Internet-based cognitive behavioural self-help for premenstrual syndrome: study protocol for a randomised controlled trial

Johanna N Kues, Carolyn Janda, Maria Kleinstäuber, Cornelia Weise, Johanna N Kues, Carolyn Janda, Maria Kleinstäuber, Cornelia Weise

Abstract

Background: With a prevalence of 3 to 8% among women of reproductive age, severe premenstrual symptoms are very common. Symptoms range from emotional and cognitive to physical changes. Severe symptoms (that is, premenstrual syndrome) can have a strong impact on everyday functioning and quality of life. Impairment can be as serious as that of dysthymic disorders. Many affected women receive either no treatment at all or are unsatisfied with their treatment. Although there is some evidence for the reduction of distress through cognitive behavioural therapy, there are only a small number of randomised controlled trials carefully investigating the efficacy of this psychotherapeutic approach. Thus, this study aims to evaluate the efficacy of a cognitive behavioural self-help treatment for women suffering from premenstrual syndrome.

Methods/design: The study is conducted as a randomised controlled trial. The complex diagnostic assessment includes the completion of a symptom diary over two consecutive cycles and a telephone interview. Eligible women are randomly assigned to either a treatment or a wait-list control group. The intervention is based on cognitive behavioural therapy principles and is provided via the internet. It consists of 14 different modules on which participants work over 8 consecutive weeks. In addition to written information, participants receive email feedback from a clinical psychologist on a weekly basis. Participants assigned to the wait-list receive the treatment after the end of the waiting period (8 weeks). The primary outcome measure is the Premenstrual Syndrome Impairment Measure. Secondary outcomes include the Premenstrual Syndrome Coping Measure, the Short-Form Social Support Questionnaire, the Questionnaire for the Assessment of Relationship Quality, and the Perceived Stress Scale. Data is collected during the premenstrual (luteal) phase at pre-treatment, post-treatment, and 6-month follow-up.

Discussion: So far, there is no study investigating internet-based cognitive behavioural therapy for premenstrual syndrome. The programme approaches the problem of high prevalence in combination with severe impairment and insufficient treatment options.

Trial registration: ClinicalTrials.gov: NCT01961479, 9 October 2013.

Figures

Figure 1
Figure 1
Study process. t = measurement points: t0 = screening for basic inclusion criteria. t1 = first assessment of primary and secondary outcome in luteal phase, first and second cycle of the symptom diary. t2 = second assessment in luteal phase, third and fourth cycle of the symptom diary, approximately 2 months after admission. t3 = for the wait-list group only, third assessment of primary and secondary outcome in luteal phase, fifth and sixth cycle of the symptom diary, approximately 6 months after admission. t4 = for the treatment group: third assessment of primary and secondary outcome in luteal phase, approximately 10 months after admission; for the wait-list group: fourth assessment of primary and secondary outcome in luteal phase, approximately 14 months after admission.

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