Online emotion-regulation cognitive behavioral therapy for premenstrual dysphoric disorder
Official title: Emotion Regulation Based Internet-delivered Cognitive Behavioural Therapy for Premenstrual Dysphoric Disorder: A Randomised Controlled Trial
Run by Uppsala University · NCT06496139 · Data updated 2026-11-12
This test tries an 8-week therapist-guided online cognitive behavioral program focused on emotion regulation to reduce symptoms in women aged 18–45 with PMDD.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 164 (estimated) |
| Sponsor | Uppsala University Academic / other |
| Locations | 1 site (Uppsala, Uppsala County) |
| Status | Recruiting |
| Started | July 14, 2025 |
| Main results expected | July 2028 |
| Study ends | July 2028 |
| Registry record updated | July 31, 2025 |
| Trial ID | NCT06496139 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18–45 who meet DSM-5 criteria for PMDD, have regular cycles (23–34 days), can read Swedish, and have internet access on a computer or mobile device.
✕Probably not a fit
People who are pregnant or breastfeeding recently, have recent changes in psychotropic or hormonal treatments, have complicating gynecological diseases, are receiving concurrent psychotherapy for premenstrual problems, or have severe psychiatric disorders or elevated suicide risk are unlikely to benefit or are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a parallel, two-group randomized controlled trial that will assign about 164 women meeting DSM-5 criteria for PMDD to either an 8-week therapist-guided internet-delivered CBT program with emotion-regulation components or to a waitlist control, with 1:1 allocation. Participants are screened via an online questionnaire, a diagnostic telephone interview, and two prospective menstrual cycles of daily symptom ratings using the DRSP before and after treatment. Primary outcomes compare pre- to post-treatment changes in luteal-phase premenstrual symptoms and functional impairment measured prospectively and retrospectively, and secondary outcomes include quality of life and difficulties in emotion regulation. The intervention is self-help ICBT with therapist guidance delivered remotely in Swedish from Uppsala University investigators.
Why it matters
Potential benefit: If successful, this could provide an accessible non-drug treatment that reduces luteal-phase symptoms and improves daily functioning for women with PMDD.
How similar studies have gone: Preliminary research suggests internet-delivered CBT can help PMDD symptoms, but adding targeted emotion-regulation components is a relatively new approach that needs more evidence.
Who can join: the full rules
Show full inclusion / exclusion 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).
Where it's running
-
Uppsala university
Uppsala, Uppsala County, Sweden Recruiting
Study contacts
- Study coordinator: Johanna Motilla Hoppe, PhD
- Email: johanna.motilla_hoppe@uu.se
- Phone: +46735252205
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.