An interventional study of Cognitive restructuring techniques and psychoeducation to improve coping strategies for menstrual pain. in Menstrual Cramps, sponsored by Universidad Autonoma de Baja California. Not yet recruiting at 1 site in Mexico. Open to female participants aged 15 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by Universidad Autonoma de Baja California · Not applicable, Interventional, and Treatment
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.
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.
430 studies on the registry are indexed under Dysmenorrhea; 107 are open to participants now.
This study's planned enrollment of 35 is below the median of 62 across 363 interventional studies indexed under Dysmenorrhea.
Browse Dysmenorrhea studies →Universidad Autonoma de Baja California is the lead sponsor of 33 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria Gender: menstruating individuals in late adolescence.
Exclusion criteria
Elimination criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
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
Time frame: Pre-post intervention evaluation, after 8 weeks
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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: Pre-post intervention evaluation, after 8 weeks
Start is estimated for Aug 2026; primary completion for Oct 2026, 2 months later.
Of 178 non-industry interventional studies with no phase under Dysmenorrhea, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 16. This study's planned 2 months is below that.
Counting every sponsor, half of 188 studies reached it within 8 months; a quarter within 3 and three quarters within 16.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Universidad Autonoma de Baja California