Treatment of Premenstrual Syndrome - Internet-based Self-help

Not Applicable

Completed

• Conditions: Premenstrual Syndrome (PMS)

• Registration Number: NCT01961479
• Lead Sponsor: Philipps University Marburg Medical Center

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 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.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-10-09
• Study First Submitted QC: 2013-10-09
• Study First Posted: 2013-10-11
• Primary Completion: 2017-07
• Status Verified: 2018-04
• Study Completion: 2018-04
• Last Update Submitted: 2018-04-10
• Last Update Posted: 2018-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 174

Inclusion Criteria

• Fulfilling of particular diagnostic criteria: positive retrospective symptom screening & confirmation of the diagnosis by a prospective PMS-Diary over 2 menstrual cycles
• Age 18-45 years
• Internet access
• Fluency in German

Exclusion Criteria

• Birth of a child or lactation going back to less than 3 months
• Pregnancy
• Symptoms exist less than three cycles
• Gynaecological diseases: Hysterectomy, Gynaecological cancer, Polycystic ovary syndrome, Endometriosis, Infertility
• Current diagnosis of psychosis or bipolar disorder
• Current diagnosis of eating-disorder
• Current diagnosis of average or severe depression
• Current diagnosis of somatisation disorder
• Acute suicidal tendency
• participation in psychotherapy due to premenstrual syndrome, currently or in the past
• Begin to take antidepressants or a change of the active pharmaceutical ingredient during the last three months
• Begin to take a combined oral contraceptive pill or a change of the preparation during the last three months
• Begin to take hormones or a change of the hormone supplement during the last three months
• The taking of Benzodiazepines/Antipsychotics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Retrospective Screening (Ditzen et al., 2011)	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)	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)	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)

Secondary Outcome Measures

Name	Time	Method
Short Form Social Support Questionnaire (Fragebogen zur sozialen Unterstützung Kurzform (F-SozU K-22); Fydrich, Sommer, & Brähler, 2007)	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)
Coping with the premenstrual symptoms (self-developed questionnaire)	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)	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)
Effort-Reward Imbalance Questionnaire (ERI-Short-form; Siegrist, Wege, Pühlhofer, & Wahrendorf, 2009)	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)	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)	pre-treatment	assessment of personality
Questionnaire of the assessment of the partnership quality (FPQ; Siffert & Bodenmann, 2010)	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)
Pain Disability Index (PDI; Dillmann, Nilges, Saile, & Gerbershagen, 1994)	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)

Trial Locations

Locations (1)

Philipps University Marburg, Dept. of Psychology, Division of Clinical Psychology and Psychotherapy; 🇩🇪 Marburg, Hessen, Germany