Relative efficacy and mechanisms of a couple-based intervention for Premenstrual Syndrome

Not Applicable

Completed

• Conditions: Premenstrual syndrome; Relationship satisfaction; Mental Health - Other mental health disorders; Reproductive Health and Childbirth - Menstruation and menopause

• Registration Number: ACTRN12616000932460
• Lead Sponsor: Professor Jane Ussher

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

Age between 20 and 45 years of age; having regular menstrual cycles (21-35 days); currently in a relationship (heterosexual or lesbian); and presence of moderate-severe premenstrual symptoms. The latter is manifested by a 30% increase in two or more affective symptoms (e.g. depressed mood, irritability, anxiety/tension, aggressive feelings, and tiredness) from pre-post menstruation in each of two adjusted menstrual cycles, as measured on a daily mood diary.

Exclusion Criteria

Presently taking hormonal or psychotropic medication or currently experiencing a major psychiatric illness; being pregnant or lactating within the previous 12 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Psychological wellbeing was measured with the Hospital Anxiety and Depression Scale (HADS)[Participants in the intervention conditions completed quantitative measures in a questionnaire pre-intervention at baseline, at post-intervention (5 months) and at three month follow-up.<br>Participants in the wait-list control completed quantitative measures in a questionnaire pre-intervention at baseline, and the equivalent of post-intervention (5 months).];Rating of premenstrual distress with a one-item measure that asked participants to what extent do you find your PMS distressing on a 10 point visual analogue scale[Participants in the intervention conditions completed quantitative measures in a questionnaire pre-intervention at baseline, at post-intervention (5 months) and at three month follow-up.<br>Participants in the wait-list control completed quantitative measures in a questionnaire pre-intervention at baseline, and the equivalent of post-intervention (5 months).]

Secondary Outcome Measures

Name	Time	Method
Relationship satisfaction was measured with the the Dyadic Adjustment Scale (DAS)[Participants in the intervention conditions completed quantitative measures in a questionnaire pre-intervention at baseline, at post-intervention (5 months) and at three month follow-up.<br>Participants in the wait-list control completed quantitative measures in a questionnaire pre-intervention at baseline, and the equivalent of post-intervention (5 months).];Rating of premenstrual coping with a one-item measure that asked participants to what extent do you feel you can manage your PMS on a 10 point visual analogue scale[Participants in the intervention conditions completed quantitative measures in a questionnaire pre-intervention at baseline, at post-intervention (5 months) and at three month follow-up.<br>Participants in the wait-list control completed quantitative measures in a questionnaire pre-intervention at baseline, and the equivalent of post-intervention (5 months).]