Emotion Regulation-based Internet-delivered Cognitive Behavioural Therapy for Premenstrual Dysphoric Disorder
Recruiting · NCT06496139 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
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).
Who can take part
Inclusion criteria
- 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 criteria
- 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).
Where it is running
1 location listed.
- Uppsala university - Uppsala, Uppsala County, Sweden