Premenstrual Syndrome (PMS) Clinical Trial
Official title:
Development and Evaluation of an Internet-based Cognitive Behaviour Therapy for Women With Premenstrual Syndrome (PMS)
The purpose of this study is to determine whether an internet-based CBT (iCBT) is effective in reducing the impairment caused by premenstrual symptoms.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03509714 -
Oxaloacetate Supplementation for Emotional PMS
|
N/A |