Status:
RECRUITING
Emotion Regulation-based Internet-delivered Cognitive Behavioural Therapy for Premenstrual Dysphoric Disorder
Lead Sponsor:
Uppsala University
Collaborating Sponsors:
Friedrich-Alexander-Universität Erlangen-Nürnberg
Utah State University
Conditions:
Premenstrual Dysphoric Disorder
Eligibility:
FEMALE
18-45 years
Phase:
NA
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,...
Detailed Description
The study is a parallel two-group RCT with 1:1 allocation to 8 weeks of a therapist-guided self-help ICBT for PMDD or a waitlist control group. Approximately 164 women (age 18-45) fulfilling the DSM-5...
Eligibility Criteria
Inclusion
- PMDD diagnosis according to DSM-5
- Menstrual cycle length between 23-34 days, i.e., 5-8 cycles in the last six months
- Sufficient proficiency in Swedish to comprehend the treatment materials
- Access to computer/tablet/mobile phone with internet connection
Exclusion
- Breastfeeding or pregnancy during the previous three months
- Initiation of or change in treatment with antidepressants, benzodiazepines, contraceptives, or hormones during the last three months
- Current or history of a gynaecological disease (e.g., endometriosis, polycystic ovary syndrome) that may confound the results
- Ongoing or previous psychological treatment for premenstrual disorders
- 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
- Elevated suicide risk (e.g., recurrent active suicidal ideation, current suicide plans, previous suicide attempts).
Key Trial Info
Start Date :
July 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT06496139
Start Date
July 14 2025
End Date
July 1 2028
Last Update
July 31 2025
Active Locations (1)
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1
Uppsala university
Uppsala, Uppsala County, Sweden, 75656