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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorUppsala University

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Therapist-guided internet-delivered cognitive behavioural therapy

Treatment groups

164 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Uppsala University

Lead sponsor

Friedrich-Alexander-Universität Erlangen-Nürnberg

Collaborator

Utah State University

Collaborator

Linkoeping University

Collaborator