Intervention in Executive Functions and Emotional Self-Regulation in Adolescents With Primary Dysmenorrhea (CALMA)

Evaluación de Una intervención psicológica Sobre Funciones Ejecutivas cálidas y autorregulación Emocional en Adolescentes Con Dismenorrea Primaria

Primary dysmenorrhea is one of the most common gynecological conditions during adolescence and is associated not only with recurrent menstrual pain, but also with emotional disturbances and difficulties in behavioral regulation. Various studies have indicated that hot executive functions-linked to emotional processing, decision-making in affective contexts, and impulse control-play a relevant role in the experience of and coping with pain.

The present project aims to design and evaluate the effectiveness of a structured psychological intervention focused on strengthening hot executive functions and emotional self-regulation in adolescents with primary dysmenorrhea. A quasi-experimental design with pre- and post-intervention assessment is proposed, using validated instruments to measure pain intensity, coping strategies, and executive-emotional performance. The intervention is expected to contribute to a reduction in perceived pain and to improvements in emotional regulation strategies, promoting more adaptive coping. This study seeks to provide empirical evidence on brief psychological interventions aimed at the comprehensive management of menstrual pain in adolescent populations.

Study Overview

• Status: Not yet recruiting
• Conditions: Menstrual Cramps
• Intervention / Treatment: Behavioral: Cognitive restructuring techniques and psychoeducation to improve coping strategies for menstrual pain.

Detailed Description

Primary dysmenorrhea is one of the most common gynecological conditions during adolescence and is characterized by recurrent menstrual pain in the absence of identifiable pelvic pathology. Its onset typically coincides with the first years following menarche and is primarily associated with increased production of endometrial prostaglandins, leading to uterine hypercontractility, reduced blood flow, ischemia, and pain. However, although its physiological basis is well documented, the experience of menstrual pain cannot be explained solely from a biomedical perspective. Its high prevalence among adolescents and its impact on academic performance, social life, and emotional well-being highlight the need to understand it from a more comprehensive framework.

The biopsychosocial model of pain proposes that the pain experience results from the interaction of biological, psychological, and social factors. From this perspective, variables such as beliefs about pain, cognitive appraisal of the experience, anticipatory anxiety, and coping strategies significantly influence perceived intensity and functional impairment. During adolescence, this interaction becomes particularly relevant due to hormonal changes and ongoing brain reorganization characteristic of this developmental stage. The limbic system, involved in emotional processing, exhibits heightened reactivity, whereas the prefrontal cortex-responsible for inhibitory control and regulation-continues to mature. This neurobiological asynchrony may contribute to intensified emotional responses to pain and difficulties in regulating them adaptively.

In this context, executive functions play a central role. These functions comprise a set of higher-order cognitive processes that enable planning, inhibition of automatic responses, decision-making, and goal-directed behavior regulation. Within this framework, hot executive functions are associated with emotional processing and decision-making in affectively charged situations. Unlike cold executive functions, which operate in abstract and emotionally neutral contexts, hot executive functions are engaged when decisions involve reward, punishment, or distress. In situations of menstrual pain, these functions influence the interpretation of discomfort, anticipation of pain episodes, and selection of coping strategies. Difficulties in these areas may be associated with greater emotional impulsivity, lower distress tolerance, and a predominance of avoidant or maladaptive coping strategies, potentially amplifying the subjective perception of pain.

Emotional self-regulation, closely linked to hot executive functions, refers to the ability to identify, understand, and flexibly modulate one's emotions in an adaptive manner. Among adolescents with primary dysmenorrhea, anticipatory anxiety, fear of pain, or catastrophizing thoughts may intensify the pain experience and increase interference in daily activities. Difficulties in applying strategies such as cognitive reappraisal, acceptance, or attentional control may contribute to a more intense and prolonged experience of distress. Conversely, the development of emotional regulation skills has been associated with better adaptation to pain and reduced functional impact.

Although pharmacological treatment represents the first-line management approach for primary dysmenorrhea, not all adolescents experience satisfactory relief, particularly regarding the emotional components associated with pain. In recent years, various psychological interventions based on psychoeducation, cognitive-behavioral therapy, relaxation techniques, and coping skills training have shown promising results in reducing pain intensity and improving quality of life. However, there remains a gap in the literature regarding interventions that specifically integrate the strengthening of hot executive functions as a central component of treatment.

Considering that adolescence represents a critical period for the development of executive functions and the consolidation of emotional self-regulation skills, designing a psychological intervention aimed at strengthening these capacities may have a significant impact on the experience of menstrual pain.

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: JAZMIN SALAS, MASTERY; Phone Number: +526861187406; Email: jazminsalas121@gmail.com

Study Locations

• Mexico
  • Estado de Baja California
    • Mexicali, Estado de Baja California, Mexico, 21700
      • Universidad Autónoma de Baja California

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria Gender: menstruating individuals in late adolescence.

• Age: 15 to 19 years.
• Estimated IQ above 80.
• With painful menstrual cycles (primary dysmenorrhea) without a prior gynecological diagnosis.
• Students at the institution selected for the intervention.
• Written expression of willingness and interest in participating in the program (informed consent in the case of minors)
• Informed consent signed by parents (in the case of minors) or by the participants (in the case of adults).
• Attendance of at least 70% of the intervention sessions.

Exclusion criteria

• Ages other than those previously indicated.
• An estimated IQ below 80.
• A prior gynecological diagnosis of a condition other than dysmenorrhea.
• Pharmacological or hormonal treatment that could, in and of itself, interfere with executive functions, pain perception, and emotional regulation.
• With psychiatric and/or neurological conditions that, in and of themselves, affect executive functions and emotional regulation.
• With pain-free menstrual cycles.
• Lack of interest or willingness to participate in the program
• Lack of informed consent or assent.

Elimination criteria

• Voluntary withdrawal from the program.
• Missing more than 30% of the sessions.
• Withdrawal of informed consent (personal, from guardians, or institutional).
• Receiving a diagnosis that meets any of the exclusion criteria during the -intervention program.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Participants will receive an intervention aimed at coping with menstrual pain, as well as education on gynecological health.	Behavioral: Cognitive restructuring techniques and psychoeducation to improve coping strategies for menstrual pain.; The intervention arm will receive a program based on cognitive restructuring techniques. The intervention will be aimed at identifying, questioning, and modifying negative automatic thoughts and cognitive distortions that influence participants' emotions and behaviors. During the sessions, strategies characteristic of the cognitive-behavioral approach will be used, such as thought monitoring/recording, identification of dysfunctional beliefs, analysis of evidence supporting and contradicting those thoughts, and the generation of more adaptive alternative interpretations. Activities will be carried out through guided exercises, discussion of examples, and structured practice designed to help participants apply these techniques to everyday life situations.
No Intervention: control group; They will not receive a psychological intervention; this group will serve as a comparison/control group to evaluate changes in the way participants cope with pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Menstrual pain	A Visual Analog Scale (VAS) (Hayes, MHS, & Patterson, DG (1921). Experimental development of the graphical rating method. Psychological Bulletin, 18) is a psychometric tool used to measure subjective and continuous phenomena such as pain, mood, or appetite. It typically consists of a 10 cm (100 mm) horizontal line anchored by opposite endpoints (e.g., "no pain" to "the worst pain imaginable"). The patient marks a point on the line corresponding to their current intensity. The distance (in mm) from the left anchor ("no pain") to the mark is measured, yielding a score from 0 to 100. Higher scores indicate greater severity. Typical cutoff points are: 0-4 mm (painless), 5-44 mm (mild), 45-74 mm (moderate), and 75-100 mm (severe). It is commonly used in clinical settings to assess symptoms, monitor treatment progress, or measure health-related quality of life. While the horizontal scale is the standard, vertical lines or digital "slider	Pre-post intervention evaluation, after 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Executive functioning	The BRIEF-2 self-report questionnaire (Gioia, Isquith, Guy, & Kenworthy, 2017) is a 55-item questionnaire designed for adolescents (ages 11-18) to assess their own executive functions-cognitive, emotional, and behavioral regulation-in daily life. It helps identify the strengths and weaknesses perceived by the adolescent themselves, complementing reports from parents and teachers to guide interventions, especially in cases of ADHD, autism, and learning difficulties. Interpretation is based on T-scores (with a mean of 50 and a standard deviation of 10), which are the standard for determining the clinical significance of executive functions. This instrument has undergone several adaptations for the Mexican population.	Pre-post intervention evaluation, after 8 weeks
Stroop test	Stroop test, will be measured from the standardized executive function test BANFE ( Neuropsychological Battery for Executive Functions and Frontal Lobes), using accuracy of response, stroop type error, no-Stroop errors, and time, Total score is transformed to normalized points 0-19 (with a mean of 10 ±3 SD, 4-6 low, 14-19 high performance).	Pre-post intervention evaluation, after 8 weeks
Gambling test	Gambling test, will be measured by calculating EF quotients from the standardized test BANFE (Neuropsychological Battery for Executive Functions and Frontal Lobes) using risk cards percentage, final total score. Total score is transformed to normalized points 0-19 (with a mean of 10 ±3 SD, 4-6 low, 14-19 high performance).	Pre-post intervention evaluation, after 8 weeks
Emotion Regulation	The Difficulties in Emotion Regulation Scale (DERS) (Gratz y Roemer, 2004) is a 36-item, self-report questionnaire designed to measure a person's typical levels of emotion dysregulation across six domains: nonacceptance of emotions, difficulty engaging in goal-directed behavior, impulse control difficulties, lack of emotional awareness, limited access to regulation strategies, and lack of clarity. Raw scores range from 36 to 180. Higher scores indicate greater difficulties with emotional regulation. A high score suggests difficulties in accepting emotions, a lack of effective strategies, and impulsive dyscontrol in response to distress.This instrument has been validated and adapted for the target population.	Pre-post intervention evaluation, after 8 weeks

Collaborators and Investigators

• Sponsor: Universidad Autonoma de Baja California

Study record dates

Study Major Dates

• Study Start (Estimated): August 30, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): March 30, 2028

Study Registration Dates

• First Submitted: March 25, 2026
• First Submitted That Met QC Criteria: April 21, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Adolescents; Emotional regulation; Menstruation; Hot executive functioning; Primary dysmenorrhea.
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathologic Processes; Pelvic Pain; Menstruation Disturbances; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Social Behavior; Self-Control; Dysmenorrhea; Emotional Regulation
• Other Study ID Numbers: MP/2026/JSB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No