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).
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
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
Parallel
Therapist-guided internet-delivered cognitive behavioural therapy
BehavioralThe intervention consists of 8 weeks of therapist-guided self-help ICBT.
Group differences in premenstrual symptoms and their impact on everyday life during the luteal phase from baseline to post-treatment
This primary outcome is assessed with the Daily Report of Severity of Problems. (DRSP) The DRSP assesses premenstrual symptoms included in DSM-5 diagnostic criteria for PMDD and their impact on everyday life. Items are rated on a scale from 1-6. Baseline and post-treatment data consist of prospective daily DRSP ratings over two consecutive menstrual cycles, both before and after treatment. Follow-up assessments will include daily DRSP ratings over one menstrual cycle.
Group differences in PMDD-related psychological and functional impairment during the luteal phase from baseline to post-treatment
This outcome is assessed using the PMS Impact Questionnaire (PMS-I) which includes two subscales: (1) psychological impairment and (2) functional impairment. The PMS-I consists of 18 items (9 for each subscale) rated on a scale from 1-4 scale (max score 72, higher points indicating higher levels of psychological and functional impairment).
Group differences in quality of life during the luteal phase from baseline to post-treatment
Quality of life will be assessed using the Brunnsviken Brief Quality of Life scale (BBQ). The BBQ includes 12 items covering six life domains (recreation, philosophy of life, self-regard, creativity, learning and friendship), rated in terms of satisfaction and importance on scale from 0-4. Higher points indicate higher quality of life.
Group differences in difficulties in emotion regulation during the luteal phase from baseline to post-treatment.
Difficulties in emotion regulation will be assessed using the Difficulties in Emotion Regulation Scale (DERS-16). The DERS-16 measures five dimensions of emotion regulation in 16 items rated on a scale ranging from 1-5 (max score 80). High scores indicate more difficulties in emotion regulation.
Group differences in health-related quality of life during the luteal phase from baseline to post-treatment
Health-related quality of life will be assessed with the Assessing quality of life 8 dimensions (AQoL-8D). The AQoL-8D has 35 items and eight dimensions, including independent living, happiness, mental health, coping, relationships, self-worth, pain, and senses). Items have different response levels, each representing increasing levels of severity.
Remission (Full/Partial)
Remission will be determined based on post-treatment DRSP symptom ratings over two menstrual cycles post-treatment using the C-PASS algorithm with a 30% change criterion. Full remission is defined as not fulfilling the criteria for PMDD or other menstrual-related mood disorders (MRMD) according to the C-PASS algorithm. Partial remission is defined as fulfilling the C-PASS algorithm for an MRMD but not for PMDD. Follow-ups: In the 6 and 12-month post-treatment follow-ups, remission will be based on the C-PASS algorithm applied to one menstrual cycle, as daily ratings will only be collected during one cycle at follow-ups.
Treatment satisfaction (treatment group only)
Satisfaction with treatment will be measured using the Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 includes 8 items rated on a scale from 1-4 (max score 32, higher scores indicate higher satisfaction).
Treatment credibility and expectations (treatment group only)
The Credibility/Expectancy Questionnaire (CEQ) will be used to evaluate how treatment credibility and expectancy impact treatment effects. The CEQ includes 5 questions rated on a scale from 1-10 (max score 50; higher ratings indicate higher credibility and expectancy of positive treatment effects).
Negative effects of treatment (treatment group only)
Negative effects of treatment will be assessed with the Negative Effects Questionnaire (NEQ). The NEQ includes 20 items rated on a scale from 0-4 (max 80, higher ratings indicating more negative effects)
Cost in relation to quality-adjusted life years (QALYs)
The QALY is a measure that comprises both quality of life and length of life and has an intrinsic value for money. QALYs will be estimated using individual scores from the Assessing quality of life 8 dimensions (AQoL-8D) and weights derived from the general population.
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Uppsala University
Lead sponsor
Friedrich-Alexander-Universität Erlangen-Nürnberg
Collaborator
Utah State University
Collaborator
Linkoeping University
Collaborator
