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

ClinicalTrials.gov IDNCT06496139

PhaseNA

Enrollment164

SponsorUppsala University

Age18 Years

SexFEMALE

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Conditions studied

Premenstrual Dysphoric Disorder

About this study

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).

Interventions

Behavioral: Therapist-guided internet-delivered cognitive behavioural therapy — The intervention consists of 8 weeks of therapist-guided self-help ICBT.

Primary outcomes

Group differences in premenstrual symptoms and their impact on everyday life during the luteal phase from baseline to post-treatment (Baseline to post-treatment (daily ratings over two menstrual cycles [ca 56 days] starting 8 weeks after baseline). Follow-up assessments at 6 and 12 months post-treatment (daily ratings one cycle [ca 28 days] beginning 6 and 12 months post-treatment).)
Group differences in PMDD-related psychological and functional impairment during the luteal phase from baseline to post-treatment (Baseline to post-treatment (first luteal phase after treatment, i.e., 8-10 weeks after baseline). Follow-up assessments at 6 and 12 months post-treatment. All assessements will be collected during luteal phase.)

Eligibility information

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).

Study locations

Uppsala university, Uppsala, Uppsala County 75656 Sweden

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.