NCT06496139 Emotion Regulation-based Internet-delivered Cognitive Behavioural Therapy for Premenstrual Dysphoric Disorder
| NCT ID | NCT06496139 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Uppsala University |
| Condition | Premenstrual Dysphoric Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 164 participants |
| Start Date | 2025-07-14 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 164 participants in total. It began in 2025-07-14 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. PMDD diagnosis according to DSM-5 2. Menstrual cycle length between 23-34 days, i.e., 5-8 cycles in the last six months 3. Sufficient proficiency in Swedish to comprehend the treatment materials 4. Access to computer/tablet/mobile phone with internet connection Exclusion Criteria: 1. Breastfeeding or pregnancy during the previous three months 2. Initiation of or change in treatment with antidepressants, benzodiazepines, contraceptives, or hormones during the last three months 3. Current or history of a gynaecological disease (e.g., endometriosis, polycystic ovary syndrome) that may confound the results 4. Ongoing or previous psychological treatment for premenstrual disorders 5. Severe mental disorders that may interfere with the person's ability to complete the treatment or complicate the interpretation of results, e.g., psychosis, bipolar disorder, severe eating disorder, or severe depression 6. Elevated suicide risk (e.g., recurrent active suicidal ideation, current suicide plans, previous suicide attempts).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06496139 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Premenstrual Dysphoric Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06496139 currently recruiting?
Yes, NCT06496139 is actively recruiting participants. Contact the research team at johanna.motilla_hoppe@uu.se for enrollment information.
Where is the NCT06496139 trial being conducted?
This trial is being conducted at Uppsala, Sweden.
Who is sponsoring the NCT06496139 clinical trial?
NCT06496139 is sponsored by Uppsala University. The trial plans to enroll 164 participants.