Clinical Trial: Treatment of Premenstrual Syndrome - Internet-based Self-help

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Development and Evaluation of an Internet-based Cognitive Behaviour Therapy for Women With Premenstrual Syndrome (PMS)

Brief 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 Summary:

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 prog
Sponsor: Philipps University Marburg Medical Center

Current Primary Outcome:

• Retrospective Screening (Ditzen et al., 2011) [ Time Frame: pre-treatment ]
  assessment of premenstrual symptoms based on the Diagnostic and Statistical Manual of Mental Disorders Text Revision (DSM-IV-TR) (self-rating)
• Prospective PMS-Diary (Kleinstäuber et al., unpublished) [ Time Frame: 6 months; pre-treatment to post-treatment (4 months after admission) ]
  prospective daily self ratings of premenstrual symptoms based on the DSM-IV-TR (self-rating)
• Impairment by the premenstrual syndrome (self-developed questionnaire) [ 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) ]
  assessment of cognitive, emotional and functional impairment by the premenstrual syndrome (self-rating)

Original Primary Outcome:

• Retrospective Screening (Ditzen et al., 2011) [ Time Frame: pre-treatment ]
  assessment of premenstrual symptoms based on the DSM-IV-TR (self-rating)
• Prospective PMS-Diary (Kleinstäuber et al., unpublished) [ Time Frame: 6 months; pre-treatment to post-treatment (4 months after admission) ]
  prospective daily self ratings of premenstrual symptoms based on the DSM-IV-TR (self-rating)
• Impairment by the premenstrual syndrome (self-developed questionnaire) [ 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) ]
  assessment of cognitive, emotional and functional impairment by the premenstrual syndrome (self-rating)

Current Secondary Outcome:

• Coping with the premenstrual symptoms (self-developed questionnaire) [ 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) ]
  assessment of coping strategies (self-rating)
• Pain Coping Questionnaire (FESV; Geissner, 2003) [ 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) ]
  assessment of PMS related coping strategies (self-rating)
• Short Form Social Support Questionnaire (Fragebogen zur sozialen Unterstützung Kurzform (F-SozU K-22); Fydrich, Sommer, & Brähler, 2007) [ 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) ]
  assessment of the availability of social support (self-rating)
• Questionnaire of the assessment of the partnership quality (FPQ; Siffert & Bodenmann, 2010) [ 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) ]
  assessment of partnership quality (self-rating)
• Effort-Reward Imbalance Questionnaire (ERI-Short-form; Siegrist, Wege, Pühlhofer, & Wahrendorf, 2009) [ 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) ]
  assessment of work strain (self-rating)
• Perceived stress scale (PSS, Cohen, 1994) [ 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) ]
  assessment of stress perception (self-rating)
• The Big Five inventory (BFI-Short-form, John, Naumann, & Soto, 2008) [ Time Frame: pre-treatment ]
  assessment of personality
• Pain Disability Index (PDI; Dillmann, Nilges, Saile, & Gerbershagen, 1994) [ 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) ]
  assessment of the degree of daily impairment by chronic pain (self-rating)

Original Secondary Outcome:

• Coping with the premenstrual symptoms (self-developed questionnaire) [ 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) ]
  assessment of coping strategies (self-rating)
• Pain Coping Questionnaire (FESV; Geissner, 2003) [ 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) ]
  assessment of PMS related coping strategies (self-rating)
• Short Form Social Support Questionnaire (F-SozU K-22; Fydrich, Sommer, & Brähler, 2007) [ 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) ]
  assessment of the availability of social support (self-rating)
• Questionnaire of the assessment of the partnership quality (FPQ; Siffert & Bodenmann, 2010) [ 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) ]
  assessment of partnership quality (self-rating)
• Effort-Reward Imbalance Questionnaire (ERI-Short-form; Siegrist, Wege, Pühlhofer, & Wahrendorf, 2009) [ 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) ]
  assessment of work strain (self-rating)
• Perceived stress scale (PSS, Cohen, 1994) [ 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) ]
  assessment of stress perception (self-rating)
• The Big Five inventory (BFI-Short-form, John, Naumann, & Soto, 2008) [ Time Frame: pre-treatment ]
  assessment of personality
• Pain Disability Index (PDI; Dillmann, Nilges, Saile, & Gerbershagen, 1994) [ 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) ]
  assessment of the degree of daily impairment by chronic pain (self-rating)

Information By: Philipps University Marburg Medical Center

Dates:
Date Received: October 9, 2013
Date Started: July 2013
Date Completion: December 2017
Last Updated: January 17, 2017
Last Verified: January 2017