Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
FEMALE
NCT06496139

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

Led by Uppsala University · Updated on 2025-07-31

164

Participants Needed

1

Research Sites

154 weeks

Total Duration

On this page

Sponsors

U

Uppsala University

Lead Sponsor

F

Friedrich-Alexander-Universität Erlangen-Nürnberg

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 45Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • PMDD diagnosis according to DSM-5
  • Menstrual cycle length between 23-34 days (5-8 cycles in the last six months)
  • Sufficient proficiency in Swedish to understand treatment materials
  • Access to a computer, tablet, or mobile phone with internet connection
Not Eligible

You will not qualify if you...

  • Breastfeeding or pregnancy during the past three months
  • Starting or changing antidepressants, benzodiazepines, contraceptives, or hormones in the last three months
  • Current or past gynecological diseases like endometriosis or polycystic ovary syndrome that may affect results
  • Ongoing or previous psychological treatment for premenstrual disorders
  • Severe mental disorders such as psychosis, bipolar disorder, severe eating disorder, or severe depression that could interfere with treatment
  • Elevated suicide risk including active suicidal thoughts, plans, or previous attempts

AI-Screening

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Trial Site Locations

Total: 1 location

1

Uppsala university

Uppsala, Uppsala County, Sweden, 75656

Actively Recruiting

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Research Team

J

Johanna Motilla Hoppe, PhD

CONTACT

M

Monica Buhrman, Associate Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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