Treatment of Premenstrual Syndrome - Internet-based Self-help
Condition: Premenstrual Syndrome (PMS)
MeSH terms: Syndrome; Premenstrual Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether an internet-based CBT (iCBT) is effective
      in reducing the impairment caused by premenstrual symptoms.
    

Detailed description: 
      Premenstrual syndrome (PMS) affects millions of women during their reproductive years. The
      disorder presents with emotional, cognitive, behavioural, and somatic symptoms during the
      final premenstrual phase and subsiding a few days after menses begins. About 75% of women of
      reproductive age experience a mild form of PMS (Campbell, Peterkin, O'Grady, & Sanson-Fisher,
      1997). The more severe form of PMS, premenstrual dysphoric disorder (PMDD; American
      Psychiatric Association (APA), 1994) is considered to affect up to 8% of women of
      reproductive age. This severe form is associated with severe disruptions in normal
      functioning in work, family, or social relationships (Halbreich, Borenstein, Pearlstein, &
      Kahn, 2003). The defining characteristics of both-PMS and PMDD- are the cyclic pattern of
      symptoms, which must be confirmed by prospective daily self ratings of symptoms (PMS-Diary)
      over two consecutive menstrual cycles (American College of Obstetricians and Gynecologists
      (ACOG), 2000). PMS and PMDD differ according to the number, severity, duration, and quality
      of symptoms.

      As a first-line intervention, the ACOG suggests pharmacotherapy, in particular selective
      serotonin reuptake inhibitors (SSRIs; ACOG, 2000). However, the side effects of SSRIs are
      intolerable to many women, leading to high rates of withdrawal from treatment (Busse et al.,
      2009; Dimmock, Wyatt, Jones, & O'Brien, 2000). Thus, cognitive behavioural treatments (CBT)
      have been suggested as an additional treatment approach (Busse et al., 2009). First studies
      showed promising results for CBT interventions for PMS (Busse et al., 2009; Hunter et al.,
      2002). However, too few randomized controlled trials have carefully investigated the efficacy
      of CBT for PMS.

      The aim of the current study is thus to develop a CBT-oriented self-help treatment programme
      for women suffering from PMS or PMDD. The treatment programme consists of psychoeducation
      (e.g., information about PMS/PMDD and its aetiology), cognitive strategies (e.g., assessing
      and restructuring dysfunctional cognitions), and suggestions for lifestyle changes (e.g.,
      sports, balanced diet, relaxation). The programme is internet-delivered (iCBT) and
      participants work on different chapters for eight weeks in a row. In addition to written
      information, participants receive e-mail feedback from a psychologist on a weekly basis.
      Participants are required to have sufficient knowledge of German in order to be able to read
      the treatment materials. After a careful diagnostic assessment (including two months symptom
      diary), eligible patients are randomly assigned either to the treatment group or a waitlist
      control group. Participants assigned to the waitlist receive the treatment after the end of
      the waiting period (eight weeks). Follow-up assessments take place six months after the end
      of the treatment.
    

Intervention name(s): Internet-based CBT for patients with PMS; Waiting list
Intervention type(s): Behavioral; Other
Intervention description(s): Internet-based cognitive-behavioural self-help treatment; During the waiting period, participants receive no treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Premenstrual syndrome (PMS); Premenstrual Dysphoric Disorder (PMDD); Internet-based Therapy; Cognitive Behavioural Therapy (CBT)