RecruitingNot ApplicableNCT06496139

Emotion Regulation-based Internet-delivered Cognitive Behavioural Therapy for Premenstrual Dysphoric Disorder

Emotion Regulation Based Internet-delivered Cognitive Behavioural Therapy for Premenstrual Dysphoric Disorder: A Randomised Controlled Trial


Sponsor

Uppsala University

Enrollment

164 participants

Start Date

Jul 14, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Premenstrual dysphoric disorder (PMDD) is a debilitating cyclic mental disorder affecting about 2-5% of women of reproductive age. PMDD is characterised by recurring emotional, behavioural, cognitive, and somatic symptoms that arise during the luteal (premenstrual) phase of the menstrual cycle and remit shortly after the onset of menses. Although pharmacological interventions are available, many women experience residual symptoms, discontinue treatment or refrain from them because of side effects. Therefore, non-pharmacological treatment options are needed. Preliminary evidence suggests that internet-delivered cognitive behavioural therapy (ICBT) is a promising candidate, but further research is warranted. Also, there is room for treatment improvement. Specifically, it has been suggested that components targeting emotional and interpersonal dysregulation should be incorporated into CBT for PMDD. The current study aims to assess the effects of an ICBT intervention for PMDD incorporating skills training in emotion regulation and interpersonal effectiveness in a randomised controlled trial (RCT).


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing an online cognitive behavioral therapy (CBT) program focused on emotion regulation to treat premenstrual dysphoric disorder (PMDD) — a severe form of PMS that causes significant mood disruption before a period. **You may be eligible if...** - You have been diagnosed with PMDD according to DSM-5 criteria - Your menstrual cycles are regular (23–34 days, with 5–8 cycles in the last 6 months) - You are proficient in Swedish - You have access to the internet via a computer, tablet, or phone **You may NOT be eligible if...** - You are pregnant or have been breastfeeding in the past 3 months - You have recently started or changed antidepressants, hormonal contraceptives, or other relevant medications - You have a gynecological condition such as endometriosis or PCOS - You have a history of bipolar disorder or psychosis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALTherapist-guided internet-delivered cognitive behavioural therapy

The intervention consists of 8 weeks of therapist-guided self-help ICBT.


Locations(1)

Uppsala university

Uppsala, Uppsala County, Sweden

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NCT06496139


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