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NCT Number: NCT07040553

Effect of Motivational Interviewing and Digital Support on Premenstrual Symptoms and Emotion Regulation

This randomized controlled trial aims to evaluate the effectiveness of an 8-week support program that combines face-to-face motivational interviewing with weekly WhatsApp messages in reducing premenstrual syndrome (PMS) symptoms and improving emotion regulation among university students.

The study was conducted with 70 female students enrolled in the Nursing Department of Erzurum Technical University in Türkiye. Eligible participants are identified using the Premenstrual Syndrome Scale (PMSS), and those scoring above 110 are considered to have PMS. Students who meet the inclusion criteria and volunteer to participate are randomly assigned to either the intervention group (n=35) or the control group (n=35), using a computer-based randomization tool. Housing locations (e.g., dorm rooms or homes) are considered to prevent cross-contamination between groups.

All participants complete three forms: a Personal Information Form (to gather data on sociodemographic, menstrual, and lifestyle characteristics), the PMSS (to assess PMS severity), and the Difficulties in Emotion Regulation Scale - Short Form (DERS-16). These are completed before the intervention and again at 8 weeks.

The intervention group receives weekly one-on-one motivational interviews and supportive WhatsApp messages based on the principles of Motivational Interviewing as defined by Miller and Rollnick (2012). No medical treatments or devices are used in this study. Participation is voluntary, and informed written consent is obtained from all students. Ethical approval was granted by the Ethics Committee of Erzurum Technical University.

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Key information

Conditions

Premenstrual Syndrome-PMS Behavior Emotion Regulation Emotional Regulation Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms Premenstrual Syndrome Self-Control Social Behavior

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Erzurum Technical University

Erzurum, 25050, Turkey (Türkiye)

About this study

This randomized controlled study aims to evaluate the impact of a intervention program on premenstrual syndrome (PMS) symptoms and emotion regulation among female university students in Türkiye. The program includes motivational interviewing and mobile-based support strategies. Participants are selected from nursing students at Erzurum Technical University, based on a set of inclusion criteria such as age, menstrual cycle regularity, and the presence of PMS symptoms above a defined threshold. Individuals with chronic gynecological conditions or recent psychiatric diagnoses are excluded. The minimum required sample size (n = 68) was calculated using G*Power software based on an effect size of 0.76 from Nam and Cha (2019), with α = 0.05 and power = 0.80. To account for potential dropouts and ensure balanced group allocation, a total of 70 eligible participants were recruited and randomly assigned to either the intervention (n = 35) or control (n = 35) group. Data collection tools include the Premenstrual Syndrome Scale (PMSS), the Difficulties in Emotion Regulation Scale - Short Form (DERS-16), and a demographic information form. Ethical approval was obtained from the Ethics Committee of Erzurum Technical University (Decision No: 05/16 - Date: 27.03.2025). Written informed consent was obtained from all participants. The study does not involve the use of any drugs or medical devices.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female university students
  • Own and actively use a smartphone with WhatsApp installed
  • Have had a regular menstrual cycle (21-35 days) for the past 6 months
  • Diagnosed with moderate or severe PMS based on the Premenstrual Syndrome Scale (PMSS)
  • Willing to provide written informed consent

Exclusion criteria

  • Diagnosed with a chronic gynecological condition (e.g., polycystic ovary syndrome, endometriosis)
  • Diagnosed with a psychiatric disorder within the past 6 months (e.g., major depression, bipolar disorder, schizophrenia)
  • Currently using oral contraceptives
  • Currently using medications that may directly affect PMS symptoms (e.g., SSRIs, progesterone-based drugs)

Treatment and study plan

Motivational Interviewing and WhatsApp Support

Behavioral

This intervention consists of weekly face-to-face motivational interviews and supportive WhatsApp messages, delivered over 8 weeks. It is based on the principles of Motivational Interviewing (Miller & Rollnick, 2012) and aims to support symptom management and emotion regulation in participants with moderate to severe premenstrual syndrome.

Other names: Behavioral PMS Support Program

Primary outcomes

  1. Change in Premenstrual Syndrome Severity

    Time frame: Baseline and 8 weeks post-intervention

    Premenstrual Syndrome severity will be measured using the Premenstrual Syndrome Scale (PMSS). Total score change from pre-test to 8 weeks post-intervention will be assessed.

Secondary outcomes

  1. Change in Emotion Regulation

    Time frame: Baseline and 8 weeks post-intervention

    Emotion regulation will be assessed using the Difficulties in Emotion Regulation Scale - Short Form (DERS-16). Score changes between pre- and post-intervention will be evaluated.

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Collaborators

  • Erzurum Technical University

Registry information

Official study title

The Effect of an 8-Week Motivational Interviewing and Weekly Digital Messaging Intervention on Premenstrual Symptoms and Emotion Regulation in Female University Students: A Randomized Controlled Trial

Acronym: MIND-PMS

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 27, 2025
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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