Emotion Regulation-based Internet-delivered Cognitive Behavioural Therapy for Premenstrual Dysphoric Disorder
NCT Number: NCT06496139
Acronym: Premensis-s
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Premenstrual Dysphoric Disorder
Interventions: BEHAVIORAL: Therapist-guided internet-delivered cognitive behavioural therapy
Sponsor: Uppsala University
Collaborators: Linkoeping University|Friedrich-Alexander-Universität Erlangen-Nürnberg|Utah State University
Sex: FEMALE
Age: ADULT
Enrollment: 164
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-11
Completion Date: 2027-11

Summary:
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).

Primary Outcome Measures: 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 includes 14 items assessing premenstrual symptoms (11 items) and their impact on everyday life (3 items). Items are rated on a scale from 1-6 (max score 84, higher points indicating higher symptom severity and impact). 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., 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, 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)., 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.
Secondary Outcome Measures: 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., 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.|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., 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.|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., 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).
Other Outcome Measures: 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)., Post-treatment (first luteal phase after treatment, i.e., 8-10 weeks after baseline)|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)., Treatment week 2 and 4 (treatment is 8 weeks in total)|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), Post-treatment (first luteal phase after treatment, i.e., 8-10 weeks after baseline)|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., 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.|Societal resources used by participants, The societal resources used by participants will be collected using an adapted version of the Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P) questionnaire, assessed retrospectively for the past 3 months., 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.