), bilateral = 0.05, power = 80% and probability of loss of follow-up 15%, The sample size was set at 92 (n = 46 for each group). This sample size was sufficient to meet the other objectives of the study, with a power greater than 80%.
Recruitment and randomization
As a first step, potential participants, who were selected using an initial eligibility criteria checklist, completed the socio-demographic and reproductive questionnaire and a validated Persian version of the symptom screening tool. premenstrual (PSST) in 19 elements. . According to the developers of the PSST , screening is positive when the woman reports at least five of the 14 symptoms of PMS. Symptoms reported should be moderate or severe, and at least one of them should be included in one of the four main symptoms of PMS. In addition, the symptoms must interfere moderately to severely with at least one of the five areas of life.
All participants who tested positive provided written informed consent. Then they were asked to complete the DRSP during the next menstrual cycle. Additionally, they were asked to complete the validated Persian version of Beck’s 21-item Depression Inventory.  one of the days of their mid-follicular phase (days + 7 to + 10 of the menstrual cycle). Participants with a score of 29 or more on the Beck inventory  were diagnosed with major depression and were subsequently excluded from the study. The remaining participants were asked to complete the DRSP during a second menstrual cycle. In addition, they completed the Sheehan Disability Scale (SDS) and Menstrual Attitude Questionnaire (MAQ) on day 1 or 2 of menstruation. In addition, they completed the Pleasure and Satisfaction with Quality of Life Questionnaire – Short Form (Q-LES-Q-SF) twice, including one on days 1 to 2 and once on days 11 to 13 of the menstrual cycle. Participants with symptoms of major depression during the follicular phase based on the 2-cycle DRSP were also excluded.
Students with moderate to severe PMS diagnosed on the basis of the DRSP were ultimately included in the study. These participants were randomly assigned to the intervention and control groups using the en-bloc randomization method. The allocation sequence was generated with randomly varying block sizes of four and six and an allocation ratio of 1: 1 using an online program (www.random.org). Sequence generation was performed by someone not involved in participant recruitment and data collection. The central telephone method was used for secret assignment, while the recruitment of participants was carried out by the first author (SB).
Only one eligible participant was recruited from each room in the dormitory (each room typically had 3-6 students) to avoid contamination. Additionally, approximately 20% of participants were not present in the residence for most of the study period because it was during the semester break or the university was closed due to the COVID-19 pandemic. .
The research team developed the educational content for eight sessions (one session per week) by reviewing all the literature, the intervention content of the previous study on this area. , and comments from some experts in reproductive health and psychology. The content of the sessions was mainly focused on the content of the intervention of the previous study in Germany . For example, general information about PMS / TDPM and etiology was presented in the first session, while the last session included instructions for patients, such as relapse prevention methods. Cognitive and behavioral strategies were discussed in sessions 2 to 7. Cognitive strategies discussed in the sessions were as follows:
Session 2: Psychological training on the role of thoughts and their relationship with emotions and behaviors (cognitive triangle)
Session 3: Changing the subject to PMS
Session 4: Reconstruction of dysfunctional perceptions
Session 5: Psychological training on certain superstitions concerning PMS and application of learned cognitive strategies
Session 6: Psychological training on effective thinking and developing new assessments
Session 7: Certain behaviors to improve PMS (use of care, seeking support and communication)
In addition, the behavioral strategies discussed during the sessions focused on the following topics:
Session 2: Psychological training on the relationship between stress and PMS and teaching relaxation techniques
Session 3: Psychological training on the interdependence between nutrition, exercise and PMS
Session 4: How to integrate exercise into daily life using a motivation program and strategy
Session 5: What is a balanced diet and how to follow it on a daily basis
Session 6: Psychological training on the impact of stress-related errors on reasoning
Session 7: Training on participation in positive activities in daily life
Participants were provided with audiovisual materials to help them learn hands-on exercises, such as relaxation techniques, thought-shifting exercises, and physical exercises, including yoga.
When the educational content was prepared, the Principal Investigator (SB) designed a counseling course on the Learning Management System (LMS) website of Tabriz University of Medical Sciences (dynamic learning environment modular object oriented (MOODLE), https://moodle.org). The course was designed under the supervision of the manager (AA) of the university’s LMS site.
Special accounts were created for each member of the response group, and account information was sent to them via email, SMS, and one of the social media platforms they used. The intervention group received the content in a scheduled manner. When content uploaded to the website, attendees received an email or text message as a reminder. In addition, we created a telegram channel for them, through which we sent them daily reminders to visit the website and receive the educational content. Prior to the course, participants were instructed on how to use the LMS website. Those who did not log into their account during the first week of class were called back by phone. In addition, they could ask questions online and receive responses from the Principal Investigator (SB).
In order to verify treatment adherence, participants were assigned homework at the end of each session and were asked to submit their weekly comments using the website or social media platforms. Participants with delays in sending comments were reminded by SMS. Those who did not respond received phone calls. In addition, all participants in the intervention group received calls from the principal investigator every two weeks to keep them motivated. In these calls, the lead researcher discussed the strategies with the participants, asked about the effectiveness of the strategies they were using, received suggestions and criticism, asked them to write down their questions using the LMS website, and answered questions.
The control group received no intervention during the study period. After performing all post-test evaluations, the control group accounts were created and they received the intervention content.
Data collection tools
We used the Persian version of the following tools to assess PMS symptom severity, quality of life, and PMS disability. The tools were not licensed. Additionally, attitude toward menstruation was assessed using the Menstrual Attitude Questionnaire (MAQ). We have obtained written permission to translate it into Persian and validate it with the original developers via email.