MedTrace Logo

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

NCT06496139 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2025-07-31

No results posted yet for this study

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).

Conditions

  • Premenstrual Dysphoric Disorder

Interventions

BEHAVIORAL

Therapist-guided internet-delivered cognitive behavioural therapy

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

Sponsors & Collaborators

  • Friedrich-Alexander-Universität Erlangen-Nürnberg

    collaborator OTHER

  • Utah State University

    collaborator OTHER

  • Linkoeping University

    collaborator OTHER_GOV

  • Uppsala University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-14
Primary Completion
2028-07-31
Completion
2028-07-31

Countries

  • Sweden

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06496139 on ClinicalTrials.gov