NCT06496139

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P75+ for not_applicable

Timeline
26mo left

Started Jul 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Jul 2025Jul 2028

First Submitted

Initial submission to the registry

May 29, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 11, 2024

Completed
1 year until next milestone

Study Start

First participant enrolled

July 14, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

3 years

First QC Date

May 29, 2024

Last Update Submit

July 28, 2025

Conditions

Premenstrual Dysphoric Disorder

Keywords

Internet-delivered cognitive behavioural therapyEmotion regulationPremenstrual dysphoric disorder

Outcome Measures

Primary Outcomes (2)

  • 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.

    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 Outcomes (4)

  • Group differences in quality of life 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.

  • Group differences in difficulties in emotion regulation 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.

  • Group differences in health-related quality of life 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.

  • Remission (Full/Partial)

    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 Outcomes (5)

  • Treatment satisfaction (treatment group only)

    Post-treatment (first luteal phase after treatment, i.e., 8-10 weeks after baseline)

  • Treatment credibility and expectations (treatment group only)

    Treatment week 2 and 4 (treatment is 8 weeks in total)

  • Negative effects of treatment (treatment group only)

    Post-treatment (first luteal phase after treatment, i.e., 8-10 weeks after baseline)

  • +2 more other outcomes

Study Arms (2)

Treatment group

EXPERIMENTAL

Therapist-guided self-help internet-delivered cognitive behavioural therapy for PMDD

Behavioral: Therapist-guided internet-delivered cognitive behavioural therapy

Control group

NO INTERVENTION

Waiting list

Interventions

Therapist-guided internet-delivered cognitive behavioural therapyBEHAVIORAL

The intervention consists of 8 weeks of therapist-guided self-help ICBT.

Treatment group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala university

Uppsala, Uppsala County, 75656, Sweden

RECRUITING

Related Publications (2)

  • Reichwein JF, Patel MC, Pagenkopf BL. Rhodium-catalyzed regioselective olefin hydrophosphorylation. Org Lett. 2001 Dec 27;3(26):4303-6. doi: 10.1021/ol016989r.

    PMID: 11784203BACKGROUND

  • Hoppe JM, Weise C, Kleinstaeuber M, Skalkidou A, Vegelius J, Comasco E, Grondal M, Kaltsouni E, Sundstrom F, Sampaio F, Andersson G, Buhrman M. Emotion regulation-based internet-delivered cognitive behavioural therapy for premenstrual dysphoric disorder: study protocol for a randomised controlled trial in Sweden. BMJ Open. 2025 Jan 22;15(1):e091649. doi: 10.1136/bmjopen-2024-091649.

    PMID: 39843366DERIVED

MeSH Terms

Conditions

Premenstrual Dysphoric DisorderEmotional Regulation

Condition Hierarchy (Ancestors)

Premenstrual SyndromeMenstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsDepressive DisorderMood DisordersMental DisordersSelf-ControlSocial BehaviorBehavior

Central Study Contacts

Johanna Motilla Hoppe, PhD

CONTACT

+46735252205johanna.motilla_hoppe@uu.se

Monica Buhrman, Associate Professor

CONTACT

+46 18 471 2126Monica.Buhrman@psyk.uu.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Randomisation will be performed externally by a person independent from the study. After group allocation, participants in the TG will be randomly assigned to one of the therapists involved in the trial. A statistician blinded to group allocation will conduct all statistical analyses.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study is a parallel two-group randomised controlled trial with 1:1 allocation to 8 weeks of therapist-guided self-help ICBT (TG) or a waitlist control group (WL)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2024

First Posted

July 11, 2024

Study Start

July 14, 2025

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

July 31, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

De-identified data will be available upon reasonable request following trial completion and publication of results.

Shared Documents
STUDY PROTOCOL, ICF, ANALYTIC CODE

Locations

SE(1)