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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age15-18
SponsorUniversidad Autonoma de Baja California

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cognitive restructuring techniques and psychoeducation to improve coping strategies for menstrual pain.

    Behavioral

    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.

Treatment groups

35 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

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