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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
174
Internet-based cognitive-behavioural self-help treatment
During the waiting period, participants receive no treatment.
Philipps University Marburg, Dept. of Psychology, Division of Clinical Psychology and Psychotherapy
Marburg, Hesse, Germany
Retrospective Screening (Ditzen et al., 2011)
assessment of premenstrual symptoms based on the Diagnostic and Statistical Manual of Mental Disorders Text Revision (DSM-IV-TR) (self-rating)
Time frame: pre-treatment
Prospective PMS-Diary (Kleinstäuber et al., unpublished)
prospective daily self ratings of premenstrual symptoms based on the DSM-IV-TR (self-rating)
Time frame: 6 months; pre-treatment to post-treatment (4 months after admission)
Impairment by the premenstrual syndrome (self-developed questionnaire)
assessment of cognitive, emotional and functional impairment by the premenstrual syndrome (self-rating)
Time frame: 10 months; pre-treatment (during luteal phase) to post-treatment (during luteal phase, 4 months after admission) to follow-up (during luteal phase, 10 months after admission)
Coping with the premenstrual symptoms (self-developed questionnaire)
assessment of coping strategies (self-rating)
Time frame: 10 months; pre-treatment (during luteal phase) to post-treatment (during luteal phase, 4 months after admission) to follow-up (during luteal phase, 10 months after admission)
Pain Coping Questionnaire (FESV; Geissner, 2003)
assessment of PMS related coping strategies (self-rating)
Time frame: 10 months; pre-treatment (during luteal phase) to post-treatment (during luteal phase, 4 months after admission) to follow-up (during luteal phase, 10 months after admission)
Short Form Social Support Questionnaire (Fragebogen zur sozialen Unterstützung Kurzform (F-SozU K-22); Fydrich, Sommer, & Brähler, 2007)
assessment of the availability of social support (self-rating)
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Time frame: 10 months; pre-treatment (during luteal phase) to post-treatment (during luteal phase, 4 months after admission) to follow-up (during luteal phase, 10 months after admission)
Questionnaire of the assessment of the partnership quality (FPQ; Siffert & Bodenmann, 2010)
assessment of partnership quality (self-rating)
Time frame: 10 months; pre-treatment (during luteal phase) to post-treatment (during luteal phase, 4 months after admission) to follow-up (during luteal phase, 10 months after admission)
Effort-Reward Imbalance Questionnaire (ERI-Short-form; Siegrist, Wege, Pühlhofer, & Wahrendorf, 2009)
assessment of work strain (self-rating)
Time frame: 10 months; pre-treatment (during luteal phase) to post-treatment (during luteal phase, 4 months after admission) to follow-up (during luteal phase, 10 months after admission)
Perceived stress scale (PSS, Cohen, 1994)
assessment of stress perception (self-rating)
Time frame: 10 months; pre-treatment (during luteal phase) to post-treatment (during luteal phase, 4 months after admission) to follow-up (during luteal phase, 10 months after admission)
The Big Five inventory (BFI-Short-form, John, Naumann, & Soto, 2008)
assessment of personality
Time frame: pre-treatment
Pain Disability Index (PDI; Dillmann, Nilges, Saile, & Gerbershagen, 1994)
assessment of the degree of daily impairment by chronic pain (self-rating)
Time frame: 10 months; pre-treatment (during luteal phase) to post-treatment (during luteal phase, 4 months after admission) to follow-up (during luteal phase, 10 months after admission)