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Trial registered on ANZCTR


Registration number
ACTRN12616000932460
Ethics application status
Approved
Date submitted
7/07/2016
Date registered
13/07/2016
Date last updated
13/07/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Relative efficacy and mechanisms of a couple-based intervention for Premenstrual Syndrome
Scientific title
Evaluation of the relative efficacy and mechanisms of a couple-based intervention for Premenstrual Syndrome through a randomised control trial using mixed methods
Secondary ID [1] 288610 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Premenstrual syndrome 297755 0
Relationship satisfaction 297756 0
Condition category
Condition code
Mental Health 297936 297936 0 0
Other mental health disorders
Reproductive Health and Childbirth 297937 297937 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
(1) Individual PMS intervention: Three monthly 90-minute sessions of therapy and a 2-month booster session conducted by a registered clinical psychologist. Sessions were delivered face-to-face or via Sykpe videoconference. This empirically supported (Hunter, Ussher et al. 2002b) one-to-one intervention uses a combination of narrative and cognitive-behavioural techniques to facilitate women’s re-authoring of their experience of PMS, improve coping, and reduce distress (Ussher, Hunter et al. 2002). Topics covered are: Information about PMS; Taking care of yourself; Taking care of your needs; Taking care of your relationships; Taking care of your thinking.

(2) Couple-based Premenstrual Syndrome (PMS) intervention: Three 90-minute sessions of brief couple-based PMS therapy, conducted on a monthly basis, and a 2-month booster session, conducted by a registered clinical psychologist. Sessions were delivered face-to-face or via Sykpe videoconference. The couple-based PMS therapy differs from the one-to-one PMS intervention on which it is based primarily in terms of modality (couple versus individual), and the addition of Couples Dialogue techniques (Hendrix 1990) to facilitate couple communication. This allows for the active involvement of the woman’s partner in understanding PMS, and in strategies of prevention and amelioration.

In both conditions, adherence to the intervention program was achieved by following a structured and manualised program for the sessions. A log of sessions was maintained by the administering psychologist and securely stored. The log recorded the date, attendees, session details and any field notes where relevant.
Intervention code [1] 294005 0
Lifestyle
Intervention code [2] 294006 0
Behaviour
Comparator / control treatment
Wait-list control: Women in this condition completed evaluation measures at baseline and 5 months later, to mirror the pre-post evaluation of the treatment conditions. Following post-measures, wait-list participants received the empirically supported self-help PMS intervention booklet developed by the project team (Ussher and Perz 2006) with the option of attending a 90 minute group session led by the clinical psychologist who administered the intervention conditions to discuss the pack.
Control group
Active

Outcomes
Primary outcome [1] 297459 0
Psychological wellbeing was measured with the Hospital Anxiety and Depression Scale (HADS)
Timepoint [1] 297459 0
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.
Participants in the wait-list control completed quantitative measures in a questionnaire pre-intervention at baseline, and the equivalent of post-intervention (5 months).
Primary outcome [2] 298866 0
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
Timepoint [2] 298866 0
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.
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 [1] 321099 0
Relationship satisfaction was measured with the the Dyadic Adjustment Scale (DAS)
Timepoint [1] 321099 0
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.
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 [2] 321102 0
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
Timepoint [2] 321102 0
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.
Participants in the wait-list control completed quantitative measures in a questionnaire pre-intervention at baseline, and the equivalent of post-intervention (5 months).

Eligibility
Key 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.
Minimum age
20 Years
Maximum age
45 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using random numbers. Random numbers generated by the computer program, Research Randomizer by the Institute for Healthcare Improvement:
http://www.ihi.org/resources/Pages/OtherWebsites/ResearchRandomizer.aspx
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The quantitative items and scales in the pre, post and follow-up questionnaires were analysed with conventional SPSS statistical tools. Standard descriptive analyses were performed to establish incidence data on depression and anxiety, ratings of premenstrual distress, ratings of premenstrual coping, and relationship satisfaction. Statistical significance testing of intervention efficacy was conducted with ANCOVAs assessing differences between groups across testing sessions. Further, as a test of clinical significance, variability of response to treatment within the sample was tested with the complementary statistical methods of Reliable Change Index and Regression-based z scores as recommended by Johnson, Dow, Lynch and Hermann (2006).
Minimum sample sizes of 20-30 women per group have been recommended for PMS research (Robinson and Garfinkel 1990). A target of 30 women in each group was deemed sufficient for the examination of differences in effect and mechanisms, between groups and allow for some natural attrition to occur. No sample size calculations were performed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW

Funding & Sponsors
Funding source category [1] 292954 0
Government body
Name [1] 292954 0
Australian Research Council
Address [1] 292954 0
GPO Box 2702. Canberra ACT 2601.
Country [1] 292954 0
Australia
Primary sponsor type
Individual
Name
Professor Jane Ussher
Address
Centre for Health Research
School of Medicine
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Country
Australia
Secondary sponsor category [1] 291725 0
Individual
Name [1] 291725 0
Professor Janette Perz
Address [1] 291725 0
Centre for Health Research
School of Medicine
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Country [1] 291725 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294460 0
Western Sydney University Human Research Ethics Committee
Ethics committee address [1] 294460 0
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Ethics committee country [1] 294460 0
Australia
Date submitted for ethics approval [1] 294460 0
02/01/2012
Approval date [1] 294460 0
31/01/2012
Ethics approval number [1] 294460 0
H6698

Summary
Brief summary
Premenstrual symptomatology is now widely recognised to be a major social and health problem, with epidemiological surveys estimating that up to 95% of women experience physical and psychological changes premenstrually (Mortola 1992). Up to 40% experience moderate distress, categorised by clinicians and researchers as Premenstrual Syndrome (PMS), and 13-19% experience severe distress and disruption to their lives, categorised as Premenstrual Dysphoric Disorder (PMDD) (Halbreich, Borenstein et al. 2003). The costs of premenstrual distress, in terms of impact upon women’s quality of life and economic functioning, are estimated to be considerable (Robinson and Swindle 2000). A range of PMS treatments have been developed, however, these have been directed solely at women with PMS, consisting of individual psychological therapy or medical intervention, and there have been no systematic evaluations of couple-based interventions for PMS. This negates research evidence that PMS is a relational issue, with premenstrual distress developing, and being positioned as ‘PMS’, within family relationships (Perz and Ussher 2006; Ussher 2006). Based within the University of Western Sydney, in partnership with FPA Health (Family Planning Association, NSW), the aims of this project were to draw on and augment an ongoing program of PMS research through:
1. Evaluating the relative efficacy of a brief couple-based PMS intervention, in comparison to an empirically supported one-to-one PMS intervention, and a wait-list control, within a randomised controlled trial, using the triangulation of qualitative and quantitative methods.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63814 0
Prof Jane Ussher
Address 63814 0
Centre for Health Research,
School of Medicine
Western Sydney University
Locked Bag 1797 Penrith NSW 2751
Country 63814 0
Australia
Phone 63814 0
+61246203953
Fax 63814 0
Email 63814 0
j.ussher@westernsydney.edu.au
Contact person for public queries
Name 63815 0
Prof Jane Ussher
Address 63815 0
Centre for Health Research,
School of Medicine
Western Sydney University
Locked Bag 1797 Penrith NSW 2751
Country 63815 0
Australia
Phone 63815 0
+61246203953
Fax 63815 0
Email 63815 0
j.ussher@westernsydney.edu.au
Contact person for scientific queries
Name 63816 0
Prof Jane Ussher
Address 63816 0
Centre for Health Research,
School of Medicine
Western Sydney University
Locked Bag 1797 Penrith NSW 2751
Country 63816 0
Australia
Phone 63816 0
+61246203953
Fax 63816 0
Email 63816 0
j.ussher@westernsydney.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary